Brilliant use of the Lost in Laos narrative to frame the MedTech regulatory misalignment problem. The point about FDA clearance closing the conversation rather than opening it is something I wish more founders understood before committing capital. I've seen this pattern repeatedly where technical validation creates false confidence while the real lock-in happens at the reimbursment layer. The observation that threats aren't discovered late but decided early and named late should be printed on every term sheet in this space.
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.
Brilliant use of the Lost in Laos narrative to frame the MedTech regulatory misalignment problem. The point about FDA clearance closing the conversation rather than opening it is something I wish more founders understood before committing capital. I've seen this pattern repeatedly where technical validation creates false confidence while the real lock-in happens at the reimbursment layer. The observation that threats aren't discovered late but decided early and named late should be printed on every term sheet in this space.
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.