Axel Wirth, co-author of the book “Medical Device Cybersecurity for Engineers and Manufacturers,” discusses with MedTech Intelligence how he thinks manufacturers should approach cybersecurity in the current landscape of expanded medical device connectivity.
Axel Wirth: If you look at the topic of medical device cybersecurity, the general discussion falls into two camps: On one end of the spectrum you have “the sky is falling”—the security researchers, and the headlines in the public press that center around the theme of “someone can hack into my pacemaker.”
The other end of the spectrum is the regulatory and standards world, which is becoming increasingly complex—people look at that and say: “this is so complicated, how can I ever solve for that?” It made us realize that we really need something in the middle.
It is not a “sky is falling” situation. It is an urgent problem we need to solve, but we don’t need to panic. Instead, we need engineering processes that enable medical device manufacturers to implement cybersecurity without breaking the bank or even exiting the business they’re in. That was our motivation: To put something in front of people that was pragmatic and executable, something that could be followed by companies large and small.
Read the full Q&A on MedTech Intelligence.
