U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry
By Matt Burton, strategic development director, IMed Consultancy
Recent U.S. elections and President Donald Trump’s new appointments have drawn global attention. Entire industries and nations brace for potential changes in their trade relationships with the world’s economic superpower.
Specifically, the medical sector faces significant changes, as the nomination of Robert F. Kennedy Jr. signals a potential restructuring of the FDA, the agency responsible for overseeing the medical devices industry. Both Donald Trump and Robert F. Kennedy Jr. have identified the FDA as a focal point for deregulation, with cost cutting and increased competition likely to be key drivers.
In addition to these financial and market reforms, there will be an emphasis on enhancing data transparency, reducing corporate influence, and prioritizing chronic disease prevention. These measures are designed to foster innovation, improve competition, and promote preventive healthcare.
However, the proposed changes lead to concerns about resource constraints and their impact on safety and international trade. What are the challenges and opportunities for the medical devices sector under the prospective deregulatory framework?
Let’s look into it.
Deregulation And Reduced Red Tape
Deregulation, and the consequent reduction of bureaucratic red tape, has the potential of introducing a more streamlined approval process for medical device manufacturers, also possibly shortening the time-to-market of new products.
The FDA’s already expedited 510(k) pathway could perhaps see further enhancements, bringing benefits to manufacturers and patients alike. For manufacturers, this means faster access to revenue streams and shorter development-to-commercialization cycles, while patients could access newer technologically advanced devices without the risk of potential regulatory bottlenecks or delays in commercialization due to bureaucracy.
However, while the new administration will be focused on cutting costs and increasing efficiency, patient safety also must remain top of the agenda. The new administration also will likely place renewed importance on transparency and on reducing corporate influence on regulatory decisions.
AI In Healthcare: Balancing Innovation And Need For Regulation
In the last year, AI has been under the spotlight in all sectors and industries, including medical devices. It presents immense potential for innovation; however, regulations are not yet in place for the use of AI and LLM (large language models) in healthcare.
This doesn’t stop innovators such as Elon Musk, who recently requested medical images to be submitted to Grok, xAi’s chatbot (in itself, this constitutes illegal practice in marketing non-regulated AI models),1 setting a dangerous precedent in sharing personal medical information, all while the debate on the use of AI continues globally.
AI’s success rates and accuracy in healthcare are still far too unreliable and, given that faulty use of this technology could cause significant patient harm, regulators worldwide need to prioritize setting stringent requirements and controls. While some of these tools may have benefits, without appropriate regulation in place, patients and clinicians are not safeguarded against potential risks.
The Impact Of Tariffs On Global Manufacturers And The Medical Device Market
Three-quarters of the available U.S.-marketed medical devices could be affected by President Trump’s proposed tariffs, with negative effects that go beyond manufacturers. Access to critical devices could in fact become scarcer and more expensive due to potential price increases to protect margins.
However, high tariffs on certain Chinese medical devices and a reduced dependence on China are measures designed by the new administration to support domestic manufacturing and create opportunities for U.S. medical device makers.
Lower regulatory barriers should foster competition, opening the market to a broader range of players. This shift to simpler, streamlined regulatory pathways can significantly lower operational costs for small and midsize enterprises (SMEs) and startups, encouraging innovation and diversity in product offerings. There is, however, the risk that established players will be the ones to adapt to procedural changes quicker thanks to their regulatory experience and manpower, further consolidating their positions. Without specialist guidance, smaller firms may well continue to struggle with the fast-changing regulatory environment, where policy shifts might lead to unexpected compliance requirements.
To level the playing field, the new administration will emphasize reducing corporate influence and increasing transparency. Greater visibility into regulatory processes and decision-making criteria could help smaller firms better understand and navigate the system, mitigating some of the challenges posed by deregulation.
To seize these opportunities U.S. based manufacturers will need to monitor the news and possible changes in regulations and requirements, as well as ramping up production capacity while maintaining competitive pricing, all with possible inventory issues as the supply chain restructures.
Potential Resource Limitations
The proposed cost-cutting measures within the FDA may, however, lead to bottlenecks, effectively negating some of the deregulation’s innate benefits. A tighter budget could in fact impact the agency’s ability to keep up with increasing volumes of device applications, triggered by deregulation. High-risk Class III devices, which require an intensive review, could be particularly affected.
Less funding could also reduce the FDA’s ability to hire and retain much-needed skilled personnel, as well as affecting investments in evaluation tools and post-market surveillance. Consequently, manufacturers may need to enhance their in-house post-market surveillance protocols and in-house testing capabilities to take on some of the burden of devices’ safety and efficacy validation.
Preventive Healthcare: Focus On Chronic Conditions
Following a worldwide healthcare shift toward more preventive care, Robert F. Kennedy Jr. as the nominated U.S. Secretary of Health and Human Services emphasizes the need to address chronic diseases, such as autism, attention-deficit/hyperactivity disorder, sleep disorders, infertility rates, diabetes and obesity, which he claims have worsened due to federal inaction.
This global trend drives up opportunities for the introduction of diagnostic devices, wearable devices, and remote monitoring systems designed specifically to manage and keep track of chronic conditions, also fostering growth and innovation in these market segments. Cross-industry collaboration also will be stimulated, with medical device companies partnering with technology firms to develop state-of-the art integrated healthcare solutions.
Getting Ready For The Proposed U.S. Deregulation
Ultimately, these new measures are poised to streamline approval processes, increase competition, and foster preventive care. They have the potential to drive innovation and market growth, especially for startups and companies dealing with chronic disease management.
Manufacturers should, however, be wary of potential resource constraints and of the complexities introduced by a transitioning regulatory framework, as well as the risks posed by allowing unregulated AI-based tools onto the general market. Changing international trade dynamics could also limit access to devices for patients and generally pose challenges to the medical device sector.
The effect of deregulation will ultimately depend on the administration's capacity to introduce balance and ensure there are suitable policies that safeguard public health while also promoting economic development. The medical device sector should remain vigilant and keep up with regulatory changes, actively collaborate with policymakers, and consult regulatory experts to make sure they are able seize opportunities that will inevitably emerge from the evolving landscape.
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About The Author:
Matthew Burton is strategic development director at IMed Consultancy. A former organic chemist, Burton transitioned into consultancy, specializing in pharmaceutical development and registrations. He then became an MHRA registered Responsible Person for GDP and a lead auditor (GxP/ISO), managing projects for innovator and generic drug products. Following his passion for medical devices, Burton became a medical device consultant, delivering projects covering medical devices, borderlines, human tissues, biocides, PPE, and cosmetics products. During the SARS-CoV-2 pandemic, he advised NHS Innovation teams on product compliance. As IMed Consultancy’s strategic development director and a principal consultant, Burton oversees Representation Services (UKRP, EUAR, PRRC) and supports clients with strategic advice, regulatory support, and team mentoring.