With high-profile failures of products such as metal-on-metal hip implants in the news and consumer advocates clamoring for safer medical devices, risk management is a topic that has been getting a lot of attention from FDA lately.

“At this point in time, FDA is extremely interested in risk management as a technique to better protect the public health,” says Michael Barile.

Barile, the founder and managing partner of Barile & Associates, a consulting firm that provides advice to FDA-regulated industries, is chairing a two-day track on risk management at this year’s MD&M East conference. The two sessions will cover topics ranging from risk management concepts, terminology, and regulatory requirements to supplier and post-production controls.

The first day’s session is a workshop on ISO 14971:2007. It will focus on introducing attendees to the requirements of the standard as well as detail FDA’s expectations for its integration into a quality management system.

“We’ll do real case studies with the group, selecting certain types of devices and walking through preliminary risk assessments, failure mode and effects analysis, fault tree analysis, path sets, and cut sets,” Barile says.

The workshop, he says, will be highly interactive, and attendees are encouraged to come with questions.

“It’s pretty informal,” Barile says. “If you put your hand in the air and I don’t see it immediately, wad up a ball fo paper and just throw it at me.”

The second day will focus on the real-life ramifications of risk management and how to integrate risk managment into a quality system.

Both sessions are geared toward a broad range of job functions, from manufacturing, quality, and design engineers to those working in regulatory and clinical affairs, Barile says. Professionals in engineering-level, supervisory, and senior management positions will come away with knowledge that will help them better do their jobs.

“Risk Management for Medical Devices: Applying 14971 Effectively Using Risk Assessment and Reliability Tools” and “Beyond Basic Risk Management: How Much is Enough?” will take place Wednesday, May 23, and Thursday, May 24, respectively. Both sessions run concurrently from 9 a.m. to 4 p.m.

—Jamie Hartford