FDA clearance is not a commercial strategy. It's permission to start building one. That distinction matters more than most international MedTech founders realize until they've already arrived in the U.S. market, pitch deck in hand, expecting momentum. What they find instead: Clinical skepticism Procurement committees Reimbursement walls Hospital IT And Decision-makers with zero emotional investment in their technology. Clearance doesn't protect you from any of that. Over the

You Built the Device. Now What? Let me paint you a picture. A brilliant founder spends three, four, sometimes seven years developing a medical device. They run studies. They survive the FDA process. They get the 510(k). They pop the champagne. Then they walk into a hospital and get absolutely nowhere. Not because the device doesn’t work. It works great. Not because there’s no clinical need. The need is obvious. But because FDA clearance and hospital adoption are two entirely