RESEARCH THERAPY
With accelerating technology innovation , medical devices are becoming more complex and more connected . Consequently , as in most mission-critical systems , safety and security are increasingly vital requirements in medical device design . In recent years , the US Food & Drug Administration ( FDA ) published an action plan designed to spur innovation towards greater medical device safety and cybersecurity . In this paper you learn about design challenges around medical device safety and security requirements as well as specific measures to deal with these challenges .
INTRODUCTION
Safety and security are two simple words that create complex requirements for missioncritical embedded systems , such as medical devices . Implementation takes great effort , in part because most device manufacturers are system integrators and do not build everything themselves . Adequate safety and cybersecurity therefore must be gauged for every component in the software bill of materials ( SBOM ).
TRENDS FOR THE MEDICAL MARKET
The FDA regulates more than 6,500 medical device product categories . Recent changes made by the FDA have brought software to the forefront of medical device regulation . As connectivity becomes a standard feature for medical devices , cybersecurity requirements also surface .
The FDA ’ s cybersecurity guidance for medical device manufacturers reflects the market ’ s awareness of lurking risks .
Device makers are required by the FDA to have a clear inventory of the software used in the device through a software bill of materials ( SBOM ), which comprises all software developed by the device maker and all software obtained off the shelf ( OTS ).
The FDA considers cybersecurity and cybersecurity testing to be the responsibility of the medical product manufacturer .
The manufacturer also bears responsibility for the safe and effective performance of the medical device .
This puts a huge burden on medical device manufacturers to test the security of third-party software , use software designed for safety and security , build in missioncritical security features , and manage lifecycle security over the life of the device in the field . �
PRESENTED BY
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SIMPLIFY SAFE , SECURE MEDICAL DEVICE DESIGN
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