Talk
Approved everywhere, paid nowhere; building evidence strategies that win both regulators and payers
Wed, Jan 28, 2026 · 10:00–10:30 AM CET Holiday Inn Munich City Centre
About this session
Medtech innovators increasingly face a paradox: devices that achieve regulatory success under MDR, FDA, or the AI Act still fail to secure EU HTA endorsement, CMS coverage, or global payer adoption. This session reveals how to engineer evidence strategies that bridge this gap, ensuring that what is clinically compelling also becomes economically undeniable.
We will outline how to design reimbursement-ready clinical programs that anticipate payer requirements without duplicating effort; how to build integrated regulatory-clinical pathways that satisfy Notified Bodies, FDA reviewers, AI Act constraints, and HTA evaluators; and how to leverage PMCF/PMPF, real-world data, and economic modelling to translate regulatory clearance into coding, coverage, payment, and sustainable market access.
Through cross-market case studies and practical frameworks, attendees will learn how to convert approval into adoption, scale, and lasting commercial success.
Speaker
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