With such variations, manufacturers must carefully consider regional reimbursement mechanisms during new product launches. Customizing commercial strategies to local reimbursement policies and processes is imperative for successful access. However, frequent reforms and ambiguities often pose challenges, especially for innovative technologies facing uncertain coverage decisions.

Shifting Focus to Real-World Health Outcomes

Traditionally, regulatory approvals and Medical Devices Reimbursement for medical devices were primarily based on data from clinical trials. However, payers are increasingly demanding evidence on real-world effectiveness, safety, and cost-impact beyond initial clinical studies. This shift reflects the need for long-term performance data on technologies post- approval and commercialization.

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