Annie Kennedy

Flipping the Script: Designing the System to Deliver for Patients

Annie Kennedy, Gigi Hirsch, Marcus Schabacker, Andy Schmeltz, Jeffrey Shuren, Marcus Wilson

Leaders from patient advocacy groups, regulators, and industry convened to address critical misalignments between regulatory data standards, payer requirements, and patient outcomes, driving a shift toward patient-led research and value-based care models. Through collaborative frameworks like FDA's Patient and Caregiver Connection and MIT's learning health systems, stakeholders are overcoming data fragmentation by integrating real-world evidence into device approvals and reimbursement decisions. This collective effort establishes a new paradigm where patient preferences directly influence benefit-risk assessments, ensuring medical innovations effectively reach the right patients at the right time while promoting equitable access.