Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Navigate Undefined Markets in Medtech: Interview with Materna Medical CEO Tracy MacNeal

Episode Date: August 19, 2025

In this episode of Medsider Radio, we sat down withTracy MacNeal, President and CEO of Materna Medical. Materna is developing two devices addressing different aspects of pelvic health: Ellora, aimed at preventing childbirth injuries during delivery, and Milli, designed to treat vaginismus, a pelvic floor condition that makes intercourse painful or impossible.Tracy is a healthcare executive and engineer with over 25 years of experience in medical devices, digital health, and women’s health, including six successful transactions. In addition to heading Materna, Tracy serves on the AdvaMed Board and leads its Women’s Health Equity Initiative, and was previously President of Diagnostics and Digital Health at Ximedica.In this interview, Tracy shares how clinical data enabled Materna to bridge B2B and B2C channels, and why clarity of focus is essential when commercialization paths diverge. Tracy also outlines what it takes to build in undefined markets, from aligning KOLs to publishing foundational definitions, and offers a candid perspective on what investors really want: clear financial returns, backed by a founder they trust to deliver when things go sideways.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 Tracy MacNeal.

But the chess game was we got those key of in the key of in the needleaders, brought them together, and that team wrote the white paper. Okay, we're taking a stand. This is what this condition is. This is what it's called. Then we got FDA clearance for it. Then we ran the landmark study,

called a self-selection study, with two of our KOLs that proved that if you give patients the right information, they know what they have. They know they have this. It's not rocket science and we don't need to be so paternalistic about it. Now that's labeling on our white people. website. So then we got OTC clearance. 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 Tracy McNeil, a healthcare executive and engineer with over 25 years of experience in medical devices, digital health, and women's health, including six previous successful transactions. She is president and CEO of Materna Medical, a device company that develops products to help improve women's pelvic health. Tracy serves on the Advent Board and leads its Women's Health Equity Initiative, and it was previously

president of diagnostics and digital health at Zymedica. Here are few of the key things that we discussed in this conversation. First, use clinical data to bridge B2B and BDC models, but don't mix them without a strategy. Consumer interests can accelerate clinical adoption, but only if both channels reinforce the same strategic goal. Clinical data gives you the credibility to communicate clearly to patients and providers alike, but without alignment, you risk burning capital without traction. Choose your primary channel early and treat the other as a multiplier, not a distraction. Second, if you're in an undefined market, expect to do the groundwork yourself. In emerging or overlooked conditions, there may be no consensus on definitions, inclusion criteria, or even the name of the

problem itself. Materna's team aligned KOLs to publish a white paper before running trials, a move that proved just as critical as the device itself. It's slow, high effort work, but it builds the foundation for clinical trials, FGA clearance, and long-term category creation. Third, lead investor conversations with a focus on returns and back it with founder fit. Investors want to know how much and how soon they'll get paid back, but in early-stage med tech, they're also judging whether the founder can weather what's ahead. It's not just about confidence it's about being able to project clarity, earn trust, and stay steady when plans inevitably change. 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 MedTech founders and CEOs. Look, we get it, keeping up with every MedSider interview, isn't 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 Medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes, plus a treasure trove of other resources.

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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, Tracy, welcome to Mid Sider Radio. Thank you so much for having me. Yeah, really looking forward to the discussion. We had a nice little pre-episode chat, and so this should be quite fun. And so with that said, I recorded a very short bio at the outside of the interview, but it probably doesn't do your background justice. But I always like to start here. If you can give us like a two-minute, you know, elevator-style pitch on your journey leading up to taking on this CO role at Materna. Let's start there.

I am a recovering engineer and I specialize in the commercialization of medical devices. And I've worked in healthcare for about 25 years now. And I've always been purpose driven. I feel like one of the things I love about working in healthcare is everyone else is too. For the most part, there's easier ways to make money. And so if that's why you're here, you don't last very long. And so I started my career in pharma actually. is at Merck, as a chemical engineer, running the reactions to make the bulk active ingredients on

the multi-ton scale and went all over the world with them and had a wonderful time. But it ended up heading over to devices after about five years and got my MBA somewhere along the way and realize I have a crackpot theory that engineers that can communicate get put into communication roles pretty quickly. So I think that defines a lot of my career. A little of this, a little of that, but always really kind of talking for a living and trying to explain the benefits of things and what kind of help teams figure out what's most important. And most recently, I'm running a fabulous company called Materna Medical. Yeah, we'll definitely get into that. But I couldn't agree with you more. Like if you can find a really talented engineer or physician for that matter

that can effectively communicate, it's like all of a sudden they are the person, right? The guy or the gal, right, that becomes sort of the face and they, you know, get pulled in a bunch of different direction. So, like, so, so true. But yeah, talk to us a little bit about Materna and maybe take us back to, like, why you decided to kind of, you know, join, join the team as CEO and taking on that role. And then maybe dive into, you know, Millie and Elora, kind of the two two kind of core products. I think that your, that your team is working on. Yeah, absolutely. So I had been minding my own business and was the president of diagnostics and digital health at a company called Zemica that has since been acquired by VarenX. And it focused on development.

and development of medical devices and diagnostics and digital products. And so my teams and I had been working on a lot of different things, certainly nothing like what Materna is working on because what Materna is doing is so unique, which is part of what caught my attention. And they had started a retained search for the CEO. And I had never heard of the things that Materna was working on, never heard of Materna. And every time I had another conversation with someone at the company, I just got more interested. I'm like, wait a minute. How big is this market?

So childbirth is the number one reason for hospitalization worldwide. And we have the worst outcomes by far of any industrialized advanced economy. And there are 54 countries. It goes up and down year to year. But right now I think there are 54 countries where it's safer to have a baby than the United States. So our postpartum hemorrhage rates are twice what they should be and what they are in other countries that's heavily skewed along racial lines. Black women are three or four more times

more likely to die compared to white women with the same symptoms. C-section rates are about twice what the World Health Organization thinks is medically necessary. And about 10 to 15 percent of all vaginal deliveries walk out with a pelvic floor injury that is called a levator anti-muscle injury. And it is the surrogate endpoint essentially for what will be called what happens later in my pelvic organ prolapse and the associated incontinence with. with prolapse. Got it. Yeah, lots of things to fix.

And so when I heard that this company had an intervention that, and just in the pilot study, the founder had worked with Baylor College of Medicine in Texas and done a randomized control trial. It wasn't pivotal. It wasn't statistically significant. But the injury rate was reduced by 60%. That was pretty impressive. And so that's really why I took the job.

I mean, it just rarely see startups with a market opportunity that size. with no competition. I mean, I don't even trust CEOs who say they don't have any competition, but I can say for sure. After I haven't talked to hundreds of investors, no one has ever asked me how we're different from the other company that's doing this. So for all this time, it's still hiding in plain sight. Yeah, some of those stats that you just mentioned with respect to injuries, sequela, et cetera, from Chabweb, I had no idea. One, and then two, this whole pelvic floor kind of like area seems like a super virginate. It's especially relevant for like, for me personally, right? My wife and I've had, we've had, my wife and my wife's had six kids,

right? So, yeah, yeah. So it's definitely something that, you know, I'm continuing to learn more about. But it's like, it's completely underappreciated. At least seemingly underappreciated, right? And leads to so many other issues, right? If not, if not sort of like properly managed or proactively manage. Yeah. So, yeah, I mean, a woman's lifetime risk is 20% of having a surgery for this injury. Wow. And five times more likely if she's had a baby. Yeah. So I'm on the, I'm on the, I'm on a the website right now, right, for everyone listening, it's Materna Medical. So just as it sounds, Materna, M-A-R-N-A-M-A-M-A-M-A-M-A-M-A-M-A-M-A-M-A-M-M-A-M-M-A-M-M-A-M-M-A-M-R-W-Sides as well. And we'll link to it in the full write-up on MedSider. So you can check out the company and the two products

in more detail. But, you know, for those of us that are those of us, you know, listening that have never, like, heard of Materna or premier the products themselves, give us like a quick overview, right, as if we were kind of, like, high school students learning about this for the first time. Yeah. So we are aiming to make childbirth safer and easier for new moms with our product, Allura. And for our other product, Millie, we're aiming to make sex possible for women for whom it is painful or impossible. And that's basically it. And so the House of Brands that is Materna, our tagline is we empower women to protect and restore their pelvic health. And if you've been watching this space, the really crowded areas are around treating incontinence and prolapse.

prolapse. Actually, a lot of people don't know what prolapse is. Not because it isn't super common, but because the people who have it do not talk about it. But it's essentially where the basket of pelvic floor muscles that hold our organs in place, one and half of the hammock can come off the bone. And so what can happen is either the uterus comes out of the body, if women can't go for a walk without their uterus coming out, or it falls forward into the bladder so they feel like they have to pee all the time or there can be some incontinence associated with that or it can fall backward into the rectum and there's fecal incontinence associated with that.

So really major quality of life stuff that people live with and don't talk about. And right now the standard of care for that is either a pestery, which is essentially a plug, which goes up in there forever and tries to hold your organs in place, which is about as much fun as it sounds. And some of them actually patients can't remove themselves. They have to go to the urchinacologist every X months and have it. taken out and cleaned and reinstalled forever. Not a great solution.

Or they can get a pelvic floor surgery, but if you were old enough to remember the pelvic mesh lawsuits, one of the largest NASTor cases in history, and I think six huge medical device companies, very publicly exited women's health, although I would argue pelvic mesh surgery is not women's health, but it is a branch of OBGYN. But anyway, I digress. That was a long time ago, but people are still stinging from it because it was so large. And so a lot of those products have even been taken off the market. So, you know, just, I'll just say it's very difficult to treat.

So then you have a lot of players doing like cable exercisers and lasers and, you know, kind of OTC stuff that, you know, aims to help. But really, it would be much better if instead of that, women could have a baby vaginally and walk out with the same pelvic floor they walked in with. Right, right, no doubt. And then before we kind of dive into some, I would say some more functional areas, right, running a startup. Give us a sense for kind of where you're at, where Materna is at, maybe with both products in terms of kind of the life cycle. So the board made an interesting decision before I

joined, which was to, with Millie, so Millie is also an expanding dilator, but for the millions of people for whom sex is painful or impossible, because their pelvic floor is too tight, sort of on the other end of the spectrum, their options are pretty limited as well. And a lot of times, they don't even really know what they have. And actually Materna wrote the white paper, getting the industry together to decide what this indication should be called. We call it Bagenismus, rhymes with Christmas. ACOG estimates that up to 17% of American women have this condition at some point in their lives. And so it's very common but not well understood. It's not routinely taught in medical school. So we're really trying to shine a light on a deeply

underserved population. That device, they made into a wellness product and put it on the market as just direct consumer. The problem I saw with that coming in was that we had a channel problem. So one of these products is a wellness D2C patient pay product and the other is a hospital sale into a global code with an intap. And they're just not the same call point. They're not the same sales team. And that's just impossible. So what I've done in my tenure, I've aimed to bring them closer together and what I would call more of a B2C. So even Allura, because it's sold into the hospital, isn't just as simple as a medical device sale into the hospital because patients would be consulted about it, not just mom,

but mom's partner. And sometimes mom's mom, like grandma gets involved sometimes, right? So this is definitely a patient-facing company fundamentally. But I've brought Millie, I took it through two, my team took it through two FDA clearances. and so now it is available and we can market it as a medical device. And that enables us to give patients the data that they need to really understand. I mean, I can sell, I could sell allura now. I don't need up to eclarence to sell allura, but I can't say what it is or what it's for.

So that's kind of where Millie was when I got here. And given how deeply underserved that population is to begin with, where they don't know that what they have is common. They may not know that it's treatable. They certainly need someone to speak. plainly to them. And in order to speak plainly, you have to have FDA clearance and clinical evidence. And so that's what we've done with Millie. We've got about 5,000 patients using Millie. Yay. And growing up into the right. And we've built out that channel so that our second product, Allura, can drop into it. And so when we commercialize Alora, we'll sell into hospitals,

but we'll use those Millie channels. So we've got 5,000, about 5,000 HCPs in our database and about 15,000 patient emails. So beginning to use some of that, just thoughtfully, efficiently using that channel that we built with Millie to accelerate Alora's launch. Got it. And then we're recording this in Q2 of 25. So if you're listening to this, you know, after the fact, give us a sense kind of for when you might expect to launch Alora then. Yeah, we're filing this summer and it's a de novo. So a contractual guidelines are six months, you know, but I would say we'd be happy if we're on the market this time next year. Okay, got it. Write your Congress people.

Good stuff, good stuff. So I want to use the next maybe 20 minutes or so, 20, 30 minutes to kind of run through some of these key functional areas. I typically kind of start out with like early stage development and then moving into like, you know, various applications of a concept, etc. But I actually, I want to start with kind of this D to C concept, right? Because I think it's quite interesting. You've been through it. Obviously, it sounds like you've got, even though with a technical background, you're commercialization is kind of right into your wheelhouse. So there's a lot. I guess I want to ask maybe two questions that are kind of related. Is one, how have you sort of sorted through that mix, right? Because I think a lot of med tech companies that sit kind of on the on the, on the fence around, you know, do we commercialize this entirely direct to consumer? Is there more of this B2B to C play? Do we just go B2B? And then what ends up happening is like you get stuck and then nothing works in essence, right?

So I'm curious kind of how you've kind of navigated that. And then as you thought maybe about this kind of revised approach, B to B to C and kind of the consumer element, you know, there have been a couple key learnings around that as well. So feel free to answer those together or parse them out, you know, but I think this is an especially interesting topic to start out with. Yeah, well, I'll just start jamming and you can, you can jump in. I can tell you, I mean, you've got a really strong commercial background too, so we can co-create here. But so the thing that's troublesome about a B to C channel, I think fundamentally is that it can be very expensive. And it's not a channel that medical device

companies. So the second sort of related topic is that medical device companies, the big ones that would acquire us, typically don't have a lot of muscle in that area. So I think it's not that it doesn't exist. I mean, for example, Phillips and Hologic and Cooper Surgical, I mean, all of them have some consumer facing something, but it's not like pharma where they can throw a billion dollars into a commercial that says, you know, ask your doctor about something, right? So I think there's just, because pharma has a couple of zeros on the end of everything they do compared to medical devices. So that's the fundamental issue there. It's not that there's, I don't think there's anything beyond that that's troublesome about talking to consumers. I think it's a little, well, maybe like a,

maybe like a step sibling about it would be that FDA gets cageder about the way you talk to consumers. But if you know how to build a company that can stay at, coloring inside the lines, it shouldn't be too bad. But when you're talking to consumers, you know, they, they would need you to be extra careful that you're not misleading with your marketing. So, you know, other than that, it's no bad news. Before you kind of get to the next topic, though, those two issues, though, are so, are so important. I'm glad you started out there because awareness, first and foremost and the capital that you've got to, that you, you know, should rightfully apply to, like, you know, awareness

and, you know, some sort of like performance marketing around that, not. only is it fairly, it's fairly expensive, especially if you, if you haven't done it before, but, but two, like if you look at the normal paid channels, right, whether it's meta or TikTok or name your kind of like consumer digital first kind of channel. Like, yeah, I mean, the, I mean, I could easily make an argument that actually those channels are more strict than even FDA, right, when it comes to messaging. And so if you've got some sort of like disease, health condition, et cetera, that you're, that you're trying to raise awareness for, it can be especially challenging, you know, through those traditional kind of DDC or BDC channels.

The other one I think is maybe equally important you mentioned is that when you look at like the reality is like for most of us, an M&A is the likely outcome, right, for investors, for, you know, for employees of the company, et cetera. IPOs are few and far between. And yeah, you bring. For now. For now. Yeah.

You bring up a really good point, though. I mean, like, not only are there the, the acquirers like significantly reduced, right, that have sort of like consumer muscle, but just to kind of add to the friction, they may not, they may look at it like as like something they don't want to even go to go down, right? So it could be, it could be like something that they're strongly considering, but they're afraid of like, you know, throwing too much, you know, too much allocation at a kind of consumer-ish company, you know what I mean? So I think those two points that you brought up are like super, super important. If you're at the stage where you're trying to evaluate, you know, going down

one path or the other. Yeah, yeah. And I think the key, so the key to it all, I think is clinical data that if you because anything you could sell to a consumer you should be able to sell to a doctor as well or some kind of HCP that's in your channel again another crackpot theory of mine I think a lot of players end up DEC patient pay because they couldn't get a funding to do it right and when I say right I mean getting a proper clinical trial to show superiority statistically significant superiority and getting FDA clearance to market to those claims I think when you can do that you shouldn't have to rely on the consumer, right? And I can't really, I think it puts so much on the consumer. But where I think there's an opportunity that our acquirers, I think, do recognize

is that when it's done right, you can really accelerate adoption among doctors when patients show up asking for it. If you can figure out a way to do that in some kind of limited market launch where you can demonstrate that the customer acquisition costs are manageable and you can use the patient demand to increase the slope of the line of your of your revenue growth when you launch. I think that that's where the magic of consumer demand really can can make the medical device industry, you know, alive again in a way that sometimes it really struggles. Waiting for doctors to change their habits is like, you want to talk expensive. No doubt, no doubt.

especially with like the prevalence of of LLMs and AI, right? I mean, I only see this continuing, right, as like more consumers try to try to play doctor first and maybe they're not getting the answers they want from their physicians and not blaming anyone in particular, but AI is certain like making, enabling a lot more of that sort of activity. But yeah, yeah, seeing it as almost an accelerant, right, to your point. I think you have to use it like that.

If you're trying to use it any other way, you have to just go be a consumer product. Right, right. That's what I think. And we chatted a little bit about this before we hit the record button. But I think that's so crucial because even the company that I started before Fastway, that was a B2C, a DDC play entirely by intention, right? And so whereas like with Materna, you're thinking more strategically that now that you're in the CEO role of like, you know, kind of repositioning sort of like the product portfolio.

And I think the important point there is make a decision ideally as early as possible around which path you're going to pursue because if they're kind of like mixed and kind of, of like, you know, all mixed in the same bowl. Sometimes that could be quite, quite difficult. And in fact, maybe even impossible, right? So. Yeah, I think if you're not really judicious about the way you're deploying capital and building the channel, you can really get lost in the woods. It's really, there's just so many. It's really infinite the number of things you can do to try to commercialize the product. And I think we can have a whole leadership conversation. But I've, I've never had trouble getting people to do things, the hardest thing. I have not.

had a lot of success getting people to not do things. Everybody wants to do everything and you can't do anything, but you can't do everything. Yeah. Yeah. I mean, it sounds like clearly saying you hear like a lot of people say that, right? Like saying no is the thing that you need to do most often, but it can be really challenging when you know, throws of that, you know? Yeah, because people are like, what if we try this? You know, maybe this will be better. Exactly, exactly. Yeah. And at some point, you've got to come and lean into your instincts and what you know about the business and be decisive, right? And stick to sort of the plan, let it play out. So with that said, let's talk a little bit about clinical data, right? Because that was another topic on the list is it can be in an area, especially I would say with in areas that maybe are underappreciated, right, like like quote unquote women's health or pelvic, you know, pelvic floor health. And it's a topic, right, it can be overwhelming for most, you know, newer CEOs or newer founders. Like how do I, how do I even begin to think about putting together the most efficient, you know, clinical roadmap that's going to get me, get me to the finish line, ideally as fast as possible. But yet also allows me to like make the claims I want to, I want to move forward with. So I guess any, any one or two, like,

key learnings, right, for other founders or CEOs that don't have a lot of swings at the plate here that you would kind of whisper in their years? I love the way you framed it because I think that if you're working in a really well-understood space, you probably don't need my advice, right? If you're the third to market, you probably know what end points are important and what you need to be able to show to be able to take market share from the first three incumbents, right? But if you're working in a space where you really are early and taking it, I mean, we calculate our team, in the advanced economy is it's $25 billion. Like, it's not a small market.

But nobody knows about it. Like, we're the first ones to really try to characterize it. So I'll give you an example of kind of what happened for us. 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.

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