Stage 05 · Medical Device Track

Commercial & Reimbursement

Decide how the device gets paid for, prove its value, then build the launch.

A device that doesn't get reimbursed doesn't get used, regardless of clearance. Stage 05 starts with the reimbursement decision — coding, coverage, payment — because every downstream commercial assumption depends on it. The Health Economics & Value Dossier then translates the reimbursement strategy into the formal evidence package payers actually use to make coverage decisions. The Route to Market Strategy synthesizes both into a channel, pricing, and launch sequencing plan that closes the loop back to the funding roadmap.

Cards below are arranged in chronological use order. Step numbers reflect the recommended sequence; an experienced practitioner may interleave or revisit cards as needed, but a first pass through this stage should follow the order shown.

Step 1

Active

Reimbursement Strategy

Coding (existing CPT, Category III, miscellaneous J-code), coverage (which payers, what evidence), payment (RVUs, hospital outpatient, ASC, physician office). Coverage evidence development plan.

Launch Tool

Step 2

Active

Health Economics & Value Dossier

Budget impact model, cost-effectiveness analysis, AMCP-format value dossier. The deliverables that payers actually evaluate coverage decisions on. Computes ICER vs. willingness-to-pay thresholds in real time; writes ICER and budget-impact-per-life back to project so Route to Market's Pricing Strategy and the Pitch Deck can consume them.

Launch Tool

Step 3

Active

Route to Market Strategy

The complete Stage 05 commercialization deliverable. Channel archetypes, pricing strategy (anchored on the Workspace novelty statement), unit economics, launch sequencing, three-tier KOL pyramid and target-account model, GPO/IDN strategy, geographic rollout, and structured training program curriculum. Subsumes what used to be a separate Commercial Launch Plan.

Launch Tool