Not long ago, the U.S. Food and Drug Administration (FDA) clearance process was the golden ticket for successful commercialization of new medical technologies in the United States, a route that many companies put significant energy and resources into. However, this has shifted dramatically over the past several years, attributable in part to the Patient Protection and Affordable Care Act (PPACA) of 2010—or what is often referred to as ‘Obamacare’.

While there have been many recent changes surrounding PPACA , hospital system consolidation, physician mergers and foundational changes—in addition to the manner in which health care is delivered today—the industry shows no signs of shifting to a pre-PPACA paradigm. As a result, medical technology companies must understand the impact of Value-Based Purchasing, Alternative Payment Models and hospital and physician incentives in order to position their technologies for market success.

This White Paper seeks to identify many of these demands as global device manufacturers act to better manage increasing costs for aging populations amid frequent technological innovations, while also addressing rising pressures of government and employer healthcare budgets. Learn how a carefully developed reimbursement strategy that addresses current market dynamics can lead to successful device commercialization.

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