Changing to Customer-Centric Design While Developing a Major New Product

 
 
 
 

Rich Wintersteller is VP Global Sales and Marketing Cardiopulmonary at LivaNova.  In this episode Rich shares why market leaders need to change their approach to product design, how LivaNova moved to embrace customer-centric design, the benefits to this approach, why software and interoperability are keys in their new product, how to manage change, and how LivaNova’s new technology is helping perfusionists deliver better patient care. 

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Episode Transcript

This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.

Patrick Kothe 00:31

Welcome! Elizabeth Newton, when she was a graduate student at Stanford, designed an experiment where she had two groups of people, tappers and listeners. The tapper picked out a well known song Something like Happy Birthday and tapped out the rhythm on a table. The listeners job was to guess the song. Before they began, the tappers were asked to predict the probability that the listeners would get it correct. What do you think it would be? Well, the tapper said 50%. Over the course of the experiment, 120 songs were tapped out. Only three of the songs were guessed correctly. 2.5% Well, what happened? When the tapper taps, it's impossible to avoid hearing the tune along with the taps. But the listener just hears some strange Morse code. The problem is that once we know something, we find it hard to imagine not knowing it. This is the curse of knowledge. Today's topic is customer centric design of new medical devices. In my experience, it's easier for a startup to embrace customer centric design than it is for a market leader. The startup has a blank slate, and they need to gather all kinds of information on everything in order to build a useful product. In a big company. There's usually a tremendous amount of knowledge they've learned from the market customers and a feedback they've received on existing products. But as you just heard, the curse of knowledge is a dangerous thing. Especially when the market is changing, which it always is. The day you stop truly listening to your customer is a day you begin your decline. Our guest today is Rich Wintersteller VP of Global Sales and Marketing in the Cardiopulmonary group at LivaNova. Rich's successful career includes significant contributions at the Ethicon division of J&J and Danaher. In our conversation, we discuss why market leaders need to change their approach to product design, how leave a nova moved to embrace customer centric design, the benefits to this approach? Why software and interoperability are keys in their new product, how to manage change, and how livanova is new technology is helping perfusionists deliver better patient care. Here's our conversation. Rich, you've spent your career on the commercial side of businesses, sales, marketing, business development types of roles. What about sales and marketing makes it a good fit for you?

Rich Wintersteller 03:42

Great question, Pat. You know, 31 years in the med device space, I can't believe I'm saying. And I am a commercial guy true and true in to my core. And I think there's a good reason for that I love being connected to the customer. It's plain and simple. I love being tied to goals. I love to be held accountable to execution. But most importantly, to my first point, I love being connected to the customer. Every day is different when you're connected to the customer. You've seen one customer, you've seen one customer and to me that just makes the whole thing that much more interesting. So I've been fortunate to be around some great technologies and some great customers. But the one common theme there is it's all about the customer. And I think that's why I'm still very, very engaged at this 10 year of my career. And really, you know, I learned pretty early on if you focus on the customer, you typically get to the right answer really easily. Right? So a really customer centric approach, not only in how we develop products, but certainly how we go to market and how we think about sales, execution and sales strategy. Right? It all starts and ends with the customer. So to me, that's a great question. And a pretty easy answer for me,

Patrick Kothe 04:51

or is that it's such a great point. I was at a at a cadaver lab, past two days, and I was with customers talking to him, and as a CEO of a company, I don't often get enough time with the customers. But I came home last night, and I made the remark to my wife, I love being with customers. It is just something about you getting in front of the customer and having that interaction that just charges me it just, it just makes you feel like you're connected. And you're hearing directly from them. And it's, it's, it's the fun part of our job.

Rich Wintersteller 05:33

Yeah, totally agreed on, especially as you gain a bit more responsibility and organization, the opportunity to connect with a customer is that much more valuable for me, right, I don't get a chance to do it every single day, like I once did very early on in my career. So I really like you, Pat, I really cherish those opportunities, try to take most advantage or best advantage of the opportunities when I get them in. What I've tried to do over certainly the last five, six years is to make sure that I schedule routine time to be in the field to be next to customers, whether it be at a trade show some sort of convention or actually working with our sales team in the field, just to make sure that I stay connected to the customer. And I'm like you it's it's invigorating, revitalizes me a bit. It's, it's what it's all about.

Patrick Kothe 06:16

You've had a really nice career with some great opportunities ahead of you. So tell me a little bit about getting into our business. And you know, what, what drew you into medical device and kind of, you know, top level and companies you've been with roles that you've had, and types of technologies you've been involved with?

Rich Wintersteller 06:38

Yeah, good question. You know, as I said earlier, over three decades in med device, I knew pretty early on this is where I wanted to be, I loved this opportunity to the idea of an opportunity to be connected to customers to actually have a purpose greater than just financial reward every single day. And so that was kind of an easy transition. For me, at least in terms of what I wanted to do, how to get there where to get there was a bit more challenging because as I'm sure you know, medical devices, as somebody right at a college or university can be a bit daunting. It's a tough place to break into. But I was really fortunate that I had a great opportunity. I started my med device career with Johnson and Johnson. And in fact, had 22 year run at Johnson and Johnson a fabulous company. I have such fond memories of a great company and just great people that I was associated with their most importantly, the great training that j&j afforded me, you know, so I started carrying the bag in 1992 in Buffalo, New York, and knew that j&j was a company that I wanted to build my career and grow with. So I was really fortunate to be able to take on roles of increasing responsibility and sales, sales management than I wanted to marketing, spent five or six years running a marketing team and then moved into senior sales management towards the end of my time at j&j. You know, with j&j. The unfortunate part is you have to move around a lot. I got to a point my life where I couldn't move anymore, right. I had a high school daughter, aged daughter, we that was kind of our family rules that once we got to that point, we weren't gonna move. So I also was afforded then, an opportunity to work for a company called Danaher, which is probably Pat, I don't know if you've ever heard of Danaher, but I imagine some of our listeners may know, but it's probably the biggest company that most people have never heard of, right? It's a fantastic organization really well run. I was brought into to run a new part of their business, kind of like a GPO organization, and kind of a strategic account approach and to build out a global professional education approach that that business had lacked at the time. So that was a ton of fun. You know, what I love about j&j was so many things I loved about j&j. But the easy thing for me to always remind myself is how good j&j is at strategy. And then when I got to Danaher, when I realized how good Danaher was at execution. So, you know, I really have this great foundation of working in two organizations, one that was really focused on strategy can tell a story or outline a strategic vision better than me and I think j&j is is still at the top of the heap and Matt, and then Danaher, where it was all looking at the business the other way, how do we operate? How do we get the most of our businesses about driving efficiencies, execution goals and holding people accountable to results. It was a fascinating dichotomy for me, but I learned a ton on both sides. And then, you know, really proud to bring that forward here to leave a nova, where I've been hanging out for for six years, and I have the good fortune of being the Vice President of Global Sales and Marketing for our cardiopulmonary business, which is obviously focused in the cardiopulmonary space, which I know you've been in and around in your career. And so I have responsibility now for North America commercial execution, and then we're set up in a business unit structure. I also serve as the liaison for the cardiopulmonary business unit globally, being responsible for coming Marshall best practices and driving synergy around the globe. So leaving opens a great organization. And we are just getting started here at Luminova. I've been here for six years now, as I mentioned, it feels like a blink of an eye. And we're on the cusp of some great things here at leaving over.

Patrick Kothe 10:16

So let's go back to j&j for a second, what what products, what division, what products and product lines were you responsible for there,

Rich Wintersteller 10:26

I started really off 22 years was in on the Ethicon side of the business. But that business changed dramatically, dramatically during my time. So I think at the time that I was the VP of sales, there was actually four different business units under under the Ethicon umbrella. So I started in wound closure, the suture side of the business, spent some time on the Endo, mechanical side of the business, was the National Sales Director for the BioSurgery, Ethicon BioSurgery business for a while, and then came full circle, where I started my career on the suture side. And they're back as the VP of sales in North America.

Patrick Kothe 11:05

So you moved, started carrying a bag, and then you moved into marketing, when you moved into marketing. Tell me a little bit about that. Because many people don't understand the differences between sales and marketing and the view that you get in sales and the view that you have in marketing. So what what opened your eyes when you moved into marketing?

Rich Wintersteller 11:24

Yeah, you know, for me, I think why I love the job that I do today, right, as I'm responsible for both strategy and execution. And as I told you, at the top here, I love execution. I'm also really fascinated with strategy, right. And I quickly saw that, oh, those marketing folks are the ones that actually get to figure out the direction of where we go and how we do it, and why we should be spending time or investment in certain areas. So the light bulb went off for me. And it also was an easy transition. But you know, having done done both at a certain point in my career, knowing that kind of coming and bringing those both back together was kind of the sweet spot for me. Still, I think, for me is the sweet spot, I think I've been able to fortunately, be able to figure out and set strategy, but then also make sure that it's a strategy that's just as easily executable, which I think is what sometimes get lost. In some, some of the businesses that I've been on the strategy sounds great, but it's just not not easily executed. And that's where I think most companies go wrong.

Patrick Kothe 12:23

Yeah, and marketing to is, to me, I look at marketing as being kind of the hub of the wheel. And you, you touch other areas of the business, you touch all other areas of the business, whether it's finance, regulatory, clinical sales, r&d, you know, you're touching all those other things. So it really helps to round out your understanding of what the business is all about. But you know, when people hear about marketing, a lot of times they think it's sales support. And that is a key. It is really a key part of the job. But it's not the only part of the job.

Rich Wintersteller 13:00

Yeah, in fact, I guess it depends on the organization. I could agree with you more, I think it's the smallest part of the job, right, and marketing. And I think you're right, it's mostly salespeople that the marketing and sales support, right. And it's clearly not right, it's so much more than that. Again, it's about, you know, looking at the market opportunity, looking at internal capabilities, and how they aligned to the external environment that any business would operate in. And, you know, setting that strategy, figuring out where we go, how we go working with r&d, with quality teams, with regulatory teams, all the things that you pointed out that really, I think make a career in marketing really fruitful and really worthwhile. And you can really make a difference, right. I know that salespeople like to say, I really make a difference every day in the field. Certainly, I think marketing teams certainly also have a great opportunity to make a big difference.

Patrick Kothe 13:48

So let's let's dig into livanova. Tell us tell us a little bit about leaving over but the business and you know what, what product lines are in and a little bit about the history?

Rich Wintersteller 13:59

Yeah, I'd love to so we've a Nova is just a shade over now a billion dollar business annually, globally. We refer to ourselves Pat as as kind of the head and the heart company. You know, so it's a billion dollars north of a billion dollars annually in revenue. We have just about 3000 Associates globally. And, you know, operating over 100 countries today. You know, the reason we call ourselves the head, the heart is by the way that we've we've structured the business across, really three business units. The first business unit is neuromodulation. neuromodulation is focused on drug resistant epilepsy, difficult to treat depression. We have some opportunities that we're working on a difficult to treat depression, as well as some opportunities, pipeline opportunities that we're working on in sleep apnea. There's a whole business focused on the neuro mod side of the business and so obviously that's the head

Patrick Kothe 14:58

side of the business and that That's the old cyberoptics Right? That's

Rich Wintersteller 15:01

exactly right. That's exactly right. That's exactly right. And then in 2015 or 2016, right cyberoptics merged with the saurian group. This is the heart side of the equation, right, which is now the cardiopulmonary business which I have responsibility for. And then, of course, we bought the tangible life business 2018, which we now call advanced circulatory support that's really focused on ECMO and advanced circulatory support options. So it's a fast growing really exciting part of our business, the newest and probably the smallest part of our business. But when you look at all that it's a billion dollars annually in revenue. cardiopulmonary is about 49% of that just to give you a kind of the breakup, so it's, it's almost 5050, between head and heart. And, you know, certainly we're really proud of the global reach we have and really strategic markets on the whole neuro mod side. And of course, as you know, we've had some other plays in and around the cardiac space, but really have decided that cardiopulmonary is our sweet, sweet, sweet spots where we want to focus. And that's where we've got a lot of investment, a lot of energy right now.

Patrick Kothe 16:07

And the history behind the Sauron group is, you know, some people will remember COBE, cardiovascular and that's, that's the history, some of the history behind and technology behind what you're doing. That's exactly right. Yeah. So which portion of the business are you managing?

Rich Wintersteller 16:23

Yeah, so why have responsibility for the cardiopulmonary business unit, which, you know, serves the perfusion community. And, you know, primarily we are, we're based on a capital side of our business, which is primarily driven by heart, lung machines, auto transfusion systems, heater, coolers, all products that are used in and around open cardiac procedures to facilitate the bypass portion of the procedure, as well as a full line of disposable products that support all of all of the hardware that we sell. So it's a really dynamic business, it's really fun. It's a well established businesses, you know, a lot of interest in and around perfusion and the changes that are happening in profusion today. And, you know, we have a market leadership position in heart lung machines, which we're really proud of, you know, we've got a large install base globally of over 7000 Heart Lung machines around the world. So, you know, that affords us some unique opportunities as a market leader. And really, we're on the precipice of what we call this new era of perfusion, right? We take great pride and great responsibility as a market leader, to really drive this new era of perfusion, this kind of change in perfusion that we are happy to lead and participate in. And it's really to sum it all up all around, elevating the role of the perfusionist. We're gonna talk a bit about perfusionist in a minute. But then certainly how perfusion is evolving, really, from almost a one size fits all approach to this new era of perfusion that really is all about patient tailored care, right. That's really what this new era of perfusion is all about. And we'll talk about some product opportunities that we're launching in the market that we think will really facilitate and drive home this new era of perfusion.

Patrick Kothe 18:08

Well, our customers are always changing technology is always changing. And as you know, we've we've talked in the past, I've got history with perfusionists, going back to the early 80s, when we were providing some technologies to fill those heart lung machine, some volume expanders to fill those. So I've got I've got history going back there, and then it's been 10 years and a heart valve industry. And, you know, obviously, perfusionists are really important there. So I've got kind of legacy stuff. But I don't know what this new, new new changes are all about. So can you tell us a little bit more about what changes are happening? Is it is a technology driven? Is it personalized medicine? What is driving the change within perfusion?

Rich Wintersteller 18:56

Yeah, first of all, let me back up because I agree with you, I think perfusion is really kind of the unsung heroes, many unsung heroes in and around the cardiac suite. But perfusionists play a really important role. We really value our relationships with the projectionists they often get overlooked, but the role that we think that they can play in this new era of perfusion is really critical. And so certainly there's you know, leaning in harder to the perfusion community, as well as bringing new technology to the forefront and you know, so we've just launched the essence perfusion system right we have a long and storied history again in cardiopulmonary we're 50 years legacy and history that we're really proud of here at lever Nova in and around the cardiopulmonary space. But, you know, we've had technology that existed in the market for well over a decade, the the S five platform you may be familiar with, but so we've recently just launched the essence perfusion system that really kind of takes this idea of patient tailored care to a A whole new level, right? Because it's much more than just a hardware play, you know, just a pump that pumps the blood.

Patrick Kothe 20:06

Well, let's take it up a level for a second because some of our listeners may not have spent much time in cardiothoracic surgery. So what is the purpose of a bypass machine? What? What is it doing?

Rich Wintersteller 20:18

I forget the obvious sometimes. Yeah. So, you know, in an open cardiac procedure, obviously, the heart is arrested. And certainly, blood needs to flow and oxygen needs to be delivered to the patient. So the heart lung machine facilitates the beating of the heart and the oxygenation that takes place in the lungs, right. So it's all done through cannulation sites, typically, in and around the heart, sometimes in the femoral artery or femoral vein. So it takes blood away from the patient into the heart lung machine, that actually serves as the heart or the pump, there's actually a disposable component called an oxygenator that serves as the lung, the blood travels through the heart lung machine, the pump through the oxygenator, where the blood is re infused with oxygen and then pumped back into the patient. And the perfusionist, obviously, is the orchestra or the conductor of the orchestra there that runs the heart lung machine, that Mark monitors, many hemodynamic variables throughout the procedure, pressure, arterial flow, oxygen delivered, carbon dioxide levels, all kinds of things that perfusionist monitors, and is responsible for as the procedure takes place. And it's obviously the machines like the essence perfusion system that facilitate cardiopulmonary bypass.

Patrick Kothe 21:37

So the old machines were roughly the size of a desk, and sometimes bigger, bigger, roughly the size of a desk, and then you've got cannula that are kind of going back and forth to the patient tubing back and forth to the patient. And that that machine is set up a few feet from where the where the patient is. And the perfusionist sits along alongside and monitors all the levels going on with that with that blood circulating through?

Rich Wintersteller 22:09

That's absolutely right. Absolutely, you can tell you spent your fair share of time in the cardiac suite

Patrick Kothe 22:13

O and B and before and before the the the case gets started, you have people banging on them to get all the all of the bubbles out and everything has been spent a little bit. So you move from one platform to another because of changes to, to what to how the technology works, how the how the perfusionists wants to interface? What is driving the change to new technology?

Rich Wintersteller 22:43

Yeah, great point. Well, first of all, technology itself has advanced tremendously in the last decade. And again, this idea that data now takes a central role in really all aspects of medicine, but But certainly, in the therapy of perfusion, right data takes a central role. Certainly linking now, devices in the operating room with hospital electronic medical records, is a key component. And that's really where we've tried to bridge the gap, you know, we we really started from scratch, we could have easily as the market leader with you know, 70 to 80% Market share around the world and Heartland machines, we could have easily said let's just come out our old platform was called the s5 We could call it the sixth or the seventh, right, let's just kind of evolve slightly, and continue to build off of a really strong heritage and legacy that we had with the S five but we knew as market leaders that that wasn't really going to serve the purpose. And certainly what we started to see around in the marketplace, the changes that we saw this shift the importance of data, this idea that one size does not fit all that you need to take data from the patient and give the best type of care and therapy to the patient. So those are some of the fundamental premises. I think, as an organization, we were smart enough to recognize that pretty early on. And then most importantly, I think, some key learnings for leaving Nova, like many organizations in the past, I think you have a tendency around product development to lean into your strengths, right? Sometimes develop products, because they line up very nicely with your core competencies. And I don't wanna say just because you can you develop a product, but many times you lean into just your core competencies. And that's probably what happened if we if we would have done I've taken a typical approach or an evolutionary approach to the s5. But what we really did kind of take a step back and knew that if we really wanted to get this right, we really needed to make the customer kind of front and center to everything that we did. So we adopted early on in our process, a true user centric design approach that looked at really every part of our process from discovery, to design and to development and you're throughout the process we've interacted with over 300 Different perfusionists around the world, literally We started with a blank white sheet of paper, what should a new heart lung machine delivered to the marketplace. And we started in theory, we then moved to a conceptual phase where we actually had perfusionists in our Munich facility in Germany, building prototypes out of boxes to try to get the ergonomic and to your point of the large size or footprint that a Heartland machine typically has in an operating room. How do we improve that we did really unique things like working with cardboard boxes and building what a typical prototype might look like to actually then evolving with the help of perfusionists along the way, to actually get into working prototypes that didn't have necessarily all the features that we had planned for, but to get take this evolutionary approach through the design and development process, over 300 sessions that took place in person virtually at conferences and hospitals. It was a wonderful process that really started in 2017. And I think that's what we're most proud of is right? We heard a lot from from those customers about what they wanted, ergonomics, safety, reliability, the ability to deliver patient tailored care, the ability to link with hospital medical records to get real time feedback, so that obviously, they can adjust their course of therapy throughout the procedure. So it was a fascinating process, we learned a lot. And, you know, I really do think that we got it right, our early feedback is we've just launched our new platform in Europe. And then here just got FDA clearance. In the United States, six weeks ago, we did our first clinical case, just two weeks ago here in the US. So things are things are working really well. So but we owe it all I think, you know, really back to this premise, fundamental premise of, of user centric design, which is now embedded across all of leaving Oh, and not just in the cardiopulmonary business, but the neuromodulation business now, and, and, of course, our ACS platform as well.

Patrick Kothe 26:59

Well, I'm going to go back to that for a second. Because as you said, it's so easy to iterate, go from six to seven to eight. But if you're a competitor, let's just say somebody, somebody was going to come into your space and say, Okay, we're going to build a new machine, they would not come in and build a seven, they would come in and build a 12. Okay, they would take and we've got to have a significant change in order to drive customers to change. So an incumbent, getting to take a leap is risky, it's easy to move the technology along step by step. It's riskier to take that leap by leap, what was going on within your company at the time to say we need to change something, we can't take this step prote approach.

Rich Wintersteller 28:00

Again, I think, being connected to the marketplace, the global marketplace, right, we did a ton of voice of customer, even before we got to this customer design process, customer centric design process to really understand what some of the trends were in the marketplace. So I think, again, it's it's smart people doing some good thinking back to strategy back to our early part of the conversation, right? A really strong global strategic marketing team that I think was really in tune with what was happening in the marketplace changes in the global marketplace, you know, some significant changes in the European marketplace, certainly some some key trends here in the US that we were able to capitalize. And, you know, I think that was also the point that we thought, Pat, that we were kind of in the best of all worlds, right to your point a new competitor really has to start from scratch has to take a big leap of faith without any experience or any track record. We've thought of it as kind of the opposite of that, right? We have this proven history and heritage of legacy safety, innovation reliability that we were able to build off of. Right. So we had a really strong base that we were able to establish and then build off of right. So you know, some of the things that we learned, again, through this design process, that safety and reliability were really important to our customers, no surprise, right when we're talking about the space that we play. And so let's not change the things that our customers really liked around safety, reliability, the way that the pumps are designed and the way that the pumps perform. Right. So there's a big component where what we learned is let's not change that. Let's build off that which we did. And then of course, look for innovation in the right spots, which is what we do.

Patrick Kothe 29:34

There's risk associated with and many people remember when Coca Cola developed and launched new coke. It was a major leap. It wasn't it wasn't a step and it was a major, major failure in the marketplace which they had had to remedy. So there is risk when you're when you're doing this, but understanding What are the bedrocks? I mean, what are the things that you absolutely cannot mess with? And what are what are some of the things that you can have changes to? That's the I think that's one of the keys that you just mentioned.

Rich Wintersteller 30:13

Yeah, for sure that again, that's, I think the reason that we lead ourselves to this user centric design process. To your point, right, we wanted to make sure that we got this right, the stakes were pretty high as a market leader. We knew that there was an opportunity to innovate, but we wanted to do it the right way. And again, not to beat a dead horse here. But that's what the user centric design process really facilitated for to help us mitigate the risk, take the right risks that we knew our customers really wanted us to, but also be able to mitigate that along the way.

Patrick Kothe 30:42

So I've been in several different companies and had an opportunity to learn good things, bad things, you know, on the product development process, and things have evolved over the years. You were in marketing in the early 2000s. At j&j, world class company, world class development. But things kind of changed to at that point in time you had been, I'll say, indoctrinated into the j&j way of how to do product development. And then you move over into another company to kind of see how they did product development. major difference, not a major difference,

Rich Wintersteller 31:21

question, size, scope, and scale for sure. A major difference, right, when you move from I think, j&j is all in house close to $100 billion organization, right to a billion dollar organization than leaving over. So certainly pros and cons trade offs to both. But one of the things I really like about leaving over is speed and agility. And the way that we can get to a quick resolve to a decision point, or a key development point, might have taken months, dare I say years and other companies that I was in the past, that we were able to get to pretty quickly? Right. So I think that nimbleness of our organization is one of the biggest things that I noticed very differently. You know, most of our, at least on the heart, lung, machine side or the cardiopulmonary side r&d Is, is based in Miranda, Italy, and Munich, Germany. So I posed a bit of a challenge, you know, for for a guy that sleeps in the US just as many nights as he can more to work kind of across time zones and cross country, international borders, sometimes it's challenging, but you know, I think our organization has kind of built that way. We operate really efficiently that way. But that's one of the one of the biggest differences that I think that I've seen, from my past experience to where I am today. The other thing for us, that was really important, right, we really probably haven't emphasize this enough to this point, we moved really from kind of a hardware platform or old technology to now probably equally hardware as well as software, right? So so that really kind of necessitated the need for us to develop new competencies around software, right? Bring in new people, new competencies into the organization, so that we can have an equal balance of software. And as you know, software is not a one and done right. It's an ever ongoing process of evolution and updates and changes, right. So having to kind of incorporate that into who we are as an organization has been a really big change for us. But a needed change, and certainly one that we think is going to help us on the path forward.

Patrick Kothe 33:22

getting customer feedback is something that has always been important, but it's become much more visible within organizations in the past 10 years or so last five years, really, where you're getting a bunch of bunch of feedback. Prior to you guys adopting this type of model. How were projects run, where they run r&d Was it was an r&d driven organization, a sales driven organization or customer driven organization. I've been part part of all three of them. So I know the everyone likes to say they're customer driven, but a lot of a lot of companies that I've been part of had been r&d or sales driven organizations. And and that's not to say that they don't involve the customer. But when all things come down, you're not really customer driven. Was that a change that the that the organization had to go through?

Rich Wintersteller 34:22

Yeah, I think so. You know, I think that's probably one of the biggest reasons that facilitated the merger back in 2015, or 2016, between cyberoptics and leaving over a soaring group at the time, ultimately now as leaving over. But I think it was a bit of stagnation in research and development and innovation. And kind of bringing the two organizations together from an investment standpoint, capability standpoint, being able to take a bit broader look into future market needs and you know, to invest in the innovation pipeline were really important. So I think we've evolved a bit and I think we were more of a commercially driven organization pre leaving a Over an I think we see a really well balanced organization, right, I think we really I think I've defined the organization, we got a new organizational structure on a business unit that really, I think equally around, you know, the strategic marketing side of the business, r&d side of the business with the with the on the ground commercial teams, I think we've got a really nice balance as an organization. And I think, you'll will start to see a nice steady state and cadence of innovation going forward. Now that we've struck this right balance,

Patrick Kothe 35:29

there are several benefits to getting your customer involved in and development of product number one, you get a better product, you got the users telling you exactly what they would want to see. And if you're really skilled at drawing out from them, not just six to seven, but let's really put emphasis on what exactly are you trying to get out of here? How can we design something that is better? What's the workflow look like? Let's let's forget about the old device and say, if you were starting from scratch, how would you do that device, that's, you know, so you've got a real benefit and being able to design a better device. But the other thing that you're able to do is you're involving your customers in your business. So the relationship that you're establishing with those 300 and, and the 1000s, that those 300 are talking to, is a different level. So tell me a little bit about the relationships that you developed with your customers through this process.

Rich Wintersteller 36:37

That's such a key point, Pat, glad to hit on that. You know, in fact, I was just that the am SEC Congress, around extracorporeal. Technology, three, four weeks ago. And what was so cool, it was well attended. First of all, it's great to see conferences back alive and well, right, people actually moving about and interacting with each other, the simple stuff that we've all, I think, come to know and love is back in full force, which was great. So a well attended conference. And it was our unveiling of the essence perfusion system, as I mentioned, just received FDA clearance two weeks before. So what was so cool was to see many of those 300 customers, certainly not all of them, because we took a very global approach, but many of them to show up at the booth and say, I actually gave that feedback. And I am so happy to see that you did that. And just that relationship that that does. The closeness that that brings us back to the profusion community has been been really gratifying for us as an organization to be able to participate and and give you countless examples, that sometimes it works the other way, we've had a couple of customers say I gave you feedback that said I wanted this and why didn't you incorporate that? And, you know, we typically take them through the thought process and, and why it may or may not have gotten in but by and large, the feedbacks been great. And now there's this sense of ownership, right to the essence profusion system outside of leaving over which we absolutely love. And we say that this this platform is a profusion system that is for perfusion, profusion isn't designed by perfusion. That's right. And you can really see that as we come to market with this new product. It's it's

Patrick Kothe 38:09

so key, I mean, all of us had to have the opportunity when we're designing products to involve our customers in it. And, and as you mentioned, not all feedback is going to be incorporated. But if you present it the right way, they know that their voice was heard, considered. And maybe it wasn't finally implemented. But as long as you hear it, consider it and make your choices. They feel like they're on your team. And they were on your team. They were on your team, and they were designing something for themselves as well. And as I said, it's the 300 people, but it's the 1000s of others that they talked to that say, this is a company that I really like and trust. They're listening to us. And if that's part of your key branding, that's gold.

Rich Wintersteller 39:00

Great point. Great point.

Patrick Kothe 39:03

So you're just getting out there and starting to get some conversations, going some sales going with it. Tell me about the comments that you're getting back from people who were not part of the process.

Rich Wintersteller 39:17

It's been great. The feedback, as I mentioned, you know, back to the Samsung conference, one of the best attended shows I've been in a while and, you know, with new technology, like we have, that was almost an endless line in our exhibit, which was also great to see. So many obviously people that were involved just as many that weren't that, I think got a sense of what we did. The focus on safety, reliability, ergonomics footprint design of the system, having now a dedicated patient monitor on the system as well as the cockpit, which is the traditional approach that every HLM has a cockpit not to bore you with the details, but now an integrated patient monitor that gives real time and accurate information to the perfusionist to kind of see that come to life, from concept to actual reality and see how efficient that can make them. However, there is now a smaller footprint in the operating room, the ergonomics behind we did this eye tracking study that, you know, shows the benefits of the new design and how they have to focus on less locations and having to be all over the place really is very apparent the first time you see the machine, especially apparent when you start to play with the machine, run a circuit and actually start to experience the essence profusion system for yourself. So it's nice to see the light bulb go off on all different sets of customers.

Patrick Kothe 40:44

I want to talk to you a little bit of I don't know if that if you've done this at all, or if it's if it's of interest within that. But you got kind of independent systems that are going on during that surgery, you've got the the anesthesiologist has got their system, they're managing it the perfusionist has got there's echo is in there. You got vital signs monitor, so there, but they all seem to be independent systems that are going on. Did anything happen with integration of that information?

Rich Wintersteller 41:14

Yeah, we call that external device management, right. And that's a big part of the essence perfusion system. You can integrate other techniques, not all but other technologies that exist cardioplegia pumps is one good example, that you can integrate and get data from those devices that can can flow through our device, again, into hospital metal medical records. So that's a big part. Without getting too much into strategies, making sure that we, we can connect to external devices in the operating room, and stay current with those devices. Again, that leads us back to a software competency and some some competencies that we need as an organization to be able to do that

Patrick Kothe 41:55

software and business development to be able to have access to everybody's that's exactly the information

Rich Wintersteller 42:02

is a little easier said than done. But it's it's something that we've done before. We certainly allowed even on the old platform, we've allowed data to flow from other devices through our device, but we've taken it to a whole new level with the new essence profusion system.

Patrick Kothe 42:17

Well, and that's one of those things where, if you're the customer, you can say I wish this would talk to that. And but they're two different companies who have their own proprietary systems. And they may be competitors and don't want to work together. But it creates a an issue for our customers. So if you really listen to your customers, and they say this would be better for the patient, we get better outcomes. If we if we had this. We as industry, we got to figure out a way to do it.

Rich Wintersteller 42:45

Yeah, I'm happy to say though, Pat, you know, not that we're perfect. You bring up some really good points. I don't know if it'll ever be perfect. But I've seen great strides in this area, right? I think collectively industry is banding together where we can right there still always going to be IP in place, other proprietary issues that we probably can't get around or legal teams won't be able to get past. But I've seen that, in fact, I won't name any any other company. But we were working well with, with what I'll call partners now to solve some of these issues. Where was a pretty yes, no conversation in the past, that the doors have really opened, the conversations are much more engaging, I think we try to understand each other's challenges. But also I see a real open mindedness to try to work better together. And I'm encouraged by that,

Patrick Kothe 43:30

Oh, that's fantastic. I'm encouraged by that, I'm really happy to hear that that's going on, because it's going to benefit the patients, it's going to make make, make our customers jobs easier and better. I want to go back. We've talked about the process from the customer standpoint, but I want to talk about change. And it's a different way of doing business, if you've got 300 people that are coming in, and it's and and again, I'm not saying that your company was r&d driven, or marketing or sales driven. I don't know what it was. But whatever it was, it changed to have this customer centric development process. And anytime that you've got that it's different for people. So what were the challenges within the company to to do it differently? What who are the stakeholders that you needed to talk about are doing doing things differently? And what were the challenges that you saw?

Rich Wintersteller 44:34

Yeah, really good question. You know, I think, Cassie that really in three buckets, one internally, right. We had this whole r&d kind of software hardware development change curve that we had to go through right? We needed again, new thought need a new competency. We need a new people right. So you know, that drove off All kinds of change in itself talk a bit more about that one. But you know, this this transition from a purely when I say purely majority of a hardware driven approach to now this balanced software and hardware, right, that clearly caused some organizational strain along the way for sure that we had to solve for the other piece, I think this is a new technology. So, as a commercial guy, right, I think a lot about our sales organizations, our feet on the street, our frontline approach to customers, big change for our sales teams, right? They, they are now selling a whole different technology and the role that we've asked our sales team, our account executives to play, it's fundamentally different than it was, you know, just one year ago, right? So there's been a big, big change curve that we've had to kind of go through. And then also think about how our customers, right, we think about how we segment our profusion customers, there's a relative scale around the adoption of new technology, to not adopting new technology, right, and we need to kind of

Patrick Kothe 46:01

incompetence competence in dealing with those things. That's exactly it. So

Rich Wintersteller 46:05

we need to find that right balance and, and how we how we line up with our customers needs. Because, you know, we're fortunate that our system can can still work on all ends of that technology scale. Right. So we feel really good about that. So change is never easy, internally or externally. But you know, I do think we've also been smart enough to recognize that there is a significant change internally and externally, and let's start to try to get ahead of that change. I think about change. And, you know, it starts I think, with almost shocker denial, like no, we're not going to change, it's worked. So well, let's let's not change that, you know, sometimes then it evolves to fear, right fear of this change are actually downright getting mad about the change and amend as you know, my experience like yours, I'm sure you see people start to understand why changes is important, why it's relevant, while it's needed, then you kind of start to see this, this gradual acceptance of change, right. And that's to me where communication becomes really critical and reinforcement and training, in many cases, like to our sales team, we're going in a few weeks, we'll go through our third round of, of really intense training with our account executive teams that get them comfortable, again, with this whole new environment and arena that this new technology kind of puts them in. So, you know, I think, I think that's part of it. And I think one of the other things we've done really well, because there's been so many successes, Pat, along the organization, we've been on this journey for we've really talked about it for five or six years now, right, this was not a quick process, not an easy process. So the other thing that I applaud our leadership team is that we've we've taken really good opportunity to celebrate success along the way recognize outstanding performance, even in the development phases, right? Because there were so many critical and key milestones to keep the project on track that we needed to, to align to that, you know, we took the opportunity to celebrate success along the way. And I'm sure now that we're on the commercial side of the equation, right, there'll be lots more celebration of successes going forward. But that's a really important part, right. So, you know, I think we've been really good about communicating really well, listening to these organizational cues and reacting to those appropriately, you know, offering the right and frequent touch points around training, which are really important, and then again, tried to make sure that we continue to reinforce what we're doing and why we're doing it, you know, by celebrating the successes. So, you know, that's been kind of our model, I think it's worked really well. And I know, we're gonna continue to watch for the next round of change. Because if there's anything I've learned in these 31 years, Pat, right. Change is constant and medical device or medical technology, right? Don't sit around and wait for it to happen. Because if you are it's probably happening around you. Right? So change is a really important part of this business, as you know.

Patrick Kothe 48:56

Yeah. And the old saying, either you change people, or you change people. So if if this is, if you're looking at it, your back, looking back at the change process, was this a really hard thing to get people internally to do you have having this customer centric approach? Was it easy? Or was it more or less a routine type of change?

Rich Wintersteller 49:31

I think I put this high on the difficulty scale, right? Because this this was new for all of us. Right? This was something that intuitively made so much sense but to be honest, we didn't know how to do it. Right. We had not really done it. We had not really done this transformational change internally that we knew that this was going to take so it was pretty hard. And I would be misrepresenting the facts. If I told you when perfectly according to plan and we hit every We milestone on time. And there wasn't any fierce debate amongst the teams. And you know, all that stuff took place. Right. But it made us a better organization. I think we've certainly, we've learned from our mistakes. And there were some mistakes made along the way. I mean, yeah, we're a much better organization, this side of all this change curve, and we were, we're on that side for sure. There is no doubt about that. My mind. You mentioned

Patrick Kothe 50:22

earlier about customers giving feedback and it wasn't accepted. And I've been in those meetings where people inside the company think they know better than the customer. Yeah, they said that, but you know, this is really the this, I imagine that you had some of that going on as well,

Rich Wintersteller 50:43

we certainly did, right? We have some very experienced tenured, smart and talented people on our research and development teams, they are intimately involved in every single detail, as you can imagine, of this project in their area of expertise. So they, like not unlike us, right, everybody has opinions and probably strong opinions. And, you know, they had theirs that didn't necessarily line up with the customer viewpoint.

Patrick Kothe 51:08

But in some instances, it did. I mean, and that's been my experience, too, is somebody's got to make the call, you're getting conflicting customer input into something, you know, I want this, I want that we can't do both, we've got to make an informed decision on which way to go. So somebody's got to do that. And that's where experienced medical device professionals can Can, can sift through all the information and keep their eye on the ball, what is going to be best for everyone, not this person, not that person, but for the market in general, for the patients, for the majority of physicians, and you got to make that call. And sometimes it's the right call. Most of the time, it's it's the right call, sometimes it isn't, you know, we all make mistakes. But if you take that approach, listen to all that feedback, and have good professionals inside to sift through it. That's when you get the get a killer product.

Rich Wintersteller 52:06

Yeah, that's really well said, really well said. So

Patrick Kothe 52:09

I want to just ask you a kind of a final question, as we're summing this up. And it has to do with leadership and has to do with change management. We've We've talked a little bit about, you know, managing the change as an individual. But we all are in leadership positions, we all have opportunities to be a change agent, we can go about and say this is what we will do, you will do it, you will, you'll do it tomorrow, which isn't necessarily a real good approach to it. But there's certain things that we do as leaders to help that change process. What did what have you learned about that, and, and some best practices when you do have change that you want to implement, and you want to bring people along at the right pace. And that's

Rich Wintersteller 53:02

the key have to bring people alive, I think so first of all, recognition, that this will be a journey, whatever any organization or anybody that may be listening out there that change is a process, it will take time. And you have to think from almost an evolutionary standpoint. So I think you need to recognize that upfront, right? That's, I think, the first step of the process. To me, the simple answer, it's all about communication, honest, open, transparent and frequent communication with the organization, some rationale as to why that you feel as a leader convicted, that the change is necessary and right, they may not always agree. In fact, did you know that most times, some constituents don't, but you have to have conviction as a leader that you're moving the organization in the right place, and then you've got to listen, right? So it's communicate and listen, communicate, and listen and get the feedback and recognize that people evolve on this change curve at their own pace, right. So I think you as a leader, need to kind of look for those cues, organizational cues, that the organization is kind of ready to move on to this next piece of the change curve, or maybe you gotta backtrack and, and reinforce the message again, or re educate, or I talked earlier about reinforcing maybe more training. And, you know, I think the other really important part you said it is, you know, this idea of bringing people along, I think bringing as many people as appropriate into the actual change process from the beginning so that you have some constituents that that understand because know that you cannot be the single messenger of change, right, that you need people in the organization to help you move the organization through that change curve. So strategically, having some some folks within the organization that you may recognize, move along this change curve a little faster and actually can help you articulate this change processes is a really important processes are part of the process. I think

Patrick Kothe 55:02

what you just described, also describes user centric design.

Rich Wintersteller 55:09

Funny enough, right? Funny enough, it does.

Patrick Kothe 55:14

Rich and livanova team took on two huge projects at once a major new product development program, but also a major internal process improvement of the two, I predict the Process Improvement Program will have a greater impact on their long term success. I hope you're looking for process improvements that are as impactful for your business. A few of my takeaways, first steps versus leaps. Sometimes, a step wise approach to product improvements, is the best way other times is leaps. I encourage you to think strategically about when a step is appropriate. But when a leap is warranted, some of the things that I think you can look at when talking about you making that decision is has the environment changed? Has it changed significantly? Is there some new technology that's available that's going to open new doors for you? And what's the competitive situation look like? Are there some major changes there that you can take advantage of either as in a stepwise approach, or as a leap? What's going to get you further down the road. The second thing is managing change. And we talked all the way through this about changing these processes and what managing change looks like some of the things that that he discussed were sharing your vision, but continue to check back make it a clear vision, but check back and make sure everyone is getting it involving others in the planning, educate, then re educate, continue to educate, bring them along at their own pace. But be realistic, you want to have changed, embrace quickly, but be realistic and make sure that you're bringing the team along and you're not out there ahead of them with nobody else following finally, collaborating with other companies. I found this to be very encouraging to hear him talk about how collaboration is working with other companies that are in in that space. If we continue to focus on what's best for our customers, work it out with other companies. If it's better clinically, we need to find a way to get it done. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast wherever you get your podcasts. Also, please spread the word and tell a friend or two to listen to the mastering medical device podcast as interviews like today's can help you become a more effective medical device leader. Work hard. Be kind

 
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