REGULATION & ACCESS
Clear the path to payment
OVERVIEW
The FDA proves you’re safe and effective. CMS and payers decide whether you get paid. We make sure your evidence answers both — the first time.
Coverage, coding, and payment are where cleared products stall, and the reason is almost always evidence: the data that satisfied the FDA isn’t the data CMS, commercial payers, or coding bodies need to say yes. We map those requirements before you generate evidence — not after — so you don’t discover the gap in a denial letter. Led by Dr. Steven Farmer, former CMS Chief Strategy Officer for Coverage, our team helped set the standards you now have to meet.
This is where evidence starts — and it’s the same asset that later powers adoption, designed from day one to do both jobs
WHAT WE DO
Get covered, coded, and paid.
Evidence Strategy Review
A clear map of what the FDA, CMS, commercial payers, and coding bodies will each require, measured against the evidence you already have, are gathering, and plan to gather. We find the gaps before they force costly repeat studies — so you generate evidence once, and generate it right.
Regulatory & Reimbursement Review
A landscape read of your coverage, coding, and payment path across Medicare, Medicaid, and commercial payers — with federal-payer strategy and a plain-language FAQ, informed by former FDA and CMS advisors. Paired with a market and product assessment.
On the roadmap
FDA and CMS submission support and CPT code development, in development with our regulatory team.
Who it’s for:
Founders and scale-ups generating clinical evidence, enterprise device manufacturers aligning evidence across a portfolio, and the investors who need to know a product is reimbursable before they commit.
Non-US early-stage device founders