Last week, the MedTech Conference in Toronto, the largest event organized by Advamed to date, attracted 4,350 participants from 48 countries. The conference featured discussions led by prominent industry leaders, including Michelle Tarver, the newly appointed acting director of the FDA’s device center, and other regulators from Canada, Europe, and Japan. Key topics included artificial intelligence, regulatory changes, diversity in clinical trials, the impact of the upcoming U.S. elections, and current trends in mergers and acquisitions within the medtech industry.
One of the critical regulatory developments discussed was the new FDA rule on laboratory developed tests (LDTs). This rule, which faces active litigation by the American Clinical Laboratory Association and the Association for Molecular Pathology, mandates that LDTs meet certain medical device reporting and quality system regulations starting May 6, 2025. While the outcome of this rule remains uncertain due to the pending lawsuit and upcoming presidential election, industry experts at the conference stressed the importance of compliance with the new regulations.
The potential impact of the U.S. election could further complicate the regulatory landscape for LDTs. Future regulatory approaches may depend on the composition of the Department of Health and Human Services and the FDA’s leadership post-election. Possible scenarios include a continuation of the rule under a new administration or legislative changes to create a unified regulatory framework for lab-developed tests and in-vitro diagnostics.
Regarding mergers and acquisitions, the MedTech industry has seen a reduction in the number of transactions from the previous year, with only 99 deals between July 2023 and June 2024 compared to 170 during the same period last year. Despite this slowdown, the average deal size has increased, influenced by several significant acquisitions by major companies like Johnson & Johnson, BD, and Boston Scientific.
The conference also highlighted the FDA’s ongoing efforts to enhance diversity in clinical trials. A new draft guidance requires companies to prepare detailed diversity action plans as part of their Investigational Device Exemption applications, outlining specific enrollment goals based on race, ethnicity, sex, and age. This initiative aims to ensure broader and more representative participation in clinical trials, enhancing the generalizability and applicability of medical research.
Artificial intelligence was another hot topic, with discussions centered around the regulatory challenges posed by medical devices that incorporate AI technologies, particularly generative AI. The FDA’s Digital Health Center of Excellence, headed by Troy Tazbaz, discussed the importance of considering lifecycle management and post-market performance for AI-enabled devices. This is crucial as the technology can adapt and evolve over time, potentially altering its functionality and impact.
Lastly, Michelle Tarver’s speech underscored the importance of patient-centric approaches in device development and regulation. With her extensive experience at the FDA, Tarver advocated for timely access to medical devices and highlighted new initiatives like the Home as a Health Care Hub. This program focuses on creating solutions that function effectively in diverse home environments, particularly for individuals with limited resources.
Overall, The MedTech Conference provided valuable insights into current challenges and developments in the medical technology sector, emphasizing the need for adaptive regulations, enhanced patient involvement, and diligent preparation for impending industry shifts.
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