It has become clear that the incoming Trump administration is hostile to perceived over-regulation in the US. This has been evidenced by the appointment of harsh critics of regulation like Robert F Kennedy Jr and Elon Musk to cabinet positions within the administration, and the combative tone of communication on the topic. While Trump and Kennedy have named the FDA as a target of particular interest for deregulation efforts, much of the rhetoric surrounds pharmaceutical companies and products, leaving the medical device market to speculation.
There are several competing ideological imperatives that will have vastly different effects on the development and approval of medical devices. An overriding call for reduced government spending is all but certain to hit the FDA budget, reducing payroll and leaving fewer staff to handle approvals, recalls, and reviews. This may be offset by attempts to streamline the approval process, allowing devices to reach the market faster and with less exhaustive scrutiny. Additionally, there are specific calls from Kennedy, whom Trump has nominated for Secretary of Health and Human Services: more data transparency, less corporate influence, and a focus on preventing chronic conditions.
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These drastic and difficult-to-manage priorities will certainly take time to implement and evaluate. The lower level of focus on medical devices unfortunately means that the reduced budgets are likely to be the prevailing effect for the next year, leading to slower approvals and a growing backlog of work for regulators. Safety recalls and breakthrough designated devices can be expected to continue relatively unaffected due to their high level of priority.
The promise of a less onerous regulatory environment and more open competitive market is an attractive one to most stakeholders in the medical devices market. Change is essential to improvement but notoriously difficult to manage. There are obvious safety concerns to address when it comes to easing scrutiny of devices that are capable of grave consequences. The regulatory landscape of medical devices is going to become more challenging before the industry should expect to see existing critiques of the process being addressed.
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