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President Donald Trump
Wara Samar

24th January 2025

President Trump’s Return: Implications for the MedTech Industry 

President Donald Trump’s second tenure in the White House has brought with it a wave of executive orders that are poised to influence U.S. policy across numerous sectors, including MedTech. Among the most significant actions is the withdrawal of the United States from the World Health Organization (WHO). This decision, citing dissatisfaction with the organization’s handling of the COVID-19 pandemic, failure to adopt reforms, and perceived political bias, halts all U.S. government funding and resources directed to the WHO.  

It also reassigned U.S. personnel previously working with the organization and called for identifying alternative partners for global health initiatives. Furthermore, this withdrawal bars the United States from participating in negotiations on the WHO Pandemic Agreement and amendments to the International Health Regulations. This move could disrupt global health collaborations and present challenges for MedTech companies operating internationally or relying on WHO-guided policies. 

Regulatory Freeze and Its Impact 

In addition to the withdrawal from the WHO, the administration has issued an executive order mandating a freeze on federal regulatory actions. This freeze affects regulatory activities under agencies such as the FDA and CMS, requiring appointees of the new administration to review and approve them before proceeding. The administration has positioned this measure as an effort to align regulations with its policy priorities, focusing on deregulation and what it describes as “common sense” governance. The order has paused the issuance of new rules, withdrawn rules that were submitted but not yet published, and postponed the implementation of certain published but not yet effective rules for up to 60 days. While the specific rules impacted are not detailed, this action is expected to create uncertainty for MedTech companies awaiting updates on Medicare payment models or FDA guidance on medical device approvals. 

Amid these policy shifts, there is cautious optimism about potential improvements in FDA processes. Kwame Ulmer, Managing Partner at MedTech Impact Partners, highlighted this perspective: “Our firm has recently conducted an analysis on the regulatory implications of the new presidential administration. Based on our assessment, we anticipate a net effect that includes an overall reduction in FDA review times. We believe this will be a direct result of initiatives aimed at streamlining the regulatory review process. Early indicators, such as the recently stated goal of reducing 10 existing rules for every new rule implemented, suggest an emphasis on expediting the review of FDA-regulated products.” 

Kwame Ulmer, Managing Partner at MedTech Impact Partners

Rescinding Biden-Era Policies 

The administration has also rescinded several executive orders from the Biden era, targeting policies related to diversity, equity, and inclusion (DEI), climate change, and artificial intelligence (AI). Notable rescissions include the dissolution of the President’s Council of Advisors on Science and Technology (PCAST), which previously focused on pandemic preparedness and advanced manufacturing. The administration has also withdrawn directives to strengthen Medicaid and ACA provisions, potentially affecting healthcare equity and access. Additionally, the removal of guidelines for trustworthy AI development alters the regulatory landscape for AI-driven medical devices, creating potential challenges for innovation and oversight in this area. 

A Period of Transition – International Perspective 

Chris Kennedy, Vice President of Partnerships at Prolucid Technologies, commented, “We have just experienced 1-2 years of time where it was extremely difficult for MedTech startups to successfully fundraise. These challenges have been felt both in the US as well as internationally. There is a light at the end of the tunnel as we see increased activity from VC and PE firms, as well as M&A market activity, notably with the acquisitions of Shockwave Medical, Axonics, and V-Wave. 

This puts us firmly in a transitional period where more capital becomes more available, but administration transition, and new FDA cybersecurity requirements have added some delays and confusion into the MedTech commercialization process. The federal mandate to pause FDA communications has been seen before and will likely pass in a couple of weeks, and with increased clarity around cybersecurity requirements, 2025 is shaping up to be a significant rebound year for the MedTech industry both domestically as well as with international partners looking to commercialize in the US.”

Chris Kennedy, Vice President of Partnerships at Prolucid Technologies

Navigating Challenges and Opportunities 

The return of President Trump to office signals a recalibration of federal regulations and processes, presenting both challenges and opportunities for the MedTech sector. While the withdrawal from global health commitments and the emphasis on deregulation may disrupt certain areas, the prospect of streamlined regulatory pathways offers potential benefits. MedTech companies will need to navigate these changes carefully, keeping a close watch on policy developments that may shape the future of medical innovation and commercialization. 

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