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Explore moore on designing products for newspace.

Epsiode 17: A Giant Step for Mankind - Designing Products for NewSpace

From vacations around the moon to universal Wi-Fi, NewSpace is a skyrocketing market with infinite opportunities. In this podcast, Elite Aerospace Group discusses how technology such as augmented reality (AR) and additive manufacturing is bringing outer space a little closer to home. 

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

Explore moore on designing products for newspace.

Episode 16: Changing the Way We See Healthcare with Augmented Reality

In this episode of The Connected Engineer, Aaron Oliker, Co-Founder of BioDigital, Inc. explains how his company has used emerging technologies, such as Augmented Reality, to create a comprehensive 3D visualization model of the human body. Considered the “Google Earth” for anatomy, diseases, and treatments, BioDigital is changing the way hospitals, scientific institutions, and universities are working with and studying the human body.

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

Explore moore on designing products for newspace.

Epsiode 17: A Giant Step for Mankind - Designing Products for NewSpace

From vacations around the moon to universal Wi-Fi, NewSpace is a skyrocketing market with infinite opportunities. In this podcast, Elite Aerospace Group discusses how technology such as augmented reality (AR) and additive manufacturing is bringing outer space a little closer to home. 

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

Explore moore on designing products for newspace.

Episode 16: Changing the Way We See Healthcare with Augmented Reality

In this episode of The Connected Engineer, Aaron Oliker, Co-Founder of BioDigital, Inc. explains how his company has used emerging technologies, such as Augmented Reality, to create a comprehensive 3D visualization model of the human body. Considered the “Google Earth” for anatomy, diseases, and treatments, BioDigital is changing the way hospitals, scientific institutions, and universities are working with and studying the human body.

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

Explore moore on designing products for newspace.

Epsiode 17: A Giant Step for Mankind - Designing Products for NewSpace

From vacations around the moon to universal Wi-Fi, NewSpace is a skyrocketing market with infinite opportunities. In this podcast, Elite Aerospace Group discusses how technology such as augmented reality (AR) and additive manufacturing is bringing outer space a little closer to home. 

Episode 13: Coming Face-to-Face with the Digital Twin

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

Explore moore on designing products for newspace.

Episode 16: Changing the Way We See Healthcare with Augmented Reality

In this episode of The Connected Engineer, Aaron Oliker, Co-Founder of BioDigital, Inc. explains how his company has used emerging technologies, such as Augmented Reality, to create a comprehensive 3D visualization model of the human body. Considered the “Google Earth” for anatomy, diseases, and treatments, BioDigital is changing the way hospitals, scientific institutions, and universities are working with and studying the human body.

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

Explore moore on designing products for newspace.

Epsiode 17: A Giant Step for Mankind - Designing Products for NewSpace

From vacations around the moon to universal Wi-Fi, NewSpace is a skyrocketing market with infinite opportunities. In this podcast, Elite Aerospace Group discusses how technology such as augmented reality (AR) and additive manufacturing is bringing outer space a little closer to home. 

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

Explore moore on designing products for newspace.

Episode 16: Changing the Way We See Healthcare with Augmented Reality

In this episode of The Connected Engineer, Aaron Oliker, Co-Founder of BioDigital, Inc. explains how his company has used emerging technologies, such as Augmented Reality, to create a comprehensive 3D visualization model of the human body. Considered the “Google Earth” for anatomy, diseases, and treatments, BioDigital is changing the way hospitals, scientific institutions, and universities are working with and studying the human body.

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

Explore moore on designing products for newspace.

Epsiode 17: A Giant Step for Mankind - Designing Products for NewSpace

From vacations around the moon to universal Wi-Fi, NewSpace is a skyrocketing market with infinite opportunities. In this podcast, Elite Aerospace Group discusses how technology such as augmented reality (AR) and additive manufacturing is bringing outer space a little closer to home. 

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

Explore moore on designing products for newspace.

Episode 16: Changing the Way We See Healthcare with Augmented Reality

In this episode of The Connected Engineer, Aaron Oliker, Co-Founder of BioDigital, Inc. explains how his company has used emerging technologies, such as Augmented Reality, to create a comprehensive 3D visualization model of the human body. Considered the “Google Earth” for anatomy, diseases, and treatments, BioDigital is changing the way hospitals, scientific institutions, and universities are working with and studying the human body.

Gavin Quinlan: Welcome to the Connected Engineer, a podcast for engineers, designers, and innovators. I'm your host Gavin Quinlan and each episode I invite experts to discuss the product development challenges companies are facing today as well as some of the new trends in the area of product development.

Many organizations strive to enter the smart connected product market but aren't sure where to start. In today's episode of The Connected Engineer, you will hear a connected device story from Welch Allyn, a leading global manufacturer of medical devices. David Kellner, Senior Manager of Mechanical Engineering, will share how Welch Allyn set new entry stakes in a mature market segment to stimulate growth and frustrate competition. Leveraging connectivity, they established a new level of expectation for their products. David, can I ask you to introduce yourself? Tell us a little bit about your background and help our audience understand a little about who Welch Allyn are.

David Kellner: Sure. Thanks, Gavin. So, I'm currently the Senior Manager of Mechanical Engineering for Welch Allyn. We're a division of the Hill-Rom Company. And I'm responsible for design engineering in our research and development group. While I've worked primarily in electronic vital signs the last several years. I've also worked fairly extensively in vision screening, physical assessment, and digital x-ray. I have my Bachelors in Mechanical and Aeronautical Engineering, and then also have my Masters in Engineering, Global Operations Management.

You know, Welch Allyn was not too long ago acquired by Hill-Rom. But prior to that, we were a family-owned private company for almost exactly 100 years. Now, we're gladly part of a much larger public company which we're really excited about. You know, we've been providing front line care technology to physician's offices, skilled nursing facilities, hospitals for a long time. And we're excited to keep doing that and keep bringing better care environments to our customers so that they can bring better care to their patients.

Gavin: So, let's talk about the product, right? So, we're here to talk about the smart connected product. What is the product?

David: So, in this particular case, the product that I wanted to talk about was the Connex Vital Signs Monitor. This is a new product that came to market for us in 2010 and that was really an inflection point for the company. Prior to 2010, some of our products were connected, kind of connected, some of our producers were really not connected. And, you know, when CVSM came out in the 2010 time frame, that was the point in time where we said, "Look, all products going forward are gonna have some sort of a connectivity strategy." And this product really, you know, kinda set the benchmark. You know, not only does it have Wi-Fi connectivity to the hospital network but it was also, you know, architected from the beginning to be designed for a thing where it could exceed us. So, not only in the clinical workflow is it a connected product but also in the service workflow. It's a connected product all the way back to, you know, Welch Allyn.

Gavin: So, this is a product that measures, the what, the vital signs. So this is a sort of thing, what you'd see on all of the TV shows, sitting beside the bed and beeping and bleeping, and stuff, that product?

David: Yeah, yeah. And we've been in the multiparameter vital signs device market for a long time, and we've made vital signs devices that were just designed to come into a patient's room, collect basic vital signs, and then leave the room. We also made continuous patient monitors that were designed to be left at the bedside, and would continuously monitor the patient's vital signs. And then they would beep an alarm if something went out of range. Now, the devices that we're building are really more hybrid devices where you can change the device to be a sort of a spot check, just sort of wandering, collect vital signs, and wander out device. Or, it could be a continuous bedside patient monitor by just changing what's called a profile on the device. And then not only does the whole user interface change but the behavior behind the parameters also changes. It definitely makes the device exciting for customers because it can kinda do both.

Gavin: Do both jobs. So, early around, I think you used an acronym called CVSM and I was going to ask you what it meant. But I guess it stands for continuous vital sign monitoring, would it be, is that right?

David: It's actually the Connex Vital Signs Monitor. Connex is sort of a sub-brand for Welch Allyn. We have a couple of different products that are in the Connex portfolio. There's a server side central station product and service side connectivity software that goes as part of the suite with the Connex Vital Signs Monitor. The monitor itself is the bedside device that actually goes into the patient room, and that's the primary interaction point between the clinician and the patient.

Gavin: So, do you mind me asking like was there a particular trigger or event that drove the smart connected design thinking?

David: Yeah. You know, for us, this is a very crowded space. If you go to any of the big annual medical device conferences and look for companies that build a multiparameter patient vital signs device or patient monitor that takes, you know, blood pressure, temperature, pulse oximetry, and maybe EKG, you will see dozens and dozens of companies that make these types of devices. The market is extremely crowded. The space is starting to really commoditize. There's a lot of import devices that are coming in that are built over in the Far East that are coming in at very inexpensive price points. And with a lot of big companies all competing for this space, it was really driving price points down and it was driving margins down. So, we had to say, "Look, we're not gonna do the Walmart strategy. We're not going to just move our products over to mainland and try and drive the prices into the floor. We're gonna really sit down, understand the challenges that our customers are having, what motivates them, what frustrates them, you know, what are the problems that they're having in their space, and how can we innovate to make a product that's really different."

You know, when we did that, we noticed that being able to accurately collect electronic vital signs was really no longer a differentiator. When we were doing that back in 2000, 2001 and people were changing from, you know, the sort of analog process of collecting this data, into now doing it digitally, that was exciting. It's not anymore. We also noticed that our customers were rapidly converting over from this really kinda mixed electronic medical records and paper medical records, and driving really hard towards complete electronic medical records. The American Recovery and Reinvestment Act of '09 really put a lot of money on the table for healthcare providers to implement EMR systems. And there's a lot of benefits for hospitals to go with a paperless workflow. Information is available very quickly to the people that need it to make decisions and information doesn't get lost. The right information goes into the right patient record and you don't get transcription errors.

But, in order to really make that whole workflow work, you needed to have a bedside device that could fully record not just the patient's vital signs but could also put that in context of exactly which patient, which clinician, exactly when it happened. And then instantaneously push that information right into the patient record. And we weren't gonna get there by just taking one of our existing devices and making a couple of updates. For us, you know, this had to be a from scratch new product.

Gavin: Yeah. So, like I said, it's not just, "Hey, let's stick a WiFi card in the machine and we're good to go." Like you said, you took that as an opportunity to say, "Let's see what's actually needed here." And I guess to that point, like, how do you determine the extra capabilities or the redesign, you know, requirements that are gonna be needed for something like this? How do you get to that place?

David: Well, you really have to spend a lot of time with your customers and you also have to realize that there are a lot of subtle but very important differences with customers based on geography. So, that standard workflow that you would see in the U.K. or France, or Germany, or in Southeast Asia, it's gonna be different from what you see in the U.S. or Australia, or Canada. There's gonna be a lot of overlap, there's gonna be similarities, but the workflow differences are really important. It's not good enough to just have a device that's got, you know, 15 or 16 different languages on the user interface. You have to understand why hospitals in France take vital signs in a way that's a little bit different than the way it's done in the U.K. or the U.S. And you have to be able to develop a product that kinda deals with that and realize that, while, some people are ready for a WiFi-connected product that wonders around on a, you know, encrypted 802.11 ABG network.

You know, there are other workflows where they're really not at that point with their infrastructure. And they want to just connect a device to a laptop over a USB cable and they want to be able to, you know, push data that way. So, if you know that, you can kind of architect a product, you know, that's going to, you know, work well for the very sophisticated, technically high-end hospital, but it's also gonna work for the smaller facilities that aren't quite there yet. And then, you know, you're gonna always have your special cases like the VA in the U.S. where...Everybody is concerned about privacy of data, but the VA, you know, has more stringent requirements than a lot of other hospitals and they have, you know, special compliance criteria that, you know, you have to meet or you can't sell your product into the VA network. And the VA network, you know, around the world is a really big hospital network, so that's an important customer. So you have to sort of, you know, start to recognize those workflow challenges.

And so a lot of research on the front end goes into understanding exactly what those needs are and how they differ, and then say, "Okay, you know, what architecture can we come up with that is modular, it's adaptable, and, you know, you can build it in such a way that it would work really well here but it would also work over here, and it would also work over there. You know, and do it in a way that's elegant and not, you know, burdensome to the end-user."

Gavin: So, I mean, like, you went in with the objective, so to speak, of a product that could work in basically any hospital across the world. You wanted to have a product that was truly global from the outset.

David: We did. Initially, during the research phase, we partnered with industrial design firm to get a really good understanding of what we were dealing with here. We split our group up and we had a group in Asia, a group in North America, and a group in Europe. And, you know, each group spent a few weeks traveling around their designated region and just spending a day in a different facility. You know, each day spending a, you know, an afternoon or a whole day in a facility. And, you know, looking at their workflow and talking to the nurses and watching how they do their stuff. And following people around and kinda hanging out in the environment to get a feel for, you know, what is it like here, what is it like there?

You know, I got to be on the Europe team and, you know, we were all across Europe in a whole range of different facilities. And, you know, that experience sort of deeply influences your understanding of what will work and what will not work. And so we all came back and became part of the marketing engineering design team for the product. And that was the foundation of knowledge that we use to make a lot of different decisions when we were choosing the touch screen and the back light, and the colors and screen layouts, and what parameters were in the device, and ergonomically how things were organized. It all kinda came back to our experiences, spending time with customers in their environment, and listening to, you know, what was important to them.

Gavin: I think every engineer sort of starts with these objectives at heart but then, you know, sometimes the work gets in the way and maybe you get a little bit disconnected, so to speak from what's going on day to day with the product. So, again, I think I can only add massive value to a device or a design. So, right, you do all this work, you partner with the industrial design company. You probably got, you know, reams and reams of feedback from the different theaters where you've assessed and you, in some way, manage to boil that down to a set of global requirements. In terms of then doing the design itself, you know, and turning that into like a first prototype or the first version, again, like, you know, was it a... Well, we have something that does 50% of this or we have nothing that's really doing any of these things today. So, like, can you give us maybe a little bit of background on the how, what was the next step forward?

David: We have a lot of intellectual property in this space because we had been doing electronic vital signs for some time. So, we were able to leverage our portfolio of sort of underpinning technology. We, you know, we already had our own thermometer. We already had our own blood pressure technology and our own, sort of, blood pressure algorithms, and stuff like that. So, a lot of the component pieces that make up a patient monitor with technology that we already had, we had to figure out a way to sort of package that and make it into a connected product. Luckily, because, you know, we hadn't been in the business of doing wireless continuous patient monitoring for so many years, and had gotten into the business of making our own wireless radios. We had gotten really good at being able to either in batch or continuously stream vital signs information over a network and do it in a way that we wouldn't drop information. And we knew how to do that really well, so we were able to sort of bring that into the mix from our continuous monitoring product portfolio. But we had to sort of figure out and say, "Okay, we're not building an ICU monitor here. We're building really a general care MedSurg floor type device which is very, very simple to use, that could work in all these different geographies. It can handle a lot of different languages and it really needs to be intuitive."

So, you know, we started iterating on, you know, user interface concepts and, you know, mechanical electrical architectures fairly early on. And so there was a lot of formative usability that happened where, you know, we were taking the design language that we had developed based on our initial interactions, and we were building that into sort of physical forms. And then reflecting that back against various customer groups and watching how they would interact with the product, and, you know, what they would sort of just naturally do. And where they would get confused and where they would just, sort of, flow very normally through the work in the way that we expected them to. And then we would just take portions of the design and we will just throw it away and say, "Okay, that was a really cool idea but it just didn't work, so let's get rid of that. Let's do something else."

And so we went through this sort of iterative process where we were building things, 3D printers, screen layouts, and trying to figure out how to build a workflow and a user interaction that was gonna be successful. You know, after several iterations, we could see that we were really starting to dial in. And then, you know, in the background, there was a lot of performance testing that had to happen in the lab to make sure that the product was, you know, not only going to be easy to use but that it was gonna last, you know. So, you know, we cycle tested devices for, you know, tens of thousands, hundreds of thousands of cycles to try and fair it out any little tiny glitches or other things. So that, you know, we would work through them in the lab and our customers wouldn't have to, sort of, suffer them in the field, because we didn't intend to build a couple of these a year. You know, we intended to build thousands upon thousands of these things a year, because, you know, we've always been able to do that.

Gavin: So, in terms of, let's say, just connecting back to the global piece of the conversation. I mean was the product created in a modular sort of way, where if you didn't need like the USB connections, you didn't have to pick that or tick that box in the selection. Or, is it, you know, is it a one size fits all sort of, you know, approach in terms of how the product finished up.

David: When we were all said and done, we decided that there were certain baseline capability that just sort of has to be there. You know, we said, wired Ethernet, USB in, USB out, and a high definition, you know, color touch screen and blood pressure were things that every single monitor absolutely had to have. Beyond that, we said, you know, we want a lot of modularity. Some of our customers have very mature wireless networks. They really want a wireless device. So, we architected in such a way that the wireless radio was sort of a modular component, and you could buy the product with it or buy the product without it. And it was really easy on the production line for them to assemble and configure the device to actually, you know, install the radio card or not install the radio card. Some of the other clinical parameters are very preferential based on region. The type of pulse oximetry that you use tends to be a region by region, facility by facility choice. So, you know, we offered our customers a choice of two really popular OEM pulse oximetry modules. They could choose whichever one they wanted and then on the production line, that was just a module.

We actually design it as a fully enclosed, you know, plastic box that would just drop right into the back of the patient monitor. And then when you put the back cover on, it would hold all these modules together. It also was part of our repair strategy, because if something went wrong in that central module, you could take the back cover off the device. You could slide out a module, slide in another module, and the device on the outside was connected but on the inside it was also connected. All the sensor modules on the inside of the device actually connect with USB cables. So, if you're having a problem with a, you know, pulse oximetry sensor module, you can literally just unplug a USB cable, swap out a module, plug in another USB cable, and put the device back together and you can deploy it back to the floor very quickly. And then you can send that, you know, that defunct module back to Welch Allyn and we'll gladly take care of it, you know, for the customer.

Gavin: So, you mentioned some other sort of let's call them, you know, items there like 3D printing and things like that. Did the project of, you know, creating the smart connected product, has it brought other learning's into play that have been taken into projects that came afterwards?

David: It really did.

Gavin: Just give me one or two ideas. Not that we don't, like I said, just one or two things, maybe again just to like from the audience perspective and I think from another engineer out there who's in the similar type of role. I think sometimes, again, you know, we don't always quantify the benefits that's brought, you know, we can see it in the project itself but sometimes there is that sort of the learning or the new way of doing something that goes into future products, that sometimes isn't quantified or spoken about.

David: Yeah. I think one of the things that was really different about this particular project was that, you know, fairly early on we realized this was really big for us. And while other projects had always been trying to, sort of, strike that balance between time and cost, we realized on this project, it was all about time. It was all about getting to a particular market window in a particular time, and we knew that the vast majority of the cost of the project was gonna be labor. Nitpicking over how much money you're gonna spend on prototypes is really irrelevant. What you need to do is finish the development and get the product to market and start earning revenue. And the faster you can get a great product out, the sooner you're gonna start earning revenue. And the soon you're gonna stop spending tremendous amounts of money on research and development. So, that really became our framework. We were always looking at things from the perspective of time.

So, if 3D printing, a mass quantity of parts was what we needed to do, you know, to get to the next prototype, to be able to tell if this was working or not working in the workflow. We would do that and we wouldn't quibble over the cost of the prototypes. If it meant going to Protomold or another, you know, rapid prototyping house and generating a bunch of parts really quickly, that we could then bring back and use for a thermal test or a drop test, or a vibration test, or a shipping test, or whatever it was. We would do that because, you know, in the end, it really wasn't about the money that we were spending on the parts. It was all about time. It was all about the time of this huge team of engineers that needed to get this product done and needed to get it done to an extremely high level of quality so we get it out the door.

Gavin: Right. So, Dave, from speaking with you just here in the short time that what we've been speaking, I mean it's quite evident that, you know, you worked, I would say like intensely on this project. I'm sure it took a number of years, you know, to deliver. For the engineer out there, for that company out there who, you know, perhaps hasn't ventured into the smart connected product space yet. But, you know, obviously with the knowledge that that's the way things are going I think costumer expectations are, you know, the products are more connected than not now. And, you know, they have to be smart or there's just that expectation, you know? What advice, if any, would you propose to give to a peer or a colleague in terms of trying to do one of these projects or take it on?

David: You know, there's a lot of technology that's available off the shelf these days. From an engineering standpoint it's so easy to drop a WiFi chipset, a Bluetooth radio, a USB port, or any other kind of connected solution into a device these days. The tricky part is not figuring out how to do the engineering work to, you know, to physically put the parts in there. It's trying to figure out why you're doing it, what problem you're trying to solve. And if you understand the customer and what their needs are and what their problems are, and you understand that better than anybody else does, then you can figure out how to do it and how to do it really well. And, you know, you'll really build a great product.

If you're trying to delay your connectivity on top of a product just for the sake of it, you'll end up, you know, with kind of a marginal solution. Then you'll have to iterate the following year with something else and then the following year with something else, and you'll eventually creep up on something. But if you start with like a really deep and thorough understanding of what is the real problem you're trying to solve here and how does connectivity solve that problem, then you can really knock it out of the park.

Gavin: In terms of the product itself and, you know, now that it's out there in the market as in...I think you said the project completed, you know, five years ago or so? Are you able to speak to the success of that product in the marketplace in any way? Again, just to help the listener, you know, have an appreciation for, you know, how did the project go? Okay, so great work, love industrial designing company involved. Obviously, a great team. Did it pay off?

David: Yeah, you know, it really did. As an example, I mean when we first launched this product, you know, we designed our production line. I think we designed our production line so it would build 50, 60, you know, somewhere in the 55, 60 devices per day margin. And within the first two years, we had to redesign the manufacturing process twice to dramatically increase output because we couldn't keep up with demand. And those are really good problems to have. And the other thing is, because the architecture is so modular, and because customers were so excited and responding so well to this product after the initial launch with all this capability, you know, we came back pretty much every year since then and released updates and upgrades. In some cases, we released, you know, a whole new better software capabilities. And, you know, customers that had bought the first device back in 2010 using the Axeda platform we're able to download that as a software upgrade. You know, upgrade a 2010 vintage device to 2016 or 2017 software, and get not bug fixes but like real kind of interesting new functionality.

You know, we also released a bunch of new sensor modules that allow the device to, you know, to do things that it couldn't do initially. And all of that was enabled by the fact that, you know, the product had really taken off. And we really have substantial market share in this electronic vital sign space. And there's a lot of big players in this space, you know, think of a, you know, large medical device company. A lot of companies build multiparameter medical devices, you know, in this vital sign space, you know. Welch Allyn, you know, consistently has the strongest market share in this segment.

Gavin: I think that's a really good evidence that, you know, this type of approach to a product design effort especially, you know, as you move into the smart connected world that can pay significant dividends.

So, that's all for today's episode of The Connected Engineer. I'd like to thank David very much for join us and sharing the Welch Allyn story. My takeaway from our conversation is that the opportunity that new solutions or technology, like the IoT, can provide to companies and engineering teams out there, is to reevaluate existing products and find news way to add value for both their customers and themselves. And I hope, David's story has proved that fact for our next episode.

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