Playing on Hard Mode with Scott Nelson, Co-Founder, FastWave Medical — The Medical Alley Podcast (Presented by MentorMate)

Startups can look fun and sexy and fast-moving, and there's a lot of gravitas, etc., but they're incredibly hard. They're very, very rewarding if you like to kind of build things and enjoy sort of pushing the boulder up the hill. But that's probably one of the key lessons learned, I guess, having done this for a bit now, is that they're just really hard. So you need to go into it kind of eyes wide open.

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Good morning, good afternoon, and good evening to everyone out there in Medical Alley. This is Frank Ciaschalti, your host on the Medical Alley Podcast, and I want to thank you for joining us on another episode. Today we're going to have a fun conversation with a serial entrepreneur who's working on a pretty cool venture. I think you'll find that interesting in its own right. but also is part of a, a broader ecosystem here in Medical Alley. And it's just a really great representation of this amazing community that you are all part of. So I wanna say thank you to Scott Nelson, the CEO and co-founder of FastWave Medical, for joining us today. Scott, thanks for being on the podcast.

Frank, so thanks so much for, for having me on. Yeah, I, I, I love what you guys are doing, uh, at Medical Alley. So, uh, pleasure to, to, to, uh, have the opportunity to to record a podcast with you.

We really appreciate it. Well, maybe the simplest place to start, could you give our audience a little bit of a background on, you know, introduce yourself and then tell us a little bit about FastWave and what the company's up to?

Yeah, so in terms of my background, I'll try to be brief, right? Because I, uh, I want to leave enough time to kind of get to the, get to the good stuff. But, uh, but first, uh, I've really at a high level spent most of my career in traditional med tech, primarily the cardiovascular space. First half of my career was with large strategics like CR Bard, which is now Becton Dickinson, a little bit of time at Boston Scientific, then actually came into Covidien through their acquisition of Bacchus Vascular way back in the day, and then stayed on board through Medtronic's eventual acquisition of Covidien. So yeah, first probably, you know, 10 to 12 years or so of my career was with large strategics, and then really over the past 8 to 9 years, I spent most of my time with early-stage startups. Uh, some of those include, um, a company called Touch Surgery, which is a London-based digital health startup that's now part of Medtronic. Uh, started a couple other companies along the way, including, including FastWave.

Oh, it's very cool. And we're gonna have to talk about Touch maybe for a second because the digital part of that's pretty darn interesting. But start with, tell us, you know, what, what is FastWave Medical doing?

Yeah, so fast— so we're designing and developing, um, intravascular lithotripsy systems, uh, or the acronym that's often used is IVL. Uh, and, um, I'll explain it, you know, for, for maybe at a high level for those as familiar with the cardiovascular space. But when it comes to cardiovascular disease, best to think about plumbing, right? In your house, when you've got a clogged pipe, you want to get that cleared up so you can reestablish flow, right? In the sense of plumbing, it's water flow. In the sense of our kind of our bodies, it's blood flow. However, when it comes to those blockages, if they're heavily burdened by calcium, which is tough to treat with traditional modalities, that's where intravascular lithotripsy system really, really comes into play. And so what, what's the technology is it's a balloon angioplasty catheter. Looks kind of like just any other balloon catheter. However, the difference, the major difference is you're delivering energy inside the balloon catheter to produce shockwaves. And, the shockwaves are then sent into the calcium to create fissures or cracks in the calcium in order to kind of modify it so you can deploy a stent, use another maybe a different sort of angioplasty catheter, et cetera. But, At the end goal, you're trying to open up the, open up the blood vessel.

And what, like, if we weren't using IVL, what's the, like, the modality we'd be using to go in and pull that stuff out?

Yeah, and it kind of depends on whether you're using this type of technology for peripheral vascular applications or coronary applications. But generally speaking, um, other, other treatment options include, you know, traditional balloon angioplasty, right? So a kind of a plain POBA or plain old balloon angioplasty, stenting, right, with either a bare metal or a drug-loading stent or tools that are referred to as atherectomy, which in essence kind of sand down plaque or try to cut it out. And so most physicians will use all of those kind of as part of their treatment algorithm to kind of depending on the patient, the burden of disease. But IVL is a relatively new type of technology that kind of fits into that, into the tool bag, so to speak.

And I gotta ask, then, what was like— what's the genesis of the company, or like how'd this get going?

Yeah, so we, we started actually working on the company, uh, back towards the back half of 2020, largely rooted in, um, in two things. One is that we, uh, were watching, um, the only incumbent in the space, which is a, a company called Shockwave Medical. They were doing, uh, fairly well, and we expected that the utilization of IVL would only continue, um, in, in the coming years. And this was before, uh, Shockwave's coronary approval, so the company really hadn't taken off like, like it has. And so We sort of had this underlying belief that IVL, the popularity of IVL and the utilization of the technology would only increase. And then two, we were keeping track of a company called CSI, Cardiovascular Systems, which is in the Twin Cities, recently exited to Abbott. We were watching the progress they were making with respect to IPR-related initiatives to sort of, for lack of a better description, kind of invalidate some of Shockwave's IP. And so anyway, based on, without getting too far into the weeds, when the USPTO ruled in CSI's favor, we, we sort of, you know, that was kind of the why now moment for us to kind of pursue this project with more rigor. And so we thought there's maybe a little bit more freedom to kind of operate than maybe others, uh, others would perceive. And that's, that's what's kind of led us to, led us to, to start working on, on this, this project versus others.

Yeah, I love hearing that, the, the kind of the strategic analysis that's in there about a growing market, IP and technical opportunities. And then the ability to bring something new into the space to improve clinical care and create a new business opportunity. And as I understand it, you're part of— FastWave is part of— and you're also part of an effort, an incubator or an accelerator in town called Big Sky Biomedical, which I find fascinating. This trend of incubation and of new models of developing medical device startups that can be more productive, more efficient than, you know, single product, single company, replicate the team over and over again. Could you tell the audience a little bit about the, the relationship to Big Sky and the, the idea behind Big Sky more broadly?

Yeah, yeah, no, it's a great question. Um, and so FastWave is actually spun out by Big Sky Partners, so it's not a direct spin-out of the, of the incubator, but partners of Big Sky spun and spun FastWave out. But I think our approach— I mean, there's a lot of, as you know, Frank, there's a lot of different accelerators and incubators, and they all have kind of various models. Some work, some have a very proven track record, others are kind of newer in their sort of evolution or lifecycle. But our take on projects that we pursue kind of out of Big Sky or kind of under that kind of broader umbrella, or folks involved with Big Sky and what projects we look at, are typically those that we feel are kind of opportunities where we can really optimize for speed. And so Most of the programs that we would pursue, you know, have a reasonably straightforward clinical and regulatory pathway. Insurance coverage and reimbursement is already in place. We're not— we don't want to, you know, typically we want to avoid having to kind of create new CPD codes as an example, right? So they're relatively straightforward where we can kind of leverage our deep domain expertise and speed to get that particular project to the next, you know, major inflection point pretty, pretty quickly. So generally speaking, I mean, I don't I'm obviously staying fairly high level, but those are typically the projects that we like to work on.

Right on. And I think it's a, it's a great exemplar for the broader ecosystem of multiple different ways to advance medical innovation, and that there can be ways of doing it that create efficiencies. It never is easy, like I'm always sympathetic to the journey of the entrepreneur, but ways to do things that can boost productivity, improve patient care, and generate superior financial outcomes, hopefully. I I want to shift in slightly because you've mentioned a couple of other ventures, this entrepreneurial journey. And, you know, as I was reading up preparing for this, I've seen you talk about in other forums that you enjoy, you know, kind of the Peter Thiel concept of going— taking something from zero to one. And we work with a lot of entrepreneurs who are for the first time doing that, right? And they don't know what they don't know. They're learning on the job. Best way to do it, but also a high-risk way to do it. As you've gone on your journey, are there, you know, things that you look back and you go, gosh, now that I know this, I can do it better, or I wish I knew that then? Like, basically, what are those words of wisdom you might impart out to some of the other entrepreneurs out there as they're on their journeys?

Yeah, yeah, no, I'm glad we're talking about this because, um, I like to, I like to, uh, kind of use it, use the analogy that, that, um, you know, startups in general are hard, right? I think, you know, most people that are listening kind of understand that, at least, at least peripherally, but doing a startup inside kind of within the medtech space, or really the broader life sciences arena, is like playing the game on hard mode, right? And so, so all of that said, that's probably the first thing that I'd mentioned is that that's one of the key lessons, sort of that I've gleaned over the past, whatever, 8, 9 years working mostly in early-stage companies is that from a distance, startups can, can look fun and sexy and fast-moving, and there's a lot of gravitas, etc. But there's are incredibly hard. Yeah, they're very, very rewarding if you like to kind of build things and enjoy sort of pushing a boulder up a hill. But that's probably one of the key lessons learned, I guess, having done this for a bit now is that they're just really hard. So you need to go into it kind of eyes wide open, right? It's a lot different than, you know, than, you know, being involved in a large strategic with endless, you know, nearly endless resources. And so that's probably one of the things that, that I, you know, mentioned at the kind of the outset, but A couple other things that really come to mind are, um, one of the things that I often see a lot of entrepreneurs, especially in medtech, one of the mistakes— it's not necessarily a mistake per se— is that they may have a really great idea, right, for this new thing that solves this, this very acute need that's very real, right? And they'll get stuck on this, this idea. And it may be, again, it may be a really, really great idea, but however, it's not a venture-backed idea, right? Right. And, and I think, you know, in this environment and in medtech, in almost every scenario, you're going to need to raise capital in order to, you know, uh, get this project or this idea kind of to the next, uh, milestone, the next inflection point. And yeah, I think, I think, um, you know, every kind of, every entrepreneurial-minded person that's listening to this, to kind of— I think I just encourage them, if you're working on an idea, just, just consider that from, from the outset, right? Is this, is this something that can be supported by, by venture capital? And so that's another thing I think that's really important. And then Probably the third major kind of key learning that I'd like to call out, and I think it would be helpful for a lot of startup folks that are listening to this, maybe you're at a strategic and have an interest in startups, is product-market fit is so, so crucial, right? And I think you can learn a lot, you can read a lot of books about product-market fit and how to look for that. But I think I can't underscore enough the importance of trying to look for that as early as possible, right? And as fast as possible without committing too many resources so that the sooner sooner that you can find sort of those, those traction signals that I like to call, where you've got some sort of, um, some, you know, some strong signals, some strong metrics, etc., that this thing that you're working on resonates with your end users, your key stakeholders, the sooner you can, you can, you can find those, those traction, um, those traction signals, as I like to refer to them, the better. Um, and, and just add a little bit more color to that. Yeah, what you want to avoid is getting into a scenario where you've got this great idea and you end up spending you know, years, potentially years on it, and kind of allocating, you know, some of your own budget towards something that eventually just doesn't have legs, you know, whether it's something that's not going to resonate with your end users, maybe it's a payer that's eventually not going to pay for it, etc. So again, the sooner that you can find some semblance of product-market fit, the better.

I mean, I think a theme I heard in all of that, in all of the comments you just made there is the importance of the external stakeholders, right? That like, you may have an idea, you may have a company, but if you're going to raise money, other people have to want to give you money. And if you're going to sell a product, other people have to want to buy the product. So having a mindset and then taking action around, well, who are the other stakeholders that are going to need to buy into this? And then what do they think versus, you know, what's in your head? That sounds like a theme that kind of is coming through your commentary.

Yeah, definitely. And I think most of us would say, well, the obvious kind of end user in the world of medtech is physicians, is clinicians, right? And I think sometimes we'll get stuck in this idea of running maybe a voice of customer kind of process. And the questions related to kind of what we're trying to ask are too high level or too superficial, where in reality we need to kind of sort of get down to brass tacks and ask that physician in this example, is this idea that we're talking about, is this something that you'd go to bat for in a committee at a hospital that's looking to possibly bring in this technology? You know, would you put, you know, if you've got very limited sort of arrows in your quiver, is this one that you would use, right? And so that's a good example of kind of really like trying to look for those sort of signals, that sort of buy-in as early as possible. Another one that you mentioned too, Frank, is on the payer side, right? Is this really something that an Optum, a Blue Cross Blue Shield, are they actually going to cover and pay for this?

Right.

You know, and so there's a lot of different stakeholders involved, right, in the healthcare ecosystem and really kind of getting into the weeds and getting in the mix with all of them is is really, really crucial to, to find, you know, product market fit again as early as possible.

Indeed. And one for the audience, one comment I'll make on the payer piece, because it just— every time I think about it, it blows my mind. But our friends at UnitedHealth Group, right, headquartered right here in Medical Alley, they employ in the U.S. more people than the entire U.S. medical device industry, and they have a higher revenue than the entire US medical device industry. And one of our board members we have, a former UnitedHealthcare executive, he made a comment once that just struck me, which was he would talk with device companies and they would talk about billion-dollar market opportunities. And he goes, you know, quite often that's things we have interns working on because their scale is so fantastic. And I think as a device industry, we sometimes don't take into account that other stakeholders are dealing with the same challenges, right? Cost and quality, but from a different scale and a different point of view that increasingly we need to get— we need to understand if we're going to drive adoption. And I take your point earlier very well of if you can bring a product to market where you don't have to go and create new codes, create new pathways, that's often a very good route to go.

Yep, yep, no doubt. And that's sort of the power of like getting involved with like organizations like Medical Alley is that the more conversations you can have with all stakeholders, right, including payers, into that mix— because I would argue that's, yeah, you know, maybe equally as important as even kind of your regulatory path, as an example— the more conversations you can have with some of those key stakeholders early in the process, the better.

Right on. So you mentioned, um, at the start of this line of questioning about it's kind of like playing on hard mode. And I was thinking, like, we have lots of smart people in this industry, they do amazing things, and they could go and do amazing things other places and probably not grind their gears as much. What, what keeps you motivated to, well, to play on hard mode?

Yeah, it's, um, it's an interesting topic, right? Because, you know, I, I, that's always been amazing to me is how, like, how many smart individuals that are really, really sharp and, you know, come with really impressive backgrounds, continue to kind of grind away, right, in the world of, you know, medical devices or medtech or the life sciences. And, you know, I've got a lot of friends, entrepreneurial friends, that, that, you know, run very successful startups outside of this, this space, right, in a completely different vertical, whether it's SaaS or something else. And maybe it's just my own personal bias because I've been in this, in this space for, for quite some time, but the reward of like building something despite all of the friction, all of the challenges, the ebbs and flows, the ups and downs, the reward of like building something that has a very, very meaningful impact in someone's life, you know, you can't underappreciate that.

Yeah.

You know, especially if what you're working on is, you know, hits home and it's sort of inwardly passionate or something that you're really passionate about. That's like icing on the cake, right? And so I think that at the end of the day, that definitely helps kind of overcome the the, the ebbs and flows and the, the ups and downs that, that inherently, uh, come with the world, the world of startups.

Right on. I, I hear that from so many people, and it, it makes me enjoy this work so much more that there is that, that deeper motivation that the entrepreneurial community has around this field. And I think we're very fortunate, particularly in Minnesota, to have such a concentration of it. And as if I remember right, you're also— you have a, another venture, a slightly different kind of venture that I have found very interesting to, to observe watch, especially even the work Medical Alley does. You're involved in a thing called MedCider. Could you tell the audience a little bit about that? And I would be personally curious, like, what's your— what is your motivation around building up this kind of, this media platform?

Yeah, um, so, so I'm a bit of a, a bit of a podcast OG, as I like to kind of refer to myself. Um, I, I actually started MedCider, which is by and large, you know, kind of a podcast-centric kind of outlet, if you will. But I started it, you know, nearly 15 years ago. Wow. Yeah. And this is when I was in— largely spent most of my medtech time in the field, right?

Yeah.

Kind of from—

were they called podcasts then?

Yeah, that's right. I'm not that old. But yeah, but yeah, I mean, this was— I mean, just to kind of date this, like, this is before, like, all— you know, this is definitely before Spotify. You know, it was kind of the days where the only way to listen to podcasts or consume them was like the native Apple Podcast app, right? I mean, there wasn't, you know, there's pretty, pretty limited options. In fact, I think when I first started recording, you know, I think most of it was done like just streaming online. But, um, but yeah, pretty old. But the reason I started doing it was, um, I got a lot of value from other startup podcasts, right? Consuming that content, it was just really, really interesting kind of media distribution channel. And I just found a lot of value out of it. But at the time, there was nothing really being recorded that was specific to medtech. And I saw all of these like new kind of innovative devices, you know, being used in clinical trials or being launched, you know, in operating rooms and cath labs, you know, across the Midwest. And I was like, I always had the question of like, where do these things come from? Right? And, you know, how do they, how do they come to, how do they come to be? And so, again, I was sort of a, you know, classic story of scratching my own itch. I was like, well, I'm gonna just start my own podcast to try to learn a little bit more about like, where are these, you know, where these startups come from. And so that's sort of like what started me on this journey. And, and, you know, I've kind of stayed at it ever since, but it's, um, It's pretty rewarding. I mean, it's definitely, I would say I've got a well enough sort of an oiled process down at this point where it doesn't take up too much of my time, but it's really rewarding because one, I get to selfishly learn a ton from other much more experienced folks. And then secondarily, you know, like I said earlier, building a medtech startup is really, really difficult. And I love being able to kind of tell the stories of other people that are doing it. And I'm sure you probably get the same sort of reward, right? Like highlighting highlighting other, you know, founders, CEOs of early-stage companies, because it is, it is, it's, it's a grind and it's very challenging but yet really rewarding. And I think it's, it's really just fun to see other, other kind of other podcasts, including Medical Alley, right, kind of, uh, highlight some of these, some of these stories.

Oh, it's very cool. And for, for the audience's benefit, um, can you give them the spelling on that? Tell them where they could go find it.

Yes, it's Medsider, so not Med Insider, which I think, I think is easy to misspell, but, uh, yeah, it's M-E-D-S-I-D-E-R, Medsider. So medcenter.com, or you can just search for it in your, in your podcast app and you'll probably find it.

Perfect. And folks, we'll make sure to include that in the show notes so you can track it down. He's interviewing fantastic people, many of which you'll recognize. Hopefully some you won't, and you'll learn about some really cool new companies. Scott, thank you. That really informative. I really appreciate you sharing the story of, you know, a little bit about you and what you've been working on. And thank you for being on the podcast.

Yeah, thanks for having me, Frank. And again, I love what you guys are doing at Medical Alley, and, uh, keep, keep going, keep going. You guys are doing great things. A lot of, a lot of A lot of, a lot of fun ahead, uh, in, uh, in, in, uh, in the Minneapolis area for sure.

Heck yeah. Well, we appreciate it. Thank you. And folks, we appreciate you for listening. This has been another episode of the Medical Alley Podcast. If you're not already a subscriber, make sure you check out medicalalleypodcast.org, or you can find us on Apple, Spotify, or now also on YouTube. And would you do me a favor? Would you share this episode with one other person? If everyone listening did that, we'd help this story and so many other great stories out of the Medical Alley community reach I'd really appreciate it. Until next time, have a great day.