UPDATED: Medtronic’s Regulatory Chief to Retire

Susan Alpert, M.D., Ph.D, senior vice president and chief regulatory officer at Medtronic, Inc., is retiring from the medical device giant when its fiscal year ends later this month. She will stay on with the company as a consultant.

Alpert joined Medtronic in 2003 and has held these positions since 2005.
“Being the innovator in a changing regulatory world is hard,” Alpert told Medical Product Outsourcing of her time at Medtronic. “Breaking molds is hard.”

During an interview with MPO, Alpert discussed some of the biggest challenges she faced during her tenure at the company including changes in the regulatory environment and the impact the U.S. Food and Drug Administration’s (FDA) focus on quality has had on the product development process.

“Large organizations that are well engaged are often hard to move,” Alpert said. “We have, however, put in place processes that will keep Medtronic prepared for whatever comes globally in the regulatory environment moving forward.”

Brian Henry, a spokesman for the Minneapolis, Minn-based firm, praised Alpert for both her service and knowledge of the device industry. “It’s been an absolute pleasure working with [Alpert]. Her knowledge of the industry, of regulatory agencies and of the importance of collaboration between the two for the benefit of patients, is unsurpassed. Her guidance and counsel have been extremely valuable and we’re pleased that she plans to continue to offer both in her retirement.”

Though her role with Medtronic officially changes on April 29, Alpert is not planning to rest on her laurels once she retires. She told MPO that she still plans to remain active in the industry and voice her opinions about the issues impacting the device sector.

“It seems to me the best way to retire is to ease into it slowly, so you can still expect to hear from me for awhile,” said Alpert, adding that she is complying with Medtronic’s mandatory retirement age requirement. “I plan to continue to work with the industry as we negotiate the next round of use fees with the FDA. I’m going to stay engaged with the 510(k) changes, as well as the regulatory changes being planned for the EU [European Union].”

Those are not the only issues Alpert plans to tackle in her retirement, though.

“The one [issue] we continue to face is that many regulators and other stakeholders are still not recognizing that the device industry is not pharma,” she said. “We are a very different industry with different needs and costs and different ways of serving patients. Because many companies are small the issues are not seen as large—but they are.”

Prior to joining Medtronic, Alpert, who also is a microbiologist and pediatrician, was vice president of regulatory sciences at Murray Hill, N.J.-based C.R. Bard, Inc. Alpert also held various positions with the FDA, including six years as the director of the office of device evaluation.

Alpert has served on various committees, including the board of the Food Drug Law Institute in Washington, D.C., the Medical Technology Leadership Forum in Indianapolis, Ind., Women Business Leaders, and the Clinical Trials Transformation Initiative, a public–private partnership between the FDA and Duke University to identify practices that will increase the quality and efficiency of clinical trials. Alpert also is a past chair of the Regulatory Affairs Professional Society and a fellow of that organization.

Alpert’s experience enabled her to witness countless changes in the industry. “When I started, regulation on medical devices was not a front-line topic,” she said. “It wasn’t even considered to be very important inside or outside of the [FDA]. Today, regulators, healthcare professionals and patients around the world are engaged in discussions about devices, their impact on public health, their pathways to market and what we learn about products after they are distributed. It’s a huge change. The advantage of this change is that there is a greater understanding and awareness of how medical devices improve the quality of life for people every day. All of the stakeholders are interested in continued advancement of these technologies in order to extend and restore healthy lives.”

Medtronic is considering Regulatory Affairs Vice President Patricia Shrader for Alpert’s replacement.