New cardiovascular (CV) device innovation in the US and increasingly elsewhere is being subjected to new economic and regulatory pressures as a result of rising health care costs. CV new device research and development is enormously expensive and risky. In the US the triad impediments to innovation are regulatory barriers related to media and public concerns about patient safety, product legal liability costs, and increasing difficulty in acquiring adequate investor funding. Added to these dynamics, bullish health system reform changes in process have dramatically increased CV physician employment by hospitals; consolidation of insurers, hospitals, and physician organizations; huge pressure to contain costs; and thus how decisions are made in terms of what devices to offer on hospital and health system formularies and how much to pay for them.
This talk will discuss the impacts of these changes on device innovation including the needs for not only comparative effectiveness research with similar agents in the marketplace, but moreover the increased pressure for cost effectiveness and economic modeling in terms of societal return on investment beyond the acute hospital care to include two or three years of post acute care costs and outcomes. Device approvals will also increasingly rely on comprehensive registry surveillance of all patients treated, rather than traditional post-approval studies, to achieve regulatory approval. Both the regulatory and the health care financing environments are in a period of rapid change. There will thus be threats to and opportunities for ongoing innovation that must be considered carefully.
