There’s a moment I see all the time in medtech: a company reaches FDA clearance—and assumes the hard part is over.
It’s not.
In many cases, that’s where the real challenges begin.
FDA gives you permission to market your device. It does not give anyone a reason to buy it—or pay for it. And that’s where launches stall.
Regulatory and reimbursement are often treated as separate steps: first approval, then payment. But they answer very different questions. The FDA is focused on safety and efficacy. Payers are focused on outcomes and economic value. One does not guarantee the other.
By the time companies start thinking seriously about reimbursement, it’s often too late. Clinical endpoints are already set, studies are complete, and the evidence gaps are locked in. At that point, you’re not building strategy—you’re fixing it. And that’s always more expensive.
Investors have learned this the hard way. Clearance alone isn’t enough. They want to understand how the device will be reimbursed, whether providers will adopt it, and whether there’s a real economic case behind it. Because a cleared device that doesn’t get used isn’t a business.
The companies that succeed don’t treat regulatory, reimbursement, and commercialization as separate workstreams. They align them early, making deliberate decisions about clinical strategy, indications, and evidence with both approval and payment in mind.
FDA clearance isn’t the finish line. It’s where commercial reality begins.
