Medical device industry leaders are congregating in Toronto for The Medtech Conference hosted by Advamed, marking one of the sector’s most significant global assemblies. The conference boasts participation from over 3,900 individuals across 48 countries, focusing on the latest trends in medical technology and evolving global regulatory landscapes.
This gathering occurs at a crucial juncture for the medical device industry, especially with the U.S. Food and Drug Administration (FDA) actively seeking a new director for its Center for Devices and Radiological Health (CDRH) amidst scrutiny surrounding the former director’s potential conflicts of interest. Additionally, the industry is contending with legal challenges to new regulations on laboratory developed tests (LDTs), which are unfolding against the backdrop of an impending U.S. presidential election.
A key highlight of the conference is the town hall scheduled for Thursday, where FDA device center leaders, including Michelle Tarver, the acting director of CDRH, will discuss the agency’s priorities and respond to inquiries. The session will also feature former CDRH Director Jeff Shuren, who recently stepped down following a report by The New York Times that raised questions about his potential conflicts of interest relating to his wife’s role as legal counsel for medtech companies. The search for a permanent CDRH director continues, with other notable CDRH figures like Owen Faris, Troy Tazbaz, and Daniel Caños also slated to speak.
One of the conference’s focal points is the increasing integration of artificial intelligence (AI) in medical devices, sparking heightened regulatory attention. Various sessions are dedicated to exploring how AI is deployed in hospitals, addressing concerns about bias and accuracy, and navigating new regulatory frameworks. Notably, on Tuesday, Troy Tazbaz and Marc Lamoureux will discuss critical considerations around AI, such as data representativeness and bias mitigation, and compliance with key legislations like the 21st Century Cures Act in the U.S. and the EU AI Act.
Another pressing topic at the conference is the future of U.S. diagnostics regulations, particularly the FDA’s recent finalization of a rule designating LDTs as medical devices, which has faced opposition from laboratory trade groups and is currently embroiled in legal battles. With the first compliance deadline set for May 6, 2025, discussions will delve into how this rule might evolve in the face of potential court delays or legislative changes, informed by insights from legal experts and industry stakeholders including Roche’s head of regulatory policy.
The conference will also tackle significant international medtech regulatory updates, such as Europe’s shift to the new Medical Device Regulation (MDR) and China’s volume-based procurement policy. Despite the original publication of the MDR in 2017, the European Commission has extended the deadlines for certification until 2027 or 2028 for most devices, signaling ongoing transitions in European medtech regulation. Additionally, challenges faced by medtech firms in China, such as those articulated by Johnson & Johnson and GE Healthcare regarding procurement policies and regulatory hurdles, will be discussed by leaders from Medtronic’s and GE Healthcare’s Chinese operations.
In essence, The Medtech Conference in Toronto serves as a vital platform for global medical device stakeholders to converge, share knowledge, and navigate the complexities of an industry that stands at the crossroads of technological innovation and regulatory evolution.
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