Convergence of two disparate fields – what are the FDA regulatory implications? What about the key reimbursement issues?

Convergence is one of the most exciting trends in the medical device industry. Convergence of drug and device technologies has led to enormous and ground breaking opportunities such as the drug eluting stent, arguably one of the most successful medical devices in the history of the industry. Drug device combinations, however, are only an example of the myriad of convergence opportunities; other examples include wireless-life science, and semiconductor-life science convergence opportunities. Despite the intriguing new possibilities that convergence offers, it is also uncharted territory with respect to some of the key issues that impact the successful adoption of new medical device platforms, such as regulatory and reimbursement policy issues.

A large non-medical company set out to converge their core technical expertise to solve key life science issues; however, in the absence of any significant experience in the life science industry, the FDA regulatory path and reimbursement strategies posed significant uncertainties (and risk) to their development plans. SI was engaged to conduct a detailed analysis of product platforms that had gone before the FDA with relevant functionality and intended use, and crafted a comprehensive analysis and strategy for FDA approval of the newly conceived convergent platform technology. Insiders within the FDA were interviewed for an informal confirmation and validation of the key conclusions and recommendations of SI’s strategy. A similar process was followed to map out the key coding, coverage, and payment issues pertaining to the reimbursement strategy. SI’s thorough analysis provided the executive management of the client company a strong sense of confidence around the feasibility, cost, and timeline of obtaining regulatory approval, and the most likely reimbursement scenario for their new convergent life science product platform.