JPM 2026: AI Compliance and BIOSECURE Top List of Device Supply Chain Concerns
As life sciences companies expand internationally, regulatory readiness must evolve into a strategic capability that supports global business planning and innovation. The upcoming Fireside Chat at the J.P. Morgan Healthcare Conference on January 12 will explore how companies can navigate increasingly complex and interconnected regulatory frameworks across the United States, European Union, China, and globally.
Key Discussion Points
Panelists will discuss strategies for integrating regulatory planning into business decisions, focusing on:
- Product launches across various jurisdictions
- Evolving regulatory requirements for novel technologies and the integration of AI
- Supply chain challenges and new restrictions, particularly those stemming from the new BIOSECURE Act
BIOSECURE and US-China Relations
On December 18, 2025, U.S. President Trump signed into law the BIOSECURE Act, which prohibits U.S. executive agencies from procuring biotechnology equipment or services from “biotechnology companies of concern.” This law is a response to concerns that U.S. genomic data obtained by non-U.S. CDMOs could be accessed by foreign adversary governments, particularly China.
The BIOSECURE Act defines a “biotechnology company of concern” to include those with ties to the Chinese military or those determined to pose a national security risk. Companies embedded in the supply chains of U.S. biopharmaceutical firms must assess whether the potential loss of federal contracts will necessitate securing alternative CDMO arrangements.
Medical Device Compliance
In light of recent geopolitical uncertainties, companies with global manufacturing operations must reassess how their footprints meet evolving compliance obligations. The FDA has modernized its Quality Management System Regulation (QMSR) to harmonize U.S. medical device current good manufacturing practices (CGMP) with global standards, effective February 2, 2026.
This new framework emphasizes management-driven quality, risk-based decision-making, and continuous improvement. For Class III PMA devices, changes to manufacturing facilities may require new FDA submissions, complicating operational adjustments.
In China, moving production can trigger complex re-registration and compliance challenges with local authorities. Panelists will advise on navigating these complexities through regulatory gap analyses, updating QMS documentation, and planning for post-market surveillance.
Global Supply Chain Management
With increasing complexity in global supply chains, manufacturers must manage differing regional standards and heightened scrutiny. Effective supply chain management now demands coordinated cross-functional oversight and flexible operational strategies to maintain market access.
- Map dependencies across multiple tiers
- Strengthen supplier qualification and monitoring
- Build redundancy to reduce vulnerability to disruption
AI & Digital Health Oversight
The FDA has announced plans for eight guidance documents in 2026, focusing on regulatory oversight of digital health products, including AI and digital health devices. Recent updates include:
- A revised policy for low-risk devices that expands the scope of products qualifying as non-device “general wellness” tools
- An updated guidance on Clinical Decision Support (CDS) Software, relaxing constraints from previous versions
One anticipated FDA guidance will clarify the types of information required in a Predetermined Change Control Plan (PCCP) for marketing submissions of AI-enabled device software. This aims to streamline pre-approval processes for intended modifications.
The FDA is also seeking public comment on evaluating devices integrating generative AI technology, emphasizing the need for robust, real-world monitoring to ensure safe and effective AI use in clinical settings.
Conclusion
As regulatory frameworks converge and expand, life sciences companies face significant challenges in compliance and strategic planning. The upcoming Fireside Chat at the J.P. Morgan Healthcare Conference will provide valuable insights into navigating these evolving landscapes and ensuring resilience in global operations.
