• January 2019

    Dallas Leipzig 2018: The promising future of medical device regulation and innovation

As medicine and technology evolve, understanding what moves a field forward becomes more than informational — it becomes critical. Leaders from industry and academia stressed this point during a panel discussion at the Dallas Leipzig conference and shared their insights on the interplay between regulation and innovation, and how changes underway could impact the U.S. device market.

The panel of experts assembled included:

  • Neil Moat, MD, Abbott Structural Heart, DVP Medical Affairs and CMO
  • Alexander Haak, Ph.D., Philips Health Systems North America, Clinical Scientist
  • Samuel Conway, MD?, Boston Scientific – VP of Interventional Cardiology, Senior Vice President of Sales at Boston Scientific
  • Karim Bandali, MD, Medtronic, VP Global Marketing & Service, Cardiac Surgery
  • Larry Wood, MD?, Edwards Life Sciences, Corporate Vice President of Transcatheter Heart Valves
  • Michael Mack, MD, Baylor Scott & White Health, Chair of the Cardiovascular Council
  • Martin Leon, MD, Director, Center for Interventional Vascular Therapy, New York Presbyterian/ Columbia University Medical Center

FDA Embracing Innovation with Shifts in Medical Device Regulations

In recent years, the United States Food and Drug Administration (FDA) has shifted to embrace innovation around medical devices. The regulatory body has taken steps that demonstrate a growing support for early feasibility studies, working with different groups to re-examine processes and protocols to gain regulatory approval. The common sentiment among panelists during this discussion was that this new early feasibility approach has been very helpful in bringing new therapies to market and addressing key areas for patient care.

Meanwhile, the European Union Medical Device Regulation (MDR) has made changes that will do the opposite in Europe.

Within the EU, safety issues with previously approved medical devices have made earning CE mark certifications that confirm that it meets European Economic Area (EEA) standards increasingly difficult to achieve. As a result, new regulations are aimed at creating a more modernized and robust EU legislative framework to ensure better protection of public health and patient safety. The new guidelines will be fully enforced in 2020.

Panelists agreed that this is a seismic shift. Ten years ago, European physicians were using medical devices that would not be available in the U.S. for several years. That gap had been closing, but now with the new EUMDR framework, the situation is reversing.

Experts on the panel were quick to emphasize that the FDA has not lowered its standards. Rather, the FDA has opened the door to accepting strong preclinical data and early feasibility clinical studies, making the regulatory process around bringing new therapies to market much smoother.

While these shifts are promising for U.S. innovation culture and patient care, it is important to note that work remains on fully-updating processes and guidelines. The bench testing side, for example, remains at a pace behind what many in the industry desire. Updated pathways are still being discussed and implemented by the FDA, so biocompatibility testing and things that need to be done before starting clinical trials remain a few steps behind clinical work.

Given past issues with medical devices such as breast implants, the FDA will remain involved in early feasibility studies as devices progress to market and with post-market surveillance. Despite the enthusiasm and optimism about the current U.S. regulatory climate, panelists did caution that the system is fragile, and everyone must work to keep it on its current course. Political circumstances, pressures from the media and other sources can all evoke change and create unpredictability, but the panel is hopeful that the FDA will continue to support new innovation and early studies.

The FDA is actively engaging medical professionals, device makers and other parties to understand the issues that make it difficult to introduce medical device trials and offerings to the market.

The panelists recognized that the success experienced to date has been the community — the ecosystem with industry, regulatory environment and academic participants like physicians, scientists and operators who are moving the field forward. And this community collaboration would be necessary to achieve what they have ultimately set out to improve.

How Artificial Intelligence is Shaping the Future of Medicine

The evolution of technology and data were recurring themes during Dallas Leipzig. Artificial intelligence (AI) in particular was a topic consistently coming up in sessions and amongst attendees. AI will dramatically change the way medicine is practiced in the next 10 years, in terms of how information is assessed and how technology is implemented, but also in terms of how clinical trials can be conducted.