A strategy for integrating regulatory, reimbursement and outcomes research functions for effective market introduction of medical devices in the USA / DFAIT

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Achieving rapid market penetration and fair pricing for innovative medical technology In today's cost- conscious U.S. healthcare
environment neceseitates a strategic approach to product development. While Food & Drug Administration (FDA) approval is
adequate to establish product safety, healthcare coverage decisions made by payera such as Health Care Finance
Administration (HCFA) or managed care plans are increasingly based on evidence of clinical effectiveness and improved patient
outcome not to mention value and cost of delivery.