PROJECT DESCRIPTION FOR PROSPECTIVE
Development and commercialization of new medical technologies have great promise for improving health care. The current realities of the US health-care system dictate, however, careful attention to costs in addition to quality of care. Participants in the commercialization process for new medical devices—payers, providers, and manufacturers—express various concerns about how well the process currently functions. Payers and providers, for example, often find that evaluating the benefits and risks of new devices takes substantial resources and that available clinical information is inadequate to make informed coverage, medical necessity, and payment decisions. Manufacturers are concerned, for example, that difficulties and delays of payers and providers in evaluating new devices for coverage impede market acceptance of medically valuable technologies and thereby undermine incentives to innovate.
The purpose of the project is twofold. First, we seek to understand current processes of managed care organizations for making coverage, medical necessity, and payment decisions, and how device developers and manufacturers prepare for and participate in these processes. Second, we seek ways to improve the processes by which new medical technologies are developed, evaluated, and adopted or rejected for coverage. It is expected that manufacturers, the managed care industry, and consumers could all benefit from this effort.