A cleared device that no one will pay for is the most common silent killer in medtech — and the question early-stage founders are least prepared to answer. Investors know it, which is why "what's the reimbursement path?" comes early in diligence. If your answer is "we'll figure it out after clearance," you've just flagged an unmanaged risk.
1 Coding, coverage, and payment are three separate problems
A CPT code (coding) doesn't guarantee a payer will cover the procedure (coverage), and coverage doesn't set the rate (payment). Each is its own hurdle. CMS coverage determinations and the CPT landscape are public starting points.
How to close it
Map all three for your procedure. Even a directional thesis — comparable codes, the payer logic, the gap you'll need to close — beats silence.
2 "Comparable code" reasoning is what investors want to see
The strongest pre-raise reimbursement story benchmarks against an existing, reimbursed procedure your device is analogous to, and explains the path from there.
The trap
Assuming a Category III CPT or an NTAP will materialize on your timeline. Model the realistic case, not the hoped-for one.
3 Reimbursement risk compounds clinical risk
If coverage hinges on evidence you don't yet have, your clinical plan and your reimbursement plan are the same plan. Investors look for that linkage.
How to close it
Tie the clinical readout that proves your endpoint to the coverage decision it unlocks — one narrative, not two.
The bottom line
You don't need reimbursement solved before you raise. You need to show you understand the coding/coverage/payment stack, have a benchmarked thesis, and know which evidence unlocks which decision. That turns a silent killer into a managed risk.
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