Getting to Yes from Regulators to Payers and Beyond - the Decision-Maker Gauntlet
Regulatory, Quality and Good Manufacturing Practices
Industry, FDA and patient groups recognize the importance and value of patient input in the ideation, design, testing and approval of new medical device technologies, but often struggle to elicit and incorporate patient input in a meaningful way. Patients can identify outcomes that are meaningful, risks that they would be willing to tolerate, and practices that can decrease the burden of participation in clinical trials. Attendees at this session will learn about an MDIC collaboration that includes medical device industry, patients and regulators, to develop a suite of tools to help medical device companies solicit input from patients and patient groups on clinical trial design elements that are aligned with patients’ real-world priorities.