Rounds

The Best MedTech Founders Don't Build Products, They Build Exits with Brent Lavin

Joseph Hashim

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0:00 | 31:22

MedTech founders build brilliant technology and expect hospitals to buy their products immediately. Technology fails every day. Clinical, regulatory, and commercial teams work in isolation. 

You need an integrator.

Brent Lavin fixes this problem by drawing upon 20 years of product management experience to unite these separate teams and build a profitable business. Learn how to turn medical ideas into successful exits.

🎯 BIGGEST TAKEAWAY [05:39]:
"I view everything through the business model. Everything should be contained within the cost and revenue function of a business model.”

MORE KEY TAKEAWAYS:

🚨 THE FATAL TRAP [07:37]:
Tired of building products that nobody buys?
"We went out and pressure tested it with real doctors. They said, ‘Nice to have, not need to have… I'm not going to pay extra for it.’"
Watch Brent explain why you must kill good ideas that lack a clear business model.

🛠️ SMART TRIAL DESIGN [17:15]:
"We often design clinical trials for approval purposes, but we're missing a massive opportunity if we don't include data for commercialization purposes."
Get the exact strategy to capture data that proves your operational value to buyers.

💰 ACQUISITION MULTIPLIER [24:50]:
"The strategics really want it at that margin level the day that they acquire it."
See exactly how top operators build acquisition readiness into their products from day one.

CHAPTERS:

00:00 - Why Medtech Innovation Fails Without Integration
01:32 - The Integrator Role in Medtech Teams
05:02 - Turning Medtech Ideas Into Businesses
06:40 - Need-to-Have vs Nice-to-Have Features
10:29 - Winning With Niche Market Positioning
12:41 - Building Strong Medtech Teams
14:08 - Driving Physician Adoption Strategies
16:20 - Pricing and Reimbursement Strategy Basics
20:43 - Adapting to ASC Market Shifts
22:12 - Building Early Acquisition Readiness
23:43 - Tailoring Strategic Buyer Pitches
27:35 - Ironwood and Fractional Leadership for Startup Growth

🔗 CONNECT WITH BRENT LAVIN:
• LinkedIn:
https://www.linkedin.com/in/brent-lavin/
• Ironwood Medtech Partners: https://www.linkedin.com/company/ironwood-medtech-partners/

#MedTech #ProductManagement #HealthcareBusiness



SPEAKER_02

If you've spent any time in MedTech, you've seen it. Brilliant technology, strong clinical promise, great early excitement, and then it stalls. Not because the signs failed, not because the market wasn't there, but because the business never came together. That's what this episode is about. Today's conversation is different. We're not talking about wearables, we're not talking about another CEO journey. We're breaking down the operational playbook behind successful MedTech companies from idea to commercialization to exit. Because the truth is, innovation alone doesn't win in this space. Integration does. My guest today, Brett Lavin, has built his career at the intersection of clinical, regulatory product, and commercial strategy, what he calls the integrator role. And in this episode, we unpack why most MedTech innovation fails before it ever reaches scale, how to kill bad ideas early, even when they look promising, what actually happens when clinical, regulatory, and commercial teams fall out of alignment, and how the best companies build with the exit in mind from day one. This is a masterclass for operators, for founders, for product leaders, for anyone trying to turn great technology into real business. Let's get into it. Brent, really appreciate you joining. I want to start with something you've been very vocal about, the integrator. Break that down for us. What is it? And why do most companies miss it?

SPEAKER_00

Yeah, thanks, Joe. I really appreciate this conversation and to bring um more uh information together uh around the integrator role. And I think in MedTech, uh because of some of the specialization and the silos that have evolved as the industry has uh progressed, uh we are missing a uh and a critical piece that brings people together between RD excellence, clinical, regulatory, uh supply chain operations. Medtech has only gotten more and more complex and more and more specialized. But as we've done that, uh we haven't necessarily always uh brought those functions together to operate as a single business unit. And so uh that's been my experience over the last 20 years, blending my engineering background and my commercial mindset to help teams gain alignment and execute according to the business plan.

SPEAKER_02

Well, it seems like your career has been well uh well guided by this principle. Now, if we apply that, you know, let's talk about you know innovation. Why do you think some innovation without integration fails?

SPEAKER_00

Listen, there's no shortage of ideas from brilliant engineers, technologists, even salespeople. Anyone can come up with great and uh ideas, uh, but it takes a real special skill set to guide uh an idea to a business. And so I've had examples in my career where we've had a brilliant technology that we frankly needed to evaluate, but then ultimately sideline because there was no business model and no way uh to make money from that. And so uh that's a level of discernment to be able to separate from what is a good idea and to say, can we make a business out of this? And I've operated in that zone where I can appreciate the technology, but then also be uh really cogent about whether there's a business model to match up with it.

SPEAKER_02

Well, that that draws us right into the you know the myth out there that great technology sells itself, right? So when you think about that and you think about your the the core of what you've done over your career, it doesn't sell itself. It needs some structure, it needs the right foundation.

SPEAKER_00

Yeah, absolutely. I I think you could look internally at the pieces that need to align uh for uh a product to be successful in the market, but I think you could also look externally um within the you know the healthcare system. And so, you know, externally it needs to fit into a reimbursement and market access climate. It needs to satisfy a value analysis committee that's ultimately going to approve it for the hospital. And it even comes down to the cath lab um or the procedure room uh where technologists uh in the background have to make a choice about whether to pull your product or the competitor's product. And there can be little things um along the way that if the user interface is confusing or if the product doesn't fit on the wire very well, um, there can be people along that journey that say, you know what, I just want to stick with the status quo. I don't want to adapt this new technology, even though it may be better ultimately for patient care. Uh, they are running a business and an operation within the procedural room.

SPEAKER_02

Well, share with us the role of a product manager as a connective tissue across clinical, regulatory, quality, and commercial teams. How does that work? I mean, what does a good product manager do?

SPEAKER_00

I think a good product manager um acts as the general manager of a product line, and they're ultimately guarding the business case uh that you're trying to set up for a particular product line. So I think they're able to integrate the perspectives of RD, clinical, regulatory, all of these specialized functions and bring that together to optimize for that particular product line. And so they're not acting in the silo of what's best for a particular function, but they're acting in the interests of what's best for the customer and ultimately the business. And so I view everything through really the business model. And so everything should be contained within the cost and revenue function of a business model. And uh you should be able to model that out. And so a good product manager keeps a very holistic view and guiding um this product line from concept to commercialization in order to achieve a business model.

SPEAKER_02

Well, you know, easier said, right? From concept to commercialization and all the required steps in between to help support that commercial effort. Um, when you think of when you think of good ideas um and how they originate, uh where do you feel that they need to be pressure tested? And how often do you review that result and say, let's move forward, or we don't think that this is a good product to move forward?

SPEAKER_00

Joe, I'd answer that question in two ways. I would talk about um from the structure and theory, and then I'll talk about it in a real life example. I subscribe and had the fortune of attending the Stanford Biodesign class. And uh right in there, we're looking to solve a significant problem for a sufficiently sized patient population with a demonstrable outcome. And so that's the first um set of tests that we're gonna put towards an innovation. Um, are we actually solving a real problem for a population? And can we demonstrate that um in an outcome, whether that's clinical or bench or competitive? Um, but the real world example I would give was, you know, a technology that we had over a decade ago that was a really interesting and cool needle guidance technology uh for ultrasound guided procedures. And um it was theoretically better for the physician. But when we went out and pressure tested it with real doctors, um, they essentially said, nice to have, not need to have. Uh, they were comfortable enough with the procedure um that they didn't really need this technology. They said, if you give it to me, I'll take it, but I'm not gonna pay extra for it. And so that's where this breaks down in practices. You can't tie that to a business model. And we ultimately had to re-review that project and uh cancel it eventually because uh we couldn't make money at it.

SPEAKER_02

So these are the real life signals that you need to be aware of. And I think uh what I've seen in my career is that many of these signals go ignored. Only really good product managers will uh address it head on and make that tough decision of do we really see some commercial traction here? Or do we put this to bed and maybe redesign something else? So when things break, how's a good product manager work?

SPEAKER_00

Yeah, uh great question. I like to deal in reality. And um, while I am an optimist and I'd like to think that, you know, innovation can solve a lot of problems. I'm also a realist when you put on scrubs and you talk to physicians and you visit labs, and uh especially with really good salespeople, you start to understand the objections that are either said or unsaid, and then deal with reality because ultimately I felt responsible for the business model that I presented to the company. And so if I don't believe that that business model is possible, I'd rather deal with that um the reality sooner rather than later, because that's ultimately kind of my, you know, uh reputation. And so um I just presented back to the business the reality of what I found in the lab. And that's often, again, working with good salespeople, because I think salespeople are naturally good at understanding objections and understanding the nice to have versus the need to have. And if they're not enthusiastic about selling this product, that's a massive red flag for me that I want to continue to evaluate and pressure test.

SPEAKER_02

Well, it sounds like working in this intersection between the clinical, clinical, regulatory, and also integrating those salespeople in there is exactly what contributes contributes to your success. Right. So when you when you work in that intersection, that integrator role, I want, I'd love you to think of an example where a product you may not have thought that would have succeeded, but through good product management, good positioning, good marketing, you've made success out of it. Is there a good example you could share with us?

SPEAKER_00

That's a that's a great question. I I'll point back to um an acquisition that we did um in 2020, uh, where we there was an uh uh uh atherectomy product on the market in in the European and and Asian markets that was not yet approved in the US. And um, we ended up uh purchasing this company and bringing it to the US in 2020 in a very, very crowded segment of peripheral vascular. And this was the seventh product for that indication. Um and to be honest, um we had to get really creative about how we were going to position this. And so um what we ultimately did is picked a niche indication within peripheral vascular and um positioned it for that specific application. We didn't try to attack uh broadly, but very specifically. And that happened to be instant rhizenosis and mixed morphology. And so we said for those types of lesions, this is the best product for these various reasons. And so I think that's an example where um instead of trying to uh boil the ocean, you got really we got really specific and said for these types of patients were the best option. And we ended up um being very successful that with that launch um because we talk specifically to the problem that we were solving.

SPEAKER_02

Yeah, I mean, when you think about much of the technology that's developed, yes, there's some de novo products that come out, and that's a that's a uh a dream to to manage and sell. But when you think about crowded and noisy markets, this is where your value really comes in. Well, I I I would say you're valuable across the board, but the value comes into positioning, taking the right approach in the market, and then developing the market within that as a uh as a segue to the entry. So it sounds like that was incredibly successful. Now, lessons learned, right? So across your career, we all have had lessons learned. What are the top two or three lessons that have you have learned that have carried you across different um projects?

SPEAKER_00

Yeah, uh, thanks for that question. Wow. Um, I would say that there's strength in numbers. And I would say that there's power in all of the various perspectives that you can bring into that room. And medtech is a team sport. And so the more that you can bring um people with expertise and perspective into the room and troubleshoot together, um, that's going to be the most powerful thing. Um, there's it's too complex for one person to kind of know it all. And the more that you can bring people together under a shared goal and work through those really challenging circumstances, they're inevitably going to occur. Uh, there is much power in that. And then um I would also go back to the um lesson of understanding the nice to have versus the need to have and being very clear about separating those two things um when you go out and do customer research um and getting feedback along the process. And so uh those are the two things that I would highlight.

SPEAKER_02

Seems like much of what we've just outlined are um along the path to commercialization. So let's talk about, you know, the the exciting time of creating a commercial plan, right? So what commercialization um strategies do you take for success?

SPEAKER_00

Yeah, I think it starts with really the science behind the product that you've created, um, the problem that you are uh addressing to um with the technology. And so starting from a segmentation approach, what are we actually doing from a science perspective? Um, and then, you know, what have you developed from a baseline of proof, whether that's you know, clinical data, bench data, competitive data, and then working strongly with the sales teams to understand how you take uh a physician from interest to activation. And that in my world generally includes awareness. How do they become aware of it? Um, and then there's usually a demonstration. And so have we created a really compelling bench top or video or something that compels them to move toward uh maybe an evaluation, right? And so what does that evaluation look like? Is it five patients? Is it 15 patients? Is it 25 patients? And then um ultimately adoption. And so the ultimate um place that you're trying to get to is adoption um in a world where they're choosing your product, whether you're in the room or not. And I think that's where, you know, some uh early and complex technology fails is if somebody is not in the room, they're not choosing your product. And that's not a scalable business. Um, and so those are the things that I think about with commercialization is how we walk uh physicians and support staff and everybody through this process toward that independent usage.

SPEAKER_02

Yeah, and those are the value propositions that you uh you wrap around the technology and make sure it's appropriately communicated. And that's the value prop that you want them to have at the forefront of their thoughts when they're about to choose your product versus a competitor. Uh that go what goes along with that is um, you know, the value analysis preparation and pricing models that reflect the customer preference. So, how's this also tie in?

SPEAKER_00

Yeah, I'm glad you brought that up because that has significantly changed over the last 10 to 15 years. And um I think if you're developing a product even at the early stages without consideration of the economics and the value analysis committee and pricing models that you're going to use, um, it can quickly uh break down at that step. And so I'd first of all start by understanding the site of service economics. And in many of our markets, that is shifting quickly in a good way from the hospital towards the uh ASC, ambulatory surgery center, and the OBLs, the office-based labs. And so understanding where that is and where that's going is going to be key as you develop those models. Um, I would also say um if you're designing clinical trials to be very proactive about building in endpoints that are ultimately going to support that business case. And so um, we often design clinical trials for approval purposes, um, but we're missing a massive opportunity if we don't include data um for commercialization purposes. And so that's just a lost opportunity. You can generally get data as secondary and observational endpoints for free. Um, and then the last piece that I would say, Joe, is um I'd really understand um if your product has a capital and disposable component, um, how that contracting process is going to work. I think um it's um really simple to say we will contract through uh a disposable um contract over a period of time uh for usage. Um however, uh it's maybe easy to sign that contract, but is it enforceable? And so some of those things need to be an early consideration as you think about the sunk costs of capital going into a lab in order to support your product. So I know there's a lot there, but it's it's complex and definitely needs to be considered early and throughout the process uh project.

SPEAKER_02

Well, there's a couple of things I heard there I'd like to dive in on. Um, two of them. One of them is the ambulatory surgical center. Over the last two to three years, there's been an incredible shift in the amount of uh ASCs that are opening. And then there's also been a shift by CMS to allow these centers to do more and more work. Um and the reimbursement looks pretty good that I'm seeing uh these ASC codes that are uh coming out and being funded more and more. So when we think about the ASCs, and then you also uh made reference to, I'd like to dive in on a bit, our endpoints of clinical studies. Let's talk about the ASC. Well, let's talk about the clinical endpoints first, okay?

SPEAKER_01

Um when creating these endpoints, what happens when the the um the path to reach that endpoint begins to shift? How do you manage that?

SPEAKER_00

Yeah, Joe, I appreciate that. I think again it goes back to beginning with the end in mind. And so uh what is your value ultimate value proposition? And if part of your value proposition is operational efficiency, then that needs to be considered as part of a secondary or observational endpoint. If part of your value proposition is patient uh satisfaction, then you need to be including a patient quality of life um indicator in there. And I know the FDA and CMS is pushing uh uh companies to have more uh patient reported outcomes. And so it will be looked on favorably by the agency. And so being proactive about including those things and collecting them in order to support your value proposition um goes a long way, saves you costs, and um ultimately you get um out what you are looking for in the end.

SPEAKER_02

So thank you for sharing. And the other um question I had was about ASCs. We see it funded more. There are really uh more and more procedures are shifting from the brick and mortar of hospitals into the ASC locations. How do you adjust for in your strategy to speak to those uh procedures being done out of the ASC?

SPEAKER_00

Yeah, I think first and foremost, it it goes back to the economics of the ASC to your point. Um, they are being supported, but ultimately the reimbursement for those procedures is generally lower than the hospital. And so, as a business, if you have a certain margin expectation, you just need to operate within that framework. Um ASCs and OBLs um may be interested in a defeatured product, which may be at a different price point um than your primary offering for the hospital in order to achieve the same procedure. And then the other thing I would say is um when it comes to commercial operations, it's important to understand how the ASC does business. Are they expecting consignment or are they willing to purchase outright? And how do they want to do business? Because that informs your supply chain plan and your internal planning um when it comes to how much product to produce.

SPEAKER_02

So when you think about uh so let's take this and let's shift a bit. Um and thank you for sharing. And much of where we're heading is now about the exit, right? So building acquisition readiness early in the life cycle, how do you do that? Take it into consideration different call points. Hospitals, uh, say hospitals and ASCs, you have your strategy, you have your your studies with your primary and secondary endpoints. But where does the acquisition readiness come in in the life cycle?

SPEAKER_00

Yeah, thanks. I think that's an excellent question. And so I'm gonna skip over some of the science and the the value proposition and the the clinical data that you've generated and really focus on um the sales efficiencies that I think the large strategics are looking for. And so it ultimately comes down to that segmentation, targeting, and positioning. And so uh, Joe, to your point before, it's important to be really specific about the segment that we're serving and how efficiently we can um gain interest, demo, do in service, um, and gain adoption. And so that's ultimately what a strategic is looking for is how many accounts have you approached? How have you been successful? How long has it taken for you to work through that process, whether that's value analysis committees or uh or whatnot? So, how long does adoption take? And how much of the market have you not approached? And how much is remaining? Because ultimately a strategic is looking at this asset to say, can I put it in my distribution channel, pour gas on it, and grow this even faster? And so to the degree that you can have a clean story around the efficiency of the commercial um effectiveness, um, it's gonna go a lot further with the strategic.

SPEAKER_02

Brent, why don't you share with us where do you think uh things break down? And in your experience, how do you circumvent that?

SPEAKER_00

Yeah, great question. I mean, I've seen uh 200 and 250 pitches from various startups, you know, over the years. And I think that um one thing I would uh point out is that, you know, the pitch really, the most effective pitches are specific to the strategic. So they understand the strategic's world in terms of their portfolio, their call points, their sales structure, um, even uh, you know, past transactions. And so the more that they can customize that pitch and fit within the current strategic structure, uh, the more receptive it's it's going to be. I would also say one of the other things that I talk about um quite a bit with early stage is understanding the margin expectations and uh margin pressures at a strategic. And so often uh we would receive pitches that say we have line of sight to 70% margin or line of sight to X. And um I understand the need to continue to build that, but the strategics really um want it at that margin level the day that they acquire it. And so um I think sometimes that's an afterthought um from early stage. Um, but the more that they can put in toward um establishing the margin at the time of the transaction, the more effective it's gonna be.

SPEAKER_02

Do you see that margins typically, you know, through the companies I've led, um, you know, as we develop and as we grow, those margins begin to compress, right? So you get better margins as the volume starts to move, your vendors start to give you some pricing discounts. Does that uh have any positive impact in your experience?

SPEAKER_00

Yeah, I think it does. And and I think um, you know, we expect that as a larger company to be able to work with those margins. Um at the same time, um, it comes with some more complex processes from quality management and some of the other supply chain considerations. And so um we don't necessarily bank on it. And so while it will happen, it may take two, three, four years to become reality. And so um it while in a startup, it's actually much easier to get your margin in order than to rely on the strategic to use their buying power to get it to a certain point.

SPEAKER_02

So, how how much uh the do you think that uh, you know, we start talking about margins, an EBITA, you know, what makes this attractive? What are their the attractive items that most buyers are looking at when you begin talking economics?

SPEAKER_00

Yeah, I would I would say that first of all, even before that, and we talked a little bit about it before, it has to be a great portfolio fit. It has to extend their reach within the call point or to extend their reach across the disease state. And so it has to be a strategic portfolio fit. And then ideally, it's going to be accretive to those product margins and accretive to EBITA because you're uh amateurizing distribution crop costs across a broader revenue range. And so ultimately it's a a game of one and one plus uh equals three. And so how those economics work is uh it's margin accretive at the product level, and then because the distribution costs are amateurized, it's it's uh greater at the EBITLA level.

SPEAKER_02

Thank you for sharing. Um I I'd like to shift to talk about Ironwood MedTech. This is uh this is your company and and your services and the wealth of experience you have. You you operate through Ironwood. So tell us a bit about Ironwood, if you can. Thank you, Brett.

SPEAKER_00

Thank you. Yeah, I've really appreciated and enjoy, you know, the 20 years of product development innovation and MA as strategic med tech companies. Uh, but about six months ago, I formed Ironwood MedTech Partners in order to provide fractional leadership and services to seed through Series B funded MedTech startups, uh, where I can play a leadership role at the intersection of product innovation, MA, um, and many of the things that we talked about here to be an integrator and to help guard the business case as the company continues to make trade-offs throughout the development uh project toward ultimately reaching an exit process. And so whether the problem is solving at the intersection of uh a failed clinical trial endpoint or figuring out what the clinical trial needs to look like, or whether that's creating a go-to-market plan prior to approval so that once approval hits, um, we can hit the ground running. That's the goal of Ironwood MedTech is to plug in on a fractional basis and help solve bringing uh the experience that I have uh from those strategic med techs.

SPEAKER_02

So I've taken a few notes as I was, you know, researching the company more. Um, you know, I see here we have you know navigating milestones, uh funding rounds, commercialization readiness, exit preparation. I mean, these are incredibly important um items that uh need to be in capable hands. So through your experience, these seem to be the top four or five items you're most um proficient with. Is there anything that I'm not covering here that you uh you certainly would like the listeners to know of?

SPEAKER_00

Yeah, no, thank you. And um, those are all things that I enjoy. And sometimes um, you know, just simply being a thought partner and providing more analysis behind various options um is exactly what the company needs. There's maybe a gut feel of the direction that they should go, but they want to evaluate options A, B, and C. And I can help provide some analytics and perspective from an outsider's view that might help fuel that analysis. I would also say one of the other things that I'm uh really passionate about is strategic customer discovery throughout the program. And I think we do that very early in programs, of course, in order to get design inputs. But to your question before, are we doing that throughout the project in order to continue to evaluate our hypotheses and our beliefs? And as reimbursement changes, as competitors change, as just the landscape changes in healthcare, have we re-evaluated whether this is still true and whether we should still proceed with exactly what we've developed? And so I can definitely help with um strategic customer insights and uh that process to help gain confidence in what's being developed.

SPEAKER_02

Well, thank you for sharing. I think the the the culmination of your experience uh that's gonna go to work through Ironwood is going to be a value for any organization that that decides to engage with you on that. And I want to once again thank you for being on rounds. It was nice to have you on and taking a look at a masterclass of a playbook on how to best commercialize a product, and then through that commercial effort with the various milestones to keep an eye on. So, Brent, thank you for your time. Look forward to the success of Ironwood MedTech.

SPEAKER_00

Joe, it's been such a pleasure. I really enjoyed this conversation and I hope that we stay in touch.

SPEAKER_02

Excellent. Thank you.