How Product Development Can Be Influenced by U.S. Reimbursement Mechanics
Published on: 04/11/2025
Learn how U.S. reimbursement mechanics—coding, coverage, and payment—should shape MedTech product design, trials, and launch strategies.
Payer CoverageEvidence Planning
Comparative Effectiveness for AI MedTech
Published on: 04/09/2024
Why comparing your AI MedTech solution to the status quo isn’t enough for payer approval.
Evidence Planning
The World After FDA Clearance: From HOORAY! To WAIT, WHAT?
Published on: 20/08/2024
FDA clearance is a milestone—not the finish line. Why reimbursement hurdles follow right after.
CommercializationFundamentalsFeatured
Wow. TCET Actually Happened.
Published on: 14/08/2024
A breakdown of the finalized TCET rule and what it means for Breakthrough Devices.
Payer Coverage
