Medsider: Learn from Medtech and Healthtech Founders and CEOs - Iterating Towards Perfection in Medtech: Interview with Sonavex CEO David Narrow

Episode Date: August 16, 2023

In this episode of Medsider Radio, we sat down with David Narrow, CEO of Sonavex, who has previously worked with multinational medical device companies on their commercialization and long-term business strategies as a healthcare consultant for Health Advances. David earned his B.S. in Biomedical Engineering with Highest Distinction from the University of Rochester before receiving his Masters from Johns Hopkins University. He was named 30 Under 30 in Healthcare by Forbes in 2016 and 40 Under 40 by the Baltimore Business Journal in 2017.In this interview with David, we talk about the art of perfecting product design, the strategies to adeptly navigate complex regulatory waters, and the nuances of capturing the trust and interest of venture capitalists. Before we dive into the discussion, I wanted to mention a few things:If you’re into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's a link to the full interview with David if you prefer reading.

You make these assumptions when you first start inventing things, but until you have your target end users actually try to implement the solution, it's all theoretical. And the road when you actually have these people put their hands on it, and that's where the real learning happens. 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 startup. in the world. Now here's your host, Scott Nelson. Hey everyone, it's Scott in this episode of Medsider, I sat down with David Nero, CEO of Sonavex. Prior to co-founding Sonavex, David worked with multinational medical device companies on their commercialization and long-term business strategies as a healthcare consultant for health advances. David earned

his bachelor's in biomedical engineering with highest distinction from University of Rochester before ultimately receiving his master's from Johns Hopkins University. David was named 30 under 30 in health care by Forbes in 2016 and 40 under 40 by the Baltimore Business Journal in 2017. Here are few of the key things that we discussed in this conversation. First, the ultimate perfection of your product design is a result of continuous iteration. Don't get married to your first prototype, but keep refining it. Solicit consistent feedback through every phase, especially from in users, to make this process as cost effective and efficient as possible.

Second, when navigating the regulatory landscape, leverage all of your resources, don't be afraid to ask for help from your network. Initiate early communication with regulatory bodies like FDA to anticipate challenges and understand their expectations. Third, there is no one-size-fits-all strategy when it comes to winning venture capital. Keep in mind that investment decisions are often driven by emotions and a hinge heavily on your management team's credibility. Utilize your contacts to connect with the right capital partners and learn what drives

them to invest. Before we jump into this episode, I wanted to let you know that we just released the latest edition of Medsider Mentors Volume 3, which summarizes the key learnings from the most popular medsider interviews over the last several months with folks like Jim Persley, CEO of Hinge Health, Carol Burns, CEO of Cajun vascular, and other leaders of some of the hottest startups of the space. 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 glean from the founders and CEOs that join our program. 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. If you're interested in learning more, head over to medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of MedSider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Nadine Yared, CEO of CVRX, Renee Ryan, CEO of Cala Health and so many others. Learn more by visiting Medsiderradio.com forward slash mentors.

All right, David, welcome to Medsider Radio. Appreciate it coming on, man. Thanks for having me, Scott. It's a pleasure to be here. Yeah, especially after a fresh move. That can't be easy. I'm sure you're juggling a lot right now, but nonetheless, I'm looking forward to the conversation. Yeah, and a five-month-old, too. Try that in the mix. You know, we were joking around before they hit to record, but I recently moved as well. And we've got a, we've got close to a two-year-old. So, uh, and know, know what that's like, for sure. But, um, with that said, people listening to this aren't interested in hearing our moving tales. They're interesting, probably learning about your, uh, your journey, you know,

from a professional standpoint, as well as kind of the journey over the past several years with, uh, with Sonavex. So let's start there, uh, you know, without going like too far into the weeds, maybe give us an elevator pitch for your background leading up to, uh, leading up to, uh, sonavex. For sure. So I started off as a biomedical engineer. I did my undergrad at, University of Rochester and then came down back to Baltimore where I grew up to go to grad school at Johns Hopkins in the same field. And while I was there was in their bi-design program, which was modeled off of one that was founded at Stanford, which was really a perfect environment for me. And during the program, I met a physician and a professor, and the three of us should

basically partner up and come up with the opportunity around Sound of X and an initial prototype before I ended up taking a job up in Boston doing healthcare strategy consulting. And I'd actually taken that role before the 3AF had met and very glad that I did because that was one of the best experiences I've had professionally and really positioned both me and the business well for Sondavex moving forward. So I was at a firm called Health Advances based in Boston, but with presence all over the world. And we would do anything for either therapeutics, diagnostics, or device companies.

Now they're doing a lot of health IT work as well, where we do financial forecasting, market research, eminated due diligence, health economic modeling, a ton of great experience, they had a phenomenal training program, great mentors, and it was outstanding.

And while I was up in Boston, the team at Hopkins that I met, continued advancing this technology from what was a kind of pathetic prototype at the time that I left Hopkins to something that was really compelling and we felt had a lot of promise not only to help patients,

but when I started looking at the business plan and the opportunity that we could build an exciting business around it. So at that point in time, I left Boston, came back to Baltimore, spun out the IP and started Taunevax. Awesome. That's a great overview. And just to set the stage for everyone listening, your time with health advances, so post kind of Hopkins, that was 2013-14 timeframe. So we're recording this mid-23. So about a decade later or so just to kind of help people get in an understanding of the

timing. So you're close to what? You're like almost nine years in to Sonavex then, about right? Yeah. Yeah. It's part of belief. Yeah, yeah. I mean, it's unbelievable how, you know, you go into these like startup, you know, projects and you're like, ah, this could be, you know, quick turnaround or, you know, this is maybe like a three to four year thing. And it's like, you're a decade in and you're like, oh, I didn't think it was going to take this long, you know. Of course, I think if everybody knew it would take that long and see a lot less company getting founded. Yeah, 100%. Okay, that's a super helpful overview. So give us a sense, though, for, I know you've got, let's say, two core products. So, like, help us understand kind of how they're positioned, like what they're utilized for kind of in the market. For sure. So our two products are called Ecomorock and ECHO shore, and they work together as a single solution. There are a number of indications where the technology is valuable, but we're primarily focused on the opportunity to improve care for dialysis patients. The whole concept there is that if you require dialysis, there will be almost five. million patients that do require dialysis worldwide in the next few years need a way to connect your bloodstream to the dialysis machine so your blood can get clean because your kidneys are no longer able to do so and that's what your dialysis access and there are three ways you can do so and where most patients initially get their dialysis is through what's called a central

venous catheter which is basically a tube that's inserted from your neck down into your heart that gives you the immediate ability to connect your bloodstream to the dialysis machine and clean your blood but these catheters are really bad for patients and payers and really all the stakeholders, they get infected very frequently and patients get hospitalized on average twice per year. It's very expensive. The catheters will get clogged and that's be replaced. So it's really the worst option for these patients. Where you ultimately want to be is on what's called an AV fistula, which is a connection between a vein to an artery in your arm, that when it ultimately undergoes this process called maturation where the little vein connected the artery grows in size to accommodate the

flow rates needed to run the dialysis machine, you can use that fistula, remove the catheter, and you have far better outcomes and fewer costs over the course of that case of life. And the key issue is right now the average time to go from that catheter to that fistula is more than six months in this country, and you suffer a lot of hospitalizations, mortalities, and other unnecessary procedures that are bad for patients, most importantly, but also for payers and physicians. And the rate-limiting step to getting these fistula's up and running and these catheters out is ensuring you can demonstrate that the fistula is ready to be used. that's mature. And the gold standard way for doing that is doing an ultrasound that tells you the flow rate, the diameter,

and the depth of the fistula that will dictate either whether the fistula is ready or whether there's an intervention, which may be endovascular, maybe surgical to improve that fissula, or in some cases to determine the fissula has failed and it needs to be replaced. And right now, there's poor access

to this patient population to getting these routine ultrasounds. They end up spending multiple hours a week for multiple times a day, sorry, multiple hours a day for multiple times a week, in this dialysis unit and the people that are working in that dialysis unit are dialysis tax that don't have any sort of ultrasound training. So they're spending all the time

and what they see is the healthcare system, but they're not getting a routine ultrasound. And when they ask these patients to come into the hospital to a trained sonographer and a specialized lab, the compliance rate is really low. It's under a third of time that they actually show up to these appointments. So the physicians don't have the information

they need to make the right decision to either demonstrate that the fistral is ready, determine if an interrupt, if an intervention is needed or detect a failed fistula. So what we've done is we've created a two-part solution called ECHOMARC and ECHO-SURE that empowers any human being with the pulse to be able to collect a vascular lab quality ultrasound in a matter of seconds

using our implantable device called ECHOMARC, which is a bioresorbable fiducial marker that's placed by the surgeon at the time of the 80 fistula creation. And then AI enabled 3D ultrasound that uses a series of deep learning and other image process algorithms to really automate the entire process of data collection, processing, and display. And then that's cloud-connected and sensitive position so that in the dialysis unit where these patients are coming multiple times per week, that data about their fistula status is getting sent

to that position to be able to make early and accurate informed decisions about how to get that catheter out as soon as possible. Got it. That's a super helpful over you. And I'm looking at your website, sonavex.com, s-on-a-v-e-x.com. if you want to learn a little bit more about the technology and don't get a chance to get to the write up for on medsator.com. But I can see both like side by side right on your homepage, Echo Mark and an EchoSure. So Echo Mark, just so I understand it, this is a file absorbable kind of,

is designed to kind of last a certain amount of time then. And it's implanted right, you know, when the actual surgeon creates the fistula for a dialysis patient. That's right. So it's, it's add one step to the existing procedure where the device is sutured in place after what's called the swing segment of the fistula where the vein connects to the artery. It sort of sits underneath the vein as a cradle, and it's manufactured with this patented manufacturing technique that basically enhances the ultrasound visibility of the device, and it gives the algorithms information that's necessary to understand what that flow rate will be. And that's a, you can get into the physics that that would be useful, but it's basically,

it helps the ultrasound understand the angle of information where the probe is being held, is one of the most challenging parts of accurately measuring flow rates. So it can solve that with algorithms based off of that structural information that was artificially created. Got it. And so the goal here, as you mentioned this earlier, so a dialysis patient is a fissula is created, but it typically takes around six months for that fissula to mature enough where, you know, they can use it for dialysis purposes. And so the goal here with ECHOMAR and ECHR is like to avoid all of these unnecessary like hospital visits and, you know, the appliance-related issues, the whole host of things that you mentioned earlier on in the conversation. But if I'm a dialysis patient, I can sort of like

be at home, this is implanted. And so can a physician kind of see like the progress remotely then? I don't even have to necessarily go into the, into the hospital. Is that kind of the goal there? Exactly. It's cloud connected. So as soon as the data is collected, the information goes for the physician's phone and desktop and then can make a decision about what needs to happen. And a lot of it's, hey, I don't need to be involved, the fishill is already ready, start using it. And that's the outcome everybody's hoping for. But oftentimes, you know, it's either too deep or it's too smaller. There's a narrowing and that needs to be addressed. Got it. Okay, cool. Now that we've got like a good, solid overview of kind of what you've been building over the past, almost, almost

decade now. I guess my first question before we go too deep is, was the initial kind of idea or technology, was it more focused on echo mark kind of out of the gate or was it on ECHOSUR or a little bit of both? So we always knew that there was a lot of value in having a non-expert user collect ultrasound type data to both determine what's happening with an AV fistula, but also in other several other types of v. Surgaries that are at risk for a post-hopper problem. And the first component of the aha moment, so to speak, that evolved was that, hey, look, a fiducial marker like Echo Mark with ultrasound is probably a direction worth pursuing. Echo Shore did not exist in any sort of related form factors it does today,

and that evolved tremendously over the years and started off with a software package on an existing ultrasound, then became a custom 2D ultrasound, then it became a custom 3D ultrasound and TEP learning algorithms. And a lot of that iteration came from usability testing and you make these assumptions when you first

start inventing things, but until you have your target end users actually try to implement the solution, it's all theoretical. And the river meets the road when you actually have these people put their hands on it. That's where the real learning happens.

Yeah, got it. Okay, cool. So give us a sense where you kind of go back and step inside the old Medsider time machine as I like to describe it. Go back in time and learn a little bit more about the journey. Give us a sense for kind of where you're at in terms of like development, regulatory, commercialization, et cetera. Yeah, so Atomic and Equisher are, you know, fully complete in terms of their development.

They've been thoroughly tested and both devices have received general indications through 510K clearances. So these technologies have sort of demonstrated their safety and efficacy and are in active clinical trials right now. We just finished enrollment in one multi-center prospective study, and we're excited about a health economics and outcome study that should kick off pretty soon. And the goal with that second study is really to demonstrate, yeah, not only that, hey, the device can deliver what we're hoping it can deliver for that user or that patient or that physician at that point in time. but hey, when this thing is used across the population of patients, how do we move the needle in terms of their outcomes? And how does the payer really benefit financially? Because we view those two elements of the value proposition to be paramount to, you know, widespread adoption and, frankly, benefit to patients.

And if they don't have access to that technology due to the lack of data or lack of reimbursement or whatever it may be, then all of this hard work over a decade is not really worthwhile. So we're really excited about that next milestone and I think that that will be a really important inflection point for getting this technology to the patients that need it. Got it. So would you consider it like Sonovex like clinical stage or are you actively commercializing it? Or I mean, if I say for example, I had a reimbursement was off the table and I could just, I wanted to use, I wanted to start using that. I'm a physician. I want to start using this in patients and I could. Could I theoretically like buy the devices from Sun of X now or? Yeah. We don't have an active commercial team. We did some limited market release activities and a few of the markets we were excited about before we started our prospective clinical trials to get some feedback and to understand how fit into some workflow. But we don't actively market the technology and we're primarily focused on the clinical development.

Okay. Okay, cool. Sounds good. All right. Let's go back in time. Maybe it's been the next 20, 25 minutes or so talking about kind of the journey and what you've learned along the way based on your cross-functional experience, both professionally and and kind of just throughout the last decade or so with Son of X. And let's start with like early stage prototypes, right? You mentioned you kind of told us a little bit about the story and kind of the initial aha moment behind the technology. But when you think back to those very, very early days when you're kind of iterating through kind of alpha and beta versions of the technology, are there a couple of things that like really stand out that you either like did really well or, you know, or maybe,

you know, lessons that you learn and maybe frame that up for other other mettech entrepreneurs that are kind of in those similar stages that are trying to be as efficient as, possible with their limited capital. For sure. I think the biggest thing that a lot of inventors or entrepreneurs will naturally follow is that their first design or implementation is not only the right one, but that there's not enough time or money to try to continually improve it to make sure it's the optimal one before moving forward. And I think we fortunately learned this early enough before it became a huge headache,

but really making sure that you've had the chance, to get the adequate user feedback and the considerations related to, you know, regulatory reimbursement adoption, all these other things that certain design changes are different decisions can, the implications those can have in the future are really paramount. We iterated a ton. Our echo mark device, we looked back at one point. We had 26 different designs before we picked the one that ultimately went into the full V&B process.

We had, I think, done one or two non-survivable animal studies with earlier ones that weren't super expensive before we fell in love with the devices. and said, hey, you know what, this is going to make it through. But if you drive too aggressively just to check that box and get to that next milestone, that next milestone doesn't end up being successful, then you've spent that money, you've wasted that time in your back at square one. So really getting the conviction that you're in a good enough place to move forward is essential. And I think it's helpful to use an objective rubric where you create a score based off different considerations

or you really try to get external input and have them rank it and use surveys or other types the market research type tools to make sure that you're in a good enough place to decide to move forward. I think it's also a lot easier emotionally to have that objective input because so much of entrepreneurship is emotional, right? The highs are great, the lows are terrible, and you want to move forward and you're stressed out as much as you can try to make that objective and have other people outside of you and maybe a co-founder or two make these decisions. The higher likelihood those decisions are going to be sound. Got it. And you mentioned something earlier, David.

that around just the earlier that you can get your, you know, your device in the hands of end users, the better. And I think at a high level, most people listening probably understand that. But sometimes it's easy to get caught up in like this, you know, this kind of behind the scenes work, constantly iterating, conceptualizing, et cetera. And then you kind of lose sight of the fact that you haven't actually got this thing in front, you know, no one's put their hands on this, right?

No one's been able to give you objective feedback. How important is that, do you think, you know, through that iteration process, you know, going from, you know, concept to concept to concept. I think it's paramount. I think doing that in the absence of end user and other external feedback is, unless you're lucky, you're bound to be unsuccessful. And I think there are a couple ways to do that without a ton of cash. Hopefully you can get an advisory board of folks that do represent your user base that can give you time for equity early on that will be with you and give you objective input, even if it's critical. and then building some relationships that, you know, for us, our end users are not only physicians, right?

We've got dialysis tax, sometimes nurses, there are other folks, so we've been able to build relationships with these end users. And, you know, sometimes it's an Amazon gift card or something straightforward that's not super expensive. But it's so important just getting two or three of those people in when you've got a new idea before you go down, even at a development sprint can just save you so much time and headache. And, you know, the newest product we're working on that's not super. We haven't announced a ton about it yet publicly. This new product, we totally over-engineered the first version, and we put it in front of our users and all the stuff that we thought was so cool, they didn't care about.

And now we totally dialed it back and we send it to a new group of users, and they love it. And it's just a perfect example of how getting this end-user feedback early on in the process before an animal study starts or before you take something to a physician is so much more valuable than thinking you've got the right insight and going as far as you can before you unveil it publicly. Yeah, no doubt. And to your point earlier, there's ways to do this that aren't, you know, super capital intensive, right?

I mean, I mean, this could be as simple as different, you know, mockups or designs in a slide deck, right? You know, to run through kind of early stage versus kind of what you're thinking and the various kind of concepts or iterations that your team is considering. But I think the most important point is like having this cadence, right? This cadence of like, we're at this, you know, the next milestone. Here's, you know, here's where we need, you know, objective feedback, right? And then, you know, kind of once you have that, be, you know, sort of, you know, going back and making the necessary visions. And obviously, it's a careful balance, right? I mean, if you get too much feedback, you could get, you know, distracted with like variety of different paths. So it's kind of a

careful balance, but, you know, getting actual hands-on feedback, right, from end, not just end users per se, but like multiple stakeholders, you know, it's definitely crucial in those early days. Let's talk a little bit about, you know, in this kind of earlier time frame of Sonavex. And it was, you mentioned earlier, it was spun out of, out of Hopkins. And, you know, so many technologies are spinouts, right? Give us a sense for kind of, you know, what other founders should expect if they're considering spitting out or licensing a technology from an academic institution. Because I think it's fairly, from my understanding, it can be pretty disparate, right? You know, some institutions are really good and they've got a formal process for how they do that.

Others, it's like the Wild West, right? So I don't know if you can, you know, maybe speak to that and kind of help under the guys, you know, of other founders or CEOs that are kind of going through this process. Definitely. The first thing I'll say is, We were incredibly fortunate. Maybe it was luck. Maybe it was right place, right time, right people that we brought on board. But we had a phenomenally positive experience with Hopkins and continue to. If I were to go into some new institution where I didn't know anything, I think there are

a couple of key things that I would make sure that I would do. The first is start developing a personal relationship with the tech transfer office as soon as possible. And there's a couple of reasons why I would suggest that. The first of which is ultimately it's a negotiation and you want to build report. and make sure that you feel like you can have the trust of that other party and that that party is going to have the faith that you're going to be successful and they license this to you versus someone else. So as much as you can demonstrate, do you know what you're doing,

that you've got a great plan and that it makes sense to get this technology in your hands, the higher likelihood that you're going to get a deal and the deal that you want. And finally, the earlier you start, the earlier you can get terms that are likely going to be more favorable versus trying to come in at the end when the tech transfer office feels like they've got all the leverage. We didn't really have that exact experience, but I think the earlier you start, the better terms you're going to get and the better chance you're going to have of having a flexible type of negotiation with the other party. The second piece is the attorney you bring to the table and finding an attorney that's negotiated with that tech transfer office, I think, is paramount.

Everybody, it's very easy for university to take a position that, hey, it should be this huge royalty rate, huge ownership percentage. But if this attorney can say, look, I've done a half dozen deals with you in the past few years, here's where we've come in at all these other times. there's so much less negotiating power from the university to give a different deal this time. And then finally, we didn't have to do this fortunately, but I think it can be very helpful if people struggle as find a group of peers who have done that type of licensing in that market to say, hey, look, here's for this type of technology in whether it's Stanford or whether it's any other institution, look, here's kind of what we've seen.

Well, let's make sure we're in this range so that we've got a few data points to triangulate. I think with those three things, I've never heard of any true horror stories. It always takes longer than you want and probably get, have to negotiate on certain items that you were hoping went a different way. But at the end of the day, most of my peers that have successfully licensed IP have gotten deals that are favorable enough to the entrepreneur, attractive enough for investors, and that make the university benefit in the event that there is a successful outcome. Got it.

Those are three like a really good, pragmatic kind of tips and tricks for anyone going, kind of going through this process. And I love the fact that you started out with something that seems reasonably kind of like straightforward, but so often we forget about it, right? It starts out with the relationship, just having a conversation, getting to know the person on the opposite side of the table, right? I remember having a conversation with Rosina Samadali, I believe is her, how do you pronounce her last name? She's the CEO of Oculogica, I think, if my memory serves me right, but she mentioned something very similar with her engagement with FDA, right? Like, hey, look, these are people on the other side of the table. Yes, the conversation can be challenging,

and you know, you have a, you have a position, they have a position, etc. But ultimately, like, you know, it's a relationship, right? You've got to try to build that in a genuine sort of fashion. And sometimes we forget about that, right? Like, these are, these are people, right? And so there's a little bit of, you know, relationship building, a little bit of salesmanship, just, you know, getting to know, someone kind of, you know, who they are, what they're trying to accomplish, et cetera. But those other two points, those are very, very pragmatic. And I think a lot of, at least a lot of the founders and CEOs that I come across, myself included, right, I make the sake too, is like you're considering this decision,

right? And you have all of these internal conversations, but you don't stop and say, let's just go on and ask some people, right, that have been here and done that, right? Let's just, what have they been through? What did they learn, et cetera? And sometimes it's just easy, it's like, it's easy to like lose side of that, right? Let's go tap our network and figure out, like, who are the people that maybe have worked, you know, I've done something similar with Yale, with a Stanford or any other like academic institution of that nature, right? with a pretty legit tech transfer office. And what do they learn?

You know, what are, what are the ranges that we're dealing with here, right? In terms of all of these, you know, whether it's royalties, equity, et cetera.

So really good points there. With that said, let's segue into kind of Ray clinical. You mentioned that, you know, where you're at from a clinical perspective right now. And I'd love for you to kind of work into kind of the health economics piece because it's so crucial.

I mean, I would argue that that's probably the most difficult thing to overcome right now, you know, in MedTech is, you know, yeah, of course, you need to kind of, it's sort of entry into the game to develop a device that that works, that's safe, that's hopefully better than, you know, the competition or at least delivers more value, et cetera. Regulatory, in most cases, generally know kind of what you're

getting into, but it's, it's reimbursement, right? And market access is like the biggest hurdle across that's oftentimes represents the biggest challenge. So talk to us a little bit about this bucket in general, like going from reg to clinical and reimbursement. And are there a couple things that like really stand out from your experiences with Son of X and prior, right, that other other, you know, MedTech founders and entrepreneurs need to keep in mind. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider premium members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews

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