Casana’s Clinical Trial Strategy: Using Studies as Your Beta Testing Ground

In software, beta testing helps refine products before launch. But what happens when regulatory requirements prevent traditional user testing? In a recent episode of Category Visionaries, Casana CEO Austin McChord reveals how clinical trials become your only path to user feedback in medtech.

The Clinical Trial Imperative

“Clinical trials is basically your only path to beta testing a med device kind of product,” Austin explains. Unlike software companies that can release MVPs and iterate based on user feedback, medical device companies must validate their products through structured clinical studies.

Rigorous Testing Requirements

The FDA’s conservative approach shapes every aspect of testing. “You can’t do something like, say, our toilet seat is made out of the same stuff as other toilet seats, so it’s safe,” Austin notes. Instead, they had to conduct “biocompatibility testing, where they literally have to tape parts of the toilet seat to the side of a living animal for a period of time.”

Gathering Market Insights

Despite these constraints, clinical trials provide valuable market feedback. “The biggest thing is just how many times people are like, ‘oh, man, I want to get one of these for my mom or dad or somebody they know,'” Austin shares. This informal feedback helps validate market demand while meeting regulatory requirements.

Iterative Approval Process

Casana’s approach involves securing approvals incrementally. They’ve obtained clearance for heart rate and blood oxygenation monitoring, while blood pressure measurement remains pending. Each successful trial builds credibility for subsequent approvals.

Technical Validation Through Trials

Clinical trials validate not just safety but technical capabilities. Their technology “measures the electrical signals from your heart, as well as actually feeling your heart pump with very sensitive weight sensors in the seat.” Each claim requires rigorous validation through clinical studies.

Post-COVID Opportunities

The pandemic created new opportunities for clinical trials. “COVID is really what made a lot of this possible,” Austin explains. “All of a sudden, people became so much more comfortable doing health stuff at home, and doctors became so much more comfortable thinking about readings and data that people generate at home.”

Long-term Vision

The goal extends beyond regulatory compliance. “This product, unlike almost anything else you could work on, we’ll directly save people’s lives when it’s in the market,” Austin states. Clinical trials help validate this vision: “There’s hundreds of thousands of seats in the world, and they’re saving lives every month, every week, every day.”

For founders entering the medical device space, understanding how to leverage clinical trials as both regulatory requirements and product validation tools is crucial. While more structured than traditional beta testing, these trials can provide valuable insights while building credibility with regulators and stakeholders.