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U.S. Department of Health and Human Services

About FDA

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Research Project: Manufacturing Effects on Drug Release

Contacts: Ken McDermott and Dave Saylor 

Researchers in the Active Materials Lab have developed methods to improve manufacturing quality control to reduce failures of medical devices post-implantation.  This work is providing industry and FDA regulators the tools needed to improve manufacturing quality and methods of testing the final product to provide optimum drug release from implants so they function properly and do not injure the patient.  This involves a multi-billion per year industry and life saving implant devices crucial to the survival of the patient. 

The investigators have designed computational and lab bench methods to predict the effects of manufacturing variations and design on the controlled delivery of drugs from cardiovascular stents and other products.  These new methods clarify relationships between drug structure, processing, and performance in quantitatively consistent ways.  They have been shared with manufacturers of drug eluting stents to promote the innovation of new, reliable products.