BMF_E9_Transcript
Dasha: [00:00:00] Welcome to the Biomedical Frontiers podcast, where we explore pivotal research projects and disruptive innovations aimed at translating scientific advancements into tangible healthcare solutions. I'm your host, Dasha Tyshlek 
Andrew: One of the things that people miss a lot about intellectual property is that the whole entire thing is about rapidly increasing the speed of innovation through sharing.
That's what IP is. And so when you disclose something to your tech transfer office, you make it available for students like yourself to then take it to the next level. It's a disclosed piece of IP to the university. When you file a patent, that patent is a public disclosure. If you didn't want to share it with the world, you could have kept it as a trade secret.
Innovation has been described to me as an increase in value, which is an equation, the benefits to cost ratio. So if you can be increasing the benefits to cost ratio, it could be maybe more benefits for the same cost or same benefits for decreasing cost, that's increasing value. When you're doing that, when you're actively doing that, innovation.  It's my favorite definition for innovation. 
How are you able to manage this relationship between hospitals and engineering students?  A lot of the clinical immersion programs that you see today are transactional relationships. Hey, our students need to identify problems, so we need access to the hospital for that to happen.
Physicians who are coming up with brilliant ideas and they need engineers or manpower to build the thing. That type of transactional relationship, I just don't see it working very well.
Dasha: What are some of the key takeaways you have learned, particularly pertaining to early career entrepreneurs in medtech?
Andrew: I think the most important thing that I want to stress to students, to anyone considering entrepreneurship is that a social service. lot of us think of entrepreneurship as a way to make money, a way to scale an idea into making money. 
 Dasha: Today on the show, we have Dr. Andrew DiMeo, who is a health innovator, a biomedical engineer, a design philosopher, and a social entrepreneur who loves authentic and meaningful relationships. He began his career in New York working on movies and TV shows, most notably The Sopranos. He has a Bachelor of Science in Physics and a PhD in Biomedical Engineering, and has spent most of his career teaching and practicing health innovation.
He has served as a team lead in NIH programs, including RADx, ITAP, Blueprint MedTech, HIV point of care testing, and C3i. He was previously a professor of practice at UNC and NC State for 12 years, where his students started multiple startups including 410 Medical, Contour Surgical, Augment Medical, Novocor Medical Systems, and MEDIC.
He was co founder of Gilero, founder of the NC Medical Device Trade Organization, and founder of CanvasGT, a SaaS startup acquired by Greenlight Guru. Today you can find him mentoring the next generation of social entrepreneurs working on his new venture, Hangar Dreys, a co-working concept in Raleigh NC, focused on addressing the loneliness epidemic or riding a bicycle somewhere in the woods.
So great to have you on the show. 
Andrew: Wow. Thank you so much for having me. This is really an honor. 
Dasha: Well, Andrew, your career trajectory has had so many different facets to it, but the line that runs through all of it so clearly is your focus on bringing creativity and inventiveness out of people and building meaningful relationships and solving problems in medicine.
I want to start with your success in teaching biomedical entrepreneurship and innovation at UNC and NC State. Notably, 410 Medical System is a company that has had success with medical devices in trauma, sepsis, and other critical situations and is now quite established and growing. Can you tell us what that was like and the story of the company and your students success?
Andrew: Yeah, well one thing I want to start with is I have had a lot of success with entrepreneurial endeavors coming out of my classroom, but it's kind of funny because I've never thought of myself as teaching an entrepreneurship class. And in fact, this particular startup 410 Medical, which has done very well, came out of biomedical engineering senior design.
So of course, all the seniors must take to graduate with a degree in biomedical engineering. Not all of those students are interested in entrepreneurship, so, how do startups come out of such a class? I do have stories of students that are the entrepreneurs, but I [00:05:00] love this one because it sort of reminds me of the analogy of the Olympic torch in entrepreneurship, keeping that torch burning from handoff to handoff to handoff, like the most important part of that is just keeping that torch burning, we can't let it drop. 
This story goes back to five young women who were on a team and senior design. We were doing clinical immersions at the hospital. They were doing their immersion with a pediatric intensive care physician. I can't remember the exact need that the physician said, but it was probably something to the effect of, I want a portable rechargeable saline delivery device.
The first step in this whole process is identify the unmet need, and I'm going to skip a whole lot of steps, but we got somewhere to something like rapidly deliver saline to patients in vascular shock in low resource settings, such as those that have no power. And I always remember these aha moments like, ah, that's the unmet need and once you get it, that unmet need is a spark for creativity and so you talked about eliciting creativity from my students. 
When you can define these things so clearly, that's where the creativity pours out, but you know, this was a series of handoffs when these students, they intelligently, and I can get into this later if you want, they intelligently assigned the intellectual property to the university, which was key in the whole process.
Oftentimes, intellectual property held by individuals is really hard to commercialize. And the first torchbearer was that physician, he was not going to let that thing drop. I worked diligently with the tech transfer office and him to get that out of there over time, and this is like years in the making.
You know, he brought on an experienced business professional and venture capitalists to form the company. You know, not that long after they brought on an experienced product development engineer, they formed partnerships with local service providers, industrial design firms, engineering, manufacturing firms, that the local ecosystem really supported this startup.
And it went full circle because at some point then they were hiring students from the NC State Biomedical Engineering Program. So it was almost like kids that started this thing were providing indirectly, but providing jobs to future students and I just love how this company came to be.
Dasha: As a professor teaching this class and mentoring these students, what was kind of the roles that you needed to play in order to help the longevity, the momentum of this project, the right partnerships? 
Andrew: Well so senior design back then, especially in the early days of biomedical engineering, senior design, I don't know if anybody listening remembers the old days of the sponsored projects. Actually, it's probably still going on in a lot of places, the standard sponsored project where students are given a task to complete and they complete it. So this class, at NC State, which I started in 2006, it's, as far as I know, it's the first undergraduate course that puts students into a clinical immersion to identify unmet needs.
And it was really successful and I've seen a lot of failures. I've been asked to speak on this topic a lot. You know, how are you able to manage this relationship between hospitals and engineering students? It's like, and we had a lot of them in there. And at the end of the day, what it comes down to is meaningful relationships. I think that a lot of the clinical immersion programs that you see today or the attempts at clinical immersion programs are what I'll call transactional relationships. They're based on a need of, hey, our students need to identify problems, so we need access to the hospital for that to happen.
And the hospitals oftentimes are happy to enter into this need because we have physicians who are coming up with brilliant ideas and they need engineers or manpower to build the thing. And that type of transactional relationship, I just don't see it working very well. You know, the way that we entered into it was a conversation about, hey, do you want to go on a journey together?
Let's put experienced professionals with young energetic students who have clinical mindsets with engineering mindsets. And let's take these ingredients and put them together and let's together identify unmet needs and as a group through a lot of honestly self discovery and self reflection and [00:10:00] learning about who you are as an individual, but then who you are as a group, as a team coming together and with your clinical mentor, identifying an unmet need to then solve it.
And, managing those relationships at the end of the day, I really honestly think my job as a senior design professor was managing relationships of the students, team building, conflict resolution, that kind of thing. 
Dasha: It's so true and it's an interesting thing you bring up because on the student side of the equation, the value is very clear.
They get to go into the clinic. They get to see the real world. The experience, I've done a clinical immersion class with David Chen when I was a student, and that was such a phenomenal experience. But what is the offer, the value, the kind of growth that clinicians can expect to see doctors or nurses or even hospital administrators who are having to be involved in these programs?
What can they expect in terms of growth and learning for their teams? 
Andrew: Yeah, well, I mean, for one, it's a different view of the kind of person that they see coming into the hospital. Yes, that's one of the first memories that I have is that the clinicians would say, what a pleasure to see bright young students who are here walking through the door as opposed to being rolled in on a stretcher, so that in and of itself was really meaningful.
At the end of the day, we're teaching this process of innovation to everyone involved so those projects that went really well, the faculty of the medical schools and the medical professionals came and participated a lot. And they were doing as much learning. 
There was a lot of different setups between the different programs. You know, some of the clinicians were so interested in the learning that they would set up their own lunch and learns and come and gather around and want to be part of the training that was occurring.
Some preferred to be a little bit more hands off. Some developed really interesting personal relationships with the students where they would host a dinner once a week and have these informal gatherings, which was incredibly valuable. There were some clinicians that would come to NC State and get access to prototyping facilities and maker spaces and get their hands dirty with prototypes.
And so there was a lot of opportunities for the clinicians through the process for sure. 
Dasha: Yeah, that's really awesome. Well, we talked about 410 Medical Systems, which persisted and succeeded, but, in that list of startups that you have seen come out from ideas generated in classes, not all of them necessarily succeeded or persisted.
But what are some of the key takeaways you have learned, particularly pertaining to early career entrepreneurs in medtech? 
Andrew: Yeah, this is a big one. And again, I kind of hold to a position that I'm teaching a process of innovation and I'm preparing students for success, no matter what they do in their future, and entrepreneurship is an option. I think the most important thing that I want to stress to students, to anyone considering entrepreneurship is that it's a social service. And I don't know if we all, a lot of us think of entrepreneurship as a way to make money, a way to scale an idea into making money.
But let me just tell you one of the stories of one of my... is it a success story or a failure? That's a great question. You know, we had a technology that came out of NC State, we licensed it successfully, we successfully raised over 2 million to bring the product all the way from a concept to a design lock, through an FDA 510K clearance, right?
So to that point, it's a success story and we had multiple employees, there was three founders, multiple employees. It was myself and two other professionals that founded the company. And then there was a round of funding that we missed because an AMA report came out that changed the clinical indication for the product we were developing.
I won't get into the details, but at the end of the day, it just took out the promise for this particular technology, and so we had to shut it down. When that happened, this really rocked me personally, because I was the [00:15:00] lead entrepreneur who convinced two other professionals with houses, and spouses, and kids, and future weddings to pay for, and future colleges to pay for.
I convinced these two guys to join me on this endeavor, and a few years later one of them was picking up his home family and moving from North Carolina to Minnesota. And that, that was a real eye opener for me. I am impacting other people's lives. And I even almost quit entrepreneurship for a bit.
I was like, whoa, this stuff, this is heavy, man. You know, I don't know that I want to be responsible for ruining other people's lives. Now saying that he would tell me today, in fact, I just had lunch with him last week. It's kind of incredible. He came into town. He's not in Minneapolis anymore, but he's in Idaho. 
At any rate, he was in town. I had lunch with him. And he would tell you to this day that that couple of years that we spent bringing that startup, doing that startup together with some of the best years of his life. And then he learned so much during that period of time and he strived to want to do it again. In fact, he did do it again and he's done it multiple times since. 
And so, yeah, that feels good, but it still doesn't take away the fact that I impacted this person's life. And it doesn't matter what kind of startup we're talking about. I mean, I love bikes. So you start a bicycle shop, that's an entrepreneurial endeavor.
You know, you have employees, you have people coming and working on bikes. You've got customers that rely on you for good service. You've got employees that are paying rent. It's a social service. You're offering these people jobs. You know, you're giving them the opportunity to rent the house or to have a good life, to take a vacation, to have benefits, depending on what kind of company you're starting.
If you're struggling, if you can't pay the bills, if you can't make payroll, that is gut wrenching for an entrepreneur. I think that if you're interested in entrepreneurship, it has to start with a place of social service. Like why am I doing this? We're doing this to bring something good to the world, to make people's lives better.
The product, the thing that we're doing is about bringing goodness to the world, and then we're also offering jobs and benefits to people. And when stuff goes wrong, it can go really wrong, and so, I don't know, that's, I think we could probably talk for two hours on that subject, I love him. 
Dasha: Well, one of the other things you mentioned in an earlier thread, It's also the relationship with the university, particularly for professors or students or clinicians who are connected with the university.
Could you talk a little bit about the route to success that you've seen there in terms of how that relationship is best developed and what to watch out for when, when you're kind of thinking about starting something that you've been working within a university, in terms of things that don't go so well?
Andrew: Yeah. Utilize tech transfer and be proactive. I know this is kind of an interesting thing because, I think a lot of people would agree that the process of licensing technology from the university can be really, really difficult. A lot of experienced entrepreneurs don't even want to touch it. They're like, oh, if it's in tech transfer, I don't even want to go near there. people that have done it before will say like I would never do that again. I'm not a fan of that kind of advice because typically these are first time entrepreneurs, or they're first time innovators who might not be the entrepreneur that starting the company.
When you work with your tech transfer office, the tech transfer is a safe space to keep technology from entering the public domain that this is like a whole talk on intellectual property that we don't also don't have time for. But the bottom line is, it's a safe space to keep that innovation ready for when it's going to be commercialized.
Right? So, even the likelihood of, say, five undergrads on a team all choosing to start a company together, it's nearly impossible. I mean, I'm not going to say that it can't happen, but the likelihood of that is really, really low. When you've got five individuals all holding onto a piece of intellectual property, that negotiation gets really messy amongst those five people.
There's no way an [00:20:00] organization would come in and license that technology because they got to negotiate with five individuals. So it's just actually never going to happen. And so if you, if you assign your technology to the tech transfer office, it's in one space. Now there's one place to negotiate with.
And maybe one of those students decides that they want to start a company and they've got the opportunity to then license that technology in a clean way. So the other thing too is as professors, I think that a lot of them that aren't familiar with entrepreneurship think that the magic is going to happen.
I'm going to submit an invention disclosure and then, voila, I've got a patent and a startup company and it's you have to be really proactive. Here's just a little tiny tidbit. Tech transfer offices are largely underfunded. They have very few people working there, so they have to set up some automated processes, which ends up being an email that says something to the effect of, hey, you haven't kept up your end of the bargain, we're going to take the technology back. 
And you know, then the professor's like gonna throw a fit. I cannot believe that I got this insensitive email and it's like, calm down. You know, there's three people serving hundreds of people. It's an automated email. Just walk over to the tech transfer office and I'm sure they'll work with you to figure out how to handle the situation, give a longer period of negotiation time. Just pick up the phone, talk to people, walk over, talk to people. 
If you proactively work with the tech transfer office, if you are a face and a name that they recognize and you visit with them and you sit down and you have coffee with them. It will all work out. So yeah, work with tech transfer. 
Dasha: And to add to that point, I kind of want to share a personal story too referring to tech transfer and student entrepreneurship. When I was a student at University of Virginia, we had several different ways that a student could teach their own class. And so I signed up to do that within the engineering school, like a one credit class.
And I went to UVA's LVG and I said, are there any technologies that, if any student was like, I'm going to commercialize this. You would say, just have it. Like we've looked at it. We can't find exactly, we just can't figure out how to commercialize it if nobody's been interested in it.
And so they gave me a list of technologies and patents that they had, all biomedical in nature, which had been laying on the shelf and nobody's shown any interest in and they haven't figured out how to commercialize. Nothing came out of that, but we did a one credit class taking those technologies and trying to figure out how you would actually go about commercializing it.
And so there's an interesting opportunity on the other side of it, which is if you have that energy to try to be an entrepreneur. To put all of that effort into it as a student, undergraduate, graduate, MBA, you could be working with the scientists through the LVG office to become a partner to them because, it's so hard to also find the kind of experts and the people with the funding and the people with the energy to go and commercialize these projects. It's a non trivial experience at all. 
It's hard to invent and it's hard to vent. Take that into a company and try to build it into a full product. So really great opportunities on both sides to partner.
Andrew: Yeah, what I'm gonna jump in there though, first of all what a cool experience to be able to do that at UVA to teach a class. You know, one of the things that people miss a lot about intellectual property is that the whole entire thing is about rapidly increasing the speed of innovation through sharing.
That's what IP is. And so when you disclose something to your tech transfer office, you make it available for students like yourself to then take it to the next level. It's a disclosed piece of IP to the university. When you file a patent, that patent is a public disclosure. It's a public disclosure that there's a trade there's quid pro quo. 
We're going to say we're going to publish this to the world, but give you some exclusive rights to it for a length of time. But the whole reason for the quid pro quo is to publish it, to make it available to everybody to be able to read it and then innovate on top of that. If you didn't want to share it with the world, you could have kept it as a trade secret.
And so the whole idea of holding something tight to the vest is the opposite of having a culture of innovation and entrepreneurship. 
Dasha: Yeah, that's a great point, and I've seen it actually. Some companies choose to keep all their IP trade secrets specifically because if you patent it, you're actually showing people how to do it.
And if you're in a field involving a lot of physics and math, there might be advantages to not sharing it actually, because even though you can't go to [00:25:00] a court of law to protect it, at the very least you're, not revealing the secret sauce of how it works. So there's some interesting decisions around that.
Well, the last question just on this topic I still want to cover is, what about the students and professors who are looking to transfer technology out and start a company, particularly in med tech? How is the funding landscape changing and what advice do you have for people who want to raise money who are first time innovators or entrepreneurs? 
Andrew: Yeah, I think, we're often thinking about, we need to raise money. And it's impossible to bring a medical device to market without raising money somewhere along the line. But I think we think of that too soon where I don't have enough time.
I don't have enough resources, so I've got to raise money so that I can put some people power around commercializing this technology. What I would say to all of those people is back up a second and raise relationships first. Go on a learning mission, that's one activity. Just talk to as many people as you can about what it is that you're doing.
Your pitch will get better and better and better as you do that. You got to explain what you're working on and if it doesn't resonate with people, then you're probably not in a position to be raising money anyway. If it does start to resonate with people, you may find out that you start to get some team members.
There's this saying if you ask for money, you're going to get advice and if you ask for advice, you're going to get money. Money at the end of the day is an investment. It could be an investment of time. And so what I would encourage anyone that's thinking about entrepreneurship is just to go on an advice, okay?
Seeking mission. Talk to as many people as you can. Hey, you've started companies before. What was it like for you? How did you do it? Anything that you don't know about? I don't know anything about intellectual property law, you know, go take five IP attorneys out to to coffee and ask for advice. Take business attorneys, hey, I'm looking to start a business, but I don't even know how.
Ask for advice, just get as much as advice as you can and what you'll find maybe what I have found is that, I end up raising investment through through human beings, through people. Some attorney is going to say, hey, I've had a cousin that has had a stroke and you're working on the stroke technology and it's really meaningful to me. I'll work on starting your business pro bono for now if you become successful, we can set up a deal where you can start to pay we can keep a tab for now just a running tab that will send you.
This is for real. I've had attorneys do this. They send me every month. I get a bill that I don't have to pay. You know, it's like, oh my god, the bill is increasing, increasing, but you only pay it if the company is successful but they've invested their time into your business. You end up with someone that's a mentor.
Hey, I've been a CEO, I've done it before, but I'm retired and they're a mentor that they get interested and driven about what you're doing. And the next thing you know, yeah, they're a board member or maybe they're part of the founding team. So, those people that invest their time when there's resources that you don't have, one of my favorite students who started a company, And he's a biomedical engineer and what he, he really needed a software developer and an electrical engineer, he found out there was a freshman who like volunteered to work.
And over the course of time, I mean, years go by this young individual spent their entire undergraduate career working on the side on this project. And by the time they were graduating, they were a founder of the company also and they had hands on built prototypes and written the code and so you don't necessarily need money to get off the ground.
You need you need a team. So start by building that team. 
Dasha: Yeah, that's great. That's great advice and goes back to that meaningful relationship building. You not only teach innovation, but you're also writing about innovation. You're speaking about it and you have written several interesting articles about kind of switching the paradigm and thinking about innovation in different ways in order to create processes, methodologies for repeating innovation over and over again.
So before we dive into the details of those, could you describe what innovation is and why it's so important to teach it was part of engineering programs or other educational programs in general? 
Andrew: Sure. And I want to make sure that we're clear with [00:30:00] everyone. There's innovation, there's entrepreneurship.
We're talking about the two topics. So I'll maybe touch on both briefly. Innovation has been described to me as an increase in value, which is an equation, the benefits to cost ratio. So if you can be increasing the benefits to cost ratio, it could be maybe more benefits for the same cost or same benefits for decreasing cost, that's increasing value. When you're doing that, when you're actively doing that, that is innovation. It's my favorite definition for innovation. I spent some time looking at the roots of these words at benefits and costs, that benefit to cost ratio.
And benefits is especially, the root of benefit is bene, which means good or to do good to. So when you're increasing benefits, you're increasing good, goodness, doing good. Cost is about bad things happening, right? You know, this was a costly event. You know, you lose things. People lose lives, lose health, lose money, lose relationships.
These are all costs, lose time. So these are all costs. So we're trying to decrease the harm. decrease the bad things. And so when I started to think about it that way, it's like, okay, so we're increasing the doing good to harm ratio, right? That's what we really want to be doing.
I've boiled this down to do good to, is to be caring. So, if you're caring, you're doing good, you're increasing goodness. And if you want to minimize harm, oftentimes, that means being thoughtful because there's a lot of choices that have to be made, and sometimes we think we're doing good, but we're actually causing more harm somewhere else.
So this is like systems thinking and try to look for all the places that the harms might occur that we weren't thinking about. So a risk analysis, a hazard analysis, these kinds of harms, it's thoughtful, it's systems thinking. So, Be caring and thoughtful is my definition for innovation in a nutshell.
I can get into entrepreneurship if you want, or we can stop there. 
Dasha: Yeah, let's actually compare the differences between what innovation versus entrepreneurship means, and particularly in an engineering setting. 
Andrew: Right. So, the bit about innovation is that it's got to result in that value increase.
So it has to get it has to get there. Now, entrepreneurship. I think of entrepreneurship as a mindset, right? You're this individual choosing to take risks and do something more than they can do as an individual, right? So it's like building that team from nothing and not everyone is, not everyone needs to be an entrepreneur at everything if that makes any sense. 
I mean, my favorite example of entrepreneurship is finding a loving relationship with another person. You're taking a risk, you're failing, you're investing your time, you're taking more risks, you're failing again, and you do this on repeat. It's relationship building. You're trying to do self discovery.
Who am I? Who is this other person? And when you do it right, the sum is greater than the parts. So to me that's entrepreneurship. It's making something out of nothing or it's making more out of the parts that you have, and it doesn't necessarily need to be going and raising money from, from investors. 
It doesn't have to be that way. I mean you can, you can start businesses without raising money, but the sum is more than the parts. It's difficult at universities, especially in academia because a lot of academia is a zero sum game. A lot of it is, hey, the NIH only has so much money for all of the research so we're all fighting for these dollars. 
And so it's like a completely different mindset then we're going to take this bit of value that we have and grow it to a much, much larger piece of pie, right? Yeah, entrepreneurship is the sum is greater than the parts. It's about team building.
Dasha: Excellent. Well, when you're teaching people to become innovative or specifically to go through a cycle of getting inventive, what is your approach and what do you teach in order to create that skill set? 
Andrew: I've got different methods, many, many different methods. I think where we're headed is talking about evolutionary design. [00:35:00] And this is in particular, we're talking about medical device product development here.
So just to give some context to everybody, especially in the world of biomedical engineering, there's biologics, there's pharmaceuticals. So just to ground everybody in medical device product development, for those that are maybe familiar with the waterfall process of design, I hope if you can picture it in your head. That's going to be a lot more helpful to you, but you start with user needs and then design inputs, the design process, design outputs, and the final medical device.
And this is often thought of as a stage gated activity. Sometimes it's thought of as a iterative activity. I think of it as an evolutionary activity, and we can get into the details about that in a minute. But one of the things that I see is that when we teach innovation, we're teaching it in a very controlled environment, universities can be very controlled.
And if you read a book like biodesign, we're starting with user needs that's the beginning of the process. And I think we often think about processes as steps, first user needs, then inputs, then the design process, then outputs, then the medical device, as opposed to thinking of it as a framework, how all these pieces fit together.
And when you change your mindset from process to framework, When you change your mindset from stage gate or iterative to evolutionary, it really changes everything. And the last thing I'll say is that innovation is in many ways a divergent process. I mean, it's both, it's divergent in places and convergent in others.
The beginning of it, to unfold a design, you really have to be in a divergent space. And to say that an innovative endeavor must start at this place, it must start with user needs, or it must start at the beginning of this process. I think it's contradictory. It's not a good practice. But hey, every idea is a good idea, you know, there's no negatives, or like all good stuff and then, oh, but you got to follow this rule. We must start here in this place and it's just not realistic. It's not how it happens. 
Dasha: So breaking this evolutionary design practice, which I'm hearing you say is instead of it being a process, you think of the process steps that we typically think of in design.
We think of them as more of a framework. You have to complete them all, but the order can be done more organically. You can start in different places and navigate to the next natural place. But how do you make that practical? Let me just explain why I asked that. I think it's easy to grasp a stage gated linear problem.
It's hard to do it because, like you said, it's a creative process. It's a discovery process, but it's easy to wrap your head around, like a folder structure, step one, step two, step three, right? But how do you bring into practice a more flexible and natural process, while still implementing those good documentation, design controls that are so necessary for medical devices specifically?
Andrew: Yeah, I think that's a great point, that it's really easy to visualize a process, Step 1, 2, 3, 4, 5. But it's really hard to live it. In fact, it's totally impractical in real life as we're going through innovation, it's just not happening in that order. And I think what happens to a lot of people is they just throw it out.
 What I see in practice is people say, that's garbage I can't do it that way. They do a complete haphazard innovation process, process of design, and when they get to the end, they kind of reverse engineer everything. They're like, okay, here's how it would have went. And oftentimes that history is lost.
It's real messy. It takes a long time to do. If there's been handoffs along the way, you lose people. Projects last longer than people. And so that reverse engineering of a design history is a really difficult situation, but people are having a hard time following the process because it's not realistic, even though they can look at it and it makes sense.
And so I know this might be difficult to visualize on a podcast, but thinking of it as a framework instead of as a process. Think of user needs, inputs, design process, outputs, and the medical device, these five buckets, and if you can see it in your mind, the lines that say design [00:40:00] reviews, if you can see that in your mind, and think of it as filling in a framework instead of following a process. The way that I like to think about it is, let's say we have five puzzles, and we mix all the puzzle pieces together, and we dump a huge pile of puzzle pieces. So stage gate, if we were to do stage gate, it would be like everybody on the team focused on puzzle number one user needs. Find all the pieces to that puzzle and build that puzzle until it's totally complete.
And then when it's totally complete, after all of that work, you have a design review. Hey, everybody, does that look good? Yes, thumbs up. Those design reviews don't happen very often. So then, you go to the next, okay, everybody's building puzzle number two, and you can see how this goes. Like you build one puzzle at a time.
That's stage game. Iterative is, okay, let's kind of cycle through this stuff. How about we build the frame of puzzle 1, just the border of puzzle 1. Design review. Okay, border of puzzle 2. Design review. Okay, border of puzzle 3. It's better, we're moving a little bit faster. You know, we're having a few more design reviews.
It's also just not realistic. We just don't move in that order. We don't necessarily start with user needs. The reality is somebody is doing a surgery and they're like, Ooh, I've got an idea. And the first thing that pops into their mind is a solution. Are they not allowed to write that down?
You know, is that illegal in the world of innovation? Right? No idea is a bad idea. Can I write it down? Can I put it in that last box? Can I do a piece of that last puzzle? So instead, all evolutionary design is saying, hey, let's just work on all five puzzles simultaneously. Let's just try to build all of them.
You know, we're separating them out. We're looking for common themes where our designer views are actually on a frequency as opposed to a gate, a stage gate, or a cycle. So maybe our designer views are weekly. Every Monday, team get together. How you doing? How's the design go? What's the puzzle? How do the puzzles look?
It's like, oh man, all the blue parts are really mixed up. You know, we gotta, let's everybody focus on blue this week. Okay, great. Everybody goes off and focuses on blue that week. And so design reviews are a frequency. Five puzzles evolve over time, fill in all five places. And when you're done, when you're completely done, you have an incredibly organized design history.
It would be, I'm going to argue that it's going to be organized even better than trying to do it stage gate or iterative, which doesn't happen. They're going to reverse engineer it. And so those very infrequent design reviews, reverse engineering doesn't give you a good picture of how those puzzles got put together.
But when you do it in an evolutionary way, you know exactly what happened and what you were working on week to week or month to month, whatever cycle you put your design reviews on. 
Dasha: Well, I want to say that in our episode description, you're going to find a link to the article where Andrew not only wrote about this process, but he has a very nifty visual representation of it and animation of different ways to think about this process.
So all of that conceptual description you can see, handy animations for in article linked below. Well, one thing I want to kind of focus in on this is for first time designers, first time innovators, and first time entrepreneurs who might be going through this process for medical devices. It comes to me that in order to do this in a more evolutionary way, you kind of have to learn a little bit more about the process up front rather than learning about it as you go through it so that you can actually pinpoint what you're doing across the entire map.
Is that also how you see it? And what are some resources maybe that you would recommend for people to study up and be familiar in order to do this process well? 
Andrew: Yeah, so I'm a big fan of the world of outcome driven innovation and jobs to be done. It's some of the foundational work of Identifying unmet needs, defining unmet needs, defining solution free statements.
I'm going to contradict myself here in a minute. But, I'm really a big fan of starting to learn about these innovation processes because what they end up doing, if you do it in a way that I'll suggest, which I call mission driven innovation, you end up building a problem solution space, and it's really about the exploration of that problem [00:45:00] solution space that begins to define what are the user needs and what are the design inputs and outputs and what are the technologies that we have to work with and why are we even doing this?
And all the different things we could be doing, a portfolio of ideas, a portfolio of projects that take together our resources, our capabilities, our mission can be born by first looking at outcome driven innovation jobs to be done and kind of getting to understand how those tools work and then expanding that to what I call mission driven innovation, which I'm happy to dig into if you want. 
Dasha: Yeah, let's, let's dig into this mission driven innovation concept. Another topic that you write and speak about. 
Andrew: Yeah. So, I'll try to boil it down to jobs to be done, outcome driven innovation, and a lot of different practices like voice of customer, need driven innovation.
If you read the biodesign book, it's the whole need statement. They all share a similar foundation, they've got their nuances, but they all share a similar foundation in what I'll call the solution free statement. Can you, can you define the solution free statement or the problem or the need or the job to be done or the desired outcome?
Can you define it clearly, free of solutions, to then allow you to brainstorm all of the possible solutions? So when you look at that waterfall, we were talking about earlier, those user needs are those solution free statements at the beginning. And then the design inputs are like the ideas to solve those needs.
And then the outputs are implementing those ideas, right? So they relate to each other, but as I said earlier, you don't necessarily start with the user need. So, the nuance that I have in this teaching is that problems and solutions are the same thing. They just matter on what perspective you look at them.
And I know this is confusing, especially again here on the radio. And you know how old I am because I just called this the radio. 
Dasha: I like that. 
Andrew: So one of the most recognized quotes in the world of jobs to be done, outcome driven innovation, is people don't need a quarter inch drill, what they need is a quarter inch hole.
And Clayton Christensen has quoted it, Theodore Levitt has quoted it. And so you can search it and find it pretty easily. But this concept is saying, hey, it's not about the solution. It's not about the drill. It's about the problem to be solved. The problem is we need a hole, the outcome that we desire as a hole.
The unmet need is we need a hole. So, now that we know we need a hole we can come up with all the possible ways to make that hole with a drill being just one of those possible ways. So it's very clear which is the problem, which is the solution. Where this starts to get fuzzy is if you start to ask the question, why?
Why do you need a hole? And let's just do a thought experiment. We need a hole to access the brain. So now accessing the brain is the problem and the solution is a hole. Well, we want to ask, why do we want to access the brain? Cause we want to remove a tumor. Okay. So, then the problem is we need to remove a tumor and the solution is to access the brain.
Right. And we can keep on going on this, like why it's to access the brain, why to remove the tumor, why to extend the quality of life, why? Because every moment in life is meaningful or make every moment in life meaningful. And so up and down this whole ladder are problems that are also solutions, that I described the hole as the solution to access and I've also described the hole as the problem that needs a drill or potentially another way to solve it. 
To understand that problems equal solutions is a game changer in doing outcome driven innovation and jobs to be done because it becomes a level set setting activity. It depends where you're working and what you're working on. You might be working at a drill company and what you make is drills and drills are actually the problem to be solved, and all the possible solutions have to do with how to make that drill last longer and run less hot and [00:50:00] make straighter holes, et cetera, et cetera. 
So we can be in this very much in this drill space and be using outcome driven innovation. We can be very much in the cure brain cancer space and be utilizing outcomes driven innovation. And so, when someone says that's not a problem, that's a solution, we need to work on problems here. Oftentimes, it's just a misunderstanding. People are just talking to each other at different levels. 
Dasha: So what is then the process of focusing on the mission? How is it different? And also, just as importantly, how does an organization start to utilize the mission driven framework? 
Andrew: Right. Great question. So in that drill and hole example, the ladder I went up was, and it's thought experiment, but we need to drill to make a hole to access the brain, to remove a tumor, to improve the quality of life, to make every moment in life meaningful. The higher you go, it can be a convergent process up the ladder to a vision.
You can diverge up the ladder to many possible visions. But if you think about it, you can converge to a mission, the mission of like make every moment in life meaningful. And as you go down, so you're asking why as you're going up, if you ask how as you go down, there's many, many possible ways to do this, right? How to make a hole? There's an infinite number of ways to make a hole. Or how to remove the tumor? You can remove the tumor, you can ablate the tumor, you can maybe use some chemical to shrink the tumor, right?
So there's many different ways to get rid of that tumor. So as you go down, it's much more of a divergent process on the way down. You're getting more and more possible solutions on the way down. So, what I like to call this mission driven innovation is just taking the teachings of outcome driven innovation jobs to be done and tying the bottom, tying your capabilities and your technologies all the way up to the top, to your mission and your vision.
And when you do this, you end up creating what I like to call the problem solution space. Problems are solutions. Solutions are problems. It just depends where you are in space. It's kind of like Einstein's theory of relativity for problems and solutions. It just depends where you are in problem solution space.
When you as an organization have that space really well defined, you can tie what you're working on to the technologies that, hey, do we have the capabilities to do this? Or do we need to outsource this? Or do we need to build this capability? But you can also look up and say, hey, is this is what we're working on here, tied to our mission and vision.
And so, looking and understanding and knowing the problem solution space of your startup company or of the company you're working for, whatever the endeavor is, it allows you to have an infinite amount of innovation within your organization that is tied from vision all the way down to capabilities.
Dasha: Yeah, that's great and I think a lot of companies do take mission and vision as some like writing exercise, maybe writing creative copy, but it's because it's very difficult to articulate one's mission, I think. But, there's so much proof out there that knowing and having a clearly defined mission. Not something that describes your capabilities, but exactly what change in the world you're trying to make at a bigger scale.
It is a very good focusing, exercise for a company. And just as a pointed example, comparing Steve Job's vision for Apple, which is so simply and clearly and beautifully stated, versus you can then look at how it evolved past Steve Jobs and how it became a description of just these are our products and we make them.
And you can sort of tell that the innovation cycle of that company also changed, during that same time. So it may be not cause effect exactly, but those things are linked for sure. 
Andrew: Yeah. 
Dasha: Well, I want to turn to another question, which is for audience, engineers, doctors, nurses, researchers, how do they build more innovation?
What are some best practices, on a regular basis, that people who want to start innovating can start adapting into their daily work? 
Andrew: I think this whole conversation keeps on looping back to building meaningful relationships and having conversations. I think the number one thing that anyone that's interested in innovation or entrepreneurship should do is to have informal conversations within the problem [00:55:00] solution space and with all stakeholders on a regular basis, just on a weekly basis.
There's too many, researchers in labs working on very important problems who are not talking to the stakeholders. Again, I'll kind of pinpoint a disease state like stroke so you're in your lab, you're working out some technology that could potentially help stroke survivors. How often are you talking to people that have had strokes, right?
How often are you visiting them in all of the types of settings? You know, are you visiting them at sub acute care in the hospital, doing stroke rehab? How long is it taking them from getting from ICU to some sort of rehab? Are you visiting them in their homes? These informal conversations that you have within the stakeholder space are honestly, I think the most critical thing that you can be doing to be innovative.
To find all the pain, I mean, you're listening for pain, you're listening for the harm and you're trying to think how to do the good, right? Be caring and thoughtful. So you're looking for ways to increase good, you're looking for ways to minimize harm, and it's really hard to do that from behind a computer screen or on a lab bench, getting out and having those conversations is critical.
It is so critical that there's a gigantic business, a ton of money around continuous stakeholder discovery, continuous customer discovery. There are tools to record conversations, annotate conversations, share those conversations with team members. Companies are struggling with this, information is coming from everywhere.
It's coming from their sales team, their marketing team, their customer success team. And they don't know how to synthesize all that information. There's a ton of solutions out there for product development people for product managers to try to synthesize all of this information. That's how important it is.
That's how much money big, big companies are spending on it. I really think that we're just overdoing it. It's overkill. I mean, I will put money on it. If you've got at your company archived videos of stakeholder interviews in dovetail that have all been annotated. Have you watched all those videos and read the annotations?
And so week after week, sitting at your computer, doing your job, thousands of hours of recordings are building up and it becomes overwhelming to the point where I don't even know where to begin to look at all of this customer discovery. It's simple. Just go out and talk to people. Every week have a conversation and that's part of those design reviews.
You know, we talked about the weekly design review. We're working, we've got five puzzles. They're all mixed together. We're trying to complete this framework. We went out, having conversations with people is part of the process. And our design review is, hey team, what did you learn from your conversations last week?
What did you learn? And that will help you write down user needs that you hadn't thought of that week or the week prior, that'll help you write down new ideas that you hadn't thought about the week prior. So, making those conversations part of your weekly habit, part of your weekly routine is critical.
Dasha: So our last topic for the podcast today, and this is quite personal too. So David Chen, our podcast producer, director of the Coulter Center that makes this podcast, he and I taught a class called Class Plus for Biomedical Engineering. And for me, it was making me really reflect on how employment, industry dynamics, recruiting practices, and technologies are really changing the paradigm for searching for jobs and opportunities for graduating biomedical engineers, amongst others, for everybody, really.
And your background is interesting in this too, because not only have you done roles that were biomedical engineering product design, but you've also worked in partnerships, communication, leadership, ecosystem building, so you have this really broad view of the industry, and of course, also focusing a lot on students. What would you advise, first of all, kind of broadly advice for early career engineers, but also what are you seeing as industry employment shifting for engineers? 
Andrew: Yeah, [01:00:00] well, for anyone looking to start their career, I mean, students in college thinking about what their first job is going to be, or do I become an entrepreneur?
What do I do? I would say, think less about what it is specifically, and more about who you are, self discovery, and what your own personal mission and vision are. All these exercises that we talked about today, and I think there'll probably be some resources that you can look at afterwards, you can use them on yourself.
You can use them on like, what are my skills? What are my drills, and what are my holes, and what's my personal mission and vision. Identifying your own personal problem solution space allows you to see what holes you want to fill. Like, oh, what skills don't I have that maybe I want to learn, or what experiences can I do that are in line with my life's vision, right?
And so it's interesting if you look at my career, teaching and writing, starting a coworking space might sound like totally different things. Working in the movie business might sound like very disparate things, but they're all serving my life mission and vision. And if you can do that, I promise you'll have a very, very successful career.
Dasha: What are you seeing in terms of how the medtech industry is shifting, and also how can People prepare to build their careers in the world of these shifts taking place. 
Andrew: Yeah, that's an interesting way to ask the question, that it's both the industry is changing and how we're working is changing.
And so the first thing that I think crosses both of those realms is holistic health. The mind and body are one and they're complex, and I'm talking about mental, physical, emotional, and social health just as some examples, right, it's even more complex than that, but we can boil it down to maybe mental and physical as two big, big buckets.
And, I want to say that we have commonly treated those as two entirely separate things. You know, mental health is different than physical health. I think that there is a ton of evidence to show that they are intertwined. In fact, I believe that they're one thing. Mental and physical health are unified and we're seeing more and more innovation in the world of holistic health.
One health, combining more practices, looking at whole bodies and minds. But, that also impacts who we are in our work life, right? You know, a lot of us have remote jobs working from home. We can, we can find ourselves getting either too segmented, you know, I've got my work life here, my personal life there.
And, it's cut off from maybe social interactions because I'm not socializing at work the way that I used to. Or we can find the opposite occurring where work has completely invaded my personal life. You know, it's like I'm working 24 seven and my work is in my pocket. Right? 
And so, being really thoughtful about how we synergize holistic health in the way that we are doing our work and in the products that we're developing to support other people, that's a big topic and maybe related is proactive health. I'm seeing a lot more about health span over lifespan. It's the quality of the years that we're living are more important than maybe how long we're keeping people alive.
You know, and so can we work on staying healthier longer instead of a reactive medicine, be proactive. Be proactive about our physical health, be proactive about our mental health, be proactive about our holistic health, both in what we're innovating and how we're living. Certainly think about the themes that we talked about here today, rethink traditional process mindsets as frameworks as flexible frameworks instead, build networks, build meaningful relationships, find your [01:05:00] own personal vision and mission.
Be mission driven. You know, it's one thing I really didn't talk about is it's one thing to sit down and write a mission. That's another thing to live it every single day. You know, this applies to anyone. You could be an NIH researcher, you could be a professor with an NIH grant and you're coming into the lab every day. Are you reciting the mission and the vision of the NIH when you do that work?
Right? So they're only words if we don't read them and save them and live by them. So, I think that's where I would wrap that up. 
Dasha: Thank you everybody for listening to Biomedical Frontiers. We have Andrew's social links and his link tree to various resources posted below and we especially encourage you to check out his Ideal Biomedical channel on Medium where you can subscribe, read, highlight, and reply so that Andrew can then further engage with your ideas and use them to write additional valuable resources on biomedical innovation.
And if you would like to suggest a guest, tell us some feedback or engage with us in any other way, feel free to write to biomedicalfrontiers @virginia. edu and we will take a look and respond to you. And before we wrap up this episode, I just want to share some exciting news. In Episode 3, we shared the story of Springbok Analytics, which uses AI and MRI images to create full body muscle images, 3D models, for health analysis.
Well, just recently, October 9th, Springbok Analytics has received full FDA 510K clearance for their product MuscleView, which is that AI based muscle health analysis. This is really exciting because now this product is going to be available more broadly for use not just scientifically but also clinically.
So congratulations Dr. Blemker and her team at Springbok Analytics. Thank you so much and we'll see you all next month.
David: Thank you for listening to Biomedical Frontiers, Stories with Innovators in Healthcare. My name is David Chen and I am the Managing Director of the Walls H. Coulter Center for Translational Research at the University of Virginia. Our mission is to help bring promising new biomedical research and technology into the hands of the provider and the patient.
If you found this episode valuable, please let us know by subscribing, following, or sharing. You can learn more about our promising translational research projects on our website. See links in and the show notes.