Session (CTI)

As medical device and diagnostic companies face growing expectations to demonstrate the value of their technologies to regulators, payers, and providers, the role of Health Economics and Outcomes Research (HEOR) has become more critical—and more multifaceted—than ever. In the MedTech space, HEOR must move beyond traditional cost-effectiveness analyses to encompass a broader set of capabilities, including measuring operational impact, quantifying human factors, and innovating methods to generate patient-centered evidence. These evolving demands also call for effective cross-functional collaboration with regulatory, clinical, and market access teams. This forum will explore how HEOR professionals can build and apply the capabilities needed to succeed in the MedTech sector, using the ISPOR HEOR Competencies Framework as a foundation. Two complementary approaches will guide the discussion: a conceptual review of the framework itself and a practical perspective grounded in project-based experience and organizational needs. Mitch Higashi (ISPOR) will open the session by reviewing the Competencies Framework and its 13 domains, drawing from his own experience as an HEOR professional and leader to reflect on how these competencies align with—and may need to evolve for—the realities of MedTech. Dr. Wherry, an HEOR leader from a MedTech company, will share examples of how real-world evidence (RWE) has been used to quantify value—such as avoiding prospective studies when RWE supports regulatory or reimbursement decisions, and accelerating patient access through evidence-driven strategies. The moderator will provide concluding remarks and open the floor for questions during the final 10 minutes of the session.