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