RAPS panel discussion

Medtronic hosts timely discussion at annual regulatory event

Medtronic Corporate Regulatory group leads first-ever ‘Innovation and Technology Panel’ at the 2016 RAPS Regulatory Convergence. 

SEPTEMBER 2016 – Medtronic left its mark during one of the year’s most important regulatory affairs events.

Annually, the Regulatory Affairs Professional Society (RAPS) brings together regulators, healthcare experts, business leaders and regulators for the RAPS’ Regulatory Convergence held, this year, in San Jose, California.

One of the main events at this year’s conference was a first for Medtronic. The company led a unique panel discussion centered on healthcare innovation and technology and its intersection with regulatory affairs. The panel featured leaders, not only from Medtronic, but from the FDA, Google and 23andMe. 

Michael Morton, Medtronic

“Medtronic has a history of working with regulatory authorities to address regulatory challenges,” said Michael Morton, the vice president of Corporate Regulatory Affairs for Medtronic and the panel moderator.  “This event provided a forum to bring leading innovators together with a leading regulator in a public discussion.”

And there is plenty to talk about in the rapidly evolving med tech sector. Today, medical devices perform a variety of tasks like integrating with consumer electronic products. For example, products like heart rate monitors, which originated in the medical device industry, have become off-the-shelf consumer fitness products.  Even software itself could be considered a medical device in some cases.

These examples illustrate the need for the industry representatives, innovators and regulators from all over the world to come together and discuss the best ways to move.

“We need to be prepared for this,” Bakul Patel told the crowd during the panel discussion. “

Patel is the FDA’s Associate Director for Digital Health and reaffirmed the need for strong partnerships.

“We need to have a collaborative environment to help get us to the next level,” he said. “The bottom line is how are we going to get these exciting technologies - that will change how we think about healthcare - safe to use.”

The panel reinforced the need to create meaningful innovation in a constantly changing digital health landscape.

“Patients are becoming more accustomed to rapid iteration in consumer electronics and they’re expecting the same for their new connected medical devices,” says Morton. 

Dr. Fran Kaufman, Vice President of Medical Affairs for Medtronic Diabetes, was part of the panel and focused on clinical implications of the ever-changing connectivity platforms in diabetes management. She believes that the healthcare industry is looking for a clear roadmap as more and more medical devices are integrating with consumer devices, sophisticated algorithms and large amounts of patient data.

“The user experience continues to matter more and more,” she says. “As a physician, I see that my patients are consumers first and that requires a change in paradigm as to how these individuals are approached and treated.”

More than 2,000 people attended the discussion which also featured regulators from other important jurisdictions such as Latin America, the Middle East, and China, to name a few.

“Medtronic is looking to transform healthcare with new partners,” said Morton. “We are recognized as a leader in medical devices, but these discussions are important as we also become leaders in healthcare solutions”.