1A: PANEL: The Synergy of Science and Medicine in Advancing CMS Objectives: Translating Biomaterials into Market-Ready Regenerative Devices

A significant barrier to the successful commercialization of medical devices lies in the limited understanding of market valuation, supply chain management, and Medicare reimbursement. Biomaterials scientists should play a more prominent role, alongside clinicians, in shaping regulatory policies to ensure fair and accurate valuation. Without their expertise, there is a substantial risk of device mispricing, which can limit both their clinical impact and the broader influence of the biomaterials field.

To strengthen our professional community and elevate the standing of our organization, it is essential for scientists to actively engage in the commercial and regulatory landscape.
This objective will be addressed through an open panel discussion aimed at identifying and analyzing key challenges faced by developers of biomaterial-based medical devices. A particular focus will be on the difficulty of conveying advanced scientific information to payers such as the CMS, which currently rely predominantly on clinical input, with minimal involvement from biomaterials scientists.

Moderators:

Dr. Subramanian Gunasekaran
BMPC SIG, SFB
President, Encoll Corp

Murugan Gunasekaran
VP Sales & Marketing
Encoll Corp