Why Regulatory and Reimbursement Strategies Must Align
Synchronizing regulatory and reimbursement strategies for medical devices is essential for successful commercialization. Over the last 15 years, we guided more than 200 biomed companies in aligning FDA approval pathways with payer reimbursement requirements.
Too often, regulatory decisions are made without considering reimbursement objectives. This misalignment can delay coverage decisions—or, in some cases, prevent reimbursement entirely—despite successful regulatory approval.
Key Steps to Synchronize Regulatory and Reimbursement Plans
This article outlines a medical device reimbursement process, detailing when to initiate regulatory and reimbursement activities to support successful commercialization.
Medical Device Reimbursement Services by Country
About the Author
