The Medical Devices Reimbursement Market is currently navigating a complex landscape of Regulatory Adaptations. In the U.S., Medicare has introduced the TEAM (Transforming Episode Accountability Model), which covers five major surgical episodes worth nearly $18 billion annually. This model shifts the focus from unit price to "entire-episode cost optimization," pushing device makers to share financial risk with hospitals and prove the long-term cost-effectiveness of their products.

In Europe, the Medical Device Regulation (MDR) continues to influence the reimbursement landscape by requiring more rigorous clinical evidence for device certification. While these regulations ensure higher safety standards, they have also created a "regulatory lag," extending the timeline for new devices to gain both approval and insurance coverage. Manufacturers are responding by focusing on Real-World Evidence (RWE) and health economics data to accelerate negotiations with national health systems like the NHS in the UK or the G-BA in Germany.

People Also Ask:

• What is the CMS TEAM model and how does it affect device manufacturers?

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