How Cross-Training and Extreme Ownership Help You Advance Your Career

Written By Patrick Kothe
 
 
 
 

Rollie Calrson is the CEO of Immunexpress, a company that is pioneering technology that can rapidly detect sepsis. Rollie contributed to the success of Abbott Laboratories for 20 years, starting off in R&D, then transitioning to leadership positions in global businesses and start-up ventures. His attraction to start-ups led him to become CEO of Asuragen and then WaferGen Biosystems. In this episode we discuss how he prepared for new opportunities, the benefits of extreme ownership, balancing company vision and mission, alignment of everyone in a company, why sepsis is such a big problem, and what Immunexpress is doing to help clinicians better manage sepsis patients.  

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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.

[00:00:00] Pat Kothe: Welcome! I'm fascinated with how leaders learn and develop. And then the paths they've taken to get where they are today. In medical device, it's common to see people taking on new challenges and moving up within their own company. It's also common for people to move to new opportunities and join teams and companies of the same or different size. Some skillsets transfer. However, some did not. What can you do to assure you're preparing for the broadest set of opportunities? Well, we're going to explore that in today's conversation.

Our guest today is Rollie Carlson, CEO of Immunexpress. A company that's pioneering technology that can rapidly detect sepsis. Raleigh contributed to the success of Abbott laboratories for 20 years, starting off in R and D then transitioning to leadership positions in global businesses and startups within Abbott. His attraction to startups led him to become CEO of Asuragen and then WaferGen Biosystems. In this episode, we discuss how he prepared for new opportunities, the benefits of extreme ownership, balancing company, vision and mission, alignment of everyone inside a company, why sepsis is such a big problem, and what Immunexpress is doing to help clinicians better manage sepsis patients. Here's our conversation.

Raleigh, the first 20 years of your career was spent, at Abbott, large company, large resources, and then you transitioned out of there into startup world. So tell me a little bit about why you did that and what drew you to startups.

[00:02:22] Rollie Carlson: I went into Abbott actually on the R& D side. I was a marine biologist by training, PhD, and Abbott was interested in looking for natural products from the sea for their pharmaceutical programs. And, what Abbott was able to do is provide resources, much broader than what we have right, right now, and to be able to fund basic R& D, but at the end of the day, it was really get a product out. And during the course of my career in R& D, Abbott was a great learning um, venue for me, in the fact that, practicality of developing a product was something, and using the product by the customer and fulfilling a customer need, uh, was really ingrained in the culture there. What Abbott really represented was a diverse health care company, and then for me, it was one where I could transition from leading R& D programs into actually leading business units there.

And I really love doing that. I raised my hand for a lot of opportunities. Took advantage of the diversity where I had both pharmaceutical businesses and diagnostic businesses and the last business opportunity I had at Abbott, the president, Rick Gonzalez, who's now a CEO of AbbVie at this point, we acquired a small company called Vysis in the Chicago area and Vysis was a molecular diagnostic company, fast growing and had a very strong brand.

And really focused on oncology and genetic disease testing. And Rick asked if I'd be interested in joining that company, running it as president, as an affiliate of Abbott. But unlike what we normally do, which would be to assimilate and indoctrinate business into the Abbott culture, it was to be run separately.

And so that was a great opportunity. We had, myself, one finance person, one R& D person sort of parachuted into a company of a hundred, uh, people that were quite entrepreneurial, very passionate about what they were doing, and they were on a growth trajectory. And it's how could I be able to help resource that?

And how could I be able to take advantage of the infrastructure of Abbott, and to be able to grow that? And it was really rewarding, and we, ran the company separately. We did take advantage of internationally and other opportunities that Abbott resources that we had, but grew the company at a growth rate of well over 60 percent per year, and, developed and got FDA clearances for some key products. One for breast cancer diagnostics, path vision, and probably one of the most successful molecular diagnostic products called Eurovision.

We grew to the point where we had to be assimilated by Abbott into Abbott Molecular. And I was being offered some great additional opportunities at Abbott, but they were to be leading a large organization, uh, 500 million plus, you were responsible for that business. But as I had learned, if you wanted to move in a direction, steer the ship, to, to 60 degrees or something like that, it might take six to nine months to be able to do that.

And the culture that I found at Vysis was that you could take action, be quick on your feet and be able to change direction if necessary, which is very important in biotechnology because the best laid plans aren't necessarily the way it turns out and you need to be able to adapt to the marketplace.

So I actually looked at my career and I said I could be very successful at Abbott and continue. It's a great company. Still is. However, for myself and fulfillment for myself, I like to be on the other side and be able to grow something and be part of the beginning of a technology group and, see what I can contribute.

[00:06:15] Pat Kothe: The way companies are managed and who's managing them is, it's always interested, uh, me and where they're coming from. There's a lot of finance people who run companies, people come up on the marketing side. It's my impression that not as many R& D folks come up and become the CEO of the company. Is that your impression too?

[00:06:37] Rollie Carlson: I would agree as far as small companies, startups, many times it'll be technology founder. in, in that regard, but really when you're moving into the operating side and, the company I'm with right now, it's an example of that. the founders, uh, uh, did a great job as far as developing early stage, you know, technology, but it's really implementing that as far as being successful and having adoption in the medical community.

And generally RD people don't have that, uh, experience, you know, when they are going, and developing their careers. Fortunately at Abbott, which are going back to, you know, with Abbott inside my first product that I developed, they said, well, congratulations, here it is, you guys go launch it.

And it was management philosophy was, oh, contrary, you're staying with this product and you're going to be out there for two to three years, you know, it's helping to support that product and find out. what's working and what's not. And it was really useful because it really made you think, uh, much deeper when you develop the next product, as far as what sort of, product need market, inputs that you need to have to develop that, uh, and made, made you better and stronger from an R& D perspective, but the fact that I had the opportunity to work for two to three years, on the front line with sales, with marketing, and certainly at Abbott, which was very fiscally, conservative and measurement oriented, put it that way, you really had to have results. And so, As a consequence of that, all those other inputs and necessary abilities, if one could be able to develop that are the ingredients, I think, for being a successful CEO.

[00:08:16] Pat Kothe: Do you remember back when they said, go ahead and take the commercial side of it? What were you thinking at that point? Was it exciting? Scary? What was it like?

[00:08:25] Rollie Carlson: it was exciting and scary at the same time. I mean, I actually, it was a circumstance where, our commercial leadership had moved on. and there was a void there. Our product was really taking off and I was really. supporting that. And I raised my hand. I said, you know, I can do this.

And, and quite frankly, I was, rolled out of the office a couple of times by the president of the division, but I think that, after, some unsuccessful candidates came in, then they, uh, were willing to take. Uh, a shot and let me have that opportunity. And so it was one where I think that, really working in conjunction with marketing, you know, there's certainly sales is important, but having a plan and being able to, to arm, arm the salespeople, with the right tools, which in biotechnology is going to be technical, but it's going to have to be something that's going to be simple enough.

You know that the medical community sees what the value is and can you can adopt it in the whatever that medical paradigm that you're trying to trying to improve.

[00:09:29] Pat Kothe: So, this was back in the 90s?

[00:09:31] Rollie Carlson: Yes. That's right.

[00:09:33] Pat Kothe: Back in the 90s, um, marketing and R& D had a handshake, but they weren't tied in, in general. They weren't tied in together as tightly as they are today. At least that's my experience. When you were, transitioning over to this, is this something that you saw that you needed to do from a career development standpoint, or was it just a opportunistic thing? I mean,were you actively managing your career and wanted to get that downstream experience? Or was it just this opportunity was there and said, Hey, I can, I can do this.

[00:10:10] Rollie Carlson: Well, it was both. I think the motivation was I wanted this. I had put a lot of time and effort in my R& D program to develop a product, and I didn't see that it was being positioned correctly. And I thought that and I wanted it to be successful. from my perspective, from a somewhat selfish standpoint, I'd, you know, you know, This is a great product. I know it can be successful, but it's just not being stewarded the right way, you know, from that standpoint

[00:10:40] Pat Kothe: I trust me. I don't trust you.

[00:10:43] Rollie Carlson: Exactly. And so what happened was, is my transition was, okay, you can lead the marketing group and the sales group will be independent of that. And to your point where the R& D and marketing

weren't in sync necessarily with 1 1 1 another. That was my job. I knew I had to be successful to that and we were very successful that regard evolved where I was able to take and run the whole business unit.

[00:11:11] Pat Kothe: So for someone who's in a, in their career right now and they could be in the marketing track, they could be in the R& D track, could be in the quality track, what do you think about cross training or what's your opinion on cross training and getting experiences outside of your, your, your chosen track?

[00:11:33] Rollie Carlson: Oh, I'm a huge advocate of that. And almost all my organizations, you know, that you talk about getting out of your comfort zone. And typically, you know, as one, I'm a marketer, I'm a quality regulatory person or something like that. And people just don't really think about that. But If you can have diverse, uh, uh, you know, experiences and be able to integrate, not only your, what your foundational, expertise is, but then be able to expand that,into other domains, It's very useful. It's very useful from an individual's career perspective because it become more versatile, you know, overall, I think, from a business standpoint, it helps the business because then you're not only looking at from the lens or silo of your domain, you're looking at it from a more comprehensive business perspective.

And then it gets more alignment, within the organization, because we're here to have goals, to be able to accomplish something, and we're all sort of in the same boat rowing together.

[00:12:34] Pat Kothe: it really is walk a mile in my shoes. Yeah, so you don't understand my problems You don't understand my limitations, you don't understand my passions now getting in there And understanding it from somebody else's viewpoint. It will help you as you start to manage things going farther and farther along Yeah so you Identify that, this is a passion of yours.

You don't want to, you want to make sure that you have, Immediate impact and decisions are not the six to nine month decisions. You can have immediate impact and be nimble and the startup side kind of worked for you. When you moved into startup land, it's a big difference.

Abbott's got all of those dollars behind you. You just go shake the money tree and stuff falls off. Not quite the same in startup land and resources as well. what was that like when you moved? into the startup world.

[00:13:33] Rollie Carlson: Well, fortunately, I did have that Vysis experience. So I really was that was a very good sort of transition experience for me overall. I went to a company called Asuragen, which was just starting up. It was a spit out of a company called, uh, Ambion that had been purchased by applied biosystems.

The founder really had core technology that was very exciting. Uh, micro RNAs for both therapeutic and diagnostic purposes and wanted to have somebody who was experienced in both pharmaceuticals and diagnostics, which is me. And when I interviewed for that, that job, I was in Austin, Texas, and, it was interesting that the founders said, well, here's our business plan, read this, tonight and then, let's talk about it tomorrow.

And let the let's talk about it tomorrow was a group of, uh 10 people who had developed this business plan around the table, and asked me, what did you think about it? And at first I said, um, and, and what I have found, which is really, the core attribute, I think of a small company is highly aspirational, and very much, looking for shooting, you know, shooting for the, for the stars.

But I asked them, I said, great aspiration, but I think you guys are smoking something from a business perspective, because, you know, we're not going to be 10 million in two years, based upon a new technology that nobody's ever seen before, and never been clinically validated, and, that was not the answer that they wanted to hear.

There was no question about it. There are, you know, better markets that you want to be in, are there bridge technologies we can do if this is a foundational, core technology, we're going to need to be able to develop it. It can do a number of things, but we have to get to know, uh, as far as, uh, the, all the opportunities for that and really focus in that regard.

Um, and I came back in Chicago and I told my wife, that's a job I won't be getting. And I got a phone call and I moved to Austin, Texas and joined the company.

[00:15:42] Pat Kothe: Let's talk a little bit about vision and mission because, in the startups, when you put that vision statement down and it is aspirational, it's who you want to be when you grow up. but you never get there unless you can dial in on the mission statement very So when you're in that type of position, as the leader of the company, you want to have you have that vision.

How do you? How do you dig down and how do you determine what that mission is?

[00:16:10] Rollie Carlson: Well, I think the mission, you have to keep the, um, frankly, the end customer and market in mind, and then how are you going to be able to, to access. You know, access. I mean, if we had a vision of being, you know, the micro RNA company, you know, and for medical, for medical solutions, and then it's like, okay, what are we going to how, how and what are we going to fulfill in in that regard and the how and why is what you have to build on. At Abbott when I was a scientist there, basically I was advised and You know, innovation is very important, but you need to be an Edisonian type of scientists.

And what does that mean? Well, it's 10 percent is the innovation and 90 percent is the perspiration of being able to make that happen and make that reality. And so you have to be able to build the scaffolding and the house by which everybody's going to be working under, to be successful. I think the mission is everybody needs to understand and believe in it, you know, because if they don't, if they're here and it's, it's a difference. I mean, Abbott, there's no question. uh, the intent of the whole organization was to, uh, provide, you know, newer, newer innovations and products to help healthcare, you know, on a broader basis, but owning it, you know, perhaps not everybody owned it, you know, and then the smaller company, uh, everybody needs needs to own it, or they may not be in the right, right place.

[00:17:40] Pat Kothe: think a lot of us too, as, leaders within companies, you get tired of saying the same thing, but unless you say the same thing, it doesn't get lived. And a mission statement is one of those things where, you know, you annually, you look at your vision statement, look at your vision, your mission statement and say, okay, these are what we want to be.

And you put the, put that back. Everyone wasn't in that room developing that vision and mission statement. And everyone, doesn't hear that routinely. And if you don't hear something routinely, it doesn't become ingrained. So it really has to be strongly and repetitively put out there in order to filter it and make sure that it gets across to everybody in the organization.

[00:18:26] Rollie Carlson: As you get products into the marketplace and, um, you know, Asuragen, was one that had multiple products, but we, but as they were in the market and making a difference, we had employee meetings and then we would actually have customers come in and tell us what the, the value of the technology, and products that we had brought to their, their, solution and for their health, healthcare, situation.

And in some cases patients, you know, that were, uh, positively impacted. That's where you want the organization. Actually, yes, leadership has to be able to repeat that. But hopefully you want the organization, you know, uh, adopting it and promoting it themselves.

Andand different ways that you can be able to have that occur. I think is really important. And even if you don't have a product on market about, somebody coming in and understanding, here's our medical need. This is what we need. If we could have this, we could have that, the marketing people who are looking at product market fit.

Certainly they, they're doing that type of research, but for the organization to understand that, I think that's. that helps. And of course, the smaller the organization, the easier it is to do that. Yeah, there's no question.

[00:19:40] Pat Kothe: Absolutely. so we've talked a little bit about, new, newer technologies and value creation based on new things. And as an R& D person, I'm assuming that's one of the things that, that's at your core.

[00:19:55] Rollie Carlson: Absolutely. I mean, for me, the, intersection of novel technologies, that could potentially be a new solution for, a classic medical need, that's really the jazz. And it's also the challenge, you know, because, particularly, if you're bringing a technology that's going to change medical practice, that's not easy to do, you know, because medical practice is pretty ingrained, and many times generational, uh, overall.

The opportunity is there for a new technology, but the, the challenge is, is how, how are you going to be able to make that successful?

[00:20:30] Pat Kothe: Ideas come from a lot of different places. They could come from, a technology that's been developed, in another field that could be applied to yours. It come, can come directly from the customer. It can come from ideas that people inside a company have. What do you think about capturing these ideas?

What's the best methodology that you've seen to capture different ideas to get to that intersection?

[00:20:59] Rollie Carlson: Well, capturing... I do want to say first is that many times what is thought to be a good idea may not be right for that time. And sometimes actually what are thought to be two bad ideas can come together and be a wonderful idea, in that regard and I,

[00:21:17] Pat Kothe: like the, that's like the post it notes from 3M. it was a poor adhesive that caused that to happen.

[00:21:22] Rollie Carlson: Well, yeah, exactly. And so it may not be right for the time might be later per later, or there's a necessary element of this that has to happen for this idea to be able to be potentially viable, in that regard. And I think that, yeah, for capturing that, certainly we, you want us to be able to set aside for, for brainstorming, in that regard.

But when you're in product development, then you're in a situation where you really need to be really structuring all of that, to get to answers. Yes, no answers and no could be just as good as yes, because you could spend a lot of time, a lot of money, and trying to, overcome something where, you know, perhaps, yeah, you can't do it. Or maybe the best thing to do is pick up the phone and try to partner with somebody that might have the capability of that particular element to do that. And that's a challenge for not only large, but particularly small organizations, because, there's a strong sort of not invented here type of attitude here.

NIH factor, I would say, and you can't afford that. You can't afford that in a small company when your resources are limited, and you're also under the time crunch. I mean, you need to get something, you know, that's going to be, a quality product out in a short amount, as short amount of time as possible.

But the worst thing you can do is be able to come up with something that doesn't fulfill a market need. You spent all that time, all that money, and then, you're struggling to keep the company going.

[00:22:50] Pat Kothe: Rollie, I want to ask you a little bit about research and development. Two different words, research and development. and how... R& D is different in a large company versus a small company, a startup company. Is it different and how is it different?

[00:23:10] Rollie Carlson: Well, it, it is, and it depends about the company though., From a company perspective, uh, R& D should be little R and big D, from my perspective, and, uh, and you look at, obviously, your budgets and what sort of proportion, in large, in, in larger companies, there's a tolerance to be able to have of your R& D budget, so to speak, have about 20 percent of that, uh, be in the R, uh, world..And then the rest was associated with, with, with development. In smaller companies, hopefully the R, the initial R has been done, you know, and so you've got the essence of what that is, and the challenge is, is to get out of that R mode and into development and do you have the right people to do that?

And in many cases, smaller companies don't. Andyou're, you're really getting into the factor where, and this is a founder syndrome, you know, quite, uh, I see many, many, many times where. This is great technology. It'll sell itself, and you look at all the things that need to happen in between and in the true development side side of things that have to happen.

Development is going to consume most of your budget. You have to make sure that you're on the right track to have something successful. And from my standpoint, the. Thank you. Moving from R to, to D is, you have to get across what I call a feasibility threshold and feasibility is really a proof of concept because if you can't, if you can't do that at that early stage, you're not going to be on the right track, from a development standpoint, and if you can't, and if you can't do proof of concept, You know what, that idea, that concept, you need to kill it, or change it, or do something, you know, take that other idea and merge it with it and make it, uh, make it better.

[00:25:04] Pat Kothe: I've always found the R& D, name, To be a little bit off, because a lot of the research that we're doing is not research into how to manufacture something or the properties of a material or anything like that, but it's research that's done into the application of the product. It's research that's done into what the physicians want, how the workflow works.

It's those types of customer discovery things, which often don't reside within the R& D department. They may reside in the marketing department. So it's, you're doing research, but it's not the traditional R& D department's responsibility only. I mean, they have that responsibility too, but other people are doing that research side as well.

[00:25:56] Rollie Carlson: Yeah, and clinical research too, medical clinical as well. The vast majority of technologies that, um, you know, for example, you know, Abbott, which became AbbVie. I was on the acquisition team at Abbott when we were looking at, at buying a BASF specifically for, Humira, which was not cleared.

It was, we had an R& D team, that was looking at auto immune diseases, really knew that, uh, anti alpha. F uh, factors were something that were the future. Did we discover any of that? No. We just we knew the science and we knew, you know, we were looking at what's the best one that is out there. And you look the first, you know, fully humanized antibody that was out there, you know, uh, in Humira, uh, that was the catalyst for us converging.

Which was, you know, one, do the deal, and the other is put that into your clinical development program,and then, what else, would complement that from a, uh, uh, from the next, you know, what would a drug candidate, you know, for example, and you build, and you build a franchise, uh, in, in, in that regard.

[00:27:03] Pat Kothe: So we spend a lot of time in the R& D side, that's your heritage, that's your background, but you're CEO, you've been CEO of a company, President and CEO for a long time. Let's talk a little bit about, about being a CEO of a company, because you've had the opportunity to be a CEO of a private company as well as public, companies.

Tell me a little bit about that and how it's different, how you do your job differently as a publicly traded, CEO versus private.

[00:27:35] Rollie Carlson: Well, of course, responsibility of a CEO, whether it's private or public, is making sure you have adequate funding and raising money, you know, uh, and in that regard and, um, and when you're private, you're generally in the, the venture, um, and private equity world, um, and you have, Hopefully, in general, your investors are, uh, understand what you're doing and, uh, and know, and, and know what the milestones that might be associated with that, uh, when you're publicly at a NASDAQ company, um, which, Wainbridge and Biosystems in the Bay Area, um, which had great technology, uh, in fact, probably the most sophisticated technology that I've, I've been around and had to manage a single cell analysis, being able to do a whole genome from a single cell.

But my investors didn't understand, uh, you know, what we were doing and I had to spend more time,the reporting responsibilities, all of, all of what's necessary to stay, you know, on being a listed company, uh, on a quarterly basis was, was time consuming. And you had to spend a lot of time with your, uh, investors, uh, on the one hand, If you needed to raise additional money, you can do, shelf registrations.

There's a completely different process, uh, that, that you do and it, uh, you, you can get, um, access to resources, uh, and if you're publicly listed, um. As long as you're performing, you know, uh, I'd say, uh, easier than a private, private company and particularly at this time, in, in, in this day and age here, when, really investments in private companies, are very challenging.

[00:29:17] Pat Kothe: One of the other challenges that we all have, whether large companies, small companies is building the team, managing the team. How's it different in an Abbott when you're hired, hired a lot of people and you've got, a lot of resources to do it. And you, and it's a certain type of person that likes to work for the big company, and then there's the startup.

How is team building different in the big company versus the small company?

[00:29:43] Rollie Carlson: We talked about vision and mission, and I think that it's harder to do that in a, in a larger company, uh, and try to get everybody, to be, uh, motivated the same way, you know. Um, there's also, job security factor where, particularly in the past, it was viewed as a lot larger companies there was more job, job security. So therefore there, they were in, employees would be insulated, and Abbott, we were very much, we always went through what we call every year an organizational inventory, OI review. During that, we would look at what, you know, you classify your, your organization and you try to find out who's your top 10 percent or performers, you know, and the top 25 and what they're contributing, et cetera, along those lines.

And we were actually challenged that in our top 10 percent percenters, that. You wanted to give them other opportunities, and many times that's outside of your own business, which was, you know, incongruent with you as a business manager saying, I need that person to be successful.,in that regard,You want to have top performers in whatever organization you have.

But I think that when you get to smaller organizations, you, You have to wear so many more hats than you do in a larger company. You know, we talked about being siloed before. You can't, I mean, I'm wearing more hats now than I think I've had in many, many years, you know, uh, in, in that regard.

Because, Yeah, certain functions. You may not have the representation that you you are used to having or experience, put that way.You look for people in your organization, in a larger company, you're really looking for him to fulfill that position and that domain expertise.

Whereas, you know, in a smaller company, it's okay. They have to have obviously some domain expertise, but what else can they contribute to? My current company, for example, it was really a discovery, a discovery and development biomarker discovery development company. But now we developed the product.

It's in the commercialization, uh, stage, uh, many of the individuals have never gone through sort of that transition from development to be in commercial. Um, and, uh, one has to be able to, one, are you willing to embrace taking on other responsibilities? And so this is not in my domain. In smaller companies, uh, there's certainly a willingness for that.

And that goes back to the passion, the mission, everybody on board. I'm pleased to see people are doing things that they haven't never done before, you know, and they're starting to excel at that. And then,the company's expecting an employee to be able to contribute.

We might give them, options or equity and things along those lines, but it's really important for each, uh employee, an individual to build their own equity. And by, I think the way they build their own equity is to have more of that diverse sort of experience and under their belt that they, they have capabilities in a number of different domains.

That will help them not only in their current job, but when they're looking at the next, next opportunity. And, you know, nowadays, um, that job security, whether it's a large or small company, uh, is, is, is no longer really the, an assumption anymore that way.

[00:33:05] Pat Kothe: When you were describing, early on in your career, you had that extreme ownership and you wanted to make sure your product was done right. So you stepped out and you benefited by that. And then as your company grows, your job as a CEO is to fire yourself from other jobs. Okay. I'm growing, so now I can bring somebody in to run the marketing organization, sales organization.

All of these different things, you're, you're, you're doing it. But the bargain that you made with the company is you have made it successful and you have built not only the company, but you built things into yourself that allow you to take that out into other areas. And you're more valuable to other companies by having that breadth of experience.

[00:33:49] Rollie Carlson: Yeah, that, that's a good summary. Very good. Well,

[00:33:53] Pat Kothe: So let's talk about your current company, Immunexpress. Very interesting space that you guys are playing in. So tell me a little bit about the company and the problem that you're solving.

[00:34:08] Rollie Carlson: Immunexpress based here in Seattle, um, or, uh, A private company and we're a small company and, we've been working in, uh, in the gene discovery world for a number of years and a lot, a lot of that technology was founded in, in, in Australia and we're looking at actually human host response to infectious disease.

So we have discovered, uh, novel genes, uh, that are associated, um, and expressed either over expressed or under expressed, due to a path pathogen infection, but not just a pathogen infection and pathogen infection. That leads to sepsis. And sepsis is what our focus is. And we, we are looking at trying to, trying to work on technologies and products, uh, that can detect sepsis early because sepsis is a dysfunctional, host response, uh, to inflammation, that results in organ dysfunction and failure and, and death. And many times what looks like you can detect sepsis in the late stages, certainly, but you can't be able to intervene at that point. Or the mortality rate is very high or morbidity rate is very high.

And we all know examples, I think, uh, of that. It can lead to severe amputeeism if somebody survives. It's a worldwide problem. In the U. S. It's the number one cause of death, uh, in the hospital. It's also the single greatest expense category, even though it's only represents about, you know, five or five to 6 percent of cases and in the hospital. And as each hour goes by and one does have sepsis, the probability of mortality goes up by 8 percent per hour.

So it's very important to be able to catch it and catch it early. And quite frankly, there aren't technologies that are out there. What we have developed is what we found was that if a human has an infection that's leading to sepsis because there's certain genes that are cer that are over expressed on white blood cells.

But early stages of sepsis looks like what is called systemic inflammatory response syndrome, or SIRS uh, which looks like sepsis with a, a path pathogen, but does not lead to that. It's,it's an ephemeral inflammatory response. So with sepsis, what is essentially happening is your immune system is overstimulated.

You start going down the cytokine cascade and that results in organ failure. So we found that if a human has SIRS, systemic inflammatory response syndrome, without an infection, that there's certain genes that are downregulated. So as a consequence, what we did was we actually went through hundreds of genes and narrowed it down to a two to four marker system that if a patient is infected and it's leading to sepsis, that gene is overexpressed and the other genes don't move at all.

And if indeed they're having a systemic inflammatory response, then. that gene does not move at all, and the other ones actually are down, downregulated. So we're, as a consequence of that, the difference between those genes expression, we can come up with a prediction of likelihood of sepsis. And, that's what we developed, uh, that's what we, uh, got FDA cleared, uh, in, uh, the end of 2021.

And we're in the midst of commercializing.

[00:37:53] Pat Kothe: Let's go back for a second and talk about current technology and how things are done. So somebody comes into the hospital and they've got an infection. and tests are run. So at what point are they saying this person is septic or not septic? What's the current testing methodology? What's the current diagnosis of sepsis like?

[00:38:16] Rollie Carlson: It's a challenge. And so if a physician right now has to be able to look at multiple inputs to make a determination as to, as do they think that this is probably sepsis, they'll look at white blood, white blood cell count, they'll look at fever, tachycardia, lactate levels, uh, perfusion, um, but the, the really there's no gold standard.

And so they're looking at about 10 or 12 inputs and trying to make that sort of determination. If there is a gold standard, it's called, it's blood culture. And so if I suspect that this patient, is becoming septic, I'll take a blood draw and be able to culture that up. And I won't get a result for maybe 18 to 24 to 48 hours, if at all.

In fact, research shows in our own clinical studies that even when somebody is sepsis with a bacterial infection, septic with a bacterial infection, you only get a positive blood culture back about 15 percent of the time. So, in the meantime, physician basically, when in doubt, I'm going to treat as sepsis.

And, certainly if there is sepsis, uh, occurring and it's due to a bacteria, administration of antibiotics is very important to get on and do, and be able to have broad spectrum antibiotics, immediately. But large epidemiological studies have shown that 43 percent of the time when a, a physician has admitted a patient to the ICU and said, this, this patient is septic, 43 percent of the time they did not have it. So therefore, you've got other itiologies are going on. that patient is sick, but they're being treated for sepsis. And so one, you're ignoring what it, what else is going on. It could be, it could be cardiovascular. It could be, brain bleed, something, something else in that regard that needs to get treated.

And treated a different, different way.so, so it's very important to be able to rule in sepsis, uh, and at that point in time, then yes, indeed, you do start your broad antibiotics. And at that point, point in time, you're being able to comply with what CMS says is that between one and three hours, you need to be able to, if somebody is septic, you need to be able to be administering a treatment.

But,In the case of patients that have kidney disease, for example, broad spectrum antibiotic could actually lead to mortality in and of itself. So it's very important to be able to, at that early stage, when doctors are really, essentially, it's a flip of the coin, to be able to rule in or rule out sepsis.

[00:41:02] Pat Kothe: I spent some time in the concussion marketplace and concussions are a constellation of symptoms is basically what it is. And it's similar here, sepsis is a constellation of other things that people say, well it's probably sepsis. Um, but we won't know until 18 hours, 24 hours till we get it back.

So we're going to, we're going to make a choice to start you on antibiotics or not start you on antibiotics. And what you talked about, with if someone is undiagnosed, they have sepsis, but it's undiagnosed every hour that goes by that you're not treating it. It increases the death rate by eight percent.

That's if we're looking at it from the sepsis, viewpoint. If you're looking at it from cardiothoracic or cardiac disease standpoint or cardiac event standpoint, and they don't diagnose the cardiac event because they think it's sepsis, well now you can start looking at what the, what the risk is for somebody that was not diagnosed for that.

So the key here is we're talking about how do you get a valid diagnosis as soon as possible so you can hit the disease or hit the injury with the appropriate treatment immediately so that you have better, better outcome. So it's all about the diagnosis.

[00:42:25] Rollie Carlson: Absolutely. You know, the, yeah, there's roughly 5, 000 hospitals in the U. S. and, uh, and they're within probably about 450, you know, hospital systems. And they all go about sort of their early diagnosis of sepsis differently. Systems typically have what they call a sepsis bundle, that if we suspect, uh, sepsis, we will do this, you know, uh, in that, in that regard, um, and there's versions of that, which many of that is, uh, driven by EMR systems that have early warning sepsis, uh, sepsis programs, their algorithms by, from Epic and Cerner, For example, um, that say they take those all, all those factors come up with the algorithm and they'll, they'll predict sepsis.

But what's going on now is, is, uh, we'll call it, you know, alarm fatigue. I mean, uh, the EMR is calling it sepsis. The sepsis team will be going there. They look at patient and indeed they do not have that. And so basically those systems are being turned off.But CMS is measuring every six months hospitals compliance with what they call the sepsis bundle.

Uh, are you administering and testing to make sure, that you're in compliance, uh,with, uh, triaging that sepsis patient? And when they met the overall nationwide score is about 60 percent compliance with that, and the range is between 20 and 80%, even within the same hospital system.

So what one really needs to have is in their sepsis bundle, a way to be able to early on be able to tell whether or not, uh, you know, predicted sepsis or not. And then you could be able to get that patient on, on the appropriate bundle. Or look for those other itiologies. And that's exactly how we're positioning, you know, our tests Septicyte Rapid, in the hospital, to be able to help improve, really compliance to your sepsis bundle and CMS one to, one to three hour resuscitation bundle.

[00:44:30] Pat Kothe: So what is Septicyte Rapid. Tell me a little bit about, the machine, the technology, what you're testing.

[00:44:40] Rollie Carlson: Sure. So what we're testing is actually the gene expression off of white blood cells. We're measuring messenger mRNA by a highly sensitive PCR test. When I first got into molecular diagnostics, if one was to do a gene test, basically, you had to have three rooms with about five different pieces of equipment, one for isolation, one for purification, one for amplification, and you had to make sure that there was no contamination at all.

So, uh, our test we've developed is actually in this cartridge in my hand, and this is essentially that whole molecular three, lab system in, in the palm of my hand. And in,

[00:45:26] Pat Kothe: For those that are, that are listening, uh, it's roughly the size of a, of two decks of cards. Put two decks, decks of cards on top of each other, that's about how big it

[00:45:35] Rollie Carlson: that's right. Absolutely. And this contains all the reagents that are necessary to be able to do the extraction, purification, isolation, et cetera, like that. And what we do is we take actually about one ml of whole blood. And I'm opening up what is a port on the top of the cartridge here that you would inject one mil of blood in, you close the cartridge up, then you actually put this cartridge in what looks like a, uh, uh, DVD, you know, uh, instrument, a tray, press the button, it goes in, uh, that's actually does the amplification and the PCR reading, uh, in and of itself.

And then, uh, within about one hour, you have a result. so you think about the current gold standard, uh, takes 18 to 24 to 48 hours. We can come and say, you know, this patient has a high probability of sepsis. So therefore, uh, rule in, get on this patient, you know, from a septic standpoint or a low probability of sepsis, which means you should be looking at for other, other itiologies.

[00:46:45] Pat Kothe: So, Raleigh, that, that cartridge,is specific to sepsis. Is my assumption that you'll have other cartridges for other types of diseases?

[00:46:56] Rollie Carlson: Yes, I mean, we're, we're staying within our, our sepsis, um, you know, focus at this point in time, but the follow on tests that we have is the next question is, okay, is, uh, you know, is it sepsis? And if indeed it is, what's causing that? And I think that everybody knows now that, uh, after the pandemic that, that COVID, uh, again, uh, obviously, uh, is something that we've all experienced, but about 30 percent of deaths associated with COVID were due to COVID sepsis, and viral sepsis was not on the radar, quite frankly, uh, as much as bacterial.

And sepsis can be done, may be due to both bacterial, viral, and fungal infections. but the next question from a treatment standpoint is, okay, if sepsis, is it bacterial or is it viral? Because you're going to do very different types of treatments, uh, modalities for that. And certainly if it's viral sepsis, it's a waste of time putting, you know, antibiotics.

Uh, administered to that, that, that patient. So we have, and we're developing that in, in, actually in the same cartridge. if sepsis, then is it bacterial or is it viral? And, uh, that's what's in our, our, our, our pipeline right now. And then finally, you know, we are able to determine if, if, if it's bacterial, is it gram positive or gram negative?

Because then, uh, you would administer different specific antibiotics instead of broad spectrum ones.

[00:48:24] Pat Kothe: So you received your regulatory clearance in the U. S., Europe as well,

[00:48:29] Rollie Carlson: Yes, now we have C mark.

[00:48:32] Pat Kothe: and, and this occurred in the middle of COVID?

[00:48:36] Rollie Carlson: Yes, that was a challenge. Um,We were doing our clinical, our final clinical trials, uh, when COVID hit. And. Uh, that obviously slowed things down because hospitals were being over overwhelmed with accrual of the number of patients that we needed.

But on the other hand, it gave us the opportunity where we had never, you know, the test was developed when there was no COVID. And then all of a sudden COVID is now as a reality and we know it's going to be a reality for some, some time. So how well does the test work with covid patients? So we conducted trials, additional trials with covid patients, uh, in both in Europe and, and the U. S. and, one, determined that highly accurate for determining, uh, covid sepsis as, as well, uh, and that was part of the submission. And then the other was actually, as you know, covid patients would show up in the hospital, covid positive, one didn't know whether or not they'd progress to severe covid cases or not.

It's very difficult to do that. And the test did a very good job of being able to predict who would end up in an ICU two or three days later, uh, in that, that regard. We finally finished our clinical trial, and then the FDA was only giving clearances to COVID tests, you know, at that point in time. So we had an extended review under, under that case.

But we were fortunate. We were one of the first tests that were non COVID, uh, that were cleared by the, by the. Uh, FDA. Um, and that was really at the very end of 2021.

[00:50:09] Pat Kothe: These are not point of care testing machines. They're, they're in, in the lab. Is that correct?

Uh, so they're not clear waived. Uh, it's, we, we say near to patient, uh, because it's, it's very simple, you know, one to administer one only has to be able to know how to pipet blood, uh, in, in that regard. So does a, does a, does a nurse, uh, draw the blood and then just send that, that vial down to the lab? Or do they put it into the, into the cartridge and send the cartridge

[00:50:43] Rollie Carlson: Well, that's a great question. In the U. S., many hospitals have what they call a stat lab, which sits between, uh, the, uh, E. R. and the I. C. U. Uh, so that's a very quick exchange. You know, we found that we, in our, our. Our work, we get a result back to the physician in about an hour and 40 minutes.

However, in Europe, uh, they're using it, they're actually putting the instrument, you know, right in the I. C. U. or the E. D. and there, uh, then, uh, you actually have both nurses and doctors that are actually doing the test itself directly themselves. That is very useful for them for fast turnaround, but for us as far as training and everything along those lines, we have to train a lot more people to be able to administer that versus a, a med tech.

[00:51:33] Pat Kothe: Yeah. the other thing I was wondering about is it's in the machine for an hour, so you may need multiple machines if you're in an ED that has multiple patients in there too.

[00:51:45] Rollie Carlson: the, um, instrument itself is, uh, uh, as a footprint, a little bit larger than a pc, a standard, uh, pc. And, um, there's a, a console that goes with it that can drive eight. Uh, instruments at one time, we think, you know, typically a customer and customers that we have have, uh, two to three instruments.

And so those are random access at that point in time. 1 is 1 is running another sample to come in. You can load that up and get that going as well.

[00:52:15] Pat Kothe: So, Raleigh, rolling out a diagnostic like this has got a couple of challenges with it. You have to educate the people that are in the lab. They're making the decision, they're the decision makers for it. But then training people to order that, uh, order that or to understand that that test is available is, is another part of the sale as well.

So what kind of challenges have you seen in rolling this product out?

[00:52:40] Rollie Carlson: Well, uh, well, 1st challenge was, is that, um, we launched, uh, the pandemic was still ongoing, you know, and so, uh, and obviously 2022 getting access to the hospital was very difficult. I mean, you could not get face to face with people as we typically would try to do. And, uh, you know, the issue is that in sepsis is really sort of a, uh, as you say, it's a constellation of symptoms, but it's also a team sport as far as you have, uh, both, uh, either a critical care doctor or, uh, an emergency, uh, department, uh, doc, doctor, infectious disease, critical care nurse, uh, and then you have the laboratory. So it's really important to be able to have education for all of those different disciplines. We have CME courses that, uh, we had for critical care nurses for describing sepsis and sepsis management and then how our tests, uh, could be administered, uh, society for critical care of medicine, uh, is one where we have, we have collaborators that are, Um, that, uh, one, our clinical trial sites, but then also now we're adopting as customers, uh, uh, provide , uh, webinars and seminars, uh, in, uh, in, in that regard.

Recently the CDC has come out, uh, with sepsis guidelines and one of their, their findings was, is that there's no single sort of owner of sepsis. Some hospitals have a sepsis coordinator, many, many, many do not. And it's really, uh, important to have somebody to have ownership. For us if there is a sepsis committee, then that's who we want to get in front of, you know, because that brings all of those different disciplines together because they're, they're the ones who put together what their sepsis bundle is and what they're going to apply that for

[00:54:36] Pat Kothe: I was recently, in the hospital with a friend of mine who had sepsis. And, for those of us in, in the business, we forget about what it's like to be a patient and what the patient's questions really are and who's managing that patient. Go into the ED. have a preliminary diagnosis, same exact thing as we talked about.

I think it's probably sepsis. Don't know, won't know for 24 hours, but just the amount of physicians and PAs that are coming in. There's not one person. There's a group that manages you. So you're trying to figure out which person you're going to see that, that person is now off for the next two days, now you got a new person from that group coming in. who's in charge of the PT? Who's in charge of the medical care? From a patient standpoint, it's really difficult to do that. but also it's who's driving the boat here? who's in charge of this? Because you get different people in charge of different things.

That ownership of whatever disease it is, is just so important and it's also important that the patient knows what it is. That's the practical side of it. The medical side is, you know, is kind of what we always focus on, but the practical side is as well. So having that one owner as, who'd you say CDC is

[00:56:00] Rollie Carlson: really pushing that.

[00:56:01] Pat Kothe: putting it as an issue?

Yeah. Having that one owner is really important.

[00:56:08] Rollie Carlson: Well, it's a real challenge for, you know, the, um, um, hospital, you know, clinicians, you know, uh, just in general. With the pandemic, I mean, there's been a lot of attrition, uh, as well, and many, uh, EDs and ICUs are actually short staffed as a consequence of that.Introducing something new, whether it's our product or any other new product into and into that backdrop is, is, is a challenge. And so it has to be a meaningful product for them to be able to, um, to, to, to adopt, you know, one thing you can have, like these sepsis owners and the sepsis committee and the larger systems have that, uh, but when you think about the a hundred bed hospital that is out there, uh, where they don't have the, that infrastructure at all, and we're seeing, there's a lot of interest in our tests and saying, look, we just, we don't have all this resident expertise, you know, we need, we need, they're, they're very focused on the patient, you know, and, and make in that determination, uh, you know, for us to make the call on sepsis is difficult for us to do.

So. A test like ours can be quite beneficial, you know, uh, for their, for their management.

[00:57:19] Pat Kothe: What has the response been?

[00:57:22] Rollie Carlson: As you look at for, for, uh, customers for innovative medical, there's always going to be the, the, the ones, uh, who are more entrepreneur and are interested in, in new technologies and evaluations of that. Uh, for us, uh, you know, we, we have customers in the U. S.,and in Europe. Many of them, even though it's FDA cleared, you have clinical trials, want to be able to see how the tests are, works in their systems. So we've got a number of, uh, uh, the processes. Evaluations, you know, and because this is in a CLIA lab, they have to meet their CLIA, standards. And I think that it's, you know, the diversity of hospitals, but also there's a diversity of needs, and you need to be very sensitive to, you know, what, what, what is your sepsis problem?

Do you have a sepsis problem? What is it? and certain institutional say it's our inpatient. So these are actually patients that are already in post surgery, things along those lines where we have a lot of difficulty. Uh, so therefore, um, what sort of studies do you have in that regard? Which we've published on. Others are about screening. Uh, This is not a screening test. I mean, this is where I mean, there's something, something going on there. Uh, so it's not like screening everybody who comes into the ED., For us, it's really, if you're thinking of doing a blood draw for, uh, that patient, that's when you really need to be looking at this test.

But use cases are very important. And so, uh, and different institutions have different needs.

[00:58:51] Pat Kothe: The benefits of a technology like this are so great. you think about the decrease of mortality alone there, but then you've got length of stay, you've got antibiotic usage, you've got you know, antibiotic resistance. You got a whole host of different benefits that kind of come in here. Who is the main decision maker when it comes to this? Is it the CEO who's, or the C level people who are looking at the cost side of it? Is it the medical management people? Where's the greatest benefit?

[00:59:29] Rollie Carlson: Well, I mean, there's, there's clearly a cost benefit for reducing length of stay, uh, has, uh, to, to your point. The critical care, um, uh, physician and critical care nurses, I think are central to, to this.They need the tools and they they, they have to have that.

From a finance standpoint, I mean, we have a unique, uh, ICD 10 code specific for the test. And, you know, if you look at, uh, the single largest clawback from Medicare and insurers, uh, for reimbursement. Uh, are related to the sepsis DRG codes, of which there's about 20 of them. And, uh, just back in, um, uh, before the pandemic, there was an audit, uh , of, of three states, and the clawback was in the order of 280 million dollars.

Uh, you know, and that's out of, out of pocket. The other is, if you look at sepsis is the leading cause of readmission. Uh, um, of a patient to a hospital, um, within 30 days. And if that happens, then it's, uh, the hospital eats the cost of, uh, care of that patient. CMS or insurers will not do that. So making sure that a patient, um, may not still have residual sort of sepsis, so to speak, at discharge is very, very important, uh, in that regard.

So, uh, as we talk to c-suite, CFOs really zero in on that, so do CEOs, uh, in, in, in that regard. And CMOs is very much about, you know, improving quality of care.

[01:01:07] Pat Kothe: Business model. Let's just quickly do that. So we've got a couple of machines are going to go into the lab and then you've got cartridges that, you know, I'm assuming you're charging per, per, per cartridge for this. Scope me about how much are we talking about for these pieces of equipment?

[01:01:27] Rollie Carlson: Well, the instruments are roughly about 50, 000 each, and the cartridge price range between 175 and 225. And, uh, I'd say that, you know, it's usually an early adoption. There's many, many cases where there's going to be a lease or rent of the instrument. Uh, and then that would be, uh, done at an upcharge for, for, for the cartridge.

Uh, and then as you get more adoption, then that, from my experience, you see a transition to where you get more direct capital purchase. Uh, from a capital purchase standpoint, that, uh, you know. That is something that doesn't necessarily fly under the radar, but doesn't really hit the capital review board, so to speak.

So you're not in that sort of annual cycle, so to speak.

[01:02:21] Pat Kothe: Is the, uh, is that business model common within the, the, uh, diagnostic space to have a cartridge to have capital equipment?

[01:02:30] Rollie Carlson: Yes. Yeah. Very much so.

[01:02:34] Pat Kothe: Okay, great. Well, thank you so much for sharing this information. Just a fascinating area, an area where diagnosis can make a huge difference in patient outcomes as well as correct use of medical care. To kind of wrap things up, I want to ask you a little bit about within our space. Um, you've got, some miles behind you as, as do I, and I've seen a lot of changes, not only within how care is delivered and how medicine is practiced, but also how companies, have functioned and how,we're all, different than we were years ago.

So if you're going to pick out a couple of things, in your experience that have, We've really been, extremely positive changes to either medicine, how medicines practice or how us, us as companies, uh, serve the medical community. What would be a couple of those things?

[01:03:31] Rollie Carlson: Personalized medicine is becoming more of a reality. Um, and I, I think that's, that's something that was an aspiration, I think, when I was, uh, in, you know, early in my career overall, but really not practiced as, as much. And I do think that if you see some of the breakthrough, uh, drugs, particularly like in, in, in, in cancer, for example, if you look at Uh, you know, CML management for leukemia, how now, I mean, basically, uh, in the beginning of my career, you had a situation where, uh, if you had that diagnosis, the likelihood of mortality within, you know, within three years was extremely high, uh, now, because of one, good diagnostics, understanding the genetic technologies, and one reason I enjoy molecular diagnostics and, and targeted, uh, molecular therapies are the fact that uh, you understand the mechanism you can be able to try to, uh, one diagnose, uh, in this case, that was BCR able, uh, fusion gene, uh, that actually, uh, had a damaging protein as a consequence. And then Novartis was able to target that specifically with a drug Gleevec, uh, and that just changed, that just changed things around.

Um, you know, the dilemma of value that diagnostics, uh, brings and the cost of diagnostics relative to interventions and therapy hasn't changed. And quite frankly, is if you look at it, where, you know, the costs of diagnostics are 10 percent or less total health care costs, but they drive about 90, 95 percent of what is the downstream.

Um, you know, decision makes and, and, and intervention, um, there's a disparity there. And so what has not improved is, is, is reimbursement quite frankly, uh, for the value of what, uh, diagnostics, uh, uh, have brought to the table and, uh. I had one example, though, when I was at Vysis, and I was mentioning PathVision and EuroVision.

At the same time, we were trying to get improved reimbursement through CMS for this technology that we had. And we were quite successful in doing that. And in doing that really helped really drive adoption of those products, which were phenomenal growth. That's not the case in on a, on a broad, broader basis.

We talked about this from a company standpoint, the view that large companies were safer, so to speak, to be able to, uh, and you have a whole career there. Uh, I think that as we as evidence over the past two years, uh, and even before that. Uh, that's not the case, whether it's large or small company.

So I do think when you see, uh, you do see a lot of the, uh, of employee migration, you know, as a consequence, not only a reduction in force, but the fact of the matter is a quote, unquote, loyalty to a company, uh, is, is one where I believe that you really have to have, uh, Uh, and employee believing in the purpose of what they're doing.

Uh, and, and that's much more important now, uh, that it's meaningful that what you're doing is making a difference. And they feel that they're making a difference, uh, as well. And I think that's a positive, quite frankly, that's, that's, that's really, really useful. And then if they're building the skill sets, as we talked about earlier, you know, and in the broadcast, I think that, you know, if they develop Um, Their own equity, uh, that's going to benefit not only their careers, but I think that benefit, um, healthcare overall because you have better products and better management.

[01:07:21] Pat Kothe: Leaders can come from any discipline within a company. I was really glad Rollie shared his journey because there's a lot that could be taken from it. And, and can be applied to, to our journeys as well. A few of my takeaways.

First cross training. You benefit, you learn, you learn a lot about yourself and other parts of the company and how to make things, uh, successful with it within a company. You also make yourself more valuable to the company. And the other thing it does, it helps a break down or prevents the formation of silos within a company. So cross training can be a really valuable, uh, thing for both you and the company.

Second the R and D function. And we spent a lot of time talking about different, different topics within R and D. Uh, Raleigh talked about the percent of our versus D big companies. You know, 20% are 80% D but much smaller with smaller companies when you have a mission to do, and not a lot of cash to do it in.

So that, that 20, 80. Uh, it doesn't really apply when you start dealing with, with startups. And he discussed the feasibility threshold. Uh, you need to make sure that your product. Uh, idea is feasible to do so proof of concept. And he said, if, if you can't get there, you need to kill it, change it, or merge it with another, uh, another idea. The other thing. It discussed in this R and D function is incorporating people outside of R and D into research. Traditional R and D actually extends out beyond the people in the R and D department.

The final thing was diagnostic devices. So many of us are in therapeutic devices, but the diagnostic market is so important. The impact on patient outcomes and overall costs is greatly influenced by the ability to quickly and accurately diagnose the situation. Yet as, Rollie said, reimbursement is in this area has been lacking. Well, it's really time to give this issue some emphasis.

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.

 
Patrick Kothe
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