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[upbeat music] But my thoughts are when you're trying to tackle risk in a startup, you wanna tackle risks that unlock your path forward.
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And what I mean by that is understand where your blockers are, and oftentimes the blockers are money and getting investment, and they're willing to-- like, an ability to go forward, to carry on, right?
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Especially in this environment. So if that is the case for your particular startup, understand your investor sensitivities. You know, what are they concerned about?
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And make sure that early development is geared towards mitigating those types of risks to optimize your chances to go forward.
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Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology.
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Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now, here's your host, Scott Nelson. Hey, everyone. It's Scott.
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In this episode of MedSider, I sat down with Brian Fahey, CEO of Adona Medical, a ShifaMed portfolio company he co-founded. Before Adona, Brian co-founded another company in the critical care space, Nevius Medical.
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He also spent time at J&J Innovation, specializing in drug device products for oncology, and contributed to the leadership team at Aerenex, a neuromodulation startup in the ENT space.
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An alumnus of the Stanford Biodesign Innovation Program, Brian holds a PhD from Duke University. Here are a few of the key things that we discussed in this conversation.
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First, there are three major risk factors in med tech: product market fit, technical feasibility, and clinical validation. When assessing an idea, the first thing to do is to try to talk yourself out of it.
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Once you reach a point where you can't argue any further, you may have something solid on your hands.
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From there, your goal should be to identify the areas with the highest risk factors and those that are quickest to mitigate.
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Second, pioneering innovations can be substantially rewarding, but the trade-off is they often demand longer and more complex clinical trials.
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Mitigate clinical risk by studying the pathways of predicate technologies to refine endpoints, patient populations, and more. True disruption requires a product that's not just better, but significantly transformational.
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Third, be selective in fundraising. Consider your sector, stage, and the size of your round you're after in order to focus your energy on your best prospects.
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Transparency and consistent communication build trust and enhance your brand in both fundraising and M&A processes.
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Before we jump into this episode, I wanted to let you know that the latest edition of MedSider Mentors is now live.
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We just published volume six, which summarizes the key learnings from the most popular interviews over the last several months with incredible entrepreneurs like Dan Rose, former CEO of Lymphflow, Dr.
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Steven Michelson, founder of TheraPulse and current CEO of Field Medical, and other leaders of some of the hottest startups in the space.
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Look, it's tough to listen or read every MedSider interview that comes out, even the best ones, but there are so many valuable lessons you can pick up from the founders and CEOs that join our program.
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So that's why we decided to create MedSider Mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place.
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To check out the latest volume, head over to medsideradio.com/mentors. Premium members get free access to all past and future volumes. And if you're not a premium member yet, you should definitely consider signing up.
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In addition to every volume of MedSider Mentors, you'll get full access to the entire library of interviews dating back to two thousand and ten.
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You'll also be able to see all of our playbooks, which are thematically handpicked collections of the most insightful interviews covering topics like capital fundraising, early-stage development, regulatory challenges, reimbursement, M&A, and much more.
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And last, considering that fundraising can be one of the most daunting tasks for any startup, we curated a database of over seven hundred VC funds, private equity firms, angel groups, and more, all eager to invest in medical device and health technology startups.
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Access to this database is a premium member exclusive, so don't miss out. Learn more about MedSider Mentors and our premium memberships by visiting medsideradio.com/mentors. All right.
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Without further ado, let's jump right into the interview. [upbeat music] All right, Brian. Welcome to MedSider Radio. Appreciate you coming on.
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Yeah, thanks. Really happy to be here. Yeah. I enjoy reading your LinkedIn posts every now and then, so it's fi- it's fun to finally have a conversation.
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Been loosely following Adona's story for, for a couple years now, so looking forward to this conversation. I hope, hope the audience finds it, finds it valuable as well.
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So with that said, I recorded a very brief bio at the outset of this interview, but to start there, if you can give us sort of an elevator pitch and maybe a couple minutes around your professional background leading up to starting the company.
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Let's start there. Yeah, sure. It, it's always a funny journey, right? Because it never takes that linear path that we all think that we're gonna have when we're younger and high in our early 20s or whatever.
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But I was an engineer by training, went to school for engineering, ended up getting a PhD in ultrasound stuff down at Duke.
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Thought I wanted to be a professor for a long time and about halfway through getting the PhD, had that crisis where I just became very disillusioned with academia as an institution.
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Not that it's a bad path, it just wasn't for me. I then had to find whatever that new path was going to be.
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By just chance, I happened to see an-- I think it was, like, an email advertisement for a fellowship at Stanford at Biodesign. Uh, applied there, took a whim on it, and came out to interview.
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Lucky enough to get to that stage and I remember this just so clearly, like, in the first ten minutes of the Stanford Biodesign introduction from Paul Yağci, I just knew exactly this is what I wanna do.
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And then I had a- another panic attack because I wasn't prepared enough for the interview process.
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[chuckles] But lo- long story short, I was lucky enough to be accepted into that fellowship, spent a year learning about med tech innovation, bench-to-bedside technologies, and just all the things that I think really resonated with me about how to make a patient impact in maybe five to seven years, not fifteen to twenty years, which is more the norm for basic science and that you see in academics.
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So completed that fellowship, spent most of the next decade after that running a startup that I founded in critical care space.
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We took that from basically ideas on a whiteboard all the way through early commercialization. Uh, had about twenty hospital paying customers throughout the US.
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Ended up that technology tied up with being strategic, which was great. I spent a few years after that doing a few other things with some other startups that was really interesting.
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Saw some other M&A processes or as we get to be part of peripherally. Did some work at J&J Innovation. Got to see innovation through the lens of a big company, strategy, business development, et cetera.
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And then ultimately ended up collaborating with someone I'd known about 10 years earlier, Amar Sawhney, who was the CEO of a group called Chief Med, by coming in as an executive residence, trying to figure out, hey, what should the next Chief Med portfolio company be?
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That was my mandate, and we ended up coming out with the ideas that became Adona. Flash forward to now I'm sticking around running the company. So it's...
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That's the whirlwind journey of the CliffsNotes as fast as I can version, but that, that's my background. No, that's a great, that's a great overview.
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And the, the, the intent is to set the stage for the, the rest of the discussion with the goal of not only learning, learning about insights that you've picked up along the way, but also what you're building at, at Adona.
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So we're recording this in mid 2024. I think you started, it looks like based on our research, you started Adona kind of Q4-ish timeframe of '19. So almost five years or about a half a decade in the making now.
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Give us a sense for kind of what you're building, and then maybe touch on where the company's at from a, a stage perspective. Yeah. So at Adona, we're building essentially heart failure platforms.
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And as I mentioned, I was there at the very beginning. I was employee zero. I was working on Adona even before we knew what Adona was, and that's by design. In that early stage, we had all sorts of ideas.
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We had some good ideas, and we had some bad ideas. And what I like to tell people is I had some ideas that I thought were great, and the physicians hated. It was very humbling. But then it's... It was...
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It's all, it's a process. You change your mind a lot. But
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what actually helped me gravitate towards Adona is I thought we had an opportunity to be disruptive in actually two separate therapy classes for heart failure, right? And
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then I also thought beyond that, to take it a step further, you could possibly integrate these two technologies in ways that had never been done before.
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Um, and by doing that, you know, it's the type of thing where the whole is greater than the sum of the parts, right? You have that synergistic relationship between these two types of technologies.
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One that's more diagnostic and one that's more therapeutic, and how they might augment each other's functionality and unlock things that you could never do before, in theory. That was the idea.
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And so early on, so the two classes of products were intra-atrial shunting, which we didn't invent. We didn't come up with that basic idea.
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We just thought that we had some ideas that possibly could make it more advanced and more patient-specific, individualized.
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And then remote pressure monitoring or hemodynamic monitoring, which again, we didn't invent that. That's a pretty robust proven technology, at least at this point.
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Five years ago, I think there were a lot more debate, but now we just got a second FDA approval from a second company to do this.
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There was just an announcement of a big acquisition that was announced last week, and there, there's a lot going on there in that space too, and we thought that we could make a best-in-class version of that, and then combining those two technologies.
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So early on, you ask about 2019, what was that was like? There was a lot of technical risk of... There wasn't a lot of product market fit risk. There was minimal clinical risk, but nothing's free, right?
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And so if you're leaving that all on the table, you're shifting those risks to a big technical lift. But that was something we were really comfortable with because we... I was an engineer by training.
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I collaborate with a lot of former engineers that are now business type folks, and we felt we got our hands on it.
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We understood what the risk profile was, and we thought that we could recruit a team of very elite innovators and gifted engineers.
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And our mission was like, "Hey, we think we can do something that's really impactful for patients. All we have to do is figure out two or three things that no one in the world has ever figured out before."
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And it sounds really big and it was ambitious, but early on it was, "Can we do this? Can we even build these things? Can we find a way to make it work?
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And if so, could we make it practical or cost-effective or reasonable?" Whatever, all the checklists that you have to go through once you have a solution, is it a valuable solution?
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And then over time, we were able to prove those things that were working.
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We were able to validate that, hey, we can design it, we can build these sorts of things, we can do some of the testing, and all that it seems like is panning out and now we're at the precipice of our initial human use, which is coming up in the next period of time, several months, a quarter or two.
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Every startup, the timeline has some error bars on it, but it, it's in our, it's in our vision, right?
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We can see this, and that's the exciting time for us because we've worked really hard and a lot of people have made a lot of really important contributions to this sort of thing, and now we're at the point where people are actually gonna start to benefit from it.
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And there's nothing more exciting in med tech than to put your innovations in the hands of physicians and actually help people. That's why we're all doing this. Yep. No doubt.
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I, I'm glad you touched on those three things, which I, I think we'll probably dig into a little bit more in more detail throughout, throughout the rest of the conversation.
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But those three risks that you called out, clinical risk, technical risk, and, and product market fit risk.
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There's other risks associated with building a startup in, in med tech, as we all know, but those are three of, of the largest.
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And so I think that's just a healthy framework for those listening that are maybe thinking of taking a swing on, on an idea. This is a lot of name of the game of startups is how do you minimize risk, right?
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Especially as you're raising capital and I, I think that that framework is really solid, simple, straightforward. You're staring down three kind of risk pillars, if you will.
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One of which was the biggest one, which is technical. So with that said, you mentioned the stage. We're, again, we're recording this mid 2024.
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Hopefully, sounds like maybe you're close to being in patients maybe before the end of the year, maybe early next year. As you mentioned, all startups have just some flex in those, in those schedules for sure.
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And if you're interested in learning a little bit more about the technology, it's adonamed.com. We'll link to it in the full writeup on Medsider, but it's A-D-O-N-A med.com, A-D-O-N-A med.com.
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And one, one other, uh, quick question before we step into the end of the time machine and go back and learn a little bit more about things you picked up along your journey. When...
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Heart failure specifically, I'm sure you were evaluating other sort of therapeutic arenas, if you will. Why heart failure? Was this something that, that resonates with you personally?
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Was it, did you have a fair amount of experience in this space? What, why'd you decide to build in this category? Yeah, it's a great question. Heart failure is very personal to me. My grandfather had heart failure.
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He suffered for a long time, and ultimately is what led to his passing. But, uh, and that wasn't really the only reason. That was just a, a nice to have motivator behind it. I think what attracted me to heart failure
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specifically is a couple of things. One is this certainly falls within the umbrella of cardiology. Uh, and cardiology I think is an interesting space in med tech to be in.
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I, again, I've worked in critical care, I've worked in ENT, I've worked in radiology, orthopedics, I've done some work in oncology and drug device combination products.
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And then this is my first time in cardiology, but one thing that's really interesting about cardiology is that
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there are a very large number of global strategic players that are still competing against one another for any new type of therapy.
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And you don't see that, for example, like in ENT or gastroenterology or, or other sectors where it's more consolidated. And so cardiology is interesting because if you have something really disruptive and compelling,
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you have a greater likelihood that you can create a competitive bidding process or an auction at the tail end, and that can help push exits to be a little bit more lucrative, but also give you flexibility, I think, to work with the right partners that align with your vision and not just work with the partners that are out there.
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And so I... Uh, cardiology in general is attractive to me and obviously it's attractive to lots of people, right? But that's one of the reasons.
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But heart failure as a sub-sector, I think it's, it's more of that nascent sector that this has typically been a medical management pharmaceutical domain, and it still largely is.
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But if you look at these patients, there's great therapies early on in heart failure when the patients really aren't that symptomatic.
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We have what we call end-stage or destination therapies like VAD and transplant that will save a patient's life at the very end. And in the middle, there's like a whole bunch of nothing, right?
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And these patients continue to get worse, they continue to deteriorate.
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Yeah, pharmaceuticals are getting slightly better, but patients don't like to take drugs and compliance is terrible, and some of these patients are on something called hyper-polypharmacy, that they're taking like a dozen drugs or something like that every day or more or whatever.
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And even those drugs, so many patients become refractory to them. They're not even working so well anymore.
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And so you're beyond the steps where like CR rounding type devices are helping patients, and then just waiting until you get sick enough to get a VAD.
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And it's not like an existence that anybody would want for their loved ones. And I thought that there's possibly a lot of opportunities there.
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And again, I'm not this savant that just saw this opportunity that no one else did.
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There's a lot of investment both in the med tech space as well as the pharmaceutical space to try to put more stones or stepping stones in that gap, right, or whatever our metaphor is.
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But to me, it was a big opportunity, and there's so many patients that these markets are just... You shift gears away from the patient perspective into, is this a good business?
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These market sizes are just enormous, even by med tech standards. If you got something that was really great at serving 10% of the market, these are still just huge opportunities.
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And of course, I saw a path that we could get more than 10% of the market and everything else. And so to me, it's just all of the stars aligned ar- around it.
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It, yes, it had personal meaningfully, meaningfulness to me as a, just as an individual, as a family member.
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I thought it could make a big impact on society, which is something that I think all of us aspire to do with our careers.
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The business aspects, the market li- lined up, and then the exit potential for partners was also there. And you start looking at all these various aspects and you're like, "This seems like a good space.
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Now let's see where to play in that space." And that's always the hard part, right? Is like where do you have an opportunity? Yeah. That's a great, that's a great kind of summary.
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And the, these journeys are so long in startups, and you're building it in, in med tech anyway. They're often really, they can be really re- rewarding, right?
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Not just from an economic standpoint, but from a technology and patient perspective, too. But if the ideal scenario is whatever you're working on checks a lot of those boxes that you mentioned, right?
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Because these are, this is not, these aren't quick flips [laughs] usually, right? These are five, seven, 10-year journeys, so it's a long time.
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So with that said, let's go, let's step in the, into the old med side or time machine, as I like to call it, and then, and cover some cross-functional topics.
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One of which I think is super pertinent considering your engineering background, is early stage development, right?
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This is the, some of the hardest stuff to do with typically pretty limited capital, right, in those early phases. Donna's a chief of med company, so you're around a lot of like other early stage companies as well.
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So when you think about that phase of a med tech startup, where do you think most founders, CEOs go, go wrong in trying to manage that early stage iteration with pretty limited resources? Yeah. A mistake I see
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frequently is that people try, I think, to tackle the wrong types of risks.
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Um, and obviously that's subjective and you could ask my assessment of something and ask 10 other people and get eight or more opinions or whatever.
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But my thoughts are when you're trying to tackle risk in a startup, you wanna tackle risks that unlock your path forward. And what I mean by that is understand where
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your blockers are, and oftentimes the blockers are money and getting investment and a willing to, like an ability to go forward, to carry on, especially in this environment.
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And so if that is the case for your particular startup, understand your investor sensitivities. What are they concerned about?
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And make sure that early development is geared towards mitigating those types of risks to optimize your chances to go forward. And because of that, startups are often non-linear.
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So if you're a very linear thinker, you've gotta throw that mindset in the trash and be ready to adapt. And so a very specific risk I see oftentimes is people jump straight to a prototype.
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And great, that's helpful, and you will reduce technical risk out the gate. I'm a technical founder. I like to think, let's all do technical, but investors often don't worry about that sort of thing, right?
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They're worried about market risk. They're worried about- Pricing or reimbursement or what is the huge hurdle ahead of you?
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Very few investors, if you check the best rest of the boxes, are gonna say, "Oh, I don't think you can build it." We put a man on the moon with the power, computing power of our cell phone, right?
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Like, humans with the right funding have an ability to figure things out. And so I'd always urge people to try to understand what box you're checking.
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When you build a prototype and you spent $100,000 on that of critical money, okay, that's important, but to who? To you or to them? And, and listen, it's important to you as a founder.
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If you're not sure you can build it, that's a great box to check also because you need to convince yourself that you're in it for that five, seven, 10-year journey that you had just described.
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Whatever the risks are, I'd suggest working to turning over those risks. The highest risks and the quickest risks to mitigate are where I would spend most of my time, and sometimes that is product development.
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Sometimes that is, let me build the crappiest prototype I can think about and show it to physicians and understand, yeah, I would use this or whatever. And, so it really...
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It's a hard question to answer concretely, but I do think that oftentimes people aren't mitigating the right risks, right? And that's how I, I would, I always try to press on people, be like, "Is this the biggest value?
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Even though it's the next logical step, it, it might make more sense to jump three steps and then work backwards." Mm-hmm. Yeah.
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That, that, that risk you highlighted around, I think the way you described it as, as the, the need to be able to, to move on, right? To get further, to advance the, the football down the field, if you will.
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That, that's such an important point, right? Because... And it speaks to the, the necessity of engaging with investors as early as possible.
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Maybe not in the, in a traditional kind of pitch format per se, but the more you engage early on, the more you'll learn about what they perceive as sensitivities and be- and in being able to fund a company like this, and that's so crucial 'cause almost every single person that's listening to this or is working on a med tech startup is working on an idea that's likely going to need external funding.
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The, the chances it won't, uh, are, are pretty low. So understanding those, those, those areas of concern, right, from outside investors is really crucial. So I'm g- I'm glad you touched on that.
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And let's use that as a segue to financing in general, right? You've, I think, raised four rounds maybe of financing, if our notes, my notes are correct here, for, for Adona.
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And then you obviously had your previous, previous experience raising for... Is it Nevius? Am I pronouncing that right? Nevius? Yeah, Nevius. But yes.
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We joked around about how the, the, the best pronunciation for Adona kind of at the outset of this conversation before I hit, hit the record button.
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But, so your experience at Nevius, then you spent a couple years at J&J DC, you're a ga- consultant with other startups along the way, et cetera, so you have, I'm sure, some pretty good thoughts around fundraising.
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So when you think about what you know now maybe versus five, 10 years ago when you used to pitch at Pitchberry invest- Pitchberry's investors, are there a couple key insights, key learnings that you've picked up along the way that really inform how you, your approach today?
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Sure. And again, there's no hard science to it, I think any of this, right? And there are different perspectives, and uh, there's more than one way to get to your, you know, final endpoint.
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One thing that I think is really important that, again, I, I see
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others sometimes get this wrong or at least in my opinion get it wrong, is the shotgun approach where we're just gonna go talk to everybody, and that's, I think, a...
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It can be a waste of people's time, and I think more importantly, it's not just time, 'cause time as a founder you can say, "Oh, my time is infinite," but really it's about focusing your time to be best prepared for your best shots on goal, right?
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And so you could... You should be able to understand, right, what sector am I in? What stage am I in? What size round am I trying to get?
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What types of participants usually participate in a syndicate of that size or that stage or that sector? And narrow down your list to the people that you think are most likely to invest, right?
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And I think that's where you're gonna get the best traction. That's where you're gonna get the best bang for your buck, right?
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And if you're raising a series A and you're going to a late-stage investor that possibly is investing or will invest in a competitor, all you're gonna do is tell them all your great thoughts that who knows where they're gonna end up.
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I'm not suggesting that it's always people sharing information, but we also know that at some level this can happen.
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And so talk to the people that you think are a good fit would be my first thing, and then to, again, understand their sensitivities, right? Don't be afraid to ask questions back.
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I don't think it's a sign of weakness or a sign of vulnerability to admit that you don't have all the answers, right?
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If someone asks you a question and it's a risk for the company, oftentimes I see people try to say, "Oh, it's not a risk because of X, Y, and Z," and maybe... I don't know.
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I, I think oftentimes, like, you just say, "Yeah, that's a risk. If you invest in this company, you're gonna have to get comfortable with that risk and our strategy to mitigate it together as partners."
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And I think that can go a long way that you're suggesting to your investors that even if you don't have a board seat, you have a voice, and we're gonna work together as a team to sort these things out.
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Because your earliest investors, those are your partners for, again, 10 years or something, right?
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You need to make sure that you can go through adversity together, that you can have a hard conversation together where you might show up and you disagree about an idea, but it... We're talking about ideas, not people.
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It's not personal, right? And how do we sort through that? And I also think especially for young entrepreneurs, it also shows that you're coachable, which I know is so important from the investor's standpoint.
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That you don't think you've got it all figured out, right? That you're going in and you're receptive to ideas, and even if you don't agree with those ideas you'll entertain them and hear people out.
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And maybe you don't completely pivot what you do, but you'll take that 15% pivot and start to align these journeys, because oftentimes the investors have seen way more than us.
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They're seeing 30 companies at once succeed and fail and flounder and thrive and everything in between, right? And raising money, it's about targeting. It's about showing that you're gonna be a good partner.
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I think it's about being honest. Being able to say, "I don't know," I think is okay. And establishing that credibility.
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One thing that I like to do oftentimes when it's really early on before a pitch, and it's something you had brought up, is go talk to investors that are never gonna write you a check because they don't match those boxes before.
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But just say, "This is not a pitch, but I want you to look at this like you're writing a check," right? You can't just ask for advice because no one wants to say anything negative to anybody, right?
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It's a great idea until you ask them to open their checkbook, and then no one wants to do it, right? And tell them, "What are your criticisms?"
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Give me all the harsh feedback, and try to hear all the harsh feedback there in a setting where it doesn't matter so that you can be better prepared to hear it in a setting that it does matter in the future.
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And I think that can be really important, too. Just invite people to trash your idea.
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And once you've gotten to the point where you feel like you've got a great defense or a strategy for anything that someone can throw at you, that's when you know you're ready. Yeah. Yeah, that's good.
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That's a, that's a nice little practical tip is practice, practice that, that presentation and it's a low-risk environment where we can get really smart feedback, but it's not a...
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doesn't come with a, a significant cost. But hearing you, you describe some of your thoughts on fundraising, um, it just, it always reminds me of this is a relationship game.
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And especially maybe even more so in the life sciences or med- or medtech specifically, your first pitch oftentimes is not gonna result in a check, right?
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It's gonna be this evolution of getting to know various investors over time, and how you run that process speaks to probably how you may...
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how that relationship could look w- could look like if that potential party does in fact write a check and, and support, support your startup financially.
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It sounds like that's been your experience over time, too, is, like, the building and the building of those relationships over time has been pretty crucial in, in getting the, the type of capital support that's needed.
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Yeah, absolutely. Listen, I think... [clears throat] And again, what I'm gonna say is obvious to people that are seasoned in our industry, but it's, I work with a lot of the fellows from Biodesign each year.
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I'm still pretty close to the program, so I have a constant stream of people that are just starting out. And again, I don't pretend to be this wise sage that knows everything, but I've seen a thing or two.
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And what is lost on a lot of young innovators or first-time CEOs is that your only goal of a first meeting is to get a second meeting. Mm-hmm. Right?
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You're not getting a check that first day, so you don't have to say everything, right? You don't have to give them 30 slides. Just show that you're credible, show that you're personable, relatable.
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Show that you have a compelling insight into a problem that is real and that has some upside potential. And then you can get into the details another time.
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If you bore everybody with fine details in the first meeting and excruciating painful detail, you're just wasting time spitting at bats. Mm-hmm. Yeah. No, no doubt.
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And, and just to touch on that, like even with Fast Wave, which is the company that I run, we, we received a term sheet that was I think maybe 18 months in the making, right, from initial kind of initial discussions.
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And so that just, for everyone listening, that gives you an idea of how long sometimes these processes take to really get to know people to support a company at a certain stage.
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So it takes a long time, and it's never [laughs] it's rarely, rarely do you ever win someone on that first pitch. It's about the, kind of the process that you run.
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And it's super important, and even more so on the M&A side when you get these companies acquired. Listen, like, a big global company will spend,
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I don't know, months and months, and they're gonna send dozens of people to your site to look at every piece of paperwork, everything that you've done. And that proper due diligence process is lengthy.
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Even for deals that aren't a billion dollars or whatever, it's a lengthy process. And still at the end of that, they're never going to find everything, right? And they know that, and we know that,
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and so that's why that trust component is so important. Mm-hmm. Right? You have to build that credibility and trust because otherwise you'll never get a deal done because they know they can't find everything.
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There's always some skeleton in some closet somewhere lurking that they have to trust us to prospectively flag it for them and then talk about why it's not a problem versus just bury it and they find it in six months and it's a disaster.
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Yeah. That's a really good point. [upbeat music] Hey, everyone. Let's take a quick break to talk about Fast Wave Medical, the company I co-founded and lead as CEO.
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Our team is developing next generation intravascular lithotripsy systems for complex calcific disease. This type of therapy is often referred to as IVL.
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The market size for IVL is over $9 billion, and there's only one player in the space with a market cap of around 10 billion, so naturally there's a lot of investor interest in Fast Wave.
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In fact, we opened up an opportunity to invest directly into the company almost a year ago, and we were blown away by the interest from our community, so much so that we ended up closing $8 million from our supporters in less than a month.
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Typically, opportunities to invest in venture-backed startups like Fast Wave are pretty rare, so based on significant and continued demand, we highly encourage you to sign up for our wait list to avoid missing out on the next opportunity to invest.
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You can opt in at fastwavemedical.com/invest. And if this is the first time you're hearing about Fast Wave, here are some key highlights.
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As I mentioned before, we are sitting on an IVL market valued at over $9 billion with only one incumbent.
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Second, we just completed our first human study with eight treated patients, resulting in 100% lesions crossed and a 93% reduction in mean diameter stenosis from baseline.
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We've raised over $20 million to date from corporate venture and cardiovascular KOLs, and we have five granted patents by the USPTO and multiple FTOs.
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If you're interested in empowering physicians with advanced IVL technology while potentially benefiting from a fast-growing IVL market, head over to fastwavemedical.com/invest and check out the details.
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Again, that's fastwavemedical.com/invest. All right, let's get back to the rest of the conversation. [upbeat music] It's one of, it's one of the reasons I'm, I'm such a big believer around beginning to...
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E- even if you're at an early stage, thinking about your company a- a- as a brand, right? And you're building this brand, and oftentimes the brand is not...
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it's not the logo, it's not the color palette, it's, it's how you're engaging with your community, right, with your stakeholders. And it's one of the reasons, like, I... by the time this goes live, I'll...
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the, the interview I had with Brian Lord with, with Pristine Surgical will have gone live, too, and we talked about this very th- same thing. It's one of the reasons I like seeing your stuff on LinkedIn.
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It's like, yeah, I don't know you personally, but I get to know you, right, and get to know the brand that you're, the company that you're building with Adona, and I think it speaks volumes for other, for that M- M&A kind of process, potential M&A process down the road, so amongst other things.
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And I wanna get your take on that, that topic in general, but before we get there- The space that you're in, heart failure, we, we chatted about this a little bit already, but it's not for the faint of heart, right?
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You're staring... The, the technical lift is pretty tall, but these runway, these clin reg roadmaps, these, these pathways are pretty, pretty intense.
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And when you ki- when you think about that, that in g- in general, like any...
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And, and maybe frame this up for other entrepreneurs that are working on products that do require a similar kind of extensive runway, any, uh, high-level advice or, like, how are you...
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H- how do you typically approach th- this process when you're staring down these, these lengthy clinical, clinical initiatives? Yeah.
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There are different schools of thought a- a- about this, of course, and I think it tailors a lot to, you know, whether you're a founder or an investor or an executive or an employee.
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You're a part of the same journey, and you have to choose which journeys you want to be part of.
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And I think some of that comes down to risk-reward tolerance, your risk tolerance, what you're looking for at the end, and where your personal sensitivities may be, right? And personally,
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I would not want to be on a very long clinical regulatory journey unless I had an ability to learn something from others along the way, right?
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I have no interest, personally, at least at this point in my career, being a first-mover pioneer in an unknown therapy class, right? Mm-hmm. Now, that doesn't mean that's not, like, a great opportunity for someone else.
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And frankly, I think it's really important for our society, right? That we are investing in these, and when they get it right, these are companies that absolutely crush it.
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They're some of the biggest exits that we've had in our industry. So there's a high reward, but a high risk.
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And I like to shift the balance a tiny bit by, for the spaces that we're in, in heart failure, we're not the first companies or company in these therapy areas to do pivotal clinical trials, right?
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And we're learning from them. We're learning from what works and what doesn't work, and who are the right patients and who are not the right patients.
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What is the dosing, and what do you measure, and when do you measure it, right? There's so many variables.
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And personally, I wouldn't want to be in a company where you have this very different product, it takes a long time to develop, your engineers do everything perfect, and you think it's gonna work.
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It's based on a sound thesis, and then you get to a clinical trial, and it just fails because clinical trials are hard and humans are hard.
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And this is especially true in heart failure, where the patients are incredibly heterogeneous and diverse.
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Our ability to phenotype or classify them is still a work in progress, so it's hard to even limit that, even if you try to limit that diversity.
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And also there's certain measurements of placebo effects or Hawthorne effects or everything else, right? There's just a lot of moving pieces. But how I think about it is I'm learning from everybody else, right?
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And that's great because it reduces a clinical risk. We talked earlier about product risk and market risk and clinical risk. That reduces a clinical risk for us, which I like.
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But again, we talked [laughs] before, nothing's free. It shifts more burden on technical risk because if I say I want
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not a conclusive clinical path, but a more informed clinical path, that means I'm gonna be late, right?
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Which means that our product, our design goal, whether we hit it or not, will be up for others to decide, but we have to aim to be, like, 500% better than everything else.
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Because if you're only 30% better and you're five years late, that's not enough to disrupt the ingrained momentum of the pioneers in the space. If you're going to be truly late, you have to be transformational, right?
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You have to be a next generation version of that therapy that, if you do your job, at least has a chance to obsolete everything else, right?
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And that is, again, our vision, and whether we hit that vision and achieve that goal is still very much to be determined, Adona. We're not even in our first patient.
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But that is the path that we set up for ourselves, is like, all right, I wanna take less clinical risk, but I'm willing to accept more technical risk, and that shifts the risk profile earlier in the company.
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So if I run into a problem, I'm gonna run into that problem at 9 months or 18 months and not 10 years, right?
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And so again, that's my general philosophy, and again, it's a philosophy that is largely shared by Amir and others at Sheaf Med, which was one of the things that I thought was really compelling about collaborating together with, with that group, is that we looked at, you know, risk and where, what types of risks we're comfortable with in a very similar way.
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Yeah. And I'm sure it helps as, for other Sheaf Med companies too, is like any outside investors that are evaluating that, that opportunity, they know what they're getting with.
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There's a, there's a, an internal thesis, a consensus around what you're, what you guys are, are, are building there.
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But I really like that, that, that sort of, that idea that, that you, you mentioned around, around the longer clinical pathway and overlaying that against the timeline.
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So if, if you're working on something that is, that does have a, that is, is gonna require a, a PMA pathway, as an example, right?
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You shouldn't necessarily be afraid of that, but you should fully understand that timeline, right? Or that approximate timeline.
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And if it's not, if your technology isn't disruptive, like truly disruptive, that likely isn't gonna result in a, in a very meaningful outcome, right?
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It's gonna be a lot of investment dollars, a lot of time, only to get to a point where you're maybe 15, 20, 25% better. That's oftentimes not gonna cut it.
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And that, that simple kind of, like, framework I think is really valuable. I'm glad, I'm glad you mentioned it. Let's chat a little bit about, about M&A.
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But when you think about M&A in general and how to engage with strategics, do you... Is your general thought to engage early to start building that relationship, as you touched on earlier?
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Or is, is your thought process to stay, to keep those strategics on the sidelines, so to speak, until you get to a certain point?
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What are you, what are your general kind of thoughts around, around, uh, around this topic? Yeah. Of course, there are different schools of thought here also, to state the obvious.
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But I think the time is right is that once you feel like you've got your core things figured out from a technical standpoint, your positioning standpoint, your feature set, whatever it might be, and that you've got most of your IP filed or all of your IP filed, and possibly even once you have something issued, although that can really extend that timeline maybe too far.
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It, to me, it's always like a one and it's all at once, right? Like you, you don't wanna do it not now, okay, everything at once. And- I do think early is better, even if it's just, "Hey, my name's Brian.
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I'm running this company. I think that there might be collaboration opportunities in the future. Can I give you a five-minute elevator pitch?" Right? Just so you know that we...
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Like, you're vaguely aware that we are out there, right?
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And sometimes that leads nothing, and sometimes it leads to more and a more conversa- And then again, you're building these relationships, you're building trust, and I think that matters quite a bit.
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It doesn't mean that you're gonna get a good outcome. No company is gonna, "Oh, we weren't gonna buy Adona, but now we will because Brian's a good guy." But it's not how it, like, works, right?
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But I do think them believing in you and establishing that credibility works during an M&A. And I actually think it works with investors too. You go to an investor and they say, "The stage isn't quite right for us now.
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We don't like this risk or that risk." Okay, tell them your milestones, and then go deliver. And then come back and say, "I said I was gonna do X, Y, and Z, and I did it on time, under budget.
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Can we talk about the next round?" And that credibility, I think, goes a long way, especially, again, for, for younger people that maybe don't have that track record.
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There are CEOs that have done this, or founders that have done this a dozen times. They don't need any more. They're already on their pedestal, right? And that's great. That's fine. They have the relationships.
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They have the ability to raise money. They have the ability to get a transaction done. But I think most of us are still aspiring to that god tier, right? Mm-hmm. And we've got a lot of work to do along the way.
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And any opportunity to increase your credibility, I, I think is, it's a good thing in general. Yeah. Yeah.
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Very little downside to at least establishing some sort of, some sort of foundation, uh, around the relationship, right, as, as early as possible.
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That doesn't mean that you're pitching them and trying to sell them on your technology per se, but you are trying to sell them a little bit to a certain extent on your, who you are, right?
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And at, at least at a high level, what you're looking to l- looking to build.
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When it comes to investment, in a similar vein, a lot more strategics are establishing corporate venture arms, and this is obviously a direct experience at J&J DC.
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Do you have a, do you have a preference on, on raising capital from strategics? Is it something that you typically avoid up until a certain stage, or do you welcome the interest? How do you think about that?
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Or maybe what are your kind of general words of advice for other entrepreneurs that are thinking about potentially raising from traditional institutional capital versus maybe a strategic corporate venture? Yeah.
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This is easy for me to say because, perhaps because I've actually never taken strategic money so far in our, my career.
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But I've been in discussions for it, and sometimes we chose not to go forward, and other times it just didn't work out at that stage. The timing wasn't right, et cetera. But I don't see a lot of downside to it.
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Again, different schools of thought on there. I think the old, like, adage from 10 years ago or more was strategic money is risky because let's say company X invests in you, and then they don't acquire you.
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Well, what does that signal to the rest of the ecosystem? What do they know that nobody else knows if it's not a fit for them?
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And I think over time, our industry has evolved to understand that corporate strategies change oftentimes in fairly dramatic ways over the course of a startup's existence, right?
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And just because they invested in you at year three and they don't want to buy you at year seven doesn't necessarily mean anything.
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And I think it's actually more and more common to see companies that have multiple strategics in a round. Mm-hmm.
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And I think that can be very compelling because you're signaling to the world that I'm open to these partnerships.
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I see that this capital can often come with advantages that go beyond the dollars in terms of access to facilities or partnerships or position relationships, whatever it might be.
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And then you want to leverage that as a company in a non-binding way. And so I, listen, I think strategic money can be very helpful. You obviously, the details matter a ton, right?
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And it's not saying that there's any detail that would be a deal breaker across the board, but know what you're getting into. Are there rights associated with it? Are they sitting on the board? Are they an observer?
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Is there a walk away? Understand those details. Make sure those details make sense for your organization. But if so, I, I think it's a good upside.
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I actually think that having a strategic in a round makes it a lot easier to raise traditional institutional money because you're almost validating that there's a potential exit market for you. Mm-hmm. Yeah, no doubt.
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And I, I would 100% agree. I, I, in my opinion, it's a bit of an old, old adage, right, that, that you should keep the strategics on the sidelines. That doesn't mean that's a definitive truth, right?
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As you mentioned, like the devil's in the details. But generally speaking, there's not a tremendous amount of downside, right?
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As long as it's, they're investing with, hopefully without rights or any significant kind of o- o- obligations or commitments on, on to, to you as a startup. So I think that's really good. That's really good advice.
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And so maybe the take home message for anyone out that, that's listening and, and raising, raising money, don't shy away. It's worth engaging and letting the chips fall where they may.
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But it se- it's seemingly becoming a lot more popular for multiple strategics to be involved, even at fairly early stages, right? Not at your series C, series D stages either.
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With that said, we got a little bit of time before we get to the rapid fire portion just to touch on this topic in more general, and I think it's pertinent because of your experience at JJADC as well as your, your kind of, your time as an EIR at the, at Chief Med.
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But when you... And, and you, you mentioned, you mentioned a little, you touched on this a little bit with the first question I asked you around how to effectively manage design and development at the early stages.
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But even before then, when you were evaluating different ideas per se, I'm sure there was a lot of them early on at, at Adona, maybe even some outside of heart failure. But you've been around a, a ton of startups.
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For those that are, for those people that are listening that think they, they're onto something, right?
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They, they, but maybe they're looking at two, three, four, five ideas, right, that they all think potentially have legs. What do you, is there a general kind of framework that you use to evaluate various ideas?
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And I know [laughs] this is, we could probably spend a whole hour talking about this thing and this topic in general, but any sort of high level advice there? Yeah, you're right. It's a very open-ended question.
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But through, I would go through all the major aspects of the business, right, first. As a first pass, make sure that you just at least understand everything comprehensively.
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So don't- But actually, I think of the technology, the solution was last, right?
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I wanna understand clinical need, I wanna understand market, I wanna understand general regulatory path, which again, without a solution, you're taking some guesses, but you can usually know, okay, you can narrow it down a little bit.
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Understand reimbursement stakeholders, who the buyers are. I always like to start thinking of the end even before I start.
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If we are successful, who is this a must-have product for in terms of the big strategics in their bag? Because nice-to-have things don't get bought, right? And that might be fine if you're willing to IPO, but great.
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Know that you're possibly gonna need to IPO, and that's something that you should be thinking about in the beginning because if you need to IPO but the market's only $250 million a year, that math is not gonna make sense.
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You're not even gonna get your round of investment, so don't even get started, you know? So just understand at least a draft of the full journey,
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um, beginning to end, knowing that it's almost certainly wrong, but it's at least within the realm of reason, and make sure that it makes sense, right?
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And then the next thing I try to do is talk myself out of everything, right? Right. I like pretend I'm on the other side of the table and try to self-criticize the idea.
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And this is actually something I think people don't do well, generally speaking, and it's something I had to learn to do well over time.
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And I'm always trying to improve on things like this, but you get an idea, human nature is to fall in love with your own idea 'cause it's a great idea. It's like your top three idea.
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It's one of the best ideas you've ever had in your life. Like how dare you criticize my idea? But it actually should be the opposite. And start to criticize your idea. Start to think about,
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if someone asked me to write a check for this, what would I be concerned about? Flag all of the problems. Don't run away from them. The problems are there, whether you acknowledge them or not. Mm.
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So you might as well just acknowledge them and get comfortable. It doesn't mean that every risk can be mitigated before you start, but be comfortable with the path to mitigate that risk.
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And once you can't talk yourself out of it, that's when you know you've got something. And a- again, something I've said before with folks is, you know,
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most, I would say, innovators or first-time innovators, typically around maybe 30 years old, give or take, right? They've usually done one or two things first and now they've got the bug, the entrepreneurial bug, right?
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And you mentioned it could take seven to 10 years for each thing, right? And maybe they're gonna retire when they're 70. All right?
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So I say you've got maybe five chances to do something in your entire professional career. Are you gonna wager 20% of your career on this idea? 'Cause if the answer is no, go do something else.
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The opportunity cost for the type of person that would do this is too high to spend up to seven years, seven to ten years on something that's mediocre, right? Mm. You'll think of something, just give it more time.
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Give it three more months and you'll come up with something better. Yeah. Don't just start something for the sake of starting something. Yeah.
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That, yeah, there's a k- like several soundba- soundbites that, that I think we'll be able to pull from this that are quotes, soundbites, et cetera, that we'll be able to pull from this interview.
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But the one that you just used around, I can't remember the exact phrase that you used, but it's around that, that, that opportunity cost, right?
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Like literally it's 20% of, of your working career potentially wasted if you don't, if you don't try to address those problems that are there, whether or not you wanna pretend they're [laughs] pretend they're there or not.
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But yeah, it's really, really solid advice. With that said, I know we've only got a few minutes left here, so I wanna give us a, a handful of minutes to run through some rapid fire questions.
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But for those listening in, again, it's adonamed.com. A-D-O-N-A med.com. That's the website.
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If you're just listening and don't get a chance to read the full summary on MedSider, in that summary, we'll link to the website as well as Brian's LinkedIn profile so you can check out his background in a little bit more detail.
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With that said, first rapid fire question, Brian, is, I think I might know the answer, but when you think about the next 12 months ahead for Adona, what are you most excited about?
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Yeah, actually just patients, helping patients. Trying to see our technology in a way that is going off the bench and hopefully making somebody's life better. That's what it's all about. Yeah. There's two from my...
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This is my own opinion, but like from the kind of inflection points that, that kind of really get you excited, it's the first time you're in patients, I think that's super fun, and then when you're preparing for eventual launch or commercialization.
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Those are two really exciting times. It'd be fun to see, see what the next few months, how the next few months unfold for Adona with respect to that.
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Next question is, since co-founding the company, five years in into the journey, um, what's the most surprising thing, uh, that you've, uh, uh, learned over that time? It's actually a positive thing.
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I'm, I'm actually surprised by how much technically we've been able to accomplish. And I know that sounds like maybe egotistical, but what I... Again, we started this company with
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such an ambitious technical vision that I thought that we would be successful if we could've hit 60% or 70% of it, and we've hit basically 100%, maybe 95% of what we were hoping to achieve, we were able to figure out.
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And that's been rewarding, and I think it's been, it's a true testament to the team, right? My contributions to stuff like that is incredibly minimal, right?
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It's about what the team has been able to pull, pull off, this multidisciplinary cross-functional team. And I'm pleasantly surprised by the level of traction and success they've had. That's good stuff.
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All right, let's, let's pr- you've probably given this presentation before, but let's, uh, presume you're, you just presented maybe it's in front of a bunch of Biodesign alumni, and you wanna leave them with one lesson that's gonna, you know, best set their, themselves or their venture up for success, what would that one thing be?
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I would say act with integrity. I know it's a silly answer 'cause it's maybe not a business answer, but you can tell a lot about a person when they do the right thing even when it's the hard thing to do.
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And I think if you act with integrity and lead with respect and empathy, and empower people to have a strong voice, you're gonna get the most out of your team, for better or for worse.
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And it's almost always for better, right?
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And so with that in mind, it's less about the ideas and more about how you conduct yourself with the investors, with your partners, with the doctors, with your- Co founders or employees or team or whatever, make that your brand, right?
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Your brand should be somebody that people want to collaborate, respect, and work with. And, and that I think is pretty good advice. Yeah. That's good stuff. All right, last question.
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Let's rewind the clock, maybe go back to your early mid-20s, that kind of general timeframe. Is there anything that you'd whisper in the ears of the, your younger version of yourself? Oh my God, there's a million things.
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I don't know, what would be the best thing? I don't have a great answer for you off the top of my head. Just it's going to be hard. Keep persevering. Get through it.
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I think most things that are worth doing are very challenging because if they weren't challenging, everybody else would be doing them, right? And not to be scared of things that seem very difficult and ambitious.
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Just take them one step at a time, break them into digestible segments, and, and go for it. Don't be scared to go for it. Yeah. That's good stuff.
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It reminds me a little bit of that, uh, you probably saw that presentation from Jensen, the CEO of, of, uh, NVIDIA.
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I don't know, it was, like, maybe a, a couple months ago where he was like, look, the, the, the only way, I'm paraphrasing, the, the only way to, to the other side is through.
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And you're gonna learn most about yourself through sacrifice, through, like, really getting through really hard challenges, hard problems. That's good stuff. Thanks a ton, Brian, for coming on the program.
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Really appreciate you carving out a little bit of time in your busy schedule. I know things are at Adona are humming. Grateful for the opportunity to sit down and have this chat. Yeah. Thank you for having me.
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It's really enjoyable conversation. Glad I got a chance to come out. Yeah, yeah. Highly encourage everyone to give, to give Brian a follow on LinkedIn.
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It's, uh, he posts some fun stuff and make you chuckle every now and then. With that said, again, for everyone listening, Adona Med is the website. We'll link to it in the full write-up on Medsider.
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Highly encourage everyone to also give that full summary piece a read too when you get a chance.
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Brian shared a ton of really valuable insights that we'll try to, we'll try to capture as best as possible in that summary article. With that said, Brian, I'll have you hold on the line.
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But for everyone listening that you made it this far, thanks as always for your attention. Until the next episode of Medsider Goes Live, everyone, take care. [upbeat music] Hey, it's Scott again.
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One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups.
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But here's the thing, I'd be super grateful if you could help me reach even more ambitious doers who share our passion.
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So if you found value in this podcast, if you found yourself nodding your head while listening, or if you simply enjoy what we're doing with Medsider, please take a moment to leave us a review. It's super easy.
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Just open your Apple Podcasts app or the podcasts app of your choice, search for our show, and scroll down to the ratings and review section.
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Leave your honest thoughts and hit that five-star rating if you think we're worthy.
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Your feedback is incredibly important, and it's the best way to ensure we keep bringing you awesome discussions with leading founders and CEOs. So take a moment to be a good friend and leave that review today.
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As always, thanks for being a part of our journey and for helping Medsider continue to grow and evolve. Your support is greatly appreciated. All right, enough talk about reviews.
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Stay tuned for another informative episode coming at you soon. [upbeat music]
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[upbeat music] But my thoughts are when you're trying to tackle risk in a startup, you wanna tackle risks that unlock your path forward.
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And what I mean by that is understand where your blockers are, and oftentimes the blockers are money and getting investment, and they're willing to-- like, an ability to go forward, to carry on, right?
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Especially in this environment. So if that is the case for your particular startup, understand your investor sensitivities. You know, what are they concerned about?
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And make sure that early development is geared towards mitigating those types of risks to optimize your chances to go forward.
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Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology.
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Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now, here's your host, Scott Nelson. Hey, everyone. It's Scott.
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In this episode of MedSider, I sat down with Brian Fahey, CEO of Adona Medical, a ShifaMed portfolio company he co-founded. Before Adona, Brian co-founded another company in the critical care space, Nevius Medical.
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He also spent time at J&J Innovation, specializing in drug device products for oncology, and contributed to the leadership team at Aerenex, a neuromodulation startup in the ENT space.
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An alumnus of the Stanford Biodesign Innovation Program, Brian holds a PhD from Duke University. Here are a few of the key things that we discussed in this conversation.
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First, there are three major risk factors in med tech: product market fit, technical feasibility, and clinical validation. When assessing an idea, the first thing to do is to try to talk yourself out of it.
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Once you reach a point where you can't argue any further, you may have something solid on your hands.
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From there, your goal should be to identify the areas with the highest risk factors and those that are quickest to mitigate.
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Second, pioneering innovations can be substantially rewarding, but the trade-off is they often demand longer and more complex clinical trials.
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Mitigate clinical risk by studying the pathways of predicate technologies to refine endpoints, patient populations, and more. True disruption requires a product that's not just better, but significantly transformational.
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Third, be selective in fundraising. Consider your sector, stage, and the size of your round you're after in order to focus your energy on your best prospects.
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Transparency and consistent communication build trust and enhance your brand in both fundraising and M&A processes.
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Before we jump into this episode, I wanted to let you know that the latest edition of MedSider Mentors is now live.
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We just published volume six, which summarizes the key learnings from the most popular interviews over the last several months with incredible entrepreneurs like Dan Rose, former CEO of Lymphflow, Dr.
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Steven Michelson, founder of TheraPulse and current CEO of Field Medical, and other leaders of some of the hottest startups in the space.
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Look, it's tough to listen or read every MedSider interview that comes out, even the best ones, but there are so many valuable lessons you can pick up from the founders and CEOs that join our program.
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So that's why we decided to create MedSider Mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place.
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To check out the latest volume, head over to medsideradio.com/mentors. Premium members get free access to all past and future volumes. And if you're not a premium member yet, you should definitely consider signing up.
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In addition to every volume of MedSider Mentors, you'll get full access to the entire library of interviews dating back to two thousand and ten.
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You'll also be able to see all of our playbooks, which are thematically handpicked collections of the most insightful interviews covering topics like capital fundraising, early-stage development, regulatory challenges, reimbursement, M&A, and much more.
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And last, considering that fundraising can be one of the most daunting tasks for any startup, we curated a database of over seven hundred VC funds, private equity firms, angel groups, and more, all eager to invest in medical device and health technology startups.
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Access to this database is a premium member exclusive, so don't miss out. Learn more about MedSider Mentors and our premium memberships by visiting medsideradio.com/mentors. All right.
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Without further ado, let's jump right into the interview. [upbeat music] All right, Brian. Welcome to MedSider Radio. Appreciate you coming on.
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Yeah, thanks. Really happy to be here. Yeah. I enjoy reading your LinkedIn posts every now and then, so it's fi- it's fun to finally have a conversation.
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Been loosely following Adona's story for, for a couple years now, so looking forward to this conversation. I hope, hope the audience finds it, finds it valuable as well.
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So with that said, I recorded a very brief bio at the outset of this interview, but to start there, if you can give us sort of an elevator pitch and maybe a couple minutes around your professional background leading up to starting the company.
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Let's start there. Yeah, sure. It, it's always a funny journey, right? Because it never takes that linear path that we all think that we're gonna have when we're younger and high in our early 20s or whatever.
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But I was an engineer by training, went to school for engineering, ended up getting a PhD in ultrasound stuff down at Duke.
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Thought I wanted to be a professor for a long time and about halfway through getting the PhD, had that crisis where I just became very disillusioned with academia as an institution.
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Not that it's a bad path, it just wasn't for me. I then had to find whatever that new path was going to be.
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By just chance, I happened to see an-- I think it was, like, an email advertisement for a fellowship at Stanford at Biodesign. Uh, applied there, took a whim on it, and came out to interview.
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Lucky enough to get to that stage and I remember this just so clearly, like, in the first ten minutes of the Stanford Biodesign introduction from Paul Yağci, I just knew exactly this is what I wanna do.
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And then I had a- another panic attack because I wasn't prepared enough for the interview process.
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[chuckles] But lo- long story short, I was lucky enough to be accepted into that fellowship, spent a year learning about med tech innovation, bench-to-bedside technologies, and just all the things that I think really resonated with me about how to make a patient impact in maybe five to seven years, not fifteen to twenty years, which is more the norm for basic science and that you see in academics.
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So completed that fellowship, spent most of the next decade after that running a startup that I founded in critical care space.
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We took that from basically ideas on a whiteboard all the way through early commercialization. Uh, had about twenty hospital paying customers throughout the US.
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Ended up that technology tied up with being strategic, which was great. I spent a few years after that doing a few other things with some other startups that was really interesting.
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Saw some other M&A processes or as we get to be part of peripherally. Did some work at J&J Innovation. Got to see innovation through the lens of a big company, strategy, business development, et cetera.
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And then ultimately ended up collaborating with someone I'd known about 10 years earlier, Amar Sawhney, who was the CEO of a group called Chief Med, by coming in as an executive residence, trying to figure out, hey, what should the next Chief Med portfolio company be?
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That was my mandate, and we ended up coming out with the ideas that became Adona. Flash forward to now I'm sticking around running the company. So it's...
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That's the whirlwind journey of the CliffsNotes as fast as I can version, but that, that's my background. No, that's a great, that's a great overview.
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And the, the, the intent is to set the stage for the, the rest of the discussion with the goal of not only learning, learning about insights that you've picked up along the way, but also what you're building at, at Adona.
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So we're recording this in mid 2024. I think you started, it looks like based on our research, you started Adona kind of Q4-ish timeframe of '19. So almost five years or about a half a decade in the making now.
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Give us a sense for kind of what you're building, and then maybe touch on where the company's at from a, a stage perspective. Yeah. So at Adona, we're building essentially heart failure platforms.
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And as I mentioned, I was there at the very beginning. I was employee zero. I was working on Adona even before we knew what Adona was, and that's by design. In that early stage, we had all sorts of ideas.
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We had some good ideas, and we had some bad ideas. And what I like to tell people is I had some ideas that I thought were great, and the physicians hated. It was very humbling. But then it's... It was...
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It's all, it's a process. You change your mind a lot. But
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what actually helped me gravitate towards Adona is I thought we had an opportunity to be disruptive in actually two separate therapy classes for heart failure, right? And
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then I also thought beyond that, to take it a step further, you could possibly integrate these two technologies in ways that had never been done before.
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Um, and by doing that, you know, it's the type of thing where the whole is greater than the sum of the parts, right? You have that synergistic relationship between these two types of technologies.
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One that's more diagnostic and one that's more therapeutic, and how they might augment each other's functionality and unlock things that you could never do before, in theory. That was the idea.
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And so early on, so the two classes of products were intra-atrial shunting, which we didn't invent. We didn't come up with that basic idea.
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We just thought that we had some ideas that possibly could make it more advanced and more patient-specific, individualized.
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And then remote pressure monitoring or hemodynamic monitoring, which again, we didn't invent that. That's a pretty robust proven technology, at least at this point.
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Five years ago, I think there were a lot more debate, but now we just got a second FDA approval from a second company to do this.
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There was just an announcement of a big acquisition that was announced last week, and there, there's a lot going on there in that space too, and we thought that we could make a best-in-class version of that, and then combining those two technologies.
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So early on, you ask about 2019, what was that was like? There was a lot of technical risk of... There wasn't a lot of product market fit risk. There was minimal clinical risk, but nothing's free, right?
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And so if you're leaving that all on the table, you're shifting those risks to a big technical lift. But that was something we were really comfortable with because we... I was an engineer by training.
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I collaborate with a lot of former engineers that are now business type folks, and we felt we got our hands on it.
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We understood what the risk profile was, and we thought that we could recruit a team of very elite innovators and gifted engineers.
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And our mission was like, "Hey, we think we can do something that's really impactful for patients. All we have to do is figure out two or three things that no one in the world has ever figured out before."
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And it sounds really big and it was ambitious, but early on it was, "Can we do this? Can we even build these things? Can we find a way to make it work?
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And if so, could we make it practical or cost-effective or reasonable?" Whatever, all the checklists that you have to go through once you have a solution, is it a valuable solution?
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And then over time, we were able to prove those things that were working.
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We were able to validate that, hey, we can design it, we can build these sorts of things, we can do some of the testing, and all that it seems like is panning out and now we're at the precipice of our initial human use, which is coming up in the next period of time, several months, a quarter or two.
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Every startup, the timeline has some error bars on it, but it, it's in our, it's in our vision, right?
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We can see this, and that's the exciting time for us because we've worked really hard and a lot of people have made a lot of really important contributions to this sort of thing, and now we're at the point where people are actually gonna start to benefit from it.
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And there's nothing more exciting in med tech than to put your innovations in the hands of physicians and actually help people. That's why we're all doing this. Yep. No doubt.
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I, I'm glad you touched on those three things, which I, I think we'll probably dig into a little bit more in more detail throughout, throughout the rest of the conversation.
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But those three risks that you called out, clinical risk, technical risk, and, and product market fit risk.
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There's other risks associated with building a startup in, in med tech, as we all know, but those are three of, of the largest.
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And so I think that's just a healthy framework for those listening that are maybe thinking of taking a swing on, on an idea. This is a lot of name of the game of startups is how do you minimize risk, right?
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Especially as you're raising capital and I, I think that that framework is really solid, simple, straightforward. You're staring down three kind of risk pillars, if you will.
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One of which was the biggest one, which is technical. So with that said, you mentioned the stage. We're, again, we're recording this mid 2024.
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Hopefully, sounds like maybe you're close to being in patients maybe before the end of the year, maybe early next year. As you mentioned, all startups have just some flex in those, in those schedules for sure.
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And if you're interested in learning a little bit more about the technology, it's adonamed.com. We'll link to it in the full writeup on Medsider, but it's A-D-O-N-A med.com, A-D-O-N-A med.com.
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And one, one other, uh, quick question before we step into the end of the time machine and go back and learn a little bit more about things you picked up along your journey. When...
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Heart failure specifically, I'm sure you were evaluating other sort of therapeutic arenas, if you will. Why heart failure? Was this something that, that resonates with you personally?
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Was it, did you have a fair amount of experience in this space? What, why'd you decide to build in this category? Yeah, it's a great question. Heart failure is very personal to me. My grandfather had heart failure.
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He suffered for a long time, and ultimately is what led to his passing. But, uh, and that wasn't really the only reason. That was just a, a nice to have motivator behind it. I think what attracted me to heart failure
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specifically is a couple of things. One is this certainly falls within the umbrella of cardiology. Uh, and cardiology I think is an interesting space in med tech to be in.
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I, again, I've worked in critical care, I've worked in ENT, I've worked in radiology, orthopedics, I've done some work in oncology and drug device combination products.
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And then this is my first time in cardiology, but one thing that's really interesting about cardiology is that
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there are a very large number of global strategic players that are still competing against one another for any new type of therapy.
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And you don't see that, for example, like in ENT or gastroenterology or, or other sectors where it's more consolidated. And so cardiology is interesting because if you have something really disruptive and compelling,
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you have a greater likelihood that you can create a competitive bidding process or an auction at the tail end, and that can help push exits to be a little bit more lucrative, but also give you flexibility, I think, to work with the right partners that align with your vision and not just work with the partners that are out there.
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And so I... Uh, cardiology in general is attractive to me and obviously it's attractive to lots of people, right? But that's one of the reasons.
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But heart failure as a sub-sector, I think it's, it's more of that nascent sector that this has typically been a medical management pharmaceutical domain, and it still largely is.
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But if you look at these patients, there's great therapies early on in heart failure when the patients really aren't that symptomatic.
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We have what we call end-stage or destination therapies like VAD and transplant that will save a patient's life at the very end. And in the middle, there's like a whole bunch of nothing, right?
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And these patients continue to get worse, they continue to deteriorate.
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Yeah, pharmaceuticals are getting slightly better, but patients don't like to take drugs and compliance is terrible, and some of these patients are on something called hyper-polypharmacy, that they're taking like a dozen drugs or something like that every day or more or whatever.
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And even those drugs, so many patients become refractory to them. They're not even working so well anymore.
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And so you're beyond the steps where like CR rounding type devices are helping patients, and then just waiting until you get sick enough to get a VAD.
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And it's not like an existence that anybody would want for their loved ones. And I thought that there's possibly a lot of opportunities there.
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And again, I'm not this savant that just saw this opportunity that no one else did.
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There's a lot of investment both in the med tech space as well as the pharmaceutical space to try to put more stones or stepping stones in that gap, right, or whatever our metaphor is.
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But to me, it was a big opportunity, and there's so many patients that these markets are just... You shift gears away from the patient perspective into, is this a good business?
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These market sizes are just enormous, even by med tech standards. If you got something that was really great at serving 10% of the market, these are still just huge opportunities.
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And of course, I saw a path that we could get more than 10% of the market and everything else. And so to me, it's just all of the stars aligned ar- around it.
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It, yes, it had personal meaningfully, meaningfulness to me as a, just as an individual, as a family member.
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I thought it could make a big impact on society, which is something that I think all of us aspire to do with our careers.
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The business aspects, the market li- lined up, and then the exit potential for partners was also there. And you start looking at all these various aspects and you're like, "This seems like a good space.
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Now let's see where to play in that space." And that's always the hard part, right? Is like where do you have an opportunity? Yeah. That's a great, that's a great kind of summary.
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And the, these journeys are so long in startups, and you're building it in, in med tech anyway. They're often really, they can be really re- rewarding, right?
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Not just from an economic standpoint, but from a technology and patient perspective, too. But if the ideal scenario is whatever you're working on checks a lot of those boxes that you mentioned, right?
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Because these are, this is not, these aren't quick flips [laughs] usually, right? These are five, seven, 10-year journeys, so it's a long time.
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So with that said, let's go, let's step in the, into the old med side or time machine, as I like to call it, and then, and cover some cross-functional topics.
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One of which I think is super pertinent considering your engineering background, is early stage development, right?
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This is the, some of the hardest stuff to do with typically pretty limited capital, right, in those early phases. Donna's a chief of med company, so you're around a lot of like other early stage companies as well.
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So when you think about that phase of a med tech startup, where do you think most founders, CEOs go, go wrong in trying to manage that early stage iteration with pretty limited resources? Yeah. A mistake I see
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frequently is that people try, I think, to tackle the wrong types of risks.
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Um, and obviously that's subjective and you could ask my assessment of something and ask 10 other people and get eight or more opinions or whatever.
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But my thoughts are when you're trying to tackle risk in a startup, you wanna tackle risks that unlock your path forward. And what I mean by that is understand where
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your blockers are, and oftentimes the blockers are money and getting investment and a willing to, like an ability to go forward, to carry on, especially in this environment.
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And so if that is the case for your particular startup, understand your investor sensitivities. What are they concerned about?
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And make sure that early development is geared towards mitigating those types of risks to optimize your chances to go forward. And because of that, startups are often non-linear.
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So if you're a very linear thinker, you've gotta throw that mindset in the trash and be ready to adapt. And so a very specific risk I see oftentimes is people jump straight to a prototype.
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And great, that's helpful, and you will reduce technical risk out the gate. I'm a technical founder. I like to think, let's all do technical, but investors often don't worry about that sort of thing, right?
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They're worried about market risk. They're worried about- Pricing or reimbursement or what is the huge hurdle ahead of you?
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Very few investors, if you check the best rest of the boxes, are gonna say, "Oh, I don't think you can build it." We put a man on the moon with the power, computing power of our cell phone, right?
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Like, humans with the right funding have an ability to figure things out. And so I'd always urge people to try to understand what box you're checking.
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When you build a prototype and you spent $100,000 on that of critical money, okay, that's important, but to who? To you or to them? And, and listen, it's important to you as a founder.
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If you're not sure you can build it, that's a great box to check also because you need to convince yourself that you're in it for that five, seven, 10-year journey that you had just described.
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Whatever the risks are, I'd suggest working to turning over those risks. The highest risks and the quickest risks to mitigate are where I would spend most of my time, and sometimes that is product development.
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Sometimes that is, let me build the crappiest prototype I can think about and show it to physicians and understand, yeah, I would use this or whatever. And, so it really...
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It's a hard question to answer concretely, but I do think that oftentimes people aren't mitigating the right risks, right? And that's how I, I would, I always try to press on people, be like, "Is this the biggest value?
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Even though it's the next logical step, it, it might make more sense to jump three steps and then work backwards." Mm-hmm. Yeah.
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That, that, that risk you highlighted around, I think the way you described it as, as the, the need to be able to, to move on, right? To get further, to advance the, the football down the field, if you will.
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That, that's such an important point, right? Because... And it speaks to the, the necessity of engaging with investors as early as possible.
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Maybe not in the, in a traditional kind of pitch format per se, but the more you engage early on, the more you'll learn about what they perceive as sensitivities and be- and in being able to fund a company like this, and that's so crucial 'cause almost every single person that's listening to this or is working on a med tech startup is working on an idea that's likely going to need external funding.
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The, the chances it won't, uh, are, are pretty low. So understanding those, those, those areas of concern, right, from outside investors is really crucial. So I'm g- I'm glad you touched on that.
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And let's use that as a segue to financing in general, right? You've, I think, raised four rounds maybe of financing, if our notes, my notes are correct here, for, for Adona.
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And then you obviously had your previous, previous experience raising for... Is it Nevius? Am I pronouncing that right? Nevius? Yeah, Nevius. But yes.
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We joked around about how the, the, the best pronunciation for Adona kind of at the outset of this conversation before I hit, hit the record button.
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But, so your experience at Nevius, then you spent a couple years at J&J DC, you're a ga- consultant with other startups along the way, et cetera, so you have, I'm sure, some pretty good thoughts around fundraising.
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So when you think about what you know now maybe versus five, 10 years ago when you used to pitch at Pitchberry invest- Pitchberry's investors, are there a couple key insights, key learnings that you've picked up along the way that really inform how you, your approach today?
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Sure. And again, there's no hard science to it, I think any of this, right? And there are different perspectives, and uh, there's more than one way to get to your, you know, final endpoint.
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One thing that I think is really important that, again, I, I see
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others sometimes get this wrong or at least in my opinion get it wrong, is the shotgun approach where we're just gonna go talk to everybody, and that's, I think, a...
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It can be a waste of people's time, and I think more importantly, it's not just time, 'cause time as a founder you can say, "Oh, my time is infinite," but really it's about focusing your time to be best prepared for your best shots on goal, right?
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And so you could... You should be able to understand, right, what sector am I in? What stage am I in? What size round am I trying to get?
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What types of participants usually participate in a syndicate of that size or that stage or that sector? And narrow down your list to the people that you think are most likely to invest, right?
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And I think that's where you're gonna get the best traction. That's where you're gonna get the best bang for your buck, right?
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And if you're raising a series A and you're going to a late-stage investor that possibly is investing or will invest in a competitor, all you're gonna do is tell them all your great thoughts that who knows where they're gonna end up.
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I'm not suggesting that it's always people sharing information, but we also know that at some level this can happen.
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And so talk to the people that you think are a good fit would be my first thing, and then to, again, understand their sensitivities, right? Don't be afraid to ask questions back.
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I don't think it's a sign of weakness or a sign of vulnerability to admit that you don't have all the answers, right?
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If someone asks you a question and it's a risk for the company, oftentimes I see people try to say, "Oh, it's not a risk because of X, Y, and Z," and maybe... I don't know.
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I, I think oftentimes, like, you just say, "Yeah, that's a risk. If you invest in this company, you're gonna have to get comfortable with that risk and our strategy to mitigate it together as partners."
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And I think that can go a long way that you're suggesting to your investors that even if you don't have a board seat, you have a voice, and we're gonna work together as a team to sort these things out.
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Because your earliest investors, those are your partners for, again, 10 years or something, right?
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You need to make sure that you can go through adversity together, that you can have a hard conversation together where you might show up and you disagree about an idea, but it... We're talking about ideas, not people.
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It's not personal, right? And how do we sort through that? And I also think especially for young entrepreneurs, it also shows that you're coachable, which I know is so important from the investor's standpoint.
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That you don't think you've got it all figured out, right? That you're going in and you're receptive to ideas, and even if you don't agree with those ideas you'll entertain them and hear people out.
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And maybe you don't completely pivot what you do, but you'll take that 15% pivot and start to align these journeys, because oftentimes the investors have seen way more than us.
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They're seeing 30 companies at once succeed and fail and flounder and thrive and everything in between, right? And raising money, it's about targeting. It's about showing that you're gonna be a good partner.
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I think it's about being honest. Being able to say, "I don't know," I think is okay. And establishing that credibility.
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One thing that I like to do oftentimes when it's really early on before a pitch, and it's something you had brought up, is go talk to investors that are never gonna write you a check because they don't match those boxes before.
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But just say, "This is not a pitch, but I want you to look at this like you're writing a check," right? You can't just ask for advice because no one wants to say anything negative to anybody, right?
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It's a great idea until you ask them to open their checkbook, and then no one wants to do it, right? And tell them, "What are your criticisms?"
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Give me all the harsh feedback, and try to hear all the harsh feedback there in a setting where it doesn't matter so that you can be better prepared to hear it in a setting that it does matter in the future.
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And I think that can be really important, too. Just invite people to trash your idea.
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And once you've gotten to the point where you feel like you've got a great defense or a strategy for anything that someone can throw at you, that's when you know you're ready. Yeah. Yeah, that's good.
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That's a, that's a nice little practical tip is practice, practice that, that presentation and it's a low-risk environment where we can get really smart feedback, but it's not a...
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doesn't come with a, a significant cost. But hearing you, you describe some of your thoughts on fundraising, um, it just, it always reminds me of this is a relationship game.
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And especially maybe even more so in the life sciences or med- or medtech specifically, your first pitch oftentimes is not gonna result in a check, right?
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It's gonna be this evolution of getting to know various investors over time, and how you run that process speaks to probably how you may...
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how that relationship could look w- could look like if that potential party does in fact write a check and, and support, support your startup financially.
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It sounds like that's been your experience over time, too, is, like, the building and the building of those relationships over time has been pretty crucial in, in getting the, the type of capital support that's needed.
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Yeah, absolutely. Listen, I think... [clears throat] And again, what I'm gonna say is obvious to people that are seasoned in our industry, but it's, I work with a lot of the fellows from Biodesign each year.
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I'm still pretty close to the program, so I have a constant stream of people that are just starting out. And again, I don't pretend to be this wise sage that knows everything, but I've seen a thing or two.
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And what is lost on a lot of young innovators or first-time CEOs is that your only goal of a first meeting is to get a second meeting. Mm-hmm. Right?
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You're not getting a check that first day, so you don't have to say everything, right? You don't have to give them 30 slides. Just show that you're credible, show that you're personable, relatable.
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Show that you have a compelling insight into a problem that is real and that has some upside potential. And then you can get into the details another time.
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If you bore everybody with fine details in the first meeting and excruciating painful detail, you're just wasting time spitting at bats. Mm-hmm. Yeah. No, no doubt.
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And, and just to touch on that, like even with Fast Wave, which is the company that I run, we, we received a term sheet that was I think maybe 18 months in the making, right, from initial kind of initial discussions.
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And so that just, for everyone listening, that gives you an idea of how long sometimes these processes take to really get to know people to support a company at a certain stage.
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So it takes a long time, and it's never [laughs] it's rarely, rarely do you ever win someone on that first pitch. It's about the, kind of the process that you run.
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And it's super important, and even more so on the M&A side when you get these companies acquired. Listen, like, a big global company will spend,
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I don't know, months and months, and they're gonna send dozens of people to your site to look at every piece of paperwork, everything that you've done. And that proper due diligence process is lengthy.
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Even for deals that aren't a billion dollars or whatever, it's a lengthy process. And still at the end of that, they're never going to find everything, right? And they know that, and we know that,
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and so that's why that trust component is so important. Mm-hmm. Right? You have to build that credibility and trust because otherwise you'll never get a deal done because they know they can't find everything.
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There's always some skeleton in some closet somewhere lurking that they have to trust us to prospectively flag it for them and then talk about why it's not a problem versus just bury it and they find it in six months and it's a disaster.
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Yeah. That's a really good point. [upbeat music] Hey, everyone. Let's take a quick break to talk about Fast Wave Medical, the company I co-founded and lead as CEO.
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Our team is developing next generation intravascular lithotripsy systems for complex calcific disease. This type of therapy is often referred to as IVL.
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The market size for IVL is over $9 billion, and there's only one player in the space with a market cap of around 10 billion, so naturally there's a lot of investor interest in Fast Wave.
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In fact, we opened up an opportunity to invest directly into the company almost a year ago, and we were blown away by the interest from our community, so much so that we ended up closing $8 million from our supporters in less than a month.
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Typically, opportunities to invest in venture-backed startups like Fast Wave are pretty rare, so based on significant and continued demand, we highly encourage you to sign up for our wait list to avoid missing out on the next opportunity to invest.
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You can opt in at fastwavemedical.com/invest. And if this is the first time you're hearing about Fast Wave, here are some key highlights.
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As I mentioned before, we are sitting on an IVL market valued at over $9 billion with only one incumbent.
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Second, we just completed our first human study with eight treated patients, resulting in 100% lesions crossed and a 93% reduction in mean diameter stenosis from baseline.
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We've raised over $20 million to date from corporate venture and cardiovascular KOLs, and we have five granted patents by the USPTO and multiple FTOs.
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If you're interested in empowering physicians with advanced IVL technology while potentially benefiting from a fast-growing IVL market, head over to fastwavemedical.com/invest and check out the details.
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Again, that's fastwavemedical.com/invest. All right, let's get back to the rest of the conversation. [upbeat music] It's one of, it's one of the reasons I'm, I'm such a big believer around beginning to...
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E- even if you're at an early stage, thinking about your company a- a- as a brand, right? And you're building this brand, and oftentimes the brand is not...
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it's not the logo, it's not the color palette, it's, it's how you're engaging with your community, right, with your stakeholders. And it's one of the reasons, like, I... by the time this goes live, I'll...
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the, the interview I had with Brian Lord with, with Pristine Surgical will have gone live, too, and we talked about this very th- same thing. It's one of the reasons I like seeing your stuff on LinkedIn.
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It's like, yeah, I don't know you personally, but I get to know you, right, and get to know the brand that you're, the company that you're building with Adona, and I think it speaks volumes for other, for that M- M&A kind of process, potential M&A process down the road, so amongst other things.
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And I wanna get your take on that, that topic in general, but before we get there- The space that you're in, heart failure, we, we chatted about this a little bit already, but it's not for the faint of heart, right?
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You're staring... The, the technical lift is pretty tall, but these runway, these clin reg roadmaps, these, these pathways are pretty, pretty intense.
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And when you ki- when you think about that, that in g- in general, like any...
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And, and maybe frame this up for other entrepreneurs that are working on products that do require a similar kind of extensive runway, any, uh, high-level advice or, like, how are you...
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H- how do you typically approach th- this process when you're staring down these, these lengthy clinical, clinical initiatives? Yeah.
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There are different schools of thought a- a- about this, of course, and I think it tailors a lot to, you know, whether you're a founder or an investor or an executive or an employee.
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You're a part of the same journey, and you have to choose which journeys you want to be part of.
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And I think some of that comes down to risk-reward tolerance, your risk tolerance, what you're looking for at the end, and where your personal sensitivities may be, right? And personally,
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I would not want to be on a very long clinical regulatory journey unless I had an ability to learn something from others along the way, right?
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I have no interest, personally, at least at this point in my career, being a first-mover pioneer in an unknown therapy class, right? Mm-hmm. Now, that doesn't mean that's not, like, a great opportunity for someone else.
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And frankly, I think it's really important for our society, right? That we are investing in these, and when they get it right, these are companies that absolutely crush it.
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They're some of the biggest exits that we've had in our industry. So there's a high reward, but a high risk.
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And I like to shift the balance a tiny bit by, for the spaces that we're in, in heart failure, we're not the first companies or company in these therapy areas to do pivotal clinical trials, right?
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And we're learning from them. We're learning from what works and what doesn't work, and who are the right patients and who are not the right patients.
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What is the dosing, and what do you measure, and when do you measure it, right? There's so many variables.
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And personally, I wouldn't want to be in a company where you have this very different product, it takes a long time to develop, your engineers do everything perfect, and you think it's gonna work.
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It's based on a sound thesis, and then you get to a clinical trial, and it just fails because clinical trials are hard and humans are hard.
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And this is especially true in heart failure, where the patients are incredibly heterogeneous and diverse.
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Our ability to phenotype or classify them is still a work in progress, so it's hard to even limit that, even if you try to limit that diversity.
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And also there's certain measurements of placebo effects or Hawthorne effects or everything else, right? There's just a lot of moving pieces. But how I think about it is I'm learning from everybody else, right?
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And that's great because it reduces a clinical risk. We talked earlier about product risk and market risk and clinical risk. That reduces a clinical risk for us, which I like.
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But again, we talked [laughs] before, nothing's free. It shifts more burden on technical risk because if I say I want
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not a conclusive clinical path, but a more informed clinical path, that means I'm gonna be late, right?
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Which means that our product, our design goal, whether we hit it or not, will be up for others to decide, but we have to aim to be, like, 500% better than everything else.
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Because if you're only 30% better and you're five years late, that's not enough to disrupt the ingrained momentum of the pioneers in the space. If you're going to be truly late, you have to be transformational, right?
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You have to be a next generation version of that therapy that, if you do your job, at least has a chance to obsolete everything else, right?
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And that is, again, our vision, and whether we hit that vision and achieve that goal is still very much to be determined, Adona. We're not even in our first patient.
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But that is the path that we set up for ourselves, is like, all right, I wanna take less clinical risk, but I'm willing to accept more technical risk, and that shifts the risk profile earlier in the company.
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So if I run into a problem, I'm gonna run into that problem at 9 months or 18 months and not 10 years, right?
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And so again, that's my general philosophy, and again, it's a philosophy that is largely shared by Amir and others at Sheaf Med, which was one of the things that I thought was really compelling about collaborating together with, with that group, is that we looked at, you know, risk and where, what types of risks we're comfortable with in a very similar way.
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Yeah. And I'm sure it helps as, for other Sheaf Med companies too, is like any outside investors that are evaluating that, that opportunity, they know what they're getting with.
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There's a, there's a, an internal thesis, a consensus around what you're, what you guys are, are, are building there.
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But I really like that, that, that sort of, that idea that, that you, you mentioned around, around the longer clinical pathway and overlaying that against the timeline.
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So if, if you're working on something that is, that does have a, that is, is gonna require a, a PMA pathway, as an example, right?
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You shouldn't necessarily be afraid of that, but you should fully understand that timeline, right? Or that approximate timeline.
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And if it's not, if your technology isn't disruptive, like truly disruptive, that likely isn't gonna result in a, in a very meaningful outcome, right?
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It's gonna be a lot of investment dollars, a lot of time, only to get to a point where you're maybe 15, 20, 25% better. That's oftentimes not gonna cut it.
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And that, that simple kind of, like, framework I think is really valuable. I'm glad, I'm glad you mentioned it. Let's chat a little bit about, about M&A.
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But when you think about M&A in general and how to engage with strategics, do you... Is your general thought to engage early to start building that relationship, as you touched on earlier?
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Or is, is your thought process to stay, to keep those strategics on the sidelines, so to speak, until you get to a certain point?
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What are you, what are your general kind of thoughts around, around, uh, around this topic? Yeah. Of course, there are different schools of thought here also, to state the obvious.
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But I think the time is right is that once you feel like you've got your core things figured out from a technical standpoint, your positioning standpoint, your feature set, whatever it might be, and that you've got most of your IP filed or all of your IP filed, and possibly even once you have something issued, although that can really extend that timeline maybe too far.
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It, to me, it's always like a one and it's all at once, right? Like you, you don't wanna do it not now, okay, everything at once. And- I do think early is better, even if it's just, "Hey, my name's Brian.
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I'm running this company. I think that there might be collaboration opportunities in the future. Can I give you a five-minute elevator pitch?" Right? Just so you know that we...
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Like, you're vaguely aware that we are out there, right?
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And sometimes that leads nothing, and sometimes it leads to more and a more conversa- And then again, you're building these relationships, you're building trust, and I think that matters quite a bit.
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It doesn't mean that you're gonna get a good outcome. No company is gonna, "Oh, we weren't gonna buy Adona, but now we will because Brian's a good guy." But it's not how it, like, works, right?
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But I do think them believing in you and establishing that credibility works during an M&A. And I actually think it works with investors too. You go to an investor and they say, "The stage isn't quite right for us now.
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We don't like this risk or that risk." Okay, tell them your milestones, and then go deliver. And then come back and say, "I said I was gonna do X, Y, and Z, and I did it on time, under budget.
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Can we talk about the next round?" And that credibility, I think, goes a long way, especially, again, for, for younger people that maybe don't have that track record.
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There are CEOs that have done this, or founders that have done this a dozen times. They don't need any more. They're already on their pedestal, right? And that's great. That's fine. They have the relationships.
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They have the ability to raise money. They have the ability to get a transaction done. But I think most of us are still aspiring to that god tier, right? Mm-hmm. And we've got a lot of work to do along the way.
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And any opportunity to increase your credibility, I, I think is, it's a good thing in general. Yeah. Yeah.
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Very little downside to at least establishing some sort of, some sort of foundation, uh, around the relationship, right, as, as early as possible.
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That doesn't mean that you're pitching them and trying to sell them on your technology per se, but you are trying to sell them a little bit to a certain extent on your, who you are, right?
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And at, at least at a high level, what you're looking to l- looking to build.
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When it comes to investment, in a similar vein, a lot more strategics are establishing corporate venture arms, and this is obviously a direct experience at J&J DC.
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Do you have a, do you have a preference on, on raising capital from strategics? Is it something that you typically avoid up until a certain stage, or do you welcome the interest? How do you think about that?
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Or maybe what are your kind of general words of advice for other entrepreneurs that are thinking about potentially raising from traditional institutional capital versus maybe a strategic corporate venture? Yeah.
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This is easy for me to say because, perhaps because I've actually never taken strategic money so far in our, my career.
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But I've been in discussions for it, and sometimes we chose not to go forward, and other times it just didn't work out at that stage. The timing wasn't right, et cetera. But I don't see a lot of downside to it.
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Again, different schools of thought on there. I think the old, like, adage from 10 years ago or more was strategic money is risky because let's say company X invests in you, and then they don't acquire you.
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Well, what does that signal to the rest of the ecosystem? What do they know that nobody else knows if it's not a fit for them?
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And I think over time, our industry has evolved to understand that corporate strategies change oftentimes in fairly dramatic ways over the course of a startup's existence, right?
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And just because they invested in you at year three and they don't want to buy you at year seven doesn't necessarily mean anything.
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And I think it's actually more and more common to see companies that have multiple strategics in a round. Mm-hmm.
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And I think that can be very compelling because you're signaling to the world that I'm open to these partnerships.
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I see that this capital can often come with advantages that go beyond the dollars in terms of access to facilities or partnerships or position relationships, whatever it might be.
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And then you want to leverage that as a company in a non-binding way. And so I, listen, I think strategic money can be very helpful. You obviously, the details matter a ton, right?
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And it's not saying that there's any detail that would be a deal breaker across the board, but know what you're getting into. Are there rights associated with it? Are they sitting on the board? Are they an observer?
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Is there a walk away? Understand those details. Make sure those details make sense for your organization. But if so, I, I think it's a good upside.
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I actually think that having a strategic in a round makes it a lot easier to raise traditional institutional money because you're almost validating that there's a potential exit market for you. Mm-hmm. Yeah, no doubt.
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And I, I would 100% agree. I, I, in my opinion, it's a bit of an old, old adage, right, that, that you should keep the strategics on the sidelines. That doesn't mean that's a definitive truth, right?
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As you mentioned, like the devil's in the details. But generally speaking, there's not a tremendous amount of downside, right?
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As long as it's, they're investing with, hopefully without rights or any significant kind of o- o- obligations or commitments on, on to, to you as a startup. So I think that's really good. That's really good advice.
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And so maybe the take home message for anyone out that, that's listening and, and raising, raising money, don't shy away. It's worth engaging and letting the chips fall where they may.
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But it se- it's seemingly becoming a lot more popular for multiple strategics to be involved, even at fairly early stages, right? Not at your series C, series D stages either.
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With that said, we got a little bit of time before we get to the rapid fire portion just to touch on this topic in more general, and I think it's pertinent because of your experience at JJADC as well as your, your kind of, your time as an EIR at the, at Chief Med.
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But when you... And, and you, you mentioned, you mentioned a little, you touched on this a little bit with the first question I asked you around how to effectively manage design and development at the early stages.
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But even before then, when you were evaluating different ideas per se, I'm sure there was a lot of them early on at, at Adona, maybe even some outside of heart failure. But you've been around a, a ton of startups.
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For those that are, for those people that are listening that think they, they're onto something, right?
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They, they, but maybe they're looking at two, three, four, five ideas, right, that they all think potentially have legs. What do you, is there a general kind of framework that you use to evaluate various ideas?
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And I know [laughs] this is, we could probably spend a whole hour talking about this thing and this topic in general, but any sort of high level advice there? Yeah, you're right. It's a very open-ended question.
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But through, I would go through all the major aspects of the business, right, first. As a first pass, make sure that you just at least understand everything comprehensively.
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So don't- But actually, I think of the technology, the solution was last, right?
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I wanna understand clinical need, I wanna understand market, I wanna understand general regulatory path, which again, without a solution, you're taking some guesses, but you can usually know, okay, you can narrow it down a little bit.
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Understand reimbursement stakeholders, who the buyers are. I always like to start thinking of the end even before I start.
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If we are successful, who is this a must-have product for in terms of the big strategics in their bag? Because nice-to-have things don't get bought, right? And that might be fine if you're willing to IPO, but great.
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Know that you're possibly gonna need to IPO, and that's something that you should be thinking about in the beginning because if you need to IPO but the market's only $250 million a year, that math is not gonna make sense.
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You're not even gonna get your round of investment, so don't even get started, you know? So just understand at least a draft of the full journey,
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um, beginning to end, knowing that it's almost certainly wrong, but it's at least within the realm of reason, and make sure that it makes sense, right?
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And then the next thing I try to do is talk myself out of everything, right? Right. I like pretend I'm on the other side of the table and try to self-criticize the idea.
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And this is actually something I think people don't do well, generally speaking, and it's something I had to learn to do well over time.
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And I'm always trying to improve on things like this, but you get an idea, human nature is to fall in love with your own idea 'cause it's a great idea. It's like your top three idea.
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It's one of the best ideas you've ever had in your life. Like how dare you criticize my idea? But it actually should be the opposite. And start to criticize your idea. Start to think about,
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if someone asked me to write a check for this, what would I be concerned about? Flag all of the problems. Don't run away from them. The problems are there, whether you acknowledge them or not. Mm.
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So you might as well just acknowledge them and get comfortable. It doesn't mean that every risk can be mitigated before you start, but be comfortable with the path to mitigate that risk.
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And once you can't talk yourself out of it, that's when you know you've got something. And a- again, something I've said before with folks is, you know,
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most, I would say, innovators or first-time innovators, typically around maybe 30 years old, give or take, right? They've usually done one or two things first and now they've got the bug, the entrepreneurial bug, right?
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And you mentioned it could take seven to 10 years for each thing, right? And maybe they're gonna retire when they're 70. All right?
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So I say you've got maybe five chances to do something in your entire professional career. Are you gonna wager 20% of your career on this idea? 'Cause if the answer is no, go do something else.
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The opportunity cost for the type of person that would do this is too high to spend up to seven years, seven to ten years on something that's mediocre, right? Mm. You'll think of something, just give it more time.
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Give it three more months and you'll come up with something better. Yeah. Don't just start something for the sake of starting something. Yeah.
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That, yeah, there's a k- like several soundba- soundbites that, that I think we'll be able to pull from this that are quotes, soundbites, et cetera, that we'll be able to pull from this interview.
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But the one that you just used around, I can't remember the exact phrase that you used, but it's around that, that, that opportunity cost, right?
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Like literally it's 20% of, of your working career potentially wasted if you don't, if you don't try to address those problems that are there, whether or not you wanna pretend they're [laughs] pretend they're there or not.
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But yeah, it's really, really solid advice. With that said, I know we've only got a few minutes left here, so I wanna give us a, a handful of minutes to run through some rapid fire questions.
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But for those listening in, again, it's adonamed.com. A-D-O-N-A med.com. That's the website.
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If you're just listening and don't get a chance to read the full summary on MedSider, in that summary, we'll link to the website as well as Brian's LinkedIn profile so you can check out his background in a little bit more detail.
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With that said, first rapid fire question, Brian, is, I think I might know the answer, but when you think about the next 12 months ahead for Adona, what are you most excited about?
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Yeah, actually just patients, helping patients. Trying to see our technology in a way that is going off the bench and hopefully making somebody's life better. That's what it's all about. Yeah. There's two from my...
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This is my own opinion, but like from the kind of inflection points that, that kind of really get you excited, it's the first time you're in patients, I think that's super fun, and then when you're preparing for eventual launch or commercialization.
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Those are two really exciting times. It'd be fun to see, see what the next few months, how the next few months unfold for Adona with respect to that.
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Next question is, since co-founding the company, five years in into the journey, um, what's the most surprising thing, uh, that you've, uh, uh, learned over that time? It's actually a positive thing.
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I'm, I'm actually surprised by how much technically we've been able to accomplish. And I know that sounds like maybe egotistical, but what I... Again, we started this company with
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such an ambitious technical vision that I thought that we would be successful if we could've hit 60% or 70% of it, and we've hit basically 100%, maybe 95% of what we were hoping to achieve, we were able to figure out.
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And that's been rewarding, and I think it's been, it's a true testament to the team, right? My contributions to stuff like that is incredibly minimal, right?
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It's about what the team has been able to pull, pull off, this multidisciplinary cross-functional team. And I'm pleasantly surprised by the level of traction and success they've had. That's good stuff.
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All right, let's, let's pr- you've probably given this presentation before, but let's, uh, presume you're, you just presented maybe it's in front of a bunch of Biodesign alumni, and you wanna leave them with one lesson that's gonna, you know, best set their, themselves or their venture up for success, what would that one thing be?
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I would say act with integrity. I know it's a silly answer 'cause it's maybe not a business answer, but you can tell a lot about a person when they do the right thing even when it's the hard thing to do.
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And I think if you act with integrity and lead with respect and empathy, and empower people to have a strong voice, you're gonna get the most out of your team, for better or for worse.
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And it's almost always for better, right?
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And so with that in mind, it's less about the ideas and more about how you conduct yourself with the investors, with your partners, with the doctors, with your- Co founders or employees or team or whatever, make that your brand, right?
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Your brand should be somebody that people want to collaborate, respect, and work with. And, and that I think is pretty good advice. Yeah. That's good stuff. All right, last question.
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Let's rewind the clock, maybe go back to your early mid-20s, that kind of general timeframe. Is there anything that you'd whisper in the ears of the, your younger version of yourself? Oh my God, there's a million things.
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I don't know, what would be the best thing? I don't have a great answer for you off the top of my head. Just it's going to be hard. Keep persevering. Get through it.
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I think most things that are worth doing are very challenging because if they weren't challenging, everybody else would be doing them, right? And not to be scared of things that seem very difficult and ambitious.
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Just take them one step at a time, break them into digestible segments, and, and go for it. Don't be scared to go for it. Yeah. That's good stuff.
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It reminds me a little bit of that, uh, you probably saw that presentation from Jensen, the CEO of, of, uh, NVIDIA.
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I don't know, it was, like, maybe a, a couple months ago where he was like, look, the, the, the only way, I'm paraphrasing, the, the only way to, to the other side is through.
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And you're gonna learn most about yourself through sacrifice, through, like, really getting through really hard challenges, hard problems. That's good stuff. Thanks a ton, Brian, for coming on the program.
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Really appreciate you carving out a little bit of time in your busy schedule. I know things are at Adona are humming. Grateful for the opportunity to sit down and have this chat. Yeah. Thank you for having me.
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It's really enjoyable conversation. Glad I got a chance to come out. Yeah, yeah. Highly encourage everyone to give, to give Brian a follow on LinkedIn.
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It's, uh, he posts some fun stuff and make you chuckle every now and then. With that said, again, for everyone listening, Adona Med is the website. We'll link to it in the full write-up on Medsider.
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Highly encourage everyone to also give that full summary piece a read too when you get a chance.
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Brian shared a ton of really valuable insights that we'll try to, we'll try to capture as best as possible in that summary article. With that said, Brian, I'll have you hold on the line.
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But for everyone listening that you made it this far, thanks as always for your attention. Until the next episode of Medsider Goes Live, everyone, take care. [upbeat music] Hey, it's Scott again.
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One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups.
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But here's the thing, I'd be super grateful if you could help me reach even more ambitious doers who share our passion.
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Leave your honest thoughts and hit that five-star rating if you think we're worthy.
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As always, thanks for being a part of our journey and for helping Medsider continue to grow and evolve. Your support is greatly appreciated. All right, enough talk about reviews.
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Stay tuned for another informative episode coming at you soon. [upbeat music]
