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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
5 days ago


Step 12 of 12: Investor & Board Alignment Pre-Clearance
The Expectation Engine That Determines Whether You Scale or Spend 18 Months Putting Out Fires Your investors are not impatient. They're doing math. That's the whole finale. Founders love to frame a demanding board as emotional, short-sighted, or "not getting it." Usually they're none of those things. They're looking at a return that lives or dies on time, and your commercialization timeline is the variable making their spreadsheet sweat. This is Step 12, the final step of the
Aug 6


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 7 of 12: Marketing, Positioning, and Demand Generation
Your Product Doesn't Speak for Itself. Neither Does Your Website. One of the biggest myths in MedTech is that great technology sells itself. It doesn't. If it did, hospitals would be full of incredible products that nobody's ever heard of instead of products backed by companies that built strong commercial engines. The reality is much less satisfying. The moment a hospital stakeholder can't immediately explain what your product does, why it matters, and why they should care,
Jun 24


Step 6 of 12: Commercial and Account Segmentation
Stop Calling Every Hospital a Prospect. They're Not. One of the fastest ways to waste a year after FDA clearance is convincing yourself every hospital is a prospect. They're not. Some hospitals move quickly. Some move slowly. Some have physician champions who can push a new technology through procurement in a matter of months. Others have enough internal politics to turn a simple pilot into a multi-quarter project. And yet one of the most common mistakes I see in early-stage
Jun 18


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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