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Two Roads, One Plan: Aligning FDA and Reimbursement from Day One
Regulatory approval and reimbursement are often treated as separate considerations, but the decisions you make for one shape your success with the other. FDA decides whether your device can be marketed. Insurers, hospitals, and physicians decide whether it will be bought, used, and paid for. Each decision maker requires different evidence, so a plan built only for FDA can leave you without what you need to succeed commercially.
The best time to align these paths is early, while your device is still at the idea or prototype stage. That’s when changes are easiest and cost the least. This session covers the basics and needs no prior experience in either area:
- Regulatory basics: The main FDA pathways and what each one asks of you
- Reimbursement basics: The three parts of getting paid (coding, coverage, and payment) and who makes each decision
- Where the paths connect: How choices like your intended use, study design, and evidence plan affect both FDA and payers
- Why planning together matters: How early alignment can help you avoid repeat studies and delays, and give investors a clearer, more credible plan
SPEAKER
Tonya Dowd
Executive Vice President, Reimbursement, Health Economics, Market Access, and Corporate Development
Pria Healthcare
SPEAKER
Kristofer Munroe, JD
Director of Compliance, Reimbursement, Health Economics, and Market Access
Pria Healthcare
SPEAKER
Sam Murray
Head of Regulatory and Quality kjsfhkshfkshedflkhslkhdlhvgdlvgjkdlfvg
Pria Healthcare
SPEAKER
Ryan Nolan
Senior Director of Reimbursement, Health Economics, and Market Access
Pria Healthcare
MODERATOR
Suzy Engwall
Senior Director, Global Business Development and Strategic Growth
Pria Healthcare
December 3, 2026 | 12:00 PM-1:00 PM
This session will be hosted via Zoom (a link will be provided upon registration).