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NTAP Explained: What the FY2027 Medicare Rule Changed
You can usually tell pretty quickly whether a founder understands how hospitals actually get paid. Ask what happens to a hospital's margin the first time it uses your device. If the answer starts with the price of the device, they're probably missing the bigger picture. If it starts with the Medicare DRG, they've at least done the work. Most haven't. That distinction matters because the economics of a new technology are not determined by what the hospital pays you. They're de
2 days ago


Step 10 of 12: Partnership and Ecosystem Strategy
The Multiplier That Turns Early Traction Into Market Momentum There's a slide in nearly every MedTech deck labeled "Partners." It's a wall of logos sorted by prestige. Most of them have never moved a single unit. That's the trap. In the U.S. market, a partnership is either a multiplier or a distraction wearing a press release. There is no middle ground. And the odds aren't your friend. The failure rate for strategic alliances is famously grim, commonly pegged at around half.
Jul 15


Step 2 of 12: Regulatory, Quality, & Risk Architecture
Every medtech founder eventually faces the same uncomfortable question: how do we talk about what this product does without overstepping what the FDA cleared us to say? Under-claim, and you waste the evidence you spent millions to generate. Over-claim, and you invite a warning letter, a stalled hospital deal, or both. FDA clearance proves your product is safe. Your documentation proves your company is trustworthy. Here's what U.S. hospitals actually evaluate before they buy.
May 20


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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