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

There’s a moment that happens in almost every hospital sales process. The physician champion finishes explaining why your technology matters clinically. Everyone nods politely. The room feels optimistic. You start mentally calculating future revenue. Then somebody from finance asks: “How does this impact the budget?” And suddenly the entire energy changes. Because now nobody cares how innovative the technology is. They care whether the economics survive scrutiny from people w