Ep. 3 – Leading The Shift

Karen (02:50)
Our guest today is someone who’s not just designing better products. She’s helping redesign the health experience for women in midlife and beyond.

Gabrielle (02:57)
Tracy MacNeal is the CEO of Materna Medical, a company using science and empathy to tackle overlooked women’s health conditions like pelvic floor disorders with real solutions that are clinically smart and emotionally intuitive.

Karen (03:11)
She’s also an engineer, a mom, and a champion of women-centered innovation. And she brings a powerful perspective on how we can build brands that meet women where they actually are.

Gabrielle (03:24)
Tracy, welcome to Two Uteruses Walk into a Bar.

Tracy MacNeal (03:27)
Thank you so much. It is such a pleasure to be here.

Gabrielle (03:33)
It’s a lot of hats. I think that’s important to call out. I don’t want to spend too much time, but I think it’s very interesting to ground us in your experience and how you landed at Materna.

Tracy MacNeal (03:45)
The way I think about myself is a technical leader. I specialize in the commercialization of medical devices. So making things that can be complicated, trying to make them simple, is what I do.I’m a chemical engineer. I started in pharma. But even in my first job out of school, I started in a manufacturing management development program. So it was very much geared towards grooming leadership and communication skills amongst technical people. And my crackpot theory is that engineers who can communicate get put in communication roles pretty quickly.
That’s more or less the story of my career—working on technical teams that were launching different kinds of innovation in healthcare. And about ten years into my career, I got my MBA. And that was a real turning point for me where I made a conscious decision to be more around commercialization, fundraising, M&A. So I worked with a startup that had a successful relationship with one of the big strategics and then worked for mid-sized companies for a couple of years, and that’s where I was Materna called. So I’m not the founder of Materna. They were running a search for essentially the commercial CEO. And I had never heard of anything that we were working on, but every time I had a conversation with another person at the company, I got more interested. I had never worked in women’s health and I never had the opportunity to run my own show that way. And as I learned how large the market was, how deeply these needs were unmet, and the lack of competition, I thought the challenge there is going to be being a first mover and telling a story about something that is maybe uncomfortable for some people or taboo or embarrassing. And I had to get over that myself because I was a respectable person working in orthopedics and whatnot. To then begin getting up every day on behalf of women’s pelvic health was a conscious decision I had to make.

Karen (05:34)
Yeah.

Tracy MacNeal (05:50)
I was going to go first. I was not going to be embarrassed about this and I was going to try to normalize it and hopefully bring other—

Gabrielle (05:56)
I love that.

Karen (05:56)
Was it the concept of pelvic health that was the issue, or was it the language surrounding pelvic health that was the issue?

Tracy MacNeal (06:06)
Six years later, things are so much better. Things have changed a lot. But in 2019, when I was accepting the interview, nobody was talking about pelvic health—not really. There were a couple of early players, like LV, the LEVA system, the Ixenonome. They were early to that party. For the most part, people were not comfortable talking about pelvic health, and the pelvic floor PT investments had not yet been made. Midi Health wasn’t a thing yet.
And then it was also, honestly, the devices that we have at Materna—they look like sex toys to a lot of people. If you’ve ever seen anything that goes into a vagina, you might associate it with that. And so this is the first time in my career where I really don’t lead with the devices because they’re very distracting for people. Even people who are comfortable, it’s still like, okay.

Karen (06:58)
It’s so interesting how those things get conflated.

Gabrielle (07:07)
And also here you are coming from an engineer background, being a communicator, and here you are faced with a portfolio and the challenge of figuring out how do we get this company profitable and what do we do. So what were some of the first things that you did in the first hundred days?

Tracy MacNeal (07:33)
Maybe I’ll talk a little bit about our products for folks that don’t know us. So we have one product on the market—it’s called Milli. It’s an expanding vaginal dilator. Pelvic floor health as a space—most of the conversation is around pelvic floor laxity, and we’re not working in that space.
Our first product on the market is Milli, treating a high-tone pelvic floor disorder. It’s sort of the opposite issue, where the pelvic floor is too tight. And usually what’s going on there is that sex has hurt for a long time—some kind of chronic thing. It can be chronic yeast infections, fibroids, endometriosis. Menopause is actually the largest group where the tissue is drier or thinner and it just hurts.
And then on top of it, her body starts to brace itself in anticipation of the pain. And sex becomes painful or impossible. And it has a name now. It is called vaginismus—rhymes with Christmas—and that’s how you can remember it.
And then our second product is finishing up a big pivotal trial aiming to prevent those pelvic floor injuries that happen during childbirth. Pelvic organ prolapse and the associated incontinence with that—those were five times more likely if we’ve had a vaginal delivery.

Karen (08:59)
It’s an exciting duo of products—able to catch an issue early in a woman’s life during her childbearing years, but also have some sort of therapy to offer for the other end of the timeline.

Tracy MacNeal (09:12)
So our second product is called Ellora, and it’s a single-use disposable that would be used during labor and delivery. And the idea would be that we could maybe make pelvic organ prolapse much less common.
Now, what happened when I joined the company was that Milli had been launched as what’s called a wellness product. So it didn’t have FDA clearance, which is fine—you can do that. But the importance of FDA clearance is really to protect the consumer: what are you saying about the product? When you get FDA clearance, it’s actually not for the product, it’s about the marketing.
So Milli was out there, and from a strategy standpoint—and really ultimately serving the patient’s need better care—we’re trying to get these channels so the patients have easy access. Having Milli without FDA clearance out as a DTC product, and then Ellora as a hospital sale used in labor and delivery—this was going to be too many things for a little company to try to do.
And ultimately, I felt like it was clear that patients deserved plainer speech about Milli: What is vaginismus? How do I know if I have it? How treatable is it? We needed to be able to talk about it, and we needed FDA clearance for that. So that was one of my earliest decisions.

Gabrielle (10:41)
When we were originally talking, you mentioned you were working a little bit backwards because you had to make this case for the indication. And you mentioned you brought together some KOLs—thought leaders in pelvic floor health.
I was looking on Reddit and typed in “painful intercourse” because you were talking about what do we even call it. There is a vaginismus community—42,000 people.

Tracy MacNeal (11:13)
42,000 people.

Gabrielle (11:15)
And I find it so interesting that you were talking about the embarrassment around the topic—giving people language about the topic and having those conversations with their clinicians who can actually help—but for a very long time people continue to go online.
Giving people the right language, giving people understanding of what’s really happening, and then guidance on how they can solve it—how have you seen the role of online in getting your messages out there and educating women? When you talked about that very first step, how did you start doing that? What channels were you using?

Tracy MacNeal (11:56)
That’s been a very interesting evolution over the last six years, and I think most people would agree that direct-to-consumer has become a very unscalable business model.
In the beginning, we were making most of our connections with patients through Google. So they’re Googling “painful sex,” and we’re bidding on those keywords—giving them landing pages that ideally would give them information about what was going on for them and whether they have vaginismus, because painful sex and vaginismus are two different things. Vaginismus is really the pelvic floor contraction. Painful intercourse can happen for other reasons—you can have a yeast infection for a week and that’s different.
That was pretty successful in the beginning, but over the years, the combination of everyone trying to get out there and bidding on the same keywords became inflationary on the costs. And the changes to privacy—which as citizens we probably support—has quintupled the costs associated with trying to reach those patients.
And then on top of it, we have censorship—not even by humans. These are bots that automatically censor things that we’re talking about. And not just because we’re in pelvic health, but medical products have become increasingly difficult to talk about through Facebook, Instagram, Google channels. I try to be fair and balanced about that. I think a lot of it is to try to protect people—protect patients from greedy entrepreneurs. And it can be very difficult to get clear communication out to people in a way that makes sense financially.

Karen (13:39)
We’ve been talking a lot about language. How important do you find the issues with language—especially now that automated systems are filtering you out based on the language you’re using when you’re trying to do direct-to-consumer marketing? Can you speak to that experience as you were trying to get your vision for the company up and running—any issues you had with language and how you used that?

Tracy MacNeal (14:11)
We made the decision to double down in the healthcare practitioner space—HCPs. For us that could include OBGYNs, nurse practitioners, physical therapists, clinical psychologists. There are a lot of types of people that see folks who have sexual function questions.
We decided it was going to be in better service to everybody—especially the patient, but also the clinicians—to bring everyone together and get alignment. We got FDA clearance, and that was great. Then everybody needed a prescription. And a lot of those folks don’t write prescriptions. Physical therapists typically would not be able to write a prescription. So that ironically creates a barrier to patients getting what they’re looking for.

Gabrielle (14:56)
Drink.

Tracy MacNeal (15:06)
So we started trying to run a clinical study to get evidence, because patients naturally want to know whether the product works. And in order to say the product works, you need clinical evidence.
And we realized there wasn’t enough alignment amongst key opinion leaders about what the condition would even be called and how you would diagnose it.
So we made the decision to bring them together and write the white paper. Our company sponsored the white paper. We brought several of the top minds in the space with a lot of great clinical practitioner experience. They have different perspectives, but we got enough agreement that we were able to get the indication and alignment that yes—this is the problem we are solving. It’s called vaginismus. And give people a name so they’re not chasing some random experience.
What we were seeing in our market research was that most people who have this situation do not know what it is, do not know that it is incredibly common, and they do not know that it is very treatable. And because it hasn’t been invested in, there hasn’t been enough research. It’s not taught in medical school. So patients go to the doctor—and if they’re the warrior types that go try to take care of themselves—the doctor may not actually know.
So we were trying to be of service in that whole ecosystem. And then the second thing that we did was we ran the first self-selection study. What we felt was that when we looked at how these patients were being treated, they were being passed around.

Tracy MacNeal (16:56)
We saw in hundreds of patients that on average they were seeing five or more clinicians who could not help them—suffering for years. And they were being told things like, “It’s all in your head.” “You’re fine.” “You’re just small.” “Have a glass of wine.” “Try to relax.” Kind of gaslighting.
And what we wanted to do was put more empowerment in the hands of the patient herself.

Tracy MacNeal (17:24)
So we ran the self-selection study to show clinically that if you give patients the right information, they know what they have. They can decide correctly—positively or negatively—if they have this condition.

Karen (17:39)
Could you talk a little bit more about that? I find that really interesting because it is absolutely talking right to today’s topic.
And tied into this is an issue with the remnants of an old way of using language in the medical space—the fact that we still call hysterectomies “hysterectomies” and not “uter-ectomies” across the board—things like that.
I’m in my early 60s and there’s absolutely a dearth of language for me growing up. There was no way to frame and talk about these things. You found a way to evidence what you just said—which is: give them the tools and they can decide things for themselves. So I want you to expand on that a little bit, because it is addressing the issue women have always had with the marketing and the medical advice and care they’ve been getting—and how a brand can address that the way you guys have.

Tracy MacNeal (18:35)
I so appreciate what you just said. Tying it back to where we started talking about leadership—for me it ended up being a relentless, unwavering asking of “why can’t we?” I had to bring together the team who could figure out what to do. I had never worked on a device that was so terribly underdefined. I had never been asked to work on a clinical device where people did not even understand what the problem was we were trying to solve.
That was really wild. I have the most amazing team ever. And it took us a while—and we have amazing investors who supported us—because this stuff isn’t free. People have no idea how much these kinds of things cost. It’s like a million dollars to get FDA clearance, at least. These are not throwaway things.
And you have to convince investors that these patients really do deserve better care—and that they will purchase this device if you help them get what they need and give them the support they’re looking for.
The way it worked in the end was: we have an educational web page which is part of our labeling, so we can’t just change our website because we feel like it. This is part of our clinical labeling. But it gives patients a fair amount of information about what vaginismus is and isn’t.
And then they went into a doctor and filled out the form and checked whether they thought they had vaginismus and whether they thought Milli would be right for them based on what they read. And then they independently saw a doctor who made the same decision. And we wanted to see whether they lined up—and they did. Women know. They don’t need a doctor to tell them whether they have vaginismus or not if they have the right information.

Gabrielle (20:32)
How did that marketing—outreach to the HCPs—what were some of the things that you did strategically to get this message out? It sounds like Materna was at the forefront of this conversation. You had the technology and now you were the plight of the pioneer—you have to do the hard fight and pave the road for other people. So what were some of the things you did?

Tracy MacNeal (21:03)
We are aiming to be the brand that’s defining the category—in the same way that Viagra does for ED. In the beginning nobody would have expected baseball players to be talking about erectile dysfunction on TV, but here we are 30 years later. We’re hoping it doesn’t take 30 years, but we’re six years in. These things do take time.
Milli is a covered benefit for veterans, and veterans have a higher-than-average incidence of vaginismus around trauma. Sexual trauma is one of the primary conditions that can lead to vaginismus. And veterans are people—they have all the same things other people have. So I’m glad it’s a covered benefit for them, and that’s where we’ve chosen to build out our clinician-facing channel mostly because health equity is important to us.
We would love for Milli to be a covered benefit for everybody. Probably a longer story—another podcast episode on reimbursement and women’s health—because I still get asked if women’s sexual health is a nice-to-have or a need-to-have. Is the fact that sex is painful or impossible for her a nice-to-have or a need-to-have?
That’s the primary barrier to broader coverage. I don’t think it’s impossible. I think it can be done. But as an entrepreneur, I have to think about what investors will pay for and where clinicians will show up helping their patients.
What we found is that over the years, as we’ve shown up with more and more clinical evidence and validation—naming what is happening and how we talk about it—leading that from a technical perspective, not as a mom-and-pop “hey, I’ve got this idea,” but like: we are a medical device company and we are in service to these patients.
We found that more and more clinicians are willing to ask themselves: “Am I asking my patients if they’re having sex?” “Am I asking if it hurts?” A lot of them are not.
They’re under a lot of pressure. They’ve got maybe 10 minutes with the patient. And if they touch on this thing, it can be a very charged experience. Most of these patients have been suffering for a long time. They’ve been gaslit. It’s affecting their relationships, self-image, relationship with their body. It’s really very painful. There can be tears. They don’t have time to deal with that in 10 minutes, so they refer out.
And I think this is where you’re seeing pelvic floor physical therapy really booming. Most people cannot get an appointment for eight months. There’s just not enough of them.

Karen (23:56)
Now the Ellora—are you having the same kind of issues with clinical understanding, or the field’s understanding of the importance of that to real health? Not a nice-to-have type of thing, because it’s preventative.

Tracy MacNeal (24:09)
It’s so exciting. The idea is to try to make vaginal delivery safer and easier for moms and babies.
Ellora is way easier to talk about because everybody’s got a mom. Everybody wants mom to be safe and happy. When you start talking about women’s sexuality, it’s complicated.
That said, obstetricians have the highest rate of malpractice insurance. I had an MFM—a maternal fetal medicine specialist—these are the ones that do the extra study and research and high-risk pregnancies. They see the most complicated things—moms with cancer and things like that. They are very conservative people. And they have not had a lot of investment in their space, so they are not used to working with industry at all—the way orthopedics or cardiology is. Cardiologists expect new technology all the time. Obstetricians have not had that, so it’s more complicated.

Karen (25:30)
Have you talked to practitioners—do they feel they’re operating in a misunderstood space themselves? Is it because women have always been able to deliver, it’s a natural process—what more can we do?

Tracy MacNeal (25:50)
That’s a tricky question in childbirth. When I was working in artificial hips, no one ever asked me, “Who are we to interfere with mother nature?” But we do ask that with childbirth. So I try to gently push back on that.
Doctors do not typically like to be challenged. So I try to do it in a way that’s respectful, but also playful. We did die a lot in childbirth—that happened. And we have a big maternal crisis in this country.
It is a paradigm shift and Materna’s right in the middle of it. We’re not the first medical device company, but we’re one of three in the last decade to try to bring a medical device into obstetrics—into vaginal delivery—that I’m aware of.
And so the question we have to answer is: are we an intervention, or are we a non-intervention intervention? Are we disabling and disempowering women because their bodies don’t know what to do? Or are we enabling something that has become harder as babies are getting bigger?
When people ask, “Why do we need this innovation now—women have been having babies since the dawn of time?” three things: one, babies are getting bigger. Two, we’re having babies later, which increases risk. Three, we are living longer. So if we all died before menopause, the way we used to, prolapse would be like, who cares. But now if I’m 50 and I’m going to live to 100, I really don’t want to spend the last 50 years with pelvic organ prolapse.
The whole framework has changed in women’s health, and how we’re thinking about it is rapidly evolving. Obstetricians have not really been trained to think about collaborating with industry the way cardiology might.
But I am hopeful that as we do what we’re doing—and we’ll be the third—I know there are several really cool technologies coming after us that I hope will have an easier time. One of our stated missions is to demonstrate to the market that when we invest in women, we all win. Make it easier for the next companies to get funded so it’s not so crazy to think about putting a medical device into making outcomes better.

Karen (28:33)
What weaves into this is part of your brand experience—respect for the end user and appreciation and respect for the end user, which I think addresses a lot of issues.

Tracy MacNeal (28:46)
Thank you. I’m really glad that comes across. It’s very important to us. I know this is true for everybody who goes to a hospital to visit their customers, but obstetricians are always doing 16 things while they’re trying to talk to me. I’m so appreciative of the amount of stress they are under. And we’re hopeful that our technology can ease some of that.

Gabrielle (29:07)
You’re in a delicate situation and you’ve seemed to navigate it well—bringing along the clinical world and making this a clinical discussion, taking the taboo, the shame, the emotion out of it while also having empathy around your messaging. Having people acknowledge this is not a nice-to-have—painful sex, pelvic floor pain is a need; you need to fix it.
How are the conversations you’re having now with funders different from what they were? And not only that you have named it, but in the last six years—what’s happened in the environment around women’s health that is making advancements possible?

Tracy MacNeal (29:56)
When I joined, we were coming off the end of the pelvic mesh lawsuits—the largest mass tort cases in medical device history. Many medical device companies had very publicly exited women’s health. Starting to raise money in that environment was challenging.
I will say we have a lot of men on our cap table and they are lovely people who care about their wives and daughters and want the world to be a better place. I think dads actually know more about women’s pelvic floor stuff than maybe they let on. I’ve had several investors say their wives have been injured.
And we’ve had several big successes: the Illidia Health exit to Organon for the Jada device in postpartum hemorrhage, huge success. The Fetal Pillow, also really successful.
Holly Sheffield has taken over as CEO of Cooper Surgical. She’s an investment banker—really inquisitive—and it’s exciting to see her consolidate. We’ve seen more interest in labor and delivery among strategics. I feel like that old wave has passed and there’s a new impetus. And as maternal health outcomes in this country keep not getting better, I’ve also seen a rise of new funds stating specifically that they’re looking to invest in women’s health. So I’m very bullish about the future.

Karen (31:46)
When it came to the Milli, the physical design of that product—personally when I looked at it, I thought that was well done. Talking a little bit about the physical design behind the brand, which is showing respect to the end user—how did that come into play on your end, and do you see that as a fulfillment of the message you’re giving your customers?

Tracy MacNeal (32:15)
Yeah, absolutely. It’s important to talk about standard of care before Milli. I don’t have vaginismus and I find this concerning—the insertion is the hard part. Multiple insertions and jumping between sizes is hard. So Milli goes in and then expands inside the anatomy one millimeter at a time, and the patient’s in control.
We’ve got a big clinical study coming out this year with a lot of publications about it, and I just want people to know it’s a very treatable condition. You can have really great reductions in pain, anxiety, and return to sexual function in 90 days. It does not have to be something you suffer with for years.
It took us longer to get the clinical research done because it was a bit more of a chess game than we thought it would be, but it was worth every penny and every minute of the time. And we’re really excited to be the first company to actually have statistically significant clinical evidence to show doctors.

Karen (32:59)
Do you find that women who find this product after suffering for years—someone who’s had it for a decade—can they still benefit to the same level?

Tracy MacNeal (33:36)
Yes. In the clinical study that we’re publishing this year, people had to have had it for more than two years. And that’s a long time. The difference between two years and five years or ten years—given that you can get statistically significant improvement in 90 days, you just need the right technique.
I think it’s about calming people down. It’s about empowerment. It’s about gentleness. It’s about: she’s in charge.

Gabrielle (34:03)
I think that’s what’s really interesting about this sector—brands aligning with a cause and really doing it in service of the patient. There’s so much intersection and overlap and potential for brands to do well by doing good.

Gabrielle (34:22)
So thank you. You’ve been a wonderful guest. I really appreciate you talking to us about this issue, about the things that are being done out there, and the advice and all of the wisdom that you’ve shared today. Thank you so much, Tracy.

Tracy MacNeal (34:22)
And thank you very much.

Karen (34:24)
Thank you, Tracy. Thank you.

Tracy MacNeal (34:35)
Thank you so much. I really appreciate your leadership in this space.

Gabrielle (34:35)
Bye.