Regulatory and Technical Challenges in the Medical Technology Sector
The The MedTech Conference, organized by AdvaMed in Boston, saw the attendance of more than 4,000 industry leaders, innovators, and regulators. Discussions focused on the technical and economic challenges facing the sector in 2026, particularly in light of increasing cyberattacks and the need for clear regulatory frameworks for artificial intelligence.
Generative AI Under Regulatory Scrutiny
Rick Abramson, Director of the Digital Health Center of Excellence at the U.S. Food and Drug Administration (FDA), confirmed that the agency is working on drafting initial guidance related to generative AI in the coming months. This step comes in response to the importance the U.S. administration places on this file, as regulatory bodies seek to balance innovation with ensuring patient safety and data privacy.
Cybersecurity as a Strategic Priority
In light of growing digital threats, Mick Farrell, CEO of ResMed and Chairman of the Board of AdvaMed, announced the association's plans to develop standardized industry benchmarks focusing on three main pillars: privacy, cybersecurity, and interoperability of medical systems. This move aims to bridge security gaps that could be exploited by cyberattacks on connected medical devices.
What is Changing Practically in the Sector?
- Portfolio Restructuring: Executives expect the continuation of tuck-in acquisitions and the reduction of investment portfolios, given the limited financial resources available to companies under current economic conditions.
- Supply Chain Resilience: Companies are moving toward more flexible strategies to counter supply chain disruptions by increasing inventory, intensifying scenario planning, and strengthening partnerships with electronic chip suppliers.
- Human Capital Recovery: Dr. Michelle Tarver, Director of the Center for Devices and Radiological Health (CDRH), indicated that the center is in an intensive hiring phase to compensate for the significant shortage of clinical reviewers and experts in AI and digital health that the agency recently lost.