How to Navigate Undefined Markets in Medtech

How to Make B2C and B2B Work Together in Medtech (Instead of Against Each Other)

When Tracy joined Materna, she inherited a unique commercialization challenge: Their first product, Milli, was being sold direct-to-consumer as a wellness device, while their pipeline product, Ellora, required complex hospital sales with global codes and new technology add-on payments.

The fundamental issue was organizational: "They're just not the same call point. They're not the same sales team. And that's just impossible," Tracy explains.

Rather than abandoning either approach, Tracy developed a strategic B2B2C model that leverages the strengths of both channels while addressing their fundamental weaknesses. The key insight: clinical data serves as the bridge between consumer demand and physician adoption.

Her first move was taking Milli through two FDA clearances, transforming it from a wellness product to an FDA-cleared medical device. "I don't need FDA clearance to sell something, but without it, I can't say what the product is or what it's for," she notes. "Given how deeply underserved that population is — 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. In order to speak plainly, you have to have FDA clearance and clinical evidence."

The strategy is already demonstrating results. Milli now has over 5,000 patients and 15,000 patient emails in their database, along with relationships with 5,000 healthcare providers. "We've built up that channel so that our second product, Ellora, can drop into it," Tracy explains. "When we commercialize Ellora, we'll sell into hospitals, but we'll also use those Milli channels."

This approach addresses two critical challenges of direct-to-consumer strategies in medtech. First, customer acquisition costs can be prohibitively expensive, especially for medical device companies without the deep pockets of pharmaceutical giants. Second, traditional medtech acquirers often lack consumer-facing capabilities, potentially limiting exit opportunities.

"When it's done right, you can really accelerate adoption among doctors when patients show up asking for it," Tracy observes. "There's an opportunity, and our acquirers  recognize it as such,  that you can use patient demand to accelerate your revenue growth when you launch."

The B2B2C model also provides crucial market validation. "Anything you could sell to a consumer, you should be able to sell to a doctor as well," she notes. "I think a lot of players end up going D2C, patient pay, because they couldn't get funding to do it right — to run proper clinical trials showing superiority and get FDA clearance to make those claims."

What You Should Do When the Medical Community Can't Agree on What You're Treating

Materna's clinical development strategy illustrates the challenges of working in undefined medical markets. When Tracy began developing clinical trials for Milli four years ago, she encountered a tricky problem: the medical community couldn't agree on basic definitions of the condition they were treating.

"We were so early to the game that there was not enough information — even in a systematic literature search — about this condition to get the inclusion criteria," Tracy recalls. "There wasn't even alignment among our key opinion leaders about what this was called, who has it, and how they would know."

The condition, vaginismus, affects up to 17% of American women at some point in their lives according to American College of Obstetricians and Gynecologists (ACOG) estimates, yet it's not comprehensively taught in medical school and is under-researched. Patients seeking help face a frustrating journey: "On average, our patients see six or seven clinicians who dismiss them and tell them it's all in their head, that they just need to relax and have a glass of wine. They've often been suffering on average for five or more years,” Tracy says. After using Milli, “patients can see significantly reduced pain and anxiety, and most are making progress on their goals in as little as 90 days.  There is no reason for women to struggle with this condition for so long, when Milli makes it so treatable."

Rather than abandon their clinical strategy due to the lack of medical consensus, Tracy orchestrated a solution that required both scientific rigor and diplomatic skill. "We got those key opinion leaders together and that team wrote the white paper. We're taking a stand. This is what this condition is. This is what it's called.  This is how we define it as a medical community."

The process required finding common ground among disparate medical opinions. "We had our chief medical officer interview three or four of the KOLs, and where everybody agreed, that was the white paper. Then there was an addendum with case studies written by each of those KOLs."

This collaborative approach extended beyond mere consensus-building. The team then conducted what is called a "Self Selection Study," the first of its kind in the field of vaginismus, proving that patients could accurately self-diagnose when given proper information — a finding that became part of their FDA labeling and enabled over-the-counter clearance.

"We proved that if you give patients the right information, they know what they have," Tracy explains. "It's not rocket science, and we don't need to be protective or paternalistic about it."

Materna's dual-product approach also helped their clinical strategy. Since Milli was already generating revenue, investors felt more confident funding Ellora's expensive clinical program. "Ellora needed a large clinical trial with 700 patients because it's in labor and delivery, which is a super high-risk area. That wasn't probably going to have an easy time getting funded, but our investors liked that we had a post-revenue product," says Tracy.

For founders working in similarly undefined clinical areas, Tracy emphasizes the importance of thoughtful self-awareness: "You have to figure out what your strong suits are and play to them and have your eyes wide open about what your soft spots are and not deny them…figure out how to get around them and build a strong company despite them."