Bioworks Event Spotlights Device Industry

By Aisling Maki

Physicians, venture capitalists, entrepreneurs, academics, government representatives and members of the Memphis area’s life sciences industry on Monday, June 11, heard Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, discuss how the center is working to become more efficient and transparent.

The event was timely, as Congress currently considers the five-year reauthorization process of the FDA. Memphis Bioworks Business Association officials said Shuren’s visit to Memphis demonstrates the importance of the city’s medical device industry to this federal reauthorization process.

“Our vision, what we should be trying to do, is to ensure that patients in the U.S. have access to high-quality, safe and effective devices of public health importance first in the world,” Shuren said.

The complimentary luncheon event at The University Club, 1346 Central Ave., was a joint session of Life Science Tennessee and Memphis Bioworks Business Association, which works to advance the bioscience industry in the Memphis region through education, advocacy and professional networking.

Life Science Tennessee is a statewide, nonprofit organization whose mission is to advance and grow the life science industry in Tennessee through advocacy, partnerships and alignment with economic and workforce development.

Before serving as director of the Center for Devices and Radiological Health, Shuren, who’s also an attorney, served as acting center director. He’s held a number of other policy and planning positions since first joining the FDA in 1998.

A board certified neurologist, Shuren also served as assistant professor of neurology at the University of Cincinnati, and previously served as director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services.

He said CDRH’s vision is to for the U.S. to be the global leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety.

The center is focused on quickly identifying poor-performing devices, accurately characterizing real-world performance and facilitating device approval or clearance.

CDRH also wants patients and caregivers to have access to understandable, science-based information regarding medical devices and to help make informed health care decisions.

Shuren said the organization is trying to create “culture change towards greater transparency, interaction and collaboration,” and to “ensure that our recommendations and decisions are consistent and predictable … .”

That transparency includes listing all the center’s current initiatives and recent actions at CDRH also provides online industry education and assistance, including online regulatory training tools and information, through the FDA’s website.

One of CDRH’s main initiatives is what it’s calling Innovation Pathway 2.0, whose goal is to shorten the time and cost to market for medical devices, especially innovative ones, and to transform how the FDA and innovators work together.

Shuren discussed the center’s updated application process, collaboration phase, clinical trials phase and, finally, market approval.

Memphis Bioworks’ next event, “Translating Spinal Research from the Lab to the Clinic,” will take place Thursday, June 14, at 5 p.m. at the Memphis Bioworks Conference Center, 20 S. Dudley St.