FDA Clearance is Not the Finish Line

FDA clearance is not the finish line.

Most founders know that. What fewer plan for is that it might not even be a pit stop with a defined length. As any F1 fan will tell you, an unexpected pit stop of unknown duration doesn't just cost you time. It can end your race.

I root for Haas. If you follow F1 you know what that means. No factory backing. Smaller budget. Running mid-pack most Sundays against teams with resources that dwarf theirs. They’re not outspending Mercedes or Ferrari. They score points by planning and executing a better strategy than their competitors, not just outdriving them. Tight strategy is key, gaming out foreseeable conditions that could result in DNF and avoiding as many as possible. Every decision is made with the knowledge that they cannot afford the mistakes that the big teams can simply absorb and drive away from.

Sound familiar?

That's every medical device startup I've ever met. You're not Medtronic. You don't have their legal team, their regulatory infrastructure, or their balance sheet. When something goes sideways, you can't just absorb it and move on. 

You have to have planned for it.

In 2026, Kezar Life Sciences, after a bruising stretch of regulatory delays and clinical setbacks, ultimately sold to Aurinia Pharmaceuticals Inc. while waiting on a rescheduled FDA meeting. The science was good enough to sell. The company couldn't survive independently long enough to see it through on its own terms.

That's a pharma story. But I promise you the dynamic is identical in medical devices, and it's getting more common.

FDA's 2025 workforce reduction didn't touch the formal reviewers. But it hollowed out the infrastructure around them. Scheduling, communication, meeting coordination. For a large company that's an inconvenience. For a startup burning through cash waiting on a Pre-Sub response or a 510(k) decision, it can be existential.

Haas doesn't pull into a pit stop without knowing exactly how long it will take and what the car will need on the other side. Their margin for error is too thin.

Yours is too.

That means knowing your payer pathway before you submit, not after. It means having your commercial relationships seeded before clearance, not started after. It means your next funding round is closed with enough cushion to survive a six-month regulatory delay without a fire sale.

Clearance is a regulatory event. Market access is a business event. The gap between them is where underprepared companies run out of time.

Build for the gap. And know what's on the other side of the pit stop before you pull in.

Rightley McConnell
VP Client Engagement