3 Missteps for Manufacturers to Avoid When Securing Medical Devices

Over the last several years of my career, I’ve had the opportunity to work with a variety of global medical device manufacturers.  Recently, I have also started working with some new organizations that are not yet global in scale.  A theme that I have discovered is that these organizations haven’t yet established true ownership for security within the organization, even though there is increasing regulatory pressure for building security, evidenced by updated FDA guidance and recognition of international standards such IEC 62443, UL 2900, and AAMI TIR 57.