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I HOPE I CAUGHT YOU BEFORE IT'S TOO LATE
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
Apr 27
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