RFK Jr.’s appointment as US HHS Secretary may reshape regulatory and market landscape of medical devices

The appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services (HHS) has raised significant discussion in the healthcare sector. Healthcare officials have voiced concerns, particularly regarding Kennedy’s history of spreading misinformation and his controversial stance on vaccines. He may advocate for greater scrutiny of medical device approvals, reflecting his general skepticism toward existing public health protocols. As a result, his appointment is expected to drive a policy shift that could reshape the regulatory and market landscape for medical devices, according to GlobalData.

While increased oversight could improve device safety, it could also delay market access, potentially slowing the adoption of innovative technologies. For instance, this approach might hinder the rollout of AI-driven medical devices, diverging from the Trump administration’s push to accelerate AI innovation.

Ashley Clarke, Senior Medical Analyst at GlobalData, comments, “Kennedy’s leadership could impact device approval processes, data transparency, and manufacturing practices. A cautious regulatory stance for AI in medical devices would result in slower approvals but could help establish higher safety standards, similar to the European Union’s approach.”

Kennedy could advocate for greater decentralisation in healthcare delivery, encouraging investment in portable diagnostics, telehealth, and remote monitoring technologies. At the same time, his focus on reducing foreign dependency could prompt medical device companies to reassess their global supply chains, increasing costs before fostering a more resilient domestic manufacturing sector.

Clarke adds, “Kennedy’s environmental concerns and distrust of large corporations may influence HHS funding priorities, directing more support toward smaller companies, and investing in sustainable manufacturing practices for medical devices. But that may not be enough to support smaller companies pressured to increase domestic production amidst rising costs.”

Kennedy’s focus on transparency could result in stricter reporting requirements for medical device manufacturers, such as more detailed safety, performance, and post-market surveillance disclosures. While these changes could enhance public trust, they may also raise compliance costs.

Clarke continues,“The added regulatory burden could slow innovation if companies must allocate more resources toward meeting new standards, potentially widening the gap between established giants and startups. However, with appropriate balance, transparency could also foster trust in the industry and guide innovation in the right direction.”

“A commitment to transparency and accountability in the medical devices sector can enhance patient safety and trust in medical devices, but the added burden on manufacturers might result in longer approval timelines and could stifle innovation. Balancing these priorities and ensuring effective communication between regulators and manufacturers will be critical to maintaining a competitive and innovative market for US medical devices,”concludes Clarke.

Edits made by EH News Bureau