December News and Updates
Implications of the 2024 US Election: Preparing for Prospective Changes to the Regulatory Landscape
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.
Introducing the NHLBI Small Business Partnering Platform!
?? Connect with top heart, lung, and blood tech innovators.
?? NHLBI links scientists to investors and partners.
?? Explore federally funded advancements.
JPM Healthcare Conference 2025
This premier conference is the largest and most informative healthcare investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.
MedTech Impact Partners'?Kwame Ulmer will be attending and would like to connect with other Medtech leaders while in San Francisco. Let us know if you're interested in scheduling a meeting.