RAPS Texas Chapter: Communicating Benefit-Risk Is Fundamental to Device Approval and Market Adoption

Come engage with professionals from your local regulatory community over dinner and hear an interactive presentation on communicating benefit-risk analysis seeking approval of a medical device. This event is coordinated by the RAPS Texas Chapter and is intended to encourage knowledge sharing and community development. A meal will be provided. RAC holders may claim 1.5 RAC recertification credits.

While demonstrating safety and effectiveness is important, sponsors may be missing an even more important question. That is, “Does the benefit outweigh the risk?” The FDA guidance on Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications provides clear direction from FDA on the framework for assessing benefit-risk.

Developing key benefit-risk messages and communicating them effectively are critical in marketing applications, advisory panels and technology assessment committees. A thorough benefit-risk assessment is the foundation for the messages surrounding unmet need, proposed indication, patient population, clinical trial results and broader clinical application. Importantly, this data can provide the cost-benefit evaluation to make reimbursement decisions. The FDA framework considers factors such as the type, magnitude, duration, and probability of benefits; the nature of adverse events and device complications; disease characteristics; patient tolerance for risk; and the availability and benefit-risks of alternative therapies.