Beyond Patching: Securing Medical Devices Postmarket

Modern healthcare settings are full of devices that use software to manage and improve patient care, from MRI machines to CT scanners to infusion pumps. Healthcare providers rely on medical device manufacturers to deliver secure and effective software upfront, but securing software once these devices are already in the field is another challenge altogether.Just last year, the FDA released new guidance on cybersecurity for medical devices, including requirements for securing medical devices postmarket. The FDA’s primary guidance is that manufacturers have a plan for the “rapid testing, evaluation, and patching of devices deployed in the field.”Patching, however, takes significant time and resources and is difficult to accomplish for Class II and Class III medical devices. 

Medigy Insights

Patching medical devices is challenging for many reasons. Vulnerability research and analysis, patch creation, and testing require significant engineering resources. Once a patch is developed medical device manufacturers then need to work with healthcare providers to manage the logistics of pushing updates to devices, including those that may not be easily accessible. Different healthcare environments also have complex deployment scenarios and manufacturers need to be able to maintain support for multiple software versions.


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