Medsider: Learn from Medtech and Healthtech Founders and CEOs - Use the ‘Arm Hair Test’ as Your Medtech Compass: Interview with Voyager Biomedical CEO Marc Penna

Episode Date: September 17, 2025

In this episode of Medsider Radio, we sat down with Marc Penna, CEO of Voyager Biomedical. Voyager is a clinical-stage company tackling one of the most persistent challenges in dialysis care: reliable vascular access. Marc has more than 20 years of experience leading clinical research and regulatory programs across cardiology, vascular disease, and oncology. Since 2014, he has focused on early-stage ventures, with leadership roles at Intact Vascular and Vesper Medical — both acquired by Philips — as well as senior positions at Edwards Lifesciences, Boston Scientific, and AngioDynamics.In this interview, Marc shares how to pressure-test new medtech ideas, why collaboration with regulators and trial sites builds lasting credibility, and how disciplined fundraising and smart exit planning can set startups apart.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Marc Penna.

I've had the real lucky sort of opportunity to build some great relationships with several key physicians across the country, right, and different specialties. So surgeons and radiologists and cardiologists to then sort of be able to go to those folks who I trust and say, here's an idea. What do you think? And it's always interesting when you do that because I feel like the first sort of reaction is kind of gonna set the path for how that product might go. You sort of know, right?

Oh, this is gonna be a hard one to sell or they get it right away. So I kind of go there. Welcome to Medsider, where you can learn from the brightest founders and CEOs in medical devices and health technology. 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 in this episode of Medsider. I sat down with Mark Pena, CEO of Voyager Biomedical at Clinical Stage Company, addressing one of the most persistent challenges in dialysis care, reliable vascular access. Since 2014, Mark has focused on early stage ventures in cardiology, vascular disease, and oncology, building out more than 20 years of clinical research and regulatory experience. His leadership roles include intact vascular and vespers medical,

both acquired by Phillips, as well as senior positions at Edwards' Life Sciences, Boston Scientific and angiodynamics. Here for you the key things that we discussed in this conversation. First, start with patient impact, not projections. Market models matter, but they can't substitute for solving a real clinical problem. Mark stresses the importance of validating patient benefit first, then checking with trusted physicians before turning to the numbers. A smaller market can still be viable if the pathway, cost, and exit opportunities are

aligned. Second, collaboration is your strongest regulatory strategy. Mark approaches every stakeholder from FDA reviewers to try. while investigators as a future partner. Early engagement with regulators builds trust that compounds through each stage of development. At the same time, he views trial sites not just as enrollment engines, but as tomorrow's customers and champions. Partnerships built on trust and clinical rigor form the credibility startups need to successfully commercialize. Third, strong fundraising is built on rehearsal and reputation, not cold calls. Before approaching top tier funds, Mark recommends founders

refine their story with lower stakes investors. Early pitches can be bumpy. He also stresses the power of network in MedTech's tight-knit community. Warm introductions and reputation open far more doors than cold outreach. All right, before we dive into this episode, I'm pumped to share that volume seven of Medsider mentors is now live. This latest edition highlights key takeaways from recent Mediator interviews with incredible entrepreneurs like Bill Hunter, CEO of Canary Medical, Brian Lord, CEO of Pristine Surgical, Don Crawford, co-founder of Safion and current CEO of Corvista Health and other proven MetTech founders and CEOs. Look, we get it. Keeping up with every MedSider interview is an easy, that's why we created Medsider Mentors. These ebook volumes distill the best practices and

insider secrets from top founders and CEOs, all in a downloadable, easy-to-digest format. To check the latest volume out, head over to medsiderrady.com forward slash mentors. Premium members get free access to all past and future volumes, plus a treasure trove of other resources. If you're not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with Swanky new features, especially for our premium members. In addition to every volume of medsider mentors, you'll get full access to our entire interview library dating back to 2010. You'll also get Medsider Playbooks, curated guides packed with actionable insights and topics like fundraising, regulatory challenges, reimbursement strategies, and more.

And if you're fundraising, don't miss our exclusive investor database featuring over 750 life science VCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider mentors and our premium memberships by visiting medsiderradio.com forward slash mentors. All right. Without further ado, let's dive in in the interview. All right, Mark, welcome to Medsider Radio. Appreciate you covered out a little bit of time on this Thursday to spend a little bit of time with our audience. Thanks for having me, Scott. Happy to be here. We've had several conversations, I guess, with more in the trenches, business stuff in the past,

but it's fun to have you on the program and talk a little bit more about Voyager and really your journey leading up to taking on the CEO role. So with that said, I recorded a very short bio the outset of this episode, but I always like to start here. And if you have like maybe a couple minute overview of kind of what you've been doing leading up to taking on the reins at that Voyager. Let's start there. Absolutely. Again, thanks for having me. Yeah, I kind of had an interesting start into the med device space.

I think I kind of hear that quite a bit. People always sort of ended up here, right? I started out very interested in medicine, but also super interested in technology. This was right around the beginning of the dot com, so back in the early mid-90s. And I pursued this path of greatness where I was going to start a dot com. be rich and sail off from the sunset. Well, we all know how that ended for a lot of people. But what I did end up finding through that sort of pathway was that intersection of technology and medicine and where those two could work together. And that was in the clinical trial space.

And that sort of set my pathway off into what I'm doing today. I've had to honor, honestly, to work for some very great companies, Boston Scientific, Edwards Life Sciences, and geodynamics. and lead some clinical programs in a very formal way. Halfway into my career, I received a call from a recruiter saying, hey, you want to come work for a startup? And my first reaction was absolutely not. I'm going to stick here with the big boys, and I'm going to really go down this corporate road in MedDevice.

But I ended up doing it after some thought, and it was the best thing that I ever did. So in 2014, I made the switch from kind of big Med Device over to my first startup, and I have not looked back since. And that's been the path I've been on leading me up to through data management, statistics, Clinops, VP of Clinical, Chief Clinical Officer, and now serving as the CEO of Voyager Biomedical. That's cool.

Certainly, I think it'll be fun to kind of dig into your wheelhouse, right, which is building clinical programs and really, you know, from the earliest stages, right, to full-scale, you know, pivotal trials. But it's funny, you mentioned the dot-com, the younger folks that are listening to this is like, what's this dot com era again? Like you older guys, yeah, we could say we're older now. It's like, yeah, that's, yeah, that was the thing back in the day is the old dot com boss. But with that said, let's talk a little bit about Voyager before we kind of dig into the meat of the discussion.

Give us a sense for kind of what the, you know, what the device is, you know, major improvements that you're kind of making in terms of standard of care. And if you're, while you're listening to this, if you don't get a chance to get to the full write-up on MedSider, it's Voyager, biomedical.com. That's the website, Voyagerbiomedical.com, just as it sounds. But yeah, Mark, tell us a little bit more about the device and, you know, what's different. Yeah, happy to. So Voyager is in a little bit of a different space than I've been in in the majority of my career. Still Med device, still a device that needs to be somehow implanted or used within the body, has to be with veins and arteries, et cetera. But it is focused on the dialysis patient. The majority of Mike PIRDA has been focused on things like CLA and peripheral disease.

So a lot of the same principles apply, but what we're focused on here is being able to protect a patient's vein or essentially what's also called a fistula for dialysis patients. It is essentially their lifeline to being able to have their blood filtered when their kidneys is no longer working. So what our product does, it's a very simple design. It's a titanium implant. It has two parts, the top and the bottom. The bottom part of the device goes under the vein or the fissula.

The top part fits over the device. And they sort of fit together in a geometrical way so that as the fistula expands or grows, the flow rate gets higher. That device can slowly grow apart with the vessel. So it essentially dynamically expands, but never enough where those two pieces can come apart. The next real key feature to the product is that it has essentially a window on the top portion of the device. And what that window does is it provides a very palpable target zone for a dialysis tech to be able to put their needle in very specifically where to go without going through the back of the vessel. Got it. So dialysis patients, if you're not kind of familiar with the space, getting dialysis, you know, on average, what, two, three times a week roughly is kind of still the number.

I think. And normal kind of standard care without a device like Voyager would be like the, you know, needle sticking into this fistula, which kind of, I presume kind of tears it apart, right? It's pretty tough on the. Yeah. And in no disrespectful way at all, it's sort of unfortunate. Dialysis techs are one of the medical specialties that actually require the least amount of medical training to be able to do their job. So you could theoretically be, you know, working in a non-medical field two months ago and two months later have applied for a job at a dialysis clinic and now be cannulating patients now they go through training and there's very good oversight but with that comes you know a level of specialty that you need to gain over the years so to your point Scott yes there is an

opportunity for that needle to go through the back of that vessel the real thing that we're trying to prevent with our product is for that fistula or that vein to no longer be used to and for that patient to now have to go on to a catheter to receive dialysis. And that's really what we're trying to get away from because catheters are really associated with so many complications, higher fatality, mortality rate. So we're really trying to get patients to avoid being on a catheter. Got it. God. I didn't know, I didn't realize that stat about dialysis text. And I totally understand where you're coming from. And it's not meant to like demean attack because they most most likely can cannulate a fissula far, far better than I could. But there is a

learning curve, right? Just like any skill set, there's going to be a learning curve here. And that's a sensitive, a very sensitive kind of protective sort of area, right? I mean, if the fissure is lost to your point, there's not like a lot of, there's kind of limited sort of fistula zones, if you will. So so I, so and just to kind of circle back around the technology itself. So this is something that's implanted. When the fissule is initially created, it's implanted at that time by the vascular surgeon or the interventional nephrologist. So at this current time, the indication for the product would be once the fistula has some sort of challenge being canulated within the dialysis clinic, they would be referred to a surgeon. And at that point,

the surgeon would obviously, fast forward to a commercial world, would essentially use our product to now surround that fistula so that when the patient goes back to the clinic, they now have a very clear target as to how to access that. Got it, got it. But maybe future state, I mean, I don't want to put words in your mouth. These are my words. But maybe future state would be this is more front line, kind of routinely implanted, right, when officials are created. Yeah.

And obviously, we'll get into some of the clinical stuff. But I think, like with a lot of technologies, right, you sort of target your clinical trial to be focused on kind of a key indication. You're proving your concept. And then from there start to kind of expand into other areas through different trials, post-market studies, you know, et cetera. Got it, got it, very good. And again, Voyagerbiomedical.com is the website.

We'll only do it in the full write-up on Medsider, but if you don't get there, highly encourage you to check out the company and the technology and a little bit more detail by visiting Voyagerbiomedical.com. So with that said, give us a sense for kind of where the company's at today. We're recording this in late Q2 of 25. So if you're listening to this kind of somewhere down the road, that hopefully frames up sort of the time reference here.

But, yeah, where's the company at now? So Voyager has actually been in motion for quite some time. It was founded by a very, very smart doctor who worked. He's actually an interventional radiologist named Dr. Glow out of the Texas area. And it was really formed out of him getting these patients who had their fistulas destroyed and him having to put catheters in and do other things like that. And he really thought, well, it has to be a better way. And that's where the idea came from.

I have to applaud him because he really stuck with this, took it through very early stage. a lot of bench top work. They then went into animal studies, self-funded, SBIR grants, and then took the trial all the way through some initial funding in partnership with an organization called Biotex, which is a contract manufacturer out of Texas as well. Through that, they raised some early funding and started their first inhuman trial out of Panama. That trial generated the data that was then utilized for an approval here.

the United States. That process took a while. This was sort of a unique design, a unique product, if you will, with a unique trial design that took some back and forth in negotiation with the regulatory agency. So they did a really great job getting that through. So where we are today, we are a clinical stage company. We are enrolling patients in our IDE Pivotal Trial here in the United States. At the same time, we are fundraising for our series A with the intention of that to help us complete the trial, get us through regulatory clearance, and ultimately to start early commercialization. Got it. Got it. Super helpful overview. Well, yeah, let's spend the next maybe 20, 30 minutes kind of diving into some functional areas, right, that most startups are going to have to navigate at some

point in their trajectory, right, to hopefully get to market or beyond. So with that said, I'm going to ask you to kind of, you know, sort of dive into the memory bank, right, based on your previous, you know, going on a decade plus now in startups. And you're probably seeing a fair number of ideas. When this, you know, even with Voyager, you know, when this first came across your desk, you obviously, you know, decided that was worth pursuing, right, with more rigor. So when you think about all of the different, you know, concepts that you've seen over the, you know, over the years, maybe evaluated, do you have a framework?

Maybe or a couple different things that kind of come to mind when you, when you choose to work on a project that you think has legs? I think a lot of people would probably start out with, number one, what's the market size? Is there a market? I think I tend to gravitate first towards what does this potentially do for a patient? Because I think that, you know, if you can figure out a way to benefit a patient population, you could probably figure out a way to have a market that could be supported through the clinical program and the raise that you have to do.

So, you know, I think going into a startup, number one, for me personally, I'd say focus just in our space, med device, if you will, right? It's how are we going to help this patient? So, you know, looking at the various products I've had the opportunity to spend over the years, things like the first trans catheter heart valve or the first drug-eluding coronary stent, right? Really novel things that I could really get behind emotionally, which I think is for me is really important. I have to be really vested emotionally in what I'm doing. I think the second piece of it is truly a clinical need, right? So, yes, it's benefiting the patient, but what's the clinical need, both short term and long term? How does that sort of appeal to a physician, right?

I've had the real lucky sort of opportunity to build some great relationships with several key physicians across the country, right? And different specialties. so surgeons and radiologists and cardiologists. So to then sort of be able to go to those folks who I trust and say, here's an idea. What do you think? Right. And it's always interesting when you do that because I feel like the first sort of reaction

is kind of going to set the path for how that product might go. You sort of know, right? Oh, this is going to be a hard one to sell or they get it right away. So I kind of go there. And then, of course, you have to evaluate the market. I don't mean to sort of downplay that, but there has to be a market because ultimately if your goal is to either commercialize, go it alone, and or potentially have a larger company take that company on, there has to be a market that they're going to find justifiable to make that purchase. I think there's a key part to that as well, though. I think that you really have to look at the company that you're working with or the one that you're planning to bring through all of this process.

Not every company, you know, is a $500 million company, right? So thinking about what is the clinical program, what is the regulatory path, what is the cost involved in that? Are we talking about an 80 patient single arm trial? Are we talking about a 2,000 patient randomized trial for a heart valve, right? Those are very, very different pathways with very different market size, right? So I think it's really important to kind of look at all of those components as you're thinking about and considering a startup. Yeah, no doubt.

On that last point, I remember an interview that I did with Paul Buckman. This has been a while. It's probably been, gosh, six, seven years. You probably know Paul, right? Maybe from your Boston Scientific days. But I think he's maybe now retired, I believe, but kind of a bit of a startup legend in his own right in the world of MetTech anyway.

But he made a very similar comedy. He said, you know, one of the things I try to encourage other startups to think about early on is what is the eventual path to exit here, right? because that will likely determine how much capital you really need. And he basically was kind of eluding to this idea that a lot of startups, ultimately, like they just raise too much money and really limit the possible outcomes, right? If you don't think about that, you're not thinking about that, you know, in the right way early on.

And so I think it sounds like you're kind of touching on that same kind of framework, right? I mean, if it's a, if maybe the ultimate, maybe acquisition price by a startup is in the $200 million range, well, you can't raise $200 to $300 million to get there, right? So yeah, I think it's a really important point. But just to circle back around to something you said earlier around kind of the emotional, kind of like you have to be kind of emotionally or you have to gravitate towards this patient benefit that you're trying to solve for. How important do you think that is, you know, when deciding to work on a project?

I think it depends on what kind of person you are, to be honest, right? And I can speak for myself. For me to get behind something and be able to stand in front of an investor, a physician, even potentially a patient and talk about my product, I have to feel it. And it's usually the arm hair test, right? Like, I know when I'm really passionate about something because I can physically feel that. And that is when I know, okay, I have something here, right? I don't want to overstate that.

This isn't every day. But you know what I mean, right? When you're really getting into it. One of the things I did, my sort of litmus test here as I was early in with Voyager, was went into a dialysis clinic with one of my team members, Jessica Lancaster, who is probably one of the most well-known coming out of a dialysis center, coming over to the med device side of things. And I went in with her and to just see the patients, right,

and then casually hear them understand what our device is and see the challenges that those patients have. And then in my mind, being able to make that connection, obviously without selling or promoting or anything like that, but being able to sort of mentally make that leap and say, oh, wow, this device would help that patient significantly. So that's something that's just really important to me as I work through various projects.

And I also have the opportunity to probably like you, right, be an advisor. I get called by lots of friends and colleagues throughout the industry to just say, hey, what do you think about this, right? I do have to say, like, I think a lot of us in the med device, space. It's a really small, close-knit community. I think that the majority of us really feel that way about what we're doing, which is one of the reasons I love working in this space. Yeah, yeah, no doubt.

And I guess, you know, I'm not sure if you're familiar with any of like Cal Newport's work at all, but I think it was maybe, was it deep work where I think he hinted at this notion of like, you don't, it's like, for some people early on, they don't know whether or not they're like truly passionate about something. But as they get better at it, it becomes, you know, become passionate about that. But I thought a lot about that within the context of a startup, right? Is like, do you have to have a, like, do you have to be so, because there's, there's some founders that like take a physician, right, where they see these problems front hand or like firsthand, I should say.

And so they're just, they're passionate about trying to solve for it, right? Or others that, you know, come into, you know, a startup don't have, don't have that same sort of like, I don't know, touch, if you will. But I think that the point, if I'm understanding correctly, the point is that there's got to be some sort of gravitation or some sort of pull towards this thing. otherwise, these are long, these are long projects, five, seven, eight, nine, ten plus years. And if you don't, if you're not, if you're not, you're not excited about trying to solve for it, it's, it's going to be a tough, tough road. There's no doubt. Let's, let's segue into talking about,

you know, something that's that's really, really in your wheelhouse. Obviously, you spent your almost your entire career building up clinical programs. First half, you know, with large strategics, probably monster clinical, clinical programs. And then, you know, with startups, have kind of seen the full scope, right? From early, early feasibility stuff to, you know, to, you know, to in the pivotal trial, which you mentioned at Voyager, which you're in the throws up right now. So when you think about how you encourage other founders or CEOs that don't have the type of experience that you have, right, building out these clinical programs, are there a couple, you know, key things that, that you think, like, they really need to nail down or maybe,

you know, maybe things that they hopefully, you know, really, really shouldn't get, get right, or really shouldn't get wrong, I should say, right, is the beginning to kind of think about their clean or egg pathway. Yeah, absolutely. I think there's two things that really come to mind. again, I think because of my unique background focused in clinical trials, this is at the top of my mind, but it's something I always share with folks that bring me in for any sort of advice. The first one is regulatory agencies, whether it's FDA or overseas or whatever, they are not the enemy, right? I think it's so important to realize that they have a job to do and to be respectful of that job, right? And a lot of that respect can come through the near sort of process of engaging those folks early on.

So for me personally, I know one of the very first things I did when I got to Voyager was reach out to my regulatory counterpart. Granted, FDA was going through quite enough hebel around election just after election time. It was very, very interesting time to be working with FDA. But I have to say, like, even through that, I think just reaching out. to them with that sort of humanistic approach of like, hey, we know there's some things going on, just want to stay connected, don't want to cause any more work. Those little things go a long way. And we have since, in my time being with Voyager, have built a good relationship with our reviewer and we can set up calls with them. So I think number one is to really be close with your regulatory

partner. And then number two, do not cut corners on your clinical trial. Now, I'm talking about companies that are a clinical stage company that have to do a clinical trial. Obviously, different mindset if you don't have to do that. But I'm very focused, obviously, on clinical trials and companies that have to do them. Do not cut corners. It is not the place that you want to skimp. Realize the amount of effort, time, and work it takes for all. of the constituents to execute this trial, so your investigators, your coordinators that are at the site staff, the various vendors you're working with. They're all really key players, and it's really important that all of that process get the full attention that it deserves.

Hey, everyone, let's take a quick break to talk about Fastwave Medical, the company I co-founded and lead as CEO. We're developing next generation intravascular lithotripsy systems, or IVL for short to tackle complex calcific disease. The IVL market is valued at over $10 billion, but there's currently only one major player. In early 2023, we opened up an investment opportunity to our community, and within a month we secured close to $10 million. Then in early 24, we closed and oversubscribed $19 million round in just a few weeks, bringing the total investment into Fastwave to over $40 million. Corporate interest in the IVL space is growing too, the $900 million acquisition of Bolt Medical by Boston Scientific, and then J&J's $13 billion acquisition

of Shockwave Medical signals a lot of attention towards emerging IBL startups like FastWave, and we're making some serious progress. FastWave recently received its seventh patent for our differentiated laser IVL platform for coronary applications. On the clinical side, last year we completed the first inhuman study of our advanced electric IVL system with some pretty compelling results. Next up in 2025, we have IDEE trials plan for both our peripheral and and coronary IVL platforms. So if you're interested in investing in the fast-growing IVL market, sign up for our investor waitlist at fastwavemedical.com forward slash invest.

Again, that's fastwavemedical.com forward slash invest. Now let's get back to the conversation. Two really good points. The first thing that you mentioned with respect to kind of your relationship with the reviewers, I was just talking about this with Howard Rosen, who I know, you know, right? He was on the program recently. We were talking about evidence and what they're building there.

Cool company, cool technology. you know, he referenced the very same thing, right, of like being very methodical about, you know, through the QSA process. And I don't know if you know Sherea met with, with Zenflow. She was a former FDA reviewer, right, is now CEO of that company. And she said the best relationships that she had as an FDA reviewer, she was on a texting, you know, basis, right, with them. Not in like an informal capacity, right, but it was that close, right, where there was that level of relationship. And I think it's just a healthy framework because for my experience, I don't think start most startups don't get to that point with with the review team right where they

establish the relationship the right way and are trying to trying to truly truly collaborate and work on something together versus you know sort of sort of budding heads if you will no totally agree one other area too i think that's super important just kind of key lesson is really staying close to your sites and your physicians kind of hit on this but i think the thing to remember is that these aren't only your trial sites that you're trying to get a trial enrolled, these are your future customers. And it's so important to stay close to them, listen to their feedback, acknowledge what they're doing. That way, as you get closer to needing to do things like, you know, early stage kind of pilot trials and things like that, you know, you've got a good relationship

with those folks. Yeah. And you've, I mean, you've been around long enough to see kind of the, I guess the ecosystem switch, if you want it, when it comes to running, you know, early stage studies, everyone used to go to Europe, right? That was the default, default path. And then to use that data to, you know, to either submit for 510K clearance here in the U.S. or at least, you know, IDE submission, right, to run a pivotal trial. It seems very much like that almost as flipped, you know, almost 180 degrees. Is that, is that kind of your, with every device being different, is that kind of your, your default kind of mode of operation here is actually starting, you know, maybe it makes the most sense just to start right away.

I mean, presuming you've gotten through, you know, feasibility studies and other geographies, but, you know, start right away in the U.S. versus Europe? 100%. And I know exactly. I have seen it. I remember early on, our default would be, well, we'll just go to Europe, right? Now it's like there's no way.

It's not even in our strategic plans, right? Because the time and the effort to get through that regulatory process is just very painful right now. So I agree 100%. Yeah. And it's it's when you kind of take a step back, I'm sure you probably appreciate this more than more than most. It's like there was such a, an ecosystem built out in Europe, right, for this early stage medical technology. Because it was the default for, I don't know, for so long. And you kind of feel bad for like all the physicians that were, you know, that were like involved in all of this early stage stuff. Not to say that they're not involved in things now. But yeah, it's just, it's switched. So what seemingly

so, you know, kind of so abruptly that, yeah, I mean, it's, it's too bad. Yeah, and, you know, it's unfortunate because I really did build such a great relationship with so many physicians, especially in Germany and, you know, other French Belgium and other countries there around there that are real hotbeds for medical device, especially Germany. I mean, so many things that trials and things that have come out, even our early heart valve studies, we did in Germany first, right? So, yeah, it really is unfortunate. It seems to have kind of closed a little bit more.

I do feel like it's kind of expanding a little bit. I'm starting to see a little bit more involvement from OUS physicians now being, you know, really involved in advisors. But from a trial perspective, less, I'm not sure. I don't see a whole ton of U.S. studies that are now trying to specifically go overseas. With that said, let's kind of maybe talk a little bit about, you know, the transition from clinical right to to commercialization and that that can sometimes be a difficult one right if you've you know what you spent a year two years three years maybe solely focused on nailing a a pivotal trial right

and then you're kind of making making the switch to you know full on full on commercialization even if even if you're starting out kind of more with with a limited sort of limited limited market release but what what have you kind of learned over the years right on how to effectively kind of make that transition or what words of advice would you kind of you know give other other CEOs that are are thinking about that now, right? Maybe they're wrapping up their pivotal trial and really staring down a commercial launch. I can speak certainly from a process I've been involved in a few times, specifically, actually with Howard Rosen, ironically. So, you know, working at an organization that we did commercialize. And I was running the clinical program and he was running the

marketing and early commercial program. And I think the key now sort of as a CEO and thinking about you know, how would I do this? It's really looking at that same kind of partnership approach. And I think the number one reason that that was successful and what I would probably emulate again is having your clinical partners involved very early on with the initial kind of rollout and pilot that you're doing within the commercial space, right? I think just trying to just immediately hit a very large market penetration could end up kind of backfiring, especially in some of the spaces we work in where these devices might need some kind of upfront training to ensure the best safety and efficacy for the device. So I think a really sort of well-orchestrated

partnership between clinical and marketing to choose the right early commercial sites that you've hopefully had in your trial, maybe not all of them. So that, and as, and just to back up a hair, as you're working with those sites in your clinical trial, keeping your marketing partners involved as well, I see so many times where these organizations get siloed, but having your marketing partners involved early on so that they're able to start building those relationships with the clinical sites as well, then as you get to that sort of transition stage, those relationships aren't new, and it's sort of a natural progression from one to the other, with it like to kind of refer to as a gentle handoff, if you will. Yeah, a smooth handing off of the

baton. But I think that's, it sounds easy to talk about, right? But when you're, you know, you're staring down at commercial launch, there's all kinds of new pressures, right, to drive revenue now. And you're at a different stage of the company. And I think just going into that eyes wide open with that advice, right, and being being very mindful of, of ensuring, the best, the best transition, the most smoothest transition, even if it's maybe a prolonged sort of handing off of the baton, right, if you, if you will, just to just to ensure as smooth as smooth of a process as possible. I think that's really, really good stuff. Let's, let's talk a little bit about your experience fundraising too, right? I know you've been around around the fundraising game

and other and other startups and it's arguably, you know, one of the highest hurdles to cross just to keep your company alive, right, to achieve maybe the next, the next, you know, clinical regulatory milestone. Now that you're you're leading, you're effectively leading, leading this effort at Voyager, what are, you know, either a couple maybe of the key learnings that you're incorporating now or just what, you know, touch on maybe you're, you know, some of the lessons that you picked up on even raising your Series A with Voyager. No, absolutely. So again, I've really had the pleasure and the luck to be surrounded by some really successful folks who have raised money. And I really just key folks throughout this industry. So, you know, anything I do or, you know,

or sort of think about now has always been sort of sparked by those who've done it before me with my own sort of, you know, kind of twist on it. And I think the biggest, the number one key thing that I know I've employed and I've been told is don't jump in until you have your ducks in a row. So really get yourself prepared. Make sure you practice. Make sure you understand the market. Make sure you understand the questions that you're going to be asked, right?

even the most difficult questions. Now, there's always going to be things that come up. And I think that then leading into sort of starting with your, you sort of list your tier one, two, and three, right, potentials. And maybe starting with your tier three is where you're like, okay, this may not go well, I need to practice this, but it may not be a huge loss. And I don't want to diminish that either.

It doesn't mean somebody can't come out. But being really strategic about how you sort of roll yourself out into the public space in the fundraising sort of spirit, if you will. That last kind of point that you made about sort of maybe even practicing, right, with some of those, you know, tier two or tier three's first, right? And sort of working out, working out some of the bugs. I think that's really, really good advice. And sometimes easy to gloss over, right, because you want to, you know, sort of want to,

I think everyone's, you know, at least early on, right, excited about like trying to get some yeses, right? Trying to get some follow up meetings, right, with potential investors. But you could end up kind of, you know, I think everyone's made that mistake, myself included kind of stepping on your toes a little bit if you're, if you're, if you're not fully prepared or if you don't really have your narrative or your story kind of nailed down, it can kind of kind of come off a little bit, a little bit clunky. And if you're, if your first swings at the plate, right, or with, you know, the more astute, savvy investors,

and, you know, maybe maybe it's not the, not the best place to start. So I think that's really, that's really good advice. And that was the exact advice that was given to me as well. And And it's always good to be able to have somebody sort of sober your mind. Your first thought is like, well, I'm going to go to the folks I know who might invest in prior companies and they're really, you know, high-end savvy investors. And they're like, those should be your last folks to go to exactly what you're talking about. Yeah, yeah. And I guess I think that the point is that in your early pitches, even if you do it the right way,

there's always going to be things that you learn and take away from a pitch and tweak and massage et cetera. But yeah, just trying to be mindful of like, look, I mean, it's going to take a few times to kind of get better at this and probably not best if you're starting with, you know, your, your tier one, your tier one players. But your, your point around kind of like gearing up for a raise, I think that's also really important because if you're listening to this and you've never really led a, let a financing, it is truly like a big campaign, right? It's not, it's not terribly different than maybe even an early commercial launch, right? Thinking about, you know, having all of the, all of the, you know, your eyes dotted, your T's crossed and really kind of thinking about it as a,

as a marathon. You're going to enter a six-month, nine-month marathon to go raise some capital. And I think that's a really healthy kind of way to approach fundraising. For sure. I think the other one key thing that, again, I just learned through others who have done it successfully is there isn't a lot that comes out of really a cold call. I think so much of this is around networking and making sure you're staying connected with the folks who have done it before. Like I said, it's a small ecosystem. So really using your network and working, mouth and reputation to be able to get connected to some of these potential investors. Yeah, yeah, there's no doubt. I mean, that upfront research to try to find a warm,

a warm introduction of some type is usually worth it, right? I'm not a big fan personally of limiting to your pitches to only warm intros. I mean, I think that, especially if you don't have a broad network, you can, you can end up with maybe 10 people on your list and you need 100, you know what I mean? But I think it's really, it's really good point. I mean, the warm, like any sort of warm intro is going to, is going to most likely result in a far, far, outcome in terms of at least getting a meeting, right, than a cold, a cold email for sure. So with that said, let's talk a, before we get to these rapid fire, rapid fire questions, let's talk a little bit about M&A, right, because you've been at, you know, intact, Desper,

both exited to Phillips. You've been around the startup game, even on the strategic side, right, where you've seen, you know, startups kind of been being swallowed up. So when you think about what, what, and you can sort of answer this in a couple different ways, I guess, when you think about either a startup trying to sort of engage with the strategic, whether it's getting them on the cap table or even maybe there's a a potential like M&A deal on the horizon or vice versa, right? Like on the integration side, right?

What's worked best? What would have to start off need to be thinking about like to ensure a smooth, a smooth integration? What is your, you know, what are your words of wisdom kind of seeing things from both sides of the fence? I think it's really around trying to understand, sort of understand like what is that company missing out on if they don't have you in their bag of tools, right? or toolbox. And I think it really comes down to a few things. And, you know, like someone has said to me,

you know, very often, like, you know, companies aren't sold their boss, right? It comes down to getting and helping a potential acquire to sort of understand why do they need this, right? And I think with that, not only comes the product, but it also comes down to, I think a big part of it is the team. So really understanding there's a team here that has a proven track record that is going to more likely lead us toward a successful approval or a successful commercialization, you know, et cetera. I think the second part of it is being able to demonstrate, and this is what I was talking about early on, about really engaging your physicians early on and making them part of the team, because all of those physicians that are part of your family are also part of the larger

families as well, right? So they kind of help make the connection between us and what does a potential acquiring company need and how would this fit into into their clinical program, if that makes sense. Yeah. It's interesting that you kind of bring up the sort of the engagement with with strategics early on and kind of helping them connect the dots a little bit, right? And kind of seeing like how, no, is this, with this really dry value, right, for their, portfolio, I remember Bruce Shook, right, who you know quite well, mentioned the space, and a big fan of Bruce. I know he helps a lot of other mentors, kind of a lot of other younger CEOs as well. But he mentioned, he's had been on the program

a couple times, but I think he, I think this was in the context of, I remember right, Vesper. I can't remember if it was intact or Vesper, but he mentioned actually the most influenced, or the most, I guess, kind of influential, supportive people on the Phillips side were actually more the commercial leaders. And he goes, not that that's, I think his point was like, not that that's rocket science, but most startups kind of think, most of their engagement is all, is with the BD. And not to underappreciate the BD team, right? But that's a certain function, right, that's trying to do some early diligence.

But ultimately, a lot of times it's the commercial leaders who are going to drive a lot of the decision making because they're going to know what's going to be best, right, for their portfolio. And, you know, there's probably other strategic things that you're not even aware of as a startup that they're already thinking about that. So I think it's a really, really good point. I guess the message being typically the onus is on us, right, as startups to kind of be thinking through that. and to help again kind of connect the dots for the strategic. That's really, really good point about the commercial leaders, not just the BD side, right? Because they're the ones who are going to get this thing now into their organization. They're going to have to get out there and make it happen.

And there's often a whole lot tied into that being successful post-acquisition, right? So I think, yeah, keeping those folks involved and making sure they understand the real value of how to, number one, the real value of the product to the physician, the patient, but how to essentially sell that product, right, as we've sold it, quote unquote, from the clinical trial early on. Yeah. If you're listening to this and never been involved in kind of a diligence process on the strategic side, it is, I mean, it is like a multidisciplinary kind of function, right? There's folks that are sort of identified or selected to be part of a team, right? And they're coming from reg. They're coming from quality, from commercial, et cetera, from BD. And your goal,

should build relationships as much as you can with all of those folks, ideally the most influential ones, right? If you want to hopefully, you know, see a deal, a deal happen. So I think that's really, really good points. Before we jump to that kind of the rapid fire portion of the interview, any other, anything else that you want to kind of mention, you know, with respect to, to Boisor at all? Or are we, you know, happy to jump into the rapid fire questions too? Yeah, I think the number one thing that I would sort of say for any new startups or new CEO trying to think about where do I focus my resources. Again, I'm obviously focused on clinical stage companies that are running trials. Really think about where to cut your corners. Do not, you know, cut dollars out of something

related to a clinical trial that's going to ultimately be what you sort of stand on as your data and your process heading out into a commercial space. Really important to think about that as you have to make some pretty big tradeoffs, right, in the early stage startup. space. Yeah, good advice for sure. And again, if you're listening to this interview and don't get a chance to get to the actual write-up, Voyager at Biomedical.com is the website. I highly encourage you to check out the company and learn a little bit more about the technology. We'll link to it again, like I said, in the full write-up on MedSiter, if you're new to these interviews, we always produce these longer-form summaries that are meant to kind of really capture a lot of the lessons learn that our

guest share like Mark. And so I encourage you to check that as well. Those are posted alongside the audio episode on Medsider. So with that said, Mark, the next few questions of rapid fire in nature, if you want to expand on your answer, totally fine. First one on the docket, though, is fast forward to take us to maybe mid, late summer of 2006. What are you most excited about at Voyager? The thing I'm most excited about is that we will see several patients who have truly benefited from our product by that time. So starting to see patients get through their dialysis, and staying off a catheters potentially. That's honestly what I'm most excited about.

I think the second thing that I'm most excited about is to be able to be out at conferences and really spreading the word amongst physicians and the medical community around what we're doing and how we are ultimately really helping patients. A lot of fun stuff kind of on the near-term horizon, it sounds like. So all right, let's, I want to have you kind of picture yourself in a maybe a more intimate setting, maybe with a group of, you know, 20, 30, you know,

med tech entrepreneurs, just wrapped up dinner. And you want to, like, leave them with, like, one, you know, one really key thing that they need to take home and really, really understand, you know, if their, if their startup's going to see any, any sort of success. What would that, what would that one thing be? Well, I think it's, it's, it's hard to say one thing, but I think there's a few things. You have to be 100% in. You can't have 50% in and you're sort of not sure. You have to be committed to your mission. Surround yourself with a good team of trusted advisors. You don't, you're never going to be able to know and answer every question. And I think the last thing that I've had to do at times and sometimes is challenging is to know

when it's time to move on from a certain strategy, a certain process or or something that you're working on, chalk it up to experience and just move on to the next thing. Yeah, that ability that to truly move on. I mean, obviously take the lessons learned, right, but move on. I mean, I think it's, it's so easy for anyone, right, right, to kind of like get stuck thinking about what they could have done better, what they could have done right, and just it's hard for them to kind of really just learn, remember, and then, you know, for, you know, forget about it, move, move on. So last question, take us back to maybe mid-20s, late 20s, right? We're a little bit maybe further removed from the dot-com era, right, at that point of your career. Anything you'd whisper

in the ears of the younger version of yourself. Oh, boy. That's a, that is, yes. I would tell myself, you don't know as much as you think you know. You and me both, man. You and me both. It's an interesting place. I mean, I'm grateful for all the experience I've had.

I've learned so much through the tons of mistakes I've made over the years. I've also learned a lot from the tons of successes that I've had. But I really would probably tell myself or any young, entrepreneur, just be patient, do the next right thing, and things will happen. Yeah, that's such a, I mean, we're kind of joking and laughing about it, but it literally is like something. It's, it's hard to say. I'd say just one thing to myself back then, that that would certainly probably be one of them or something along those lines, right? It's so hard to some time. I mean, if you're ambitious, right, so hard to kind of be patient

and, you know, I think most ambitious people that I know, that I know, maybe realize they don't know what they don't know either, you know what I mean, myself included. And so, so yeah, but it's a good, good kind of thing to end, in the, in the, in the, in the show on, right? Yeah. As, uh, I don't, I don't, I don't ever, I don't ever fault someone for being ambitious, but, you know, sometimes it's good to kind of slow down a little bit and be, be patient and, uh, be, be okay with, uh, you know, maybe being a little bit of comfortable. So, but that said, I can't thank you enough, Mark for coming on the program,

uh, fun, fun discussion for sure. Again, everyone listening, Voyagerbiomedical.com is the website, just as it sounds. We'll link to it in the full write-up on medsider. Mark, I have you a hold on the program. But again, thanks for, Thanks for joining us, man. Appreciate it. Thank you, Scott, for having me. And for everyone listening, you made it this far. Appreciate your attention, as always, until the next episode of MedSider goes live.

Everyone, take care. Hey, it's Scott again. 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. But here's the thing. I'd be super grateful if you could help me reach even more ambitious doers who share our passion. 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,

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