Private-Public Partnership between FDA and Device Industry Kicks Off Inaugural Meeting

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Understanding that collaboration is the best path forward, the FDA and Minnesota trade group LifeScience Alley came together in Minnesota back in August 2011 with a desire to create a unique public-private partnership that would look at the issue of regulatory science.

Regulatory science is a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices. That intent was cemented when the Medical Device Innovation Consortium was formed more than a year later in December 2012. The goal of the partnership is to facilitate a path for novel, innovative medical devices get early and speedy assessments through funding projects that will benefit the industry as a whole.

On Tuesday the group announced that it has held its first official board of directors meeting in addition to naming board members. The group's chairman is former Medtronic CEO William Hawkins III, currently, president and CEO of Immucor. 

"The MDIC is up and running and is seeking new members and partners to help put our projects into operation," said Bill Hawkins, in a MDIC news release. "We are putting structure and processes in place to engage stakeholders in tackling specific issues that have the ability to advance the tools used to evaluate and approve medical devices."

At the inaugural meeting, the board identified three initial project areas that the group will take up - clinical trial reform, computer modeling and simulation and patient centeredness/risk management. The board also plans to hire a full-time executive director. Previously another former Medtronic executive Maura Donovan was the interim executive director. Now that role will be filled by Dale Wahlstrom, president and CEO of LifeScience Alley, also a board member.

Allan Coukell, deputy director of medical programs at The Pew Charitable Trusts, will be serve as the group's vice chair; Michael Minogue, president, CEO and chairman, Abiomed will function as secretary; David Perez, president and CEO, Terumo BCT, will be MDIC's treasurer.

CDRH director Jeffrey Shuren is a board member of MDIC.

"The FDA is committed to working with all constituents in the medical device community to improve the health of patients through the availability of innovative and life-saving technologies," Shuren said in the news release.  "Working in the pre-competitive space gives us the opportunity to share vital resources that can advance regulatory science to help bring important, safe and effective devices to patients and providers more quickly and at lower cost."

Besides Shuren who represents the FDA, here are other board members that bring different perspectives by virtue of their professional affiliations:

Glenn Criser, senior vice president, quality, regulatory and clinical affairs, Biomet Inc.

Vincent Forlenza, president, CEO and chairman, Becton, Dickinson and Co 

Kathy Hudson, PhD, deputy director of science, outreach and policy, National Institutes of Health (NIH)

Tamara Syrek Jensen, JD, deputy director, coverage and analysis group, Center for Medicare & Medicaid Services (CMS)

Richard Kuntz, MD, senior vice president and chief scientific, clinical and regulatory officer, Medtronic Inc.

Dee Mellor, chief quality officer, GE Healthcare; 

Daniel Moore, president and CEO, Cyberonics Inc. 

Ross Jaffe, managing director, Versant Ventures and representing the National Venture Capital Association (NVCA) 

Peter Saltonstall, president and CEO, National Organization for Rare Disorders (NORD) 

Randall Schiestl, vice president, research and development and global technology, Boston Scientific Corp.

Dale Wahlstrom, president and CEO, LifeScience Alley and The BioBusiness Alliance of Minnesota 

Nadim Yared, president and CEO, CVRx Inc.  

-- By Arundhati Parmar, Senior Editor, MD+DI

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