5 Go-to-Market Lessons from Casana’s Journey in Regulated Medtech
Launching a product in a heavily regulated market requires a fundamentally different go-to-market approach. In a recent episode of Category Visionaries, Austin McChord, CEO of Casana, shared insights from transitioning from cybersecurity to medtech, revealing crucial lessons for founders navigating regulated spaces.
- Balance Humor with Scientific Credibility
When your product naturally draws attention (like a health-monitoring toilet seat), leverage it strategically. “Our strategy is really to catch you with the humor, but then win you over with the science,” Austin explains. This approach helps Casana stand out while maintaining medical credibility.
The key is understanding regulatory constraints without letting them stifle creativity. “The FDA cares a lot about what you say about your product,” Austin notes. “We cannot say that we do anything we do not do. We cannot claim anything that we do not have approved by the FDA.”
- Rethink Traditional Growth Metrics
Medtech companies operate on different metrics than software startups. As Austin reveals, “If we were a software company, that would be an enormous amount of money, and we would have had to demonstrate a ton of traction. In med device, we raised this money on $0 in revenue, and that’s not uncommon.”
This shift requires educating investors and stakeholders about industry-specific milestones. Clinical trials become your beta testing, and regulatory approvals replace traditional growth metrics.
- Embrace the Long Game
Regulatory approval timelines fundamentally shape your GTM strategy. After three and a half years, Casana is still working toward full FDA clearance. Austin compares this to other medtech success stories: “The very first product that Moderna ever really shipped or sold was the COVID vaccine, and they were around for over a decade before selling that.”
- Trust Your Contrarian Instincts
While expert advice is valuable, Austin emphasizes the importance of trusting your instincts: “The places that I’ve stumbled most are the places where I’ve been talked out of something, or experts have said, don’t do it this way.” He admits, “We assumed time following some paths that we potentially didn’t need to follow, and I should have fought a little bit harder on the contrarian opinions.”
- Build for Post-COVID Market Dynamics
The pandemic has reshaped healthcare delivery and consumer behavior. “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.”
This shift creates new opportunities for home health monitoring solutions, but requires careful navigation of both regulatory requirements and changing consumer expectations.
Looking ahead, Austin’s vision remains focused on impact: “This product, unlike almost anything else you could work on, we’ll directly save people’s lives when it’s in the market.” His five-year goal is clear: “There’s hundreds of thousands of seats in the world, and they’re saving lives every month, every week, every day.”
These lessons from Casana’s journey highlight how building in regulated markets requires rethinking traditional GTM playbooks. Success comes not from fighting regulations, but from finding creative ways to work within them while maintaining your product’s core value proposition.