Medical device leaders will gather in Toronto this week for Advamed’s The Medtech Conference, one of the medical technology industry’s largest gatherings. The meeting will bring together more than 3,900 people from 48 countries to discuss medtech trends and global regulatory developments.
The event comes at a pivotal moment in the medical device industry. The Food and Drug Administration is seeking a new director for its Center for Devices and Radiological Health as the former leader faces questions about conflicts of interest. New regulations governing laboratory developed tests are also being challenged in court ahead of a U.S. presidential election.
MedTech Dive will be in Toronto to cover the conference this week. Here are four trends we’re watching:
1. New CDRH leader
Leaders from the FDA’s device center will share the agency’s top priorities and field questions during a town hall on Thursday. Michelle Tarver, who was named acting director of CDRH in July, is scheduled to speak at the event. Former CDRH Director Jeff Shuren is also listed as a speaker on the agenda. Shuren stepped down this summer ahead of a New York Times report that raised concerns about potential conflicts of interest during his 15 years leading the division. Two House Democrats called for an Office of Inspector General investigation following the report, which focused on how Shuren led CDRH as his wife worked as legal counsel for medtech companies.
CDRH is searching for a permanent successor.
Other CDRH leaders speaking at the session include Owen Faris, principal deputy director of the Office of Product Evaluation and Quality; Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence; and Daniel Caños, director of CDRH’s Office of Clinical Evidence and Analysis.
2. Focus on AI
As a growing number of medical devices use artificial intelligence, regulators are sharpening their focus on the technology. Several sessions at the conference address how AI is being used in a hospital setting, how to address concerns about bias and accuracy, and how to navigate new regulations.
On Tuesday, Tazbaz and Marc Lamoureux, manager of the Digital Health Division for Canada’s Medical Devices Directorate, will speak about important considerations around AI such as ensuring data is representative and mitigating bias. They will also discuss how to navigate various requirements, including the 21st Century Cures Act in the U.S., and the EU AI Act, which was adopted earlier this year.
Another session on Tuesday will focus on how generative AI is used in patient care, with speakers from Stryker and Intuitive Surgical.
3. Future of U.S. diagnostics regulations
In April, the FDA finalized a rule clarifying lab developed tests should be regulated as medical devices. Since then, the rule has faced pushback from laboratory trade groups and is the focus of two major lawsuits.
The first deadline for the LDT rule is scheduled for May 6, 2025, but it’s possible the rule could be delayed in court or Congress could come up with an alternative proposal. On Wednesday, attorneys and Roche’s head of regulatory policy will speak with the leader of AdvamedDx, a division of Advamed, about the LDT rule and how Congress and upcoming elections could affect other diagnostics initiatives.
4. Global regulations
The conference will also address other notable global medtech regulations, including Europe’s transition to the new Medical Device Regulation (MDR) and China’s volume-based procurement policy.
The EU first published the new medical device regulation in 2017, but the European Commission has extended deadlines for notified body certification until 2027 or 2028 for most devices. A session on Wednesday will provide a regulatory update.
Medical device regulations in China have also been a focus for several large medtech firms. Companies including Johnson & Johnson and GE Healthcare have called out China’s volume-based procurement policy, anti-corruption campaign and a slower-than-anticipated rollout of a financial stimulus program as challenges in the last year. On Tuesday, the leaders of Medtronic’s and GE Healthcare’s businesses in China will talk about the country’s current market dynamics.