Build Evidence in Layers, Not Leaps

Build Clinical Evidence in Layers, Not All at Once

Clinical evidence is the backbone of every medtech startup — not just for regulators, but for physicians, payers, and even internal teams. And according to Colby, the bar has never been higher.

“As we have more and more devices, there seem to be fewer and fewer dollars,” she explains. “The threshold for evidence is really high.”

That perspective comes from experience. Before joining May Health, Colby helped guide the clinical strategy at Alydia Health, a women’s health company focused on treating postpartum hemorrhage. There, she saw firsthand how powerful a staged clinical program can be.

The Alydia team didn’t try to answer every question at once. Instead, they built evidence in deliberate layers: a small early study, a tightly controlled 100-patient trial with respected thought leaders, and an 800-patient post-market study with lighter requirements.

“That cadence really helped us grow the story,” she says. “You don’t need to do everything in the first pass.”

The key is understanding what each phase needs to accomplish. Early studies should build conviction with investigators and regulators. Later stages can expand the dataset, validate real-world use, and create momentum for commercialization — all without forcing a young company to raise capital for an oversized, premature trial.

Colby is applying the same discipline at May Health. The company is in the midst of a 150-patient pivotal investigational device exemption (IDE) study in the U.S., with over 50 patients already treated. In Europe, earlier feasibility work in 32 patients produced encouraging signs of ovulation and 12 pregnancies, including eight live births — data now supporting their CE mark pathway.

She notes that early commercialization in Europe could begin as soon as 2026, but only after the company’s next-generation system receives approval.

Why Early Commercialization Should Be Slow and Deliberate

Early commercialization isn’t about scaling — it’s about learning. And for Colby, that mindset has become a non-negotiable across every launch she’s worked on.

“I have just not been in a single launch where you don't find out something in the first few months,” she says.

Those discoveries aren’t usually failures. They’re mismatches — between what the team expected based on clinical trials and what actually happens in the hands of everyday clinicians. That’s why Colby advocates for a slow, methodical approach to the early market.

The first pillar is evidence. Hospitals and practices are demanding more data than ever before, and having that evidence “fully baked” is a prerequisite to even start the conversation. But evidence isn’t enough on its own. Teams also need credible early adopters — whether academic key opinion leaders (KOLs) or high-volume clinicians — who are willing to speak honestly about what the device feels like in real use.

“Making sure you understand the experience your customers are going to have with your product… and having those customers be willing to speak on your behalf — that early, limited launch where you go deep is really key,” Colby says.

Depth also creates space for the surprises. Real-world use always introduces variables not present in clinical studies: a new staff member, a slightly different patient type, a workflow nuance, or a user expectation shaped by previous technologies. Colby has learned that these moments are gold — if teams listen.

At May Health, they’re actively listening for such insights during their pivotal study. 

Whether the solution is training, messaging, or a small product tweak, the key is catching issues early with a small group of engaged users — before broad commercialization.