Implications of the 2024 US Election: Preparing for Prospective Changes to the Regulatory Landscape
The recent US presidential election has significant implications for the medical device industry. Here's a breakdown of key areas to watch:
Manufacturing Incentives and Supply Chain Resilience
Onshoring Hardware CDMO Work: The potential for increased manufacturing incentives in the US could make onshoring CDMO work a more attractive option. This move could streamline your quality management system and mitigate supply chain risks, improving your marketing submissions and optimizing your overall operational efficiency.
Breakthrough Device Designation and Market Access
MCIT vs. TCET: The Trump administration's potential push for MCIT could impact the duration of market exclusivity for breakthrough devices, with MCIT not requiring the same post-market evidence collection as TCET. Stay informed about any changes to this designation and its implications for your product's market access strategy.
Increased FDA Oversight: Key Areas to Monitor
Cybersecurity, Digital Health, and AI/ML: Cybersecurity has been a major focus of the FDA, but expect this focus to intensify as it relates to digital health and AI/ML technologies. Keep an eye on key hires within the agency to understand the specific areas of increased scrutiny.
Enforcement Actions: Be prepared for potential increases in enforcement actions, particularly in areas related to cybersecurity and digital health.
Proactive Strategies for Medical Device Companies:
Stay Informed: Continuously monitor regulatory updates and changes in FDA leadership to anticipate potential shifts in enforcement priorities.
Consider the factors of onshoring CDMO: Plan for shifts in operational, regulatory, and financial aspects.
Enhance Cybersecurity: Prioritize cybersecurity measures to protect your devices and patient data from potential threats, and bolster your product’s submission.
Embrace Digital Health and AI/ML: Leverage these technologies to improve patient care and device performance, while adhering to evolving regulatory requirements.
Engage with the FDA: Maintain open communication with the FDA to understand their expectations and seek guidance on regulatory compliance.
By proactively addressing these areas, medtech companies can navigate the evolving regulatory landscape and ensure the success of their products.
MedTech Impact Partners is committed to helping you navigate these complex regulatory hurdles. Reach out to us to learn more about how we can prepare your company for these prospective implications.