Healthcare safety awakening tests the patience of medical device buyers

Healthcare buyers have reached a turning point after accepting cybersecurity as a problem with others. If costs and features once dominated procurement decisions, cybersecurity requirements are now mandatory gatekeepers that can be considered entirely by suppliers.

Recent regulatory actions highlight this shift. In early 2025, the FDA and CISA issued warnings about critical cybersecurity defects in CONTEC and EPSIMET patient monitors – which threaten device integrity and patient safety. Discovery monitors contain hidden firmware backdoors that allow unauthorized remote access and potential manipulation of patient data. Although no harm was reported, the information from the regulator is clear: In a clinical setting, no safe medical equipment is no longer acceptable.

Healthcare buyers are expressing their voices. Recent research has found that nearly half of medical equipment now purchases medical equipment due to cybersecurity issues. In other words, equipment security has evolved from “good” to unnegotiable procurement requirements.

Accountability awakening

Healthcare providers have learned a hard lesson from years of cyberattacks. Hospital destruction is increasingly pouring into medical equipment and operational technology environments. In 2017, the WannaCry ransomware attack infected 1,200 diagnostic devices worldwide and forced emergency rooms in five UK hospitals to close and transfer patient care. Buyers now know that devices cannot be considered as siloed systems. They must be secure in complex, interconnected care networks.

For equipment manufacturers, this means a sharp rise in bars. Customers are no longer willing to accept vague assurances of security. Instead, they expect evidence of security design, documenting vulnerability management processes and transparency about software components.

A truly safe premium

Perhaps most obvious is that healthcare organizations are supporting their safety requirements with real money. Now, many buyers are willing to pay a premium for equipment equipped with advanced exploitation prevention and runtime protection. This willingness reflects the understanding that complex defense capabilities require continuous investment in R&D, maintenance and repair.

Calculus is simple: the cost of prevention is far less than the cost of compromise. The above WannaCry attack caused the NHS £92 million, or about $124 million. Healthcare organizations have experienced the financial and clinical consequences of weak cybersecurity in person – each incident suggests that device vulnerability is a patient safety issue with millions of dollars in consequences.

Transfer to safety through design

Urgent appeals to require medical equipment safety from the outset. Healthcare buyers are no longer willing to accept additional fixes after deployment. This shift reflects the hard fact that many healthcare environments rely on older systems that are difficult to patch and must run 24/7. When security is an afterthought, the burden falls on the provider, and limited tools are often used to mitigate the risk.

Now, government regulators are strengthening this expectation. Last June, the FDA updated the title “Cybersecurity in medical equipment: Precautions and forecasts for quality systems. ” Among other things, it recommends manufacturers to demonstrate threat modeling, provide software bill of materials (SBOM) and integrate cybersecurity throughout the product lifecycle, a practice that explicitly calls for secure design.

Meanwhile, it urges manufacturers to comply with a secure product development framework (SPDF) – essentially embedding cybersecurity elements such as threat modeling and patch management into their internal quality systems and in line with 21 CFR Part 820.

Meanwhile, the Department of Homeland Security's CISA has launched its own “security” program. It encourages technology providers, including medical device manufacturers, to shift responsibility upstream – prioritizing core safeguards such as multi-factor authentication, logging and security defaults, which are part of the design rather than optional additional features.

These regulatory and policy developments have jointly reshape expectations across the supply chain. Now, equipment manufacturers are under increasing pressure to show that they have baked safety before the product leaves the factory.

Medical equipment safety as a common responsibility

These shifts are reshaping the competitive landscape. Security is no longer something manufacturers can think of it as a compliance checkbox – it has become a core expectation for regulators, hospital systems and patients.

Healthcare organizations are also beginning to recognize their role in this equation. By prioritizing the security of procurement and budget decisions, they help create demand signals that drive stronger protection throughout the supply chain.

Ultimately, cybersecurity in healthcare is no longer a unilateral responsibility. Progress will depend on the vendor agreed to by the buyer and supplier – bringing security together through deployment and viewing resilience as the core of patient safety.

Photo: Marchmeena29, Getty Images