Cybersecurity must be a priority for any medical device that connects to the internet, from its earliest design phase to the end of its product lifetime, said a panel of experts who spoke at the 2023 Combination Products Summit held by the AFDO/RAPS Healthcare Products Collaborative.
“Cybersecurity definitely spans the total product lifecycle,” said Aftin Ross, acting deputy director of the Division of All Hazards Response, Science and Strategic Partnerships at the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH).
“This is a shared responsibility,” between manufacturers and regulators, she said. “You have to think about it very early on in development, all the way through the obsolescence of your device. It’s critical that you start thinking about that at the beginning because it is very challenging to try to bolt it on at the end.”…
