Medical Device Commercialization Roadmap: From 510(k) to Scale
A practical roadmap that connects regulatory clearance to clinical adoption, payer coverage, and a repeatable medtech sales motion.
Stage 1 — Pre-clearance evidence
Design your pivotal trial with reimbursement in mind, not just regulatory approval. Endpoints that satisfy FDA may be invisible to payers.
Stage 2 — Clearance to first 10 sites
First 10 implanting sites are not a sales target — they are an evidence factory. Pick centers that will publish, present, and recruit peers.
Stage 3 — Coverage and coding
CPT or HCPCS pathway, Category III to I migration plan, MAC engagement, and commercial payer coverage policies. None of this is optional.
Stage 4 — Repeatable sales motion
Standard call plan, value-analysis committee package, IDN account playbook, and rep ramp curve documented and reproducible.
Stage 5 — Category leadership
Guideline inclusion, registry leadership, post-market RWE engine, and a defensible economic story versus the next entrant.
Ready to put this into practice?
We embed with HealthTech, pharma, and medical device commercial teams as growth partners — not consultants. Start with a 10-minute Trust Audit or book a discovery call.