Beyond Traditional Metrics: How Casana Redefined Success in Regulated Markets

Traditional startup metrics fall apart when building in regulated markets. In a recent episode of Category Visionaries, Casana CEO Austin McChord reveals how medtech companies measure progress when revenue and user growth take a back seat to regulatory milestones.

Redefining Fundraising Success

In the software world, raising $46 million would typically require significant traction. But as Austin explains, “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 disconnect requires educating investors on alternative progress indicators. Austin points to Moderna’s journey as an example: “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.”

Clinical Trials as Beta Testing

Without traditional user feedback channels, Casana relies on clinical trials for validation. “Clinical trials is basically your only path to beta testing a med device kind of product,” Austin notes. These trials provide crucial 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.'”

Regulatory Milestones as Growth Markers

FDA clearances become key progress indicators. Casana has secured approval for heart rate and blood oxygenation monitoring, with blood pressure measurement pending. Each clearance represents a significant milestone in the company’s development.

Reimbursement Strategy as Market Validation

Instead of direct sales metrics, Casana focuses on insurance coverage potential. “Medicare will pay to have a lot of those vitals tracked for the right patients because it couldn’t matter so much,” Austin explains. “There’s an ability to get reimbursed both by the government and by private insurance for being able to track these core important vitals in at risk populations.”

Impact Metrics Over Traditional KPIs

Rather than focusing solely on financial metrics, Casana measures potential impact. “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. His vision for success centers on reach and impact: “There’s hundreds of thousands of seats in the world, and they’re saving lives every month, every week, every day.”

The Long Game

Success in regulated markets requires patience and alternative progress markers. After three and a half years, Casana is still working toward full clearance. This timeline shapes how they measure progress, focusing on regulatory achievements, clinical validations, and potential market impact rather than traditional growth metrics.

For founders entering regulated markets, understanding these alternative success indicators is crucial. The path to market may be longer, but the impact potential often justifies the journey.