Thank you — that’s exactly the trap I was trying to surface.
FDA clearance often feels like a finish line, but in practice it just shifts risk downstream, where it’s harder and more expensive to unwind assumptions. Reimbursement, workflow, and evidence timing quietly become the real locking mechanisms.
And yes — the uncomfortable truth is that most “late-stage surprises” were actually early decisions that went unnamed. By the time they show up, optionality is already gone.
I appreciate you reading it the way it was intended.
Thank you — that’s exactly the trap I was trying to surface.
FDA clearance often feels like a finish line, but in practice it just shifts risk downstream, where it’s harder and more expensive to unwind assumptions. Reimbursement, workflow, and evidence timing quietly become the real locking mechanisms.
And yes — the uncomfortable truth is that most “late-stage surprises” were actually early decisions that went unnamed. By the time they show up, optionality is already gone.
I appreciate you reading it the way it was intended.