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Step 8 of 12: Operational Scalability and Deployment
You Sold the Hospital! Now the Real Work Begins. One of my favorite memories from my time as a clinical specialist went something like this. My phone would ring. "Hey Rob, good news. We sold a robot." "Awesome. Where?" "Hospital X." "Nice. When do they want to launch?" "Tomorrow." "...Tomorrow?" "Yep." My facial expression after I get the news of an urgent launch so the capital rep can recognize revenue before the end of the quarter. That was usually the extent of the handoff
Jun 30


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 4 of 12: Productization & Technical Readiness
There's a sentence I hear from founders that tells me almost everything about how their U.S. launch is going to go. "We're FDA-cleared. We're ready to scale." That's usually the moment I know the next six months are going to hurt. Clearance means your product is safe and effective under controlled conditions. It does not mean it's usable, integrated, supportable, deployable, or anything a hospital IT director would describe as "ready." Those are different problems entirely, a
Jun 5


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
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