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Stanford researchers publish comprehensive model for medical device development
Date:6/29/2009

maceuticals, and the corresponding differences in their development processes and regulatory requirements. Such variations have dramatic downstream effects that distinguish the capital requirements, product development methods, clinical testing requirements, manufacturing methods, and overall life cycle for products in the two sectors.

"Drug-device differences underscore challenges associated with developing combination products, such as drug-eluting stents, which play an increasingly important role in healthcare innovation," says Pietzsch. "It is our aim to contribute to a greater understanding of such differences, particularly as policymakers and regulators work to design the least burdensome approaches to medical device regulation."

The article emerged from research performed by the authors as part of a study, "Medical Device Development Models," funded by the Institute for Health Technology Studies (InHealth). A review of the background, mission, and statutory requirements for medical device regulation in the United States was published by the authors in the December 2007 issue of the Journal of Medical Devices.


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Contact: Robyn Stein
Robyn.Stein@gabbe.com
212-220-4444
InHealth: The Institute for Health Technology Studies
Source:Eurekalert

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