MDIC Update | April 21, 2014

 

MDIC gets 501(c)(3) approval

 

It’s official: MDIC is a nonprofit organization. The IRS last month approved MDIC’s application for 501(c)(3) status, a critical first step in MDIC’s mission to foster fruitful, public-private collaboration on early-stage regulatory science.

 

Nonprofit status is key to MDIC’s vision of creating a safe space where medical device stakeholders can share resources, data, and expertise to achieve common goals. Together, MDIC members are setting out to tackle some of the biggest challenges facing the industry, developing new methods, tools, and standards to bring safe, effective medical devices to market more quickly and at lower cost.

 

MDIC and FDA co-host symposium at Design of Medical Devices (DMD) conference

 

MDIC and the FDA teamed up to present a regulatory science symposium at the world’s largest annual medical device conference, held earlier this month at the University of Minnesota.

 

MDIC Senior Program Manager Dawn Bardot, PhD and Tina Morrison, PhD, Advisor of Computational Modeling at the FDA’s Center for Devices and Radiological Health (CDRH), co-hosted the symposium at the 13th Annual Design of Medical Devices Conference. The symposium highlighted opportunities to advance regulatory science—the study of new tools, standards, and approaches to evaluate FDA-regulated products—in an era of rapidly evolving technology. Among other challenges, presenters discussed how to establish computational modeling and simulation as valid scientific evidence, which would transform the regulatory pathway for future medical devices.

 

Michelle McMurry-Heath MD, PhD, Associate Director for Science at the CDRH, gave a capstone presentation at the symposium. Morrison and Kathryn O’Callaghan of the FDA also spoke, as did MDIC President Bill Murray and Steve Levine, PhD of Dassault Systèmes SIMULIA Corp.

 

Bardot also gave a talk at the conference on the future of computational modeling in the pre-clinical assessment of cardiac devices.

 

Women in MedTech Award honors Strahlman

 

Ellen Strahlman, MD, MHSc, a senior executive at BD received the Women in MedTech Award, an honor given for the first time this year by the Design in Medical Devices (DMD) Conference, MDIC, and LifeScience Alley.

 

Strahlman is a senior vice president and chief medical officer at BD, a leading global medical technology company. Strahlman gave a keynote address after receiving the award at the DMD Conference at the University of Minnesota this month.

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