Intro  00:21

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Ben Wagner  01:00

Hi everybody and welcome to the Medical Alley Podcast. My name is Ben Wagner and I am delighted to be joined by two experts here in the medical device industry, really experts in the bio design process. What is bio design? We're gonna get into that here in just a second. But our guests here today are Todd Brinton, the Chief Scientific Officer at Edwards Life Sciences and the past fellowship director of the Stanford Byers Center for Biodesign, along with Greg Johnson, who's the Director of Human Centered Design at Veranex. Gentlemen, welcome to the Medical Alley Podcast.

 Greg Johnson  01:47

Thanks for having us.

 Ben Wagner  01:48

Excellent. Todd, Greg, and we'll start here with Todd. Why don't you introduce yourself and kind of share a bit about your history with the biodesign program?

 Todd Brinton  01:56

Yeah, no, well, thanks very much for having me. So I was trained as an engineer, biomedical engineer initially and then and worked in industry and then went back to medical school a little bit late, and trained ultimately as an interventional cardiologist. I spent actually 15 years at Stanford Medical Center, where I started with the Stanford Biodesign process, actually, as a fellow. So I was actually one of the early fellows in the program, and ultimately, was fortunate to kind of take over the fellowship program for Josh Makower, one of the really well known innovators in the space, and kind of got ingrained in that program and ran the program for 15 years. I had a number of fellows over the course of the years. We've spun out a number of companies that have come from that, but became kind of intimately involved. And then had the opportunity myself to start companies and really applied a lot of the principles. And frankly, I brought those same principles here to Edwards Lifesciences now.

 Ben Wagner  02:46

Excellent. And Greg, I'm going to send the same question to you just a bit about yourself and your history with the biodesign program.

 Greg Johnson  02:52

My name is Greg Johnson, Director of Human Centered Industrial Design for Veranex. My first exposure goes back years to the biodesign process, because J&J was an early investor in that process in time and manpower. My previous director was a graduate of the program that Todd had just mentioned. So those philosophies and practices were really integrated into our development process. In more recent years, I was involved in the Stanford Biodesign leadership program, where we had a chance to really dig in and investigate the true value, a lot of the front end investment into this process, which is really key to it, the needs finding understanding those needs, being able to leverage those, those needs without bias into a process to develop new and meaningful products and meaningful disease state spaces.

 Ben Wagner  03:48

This whole, this bio design process is really fascinating to me. Todd, can you can you explain what is biodesign? And really, what does it teach us?

 Todd Brinton  03:58

Yeah, so you know, biodesign is a unique process, a structural process for how we think about innovation. And most people associate, you know, innovation as being creativity. And they think, well, how could it be structured? The idea is to kind of be a staged process, how we think about identifying opportunities or identifying we call clinical needs, unmet sometimes latent. In other words, we don't know that they really exist until we kind of peel back the onion and find out where those opportunities are. So I think that's identify side. Then invent, the opportunity to invent new creative concepts that take on those problems, and then ultimately, to implement those. So it's a stage process for innovation, but it's very needs driven, meaning it's centered on fundamental needs as opposed to being centered on the concept or the actual technology itself. The technology, the embodiment, those are all possible pathways to solve a potential problem. So you go deep and understanding kind of the eight headed monster called healthcare as a user, as opposed to thinking like, Hey, who's the user for the iPhone? I think we all know who that is. Who's a user for healthcare? Well, there's lots of users like the patient, the doctor or the system, payers, insurers, you know, the USPTO. I mean, there's lots of people are going to be associated with. So how do all those things interact to create opportunity? So really, it's a kind of a structured approach to how you think about innovation specific to healthcare. 

 Ben Wagner  05:21

Interesting, because innovation is always such a big, often use word. And this is really structuring that into a process and saying, if you follow these steps, you can innovate too.

 Todd Brinton  05:34

Yeah, no, absolutely, I would agree with you. 100%. Innovation is the catchphrase everyone loves to use. But what really is it? This is a structured process. And so there are some incredible inventors in healthcare that have surprisingly don't just have a spontaneous thought in the shower. They have a structured approach for how they think about developing technology for specific problems. And in fact, it turns out that in healthcare, specifically medical devices, a large number of those were invented by physicians, because they saw a potential problem and they identified the problem, they worked with engineers and with marketeers to develop the problem a little bit further, better understand it, then come up with concepts and then take the ideas forward. 

 Ben Wagner  06:13

Greg, you're working with companies both large and small at Veranex. So how does bio design really influenced your work? 

 Greg Johnson  06:20

Well, I mean, at the end of the day, regardless of the scale of our client, we're hired to be an innovation engine, and all the responsibility that comes with that. And being in innovation and R&D for what, almost 25 years, really true, meaningful methods to democratize innovation, to be honest about innovation. And innovation is many things. But I think what we've traditionally seen over the last 20, 30 years is tech push innovation. We have a widget, we want to apply it to a space, throw it at the wall, what sticks where. This is a very, very different approach in that it looks at innovation from a true need standpoint. Things like human centered design, user based, innovation itself are words that are bandied about and leveraged by everybody. But true innovation, true ability to fill a need, the tools to do that are not or haven't changed much over the decades. The biodesign process is the first truly innovative approach that looks at true needs, agnostic of agenda, to see, hey, this is a disease state that needs addressed. This is what that market looks like, are you looking in the right place? Are you not looking in the right place? So having those tools for our clients, big and small, to make us and give us the ability to have more informed solutions to guide our clients. I mean, we can develop anything, but it's always more meaningful to know you're developing something that truly fills a need. So whatever we made, fine, but we want to be honest with our clients, we want to be honest with the market. And at the end of the day, I think everybody in this industry wants to be honest, that we're filling a need. And I think that's the real differentiator of biodesign is it gives you that tool and it gives everybody that tool to do that.

 Ben Wagner  08:23

You're innovating innovation, essentially.

 Greg Johnson  08:25

Yeah, that's well, yep, that is one way to put it. Biodesign is probably the first real innovation in med tech that I've seen in a long time.

 Ben Wagner  08:34

Great. I'll stick with you here too, for this next question, which is, you know, how can companies bring bio design principles into their work now? So, you know, could you give me some key things they may need to know? And, you know, is it useful to get outside help?

 Greg Johnson  08:48

Well, you know, I think help in any facet of life is always a benefit. I think there's definitely value in going with people who know, have tested, tried, failed and done something. But really, yes, I think this can be exercised by anyone. It's not magic, but it does require discipline, and it does require knowledge and understanding. And I think for most organizations, if you're a small organization, you probably haven't innovated before or innovated often, right? So having that good foundational tool set to have the discipline to innovate without preconceived notions or biases. For larger companies who have invested technologies and want to promote those technologies, but there's really a paradigm shift required in the field, it can be a difficult effort or endeavor to say, hey, you know what, what we have done up to this point is no longer meeting the need. And we have to look at it from a different way, especially in a sea of competition. I think that's the other real value of this program is, I mean, it is unbiased, it is not a tech push. If you really want to know what the best solution to a space is, you have to step back from what you know, the technologies you know occasionally and approach it with a new lens. And this provides you that means and it provides anybody that means, but it's always good to have a coach.

 Ben Wagner  10:19

Absolutely. Todd, I wonder if you have any advice to a company that's looking to innovate and maybe considering, you know, bringing these biodesign principles into their own work?

 Todd Brinton  10:31

Yeah. So as Greg mentioned, we run an executive ed course at Stanford that we've run now for, I think, 11 or 12 years for companies, med tech companies, big and small to, you know, kind of learn the principles and really think of managing innovation, it's not specific to just biodesign is how you apply biodesign to the innovation process at your company. You know, as an individual, there's training programs. We have undergraduate and graduate courses at Stanford. There's a number of programs in the country. One of the big things we're proud of is we've launched a huge number of programs in the US and internationally. And we have a textbook that's in its second edition. It's a textbook that's used in a lot of biomedical engineering and medical device classes, basically, in the US. So I think there's a lot of ways to get familiar with Biodesign. I just think that the question for most people is, what value is it? What's it going to help you do? And I think Greg hit it really well. It's about discipline, it's about structure. And that may not seem appealing on the surface. But as I say, you peel things back, it really does teach you some very nice principles about thinking about innovation. 

 Ben Wagner  11:32

So you both are involved in organizations beyond your day jobs. I'm curious if you'd share a bit about that work. Todd, starting with you, and why you decided to give back to the industry? 

 Todd Brinton  11:43

Yeah. So for me, it's been a continuum. I started as an engineer, clinician. I was very fortunate, Paul Yock and Josh Makower, who started biodesign, took me in early, in the very early years of biodesign. I was so hooked, I stayed with the program for 15 years and helped run it and was involved in lots of startup companies. Of all the companies that I started that were based on those principles that had different levels of success. and then really the opportunity to take it to a large company and really demonstrate how you can think about innovation in a larger structured company. Most people, the premise is that small companies innovate, and big companies acquire innovation. And I think that's that's a myth. I think there's a lot of reasons that that happens. And one of the reasons that people think that the challenge is can you apply Biodesign in a different way? Can you apply biodesign to some of the things that are more entrepreneurial to a large organization? And the answer is I believe you can and that's much of what I wanted to take on the challenge. And that's why I went to Edwards Lifesciences. 

 Ben Wagner  12:40

Excellent. And, Greg, same question to you. 

 Greg Johnson  12:42

Yeah, I mean, at the end of the day, we spend a lot of time doing what we're doing. And we're devoted to medtech our entire careers. We probably spend more time developing products than we do, sadly, maybe, with our families. It matters to us, we were drawn to this for a reason. It's an increasingly complicated world, it's an increasingly challenging environment in medtech to be differentiated, to be creative. The decline of rural hospitals, the demand for surgeons in 2030 that are, you know, we're gonna have a 20,000 surgeon shortage, a million nurse shortage coming in a few short years. How do you address that? Through innovation. This is the world that our children get. And you know what, honestly, it might have taken me more years than I know to get there. But I really believe in innovating in this space, because I don't know another solution to our future if we're not innovating in med tech, and there's just inherent value there. So anytime I spend doing this, I realize it's a privilege, one, to work with the partners that I work with, and to impact something that truly brings value. So it's, you know, where we can, you know, we do the job, we get paid to do the job, and we volunteer our time in other areas where we can just to advance this field. So I don't know if that fully answers your question, that definitely is my philosophy, my belief on you know, the value of innovation and how I spend my time in med tech. 

 Ben Wagner  14:25

Yeah, I always like to ask, you know, what gets you out of bed in the morning? What gets you excited about your 40, 50, 60, who knows however long workweek. And I think you hit on it really well. You know, innovation is the way we solve the problems of the future.

 Todd Brinton  14:42

I'd just add, you know, I had a mentor, one of my mentors, Tom Krummel, who was the chair of surgery at Stanford for a long time and was a director of the biodesign program. It used to say that old adage, you can give someone a fish or you can teach them to fish. And so in a lot of ways as a practitioner, I was taking care of the patient in front of me, I would felt greatly rewarded from that. But the opportunity to innovate in medical technology is the opportunity to impact thousands, millions of patients as opposed to just the one that's necessarily in front of you at the time. That's obviously cliche, but it's the truth. I think most of us are looking for the opportunity for impact. We want to do something that really matters. And so, you know, I spend lots of time with with employees at Edwards and I did at Stanford when I was a professor there, you know, at the end of the day, seeking what matters to you. And different things mattered to different people. But what matters to you. And I think for both clearly Greg and I, and in a huge number of people in med tech, and in healthcare, what matters to us is being impactful. Doing something that matters. At the end of the day, that's what's fulfilling. And I agree completely on, we've got a lot of challenges in front of us as far as health care. But I would also argue, there may not be a greater time to innovate and a greater time for opportunity then there is right now, if you understand some of the challenges and dynamics going on. And coming back to kind of what that's what Biodesign is about, really understanding how Medicare, payment, reimbursement, how the regulations are changing and modifying. If you really understand that, you can really innovate in a meaningful way to make big impact for patients.

 Ben Wagner  16:16

Todd, you led right into my next question here, which is really what is next for Biodesign?

 Todd Brinton  16:21

Well, I think there's a lot ahead. I think Biodesign is actually, as I understand it, really broadening itself. So we really started Biodesign in medical technology, and define that is really initially med tech, medical devices. I think it became broader as to more healthcare IT. Now we're thinking of across pharma and biotech as an application that you can apply the same principles. Even though some of the details may be a little bit different, the fundamental principles may be the same. And then I think that important piece of Biodesign is actually now a policy program that started at Stanford, which thinks about how do you apply these same principles to how we change government? How do we apply what we do about payment, what we do about regulation, to drive innovation? Because it's not just about the entrepreneurs, it's also about our partners in government.

 Ben Wagner  17:07

And it really does feel like this could be, you know, maybe with a few tweaks here and there, could be a formula for innovation really across the healthcare continuum. Medical Alley represents medical technology, along with bio, along with pharma, along with digital. It seems like this could be the process that could help everyone innovate.

 Greg Johnson  17:26

You know, I think just to add on to that a little bit, I look at countries like Israel that invest massive amounts of their resources to medical innovation specifically. A lot of startup programs, you know, something like the Stanford Biodesign Program integrated at that level could really push and keep us as the US in that lead spot of medtech innovation. And, you know, I think it's worth a question as this branches out and the need for innovation and the, you know, economic drivers, medical needs that we already mentioned, that there's a real value into maybe looking at how we can institutionalize this and capitalize from it, frankly.

 Ben Wagner  18:13

Well this has been a really incredible conversation, Greg and Todd. Todd, I'll leave this last part to you, which is somebody who's listening and may have some deeper questions or looking for maybe some more information, where can they go to find that?

 Todd Brinton  18:29

Yeah, so you know, Stanford has, you know, one of the elite programs in the country. I look at that the Byers Stanford Center at Stanford. There's a number of other programs though. UCLA has a program. There's a number of other programs in the US that are very, very strong programs. International, if you're international listening, there's programs and a number of countries that have partnered with Stanford. It doesn't matter whether you're in Israel or you're in you're in some other country in Europe, there's a lot of programs. So it's worth a read or pick up a textbook. Not that I'm invested in you picking up a textbook, which I am, but just kidding. No, I think there's lots of opportunities to kind of get a better understanding what it is. And you'd be surprised. Many colleagues people around I bet you're familiar with Biodesign or have touched it in some way. That's another good way to find out about it.

 Ben Wagner  19:13

Excellent. Todd Britton, Greg Johnson, thank you both for for joining the Medical Alley Podcast this week. 

 Todd Brinton  19:19

All right. Thank you so much.

 Greg Johnson  19:20

Thank you so much, really appreciate it.

 Ben Wagner  19:21

And and thank you to listeners at home for tuning in to this week's Medical Alley Podcast. Make sure you hit subscribe, wherever you find your podcasts. And with that, we'll close out this podcast. Have a great week.