5A: PANEL: Navigating Commercialization Challenges of Medical Devices from a Scientist’s Perspective

Given the challenges researchers face when bringing a medical device to market, it’s essential to understand how Medicare determines its real-time commercial value for these products.   To address this, it is essential that Scientists specializing in Biomaterials take a more prominent role in shaping regulatory policies, alongside Clinical Experts on the Relative Value Scale Update Committee (RUC).  The prevailing technical misconcepts in the evaluation have to be addressed. Further, their expertise is vital for accurate assessment and avoiding the undervaluation of Biomaterial Devices. Incorporating scientific perspectives into these processes not only amplifies the impact of Biomaterial Scientists but also enhances the credibility and influence of our Society for Biomaterials.  By gaining a deeper understanding of commercial and regulatory dynamics, Scientists can make significant contributions to the field and strengthen our professional reputation.  Additionally, improving the commercialization of medical devices can be achieved by acquiring knowledge in supply chain management and Medicare reimbursement processes.