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.
U.S. ReimbursementMedTech Product DevelopmentCodingCoverageReimbursement StrategyMedicareCPT codesHCPCSPhysician Fee ScheduleMarket Access
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.
AIAI MedTechMedicareReal-World EvidenceRWEClinical UtilityPayer ExpectationsComparative EffectivenessPolicy
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.
FDAPayer ExpectationsMedicarePayment ReadinessCommercial
Wow. TCET Actually Happened.
Published on: 14/08/2024
A breakdown of the finalized TCET rule and what it means for Breakthrough Devices.
TCETMedicareNCDCEDEvidence DevelopmentEvidenceCMSCMS Device Nomination
