See more of the story

Medtronic has tapped Scott Cundy, a regulatory official from one of the industry's largest life sciences companies, as its new chief quality officer. The move comes in the wake of the Minneapolis-based medical device maker dealing with an atypically high number of serious recalls over the past two years.

Medtronic CEO Geoff Martha announced the hire on LinkedIn this week.

"His robust background in product quality, engineering and regulatory — along with deep executional experience and operating rigor — will enable us to continue the crucial and impactful work underway in safety and quality," Martha wrote.

Medtronic was hit with 23 Class I recalls from the U.S. Food and Drug Administration in 2021 and 2022. The FDA assigns Class I status to recalls of devices which could cause "serious injuries or death."

Cundy has been vice president of quality, regulatory and clinical affairs for Danaher Corp.'s life sciences and diagnostics platforms for the past two years; he has been with the company since 2010.

Washington, D.C.-based Danaher, a conglomerate with more than 20 operating companies, is at a scale on par with Medtronic. For 2021 Danaher reported revenue of $29.5 billion. Medtronic saw sales of $31.7 billion for its fiscal 2022 that ended in April.

Cundy, who started in his new role on Monday, previously worked for Medtronic in a regulatory role for 10 years before departing in 2010.

Industry watchdog Diana Zuckerman said bringing in a new chief quality officer is an encouraging sign for patients and providers who have concerns about medical device safety.

"I think the issue here is when the company has a lot of recalls, it's embarrassing to the company," said Zuckerman, president of Washington, D.C.-based National Center for Health Research, a nonprofit think tank that works to improve the safety and effectiveness of medical products.

"It makes perfect sense to make a change that, at the very least, shows the company is taking it seriously," she said.

Medtronic previously established a central medical safety organization and added a patient safety and risk board. The board includes senior leaders from several departments — medical safety, quality, regulatory and legal — and provides oversight for patient safety decisions. Those steps, taken to address the recall issues, were implemented in 2022.

Noel Colón, Medtronic's previous chief quality officer, has now moved into a newly created role as senior vice president for research and development productivity.

Erika Winkels, a spokeswoman for Medtronic, said that the company is seeing results from its efforts to make improvements.

"Noel's strong leadership and partnership with Laura Mauri, chief scientific, medical and regulatory officer, has enabled us to reimagine our approach to patient safety and quality," Winkels said. "We are seeing meaningful progress across the enterprise with our quality improvement plans."

Medtronic received a warning letter in December 2021 from the FDA over how its diabetes business unit handled complaints, assessed product risks and dealt with recalls for some insulin pump devices.

The company says that it has addressed those issues and awaits a review from the FDA.

"We've now completed 100 percent of our warning-letter commitments and have welcomed the FDA for reinspection to review our current status," Winkels said.