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.

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Title (French)	Une stratégie d'intégration des questions de réglementation, de remboursements et des résultats des recherches, pour réussir à introduire avec succès des appareils médicaux sur le marché des États-Unis / MAECI
Update Frequency	not_planned
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Sensitivity Level	unrestricted
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Contact Email	opengovernment@international.gc.ca
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Open Canada Date Published	1999-01-01 00:00:00
Open Canada Date Modified
Open Canada Subject	["economics_and_industry", "government_and_politics", "health_and_safety"]
Open Canada Keywords	{"en": ["Government of Canada Publications", "United States", "Medical devices"], "fr": ["Publications du gouvernement du Canada", "États-Unis", "appareils médicaux"]}
Open Canada Collection	publication
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