The U.S. Food and Drug Administration (FDA) has released a white paper emphasizing the need to embed cybersecurity into the advanced and smart technologies used in medical product manufacturing. Modern manufacturing environments rely on a growing number of connected devices, known as operational technologies (OT), which were traditionally built for reliability rather than security. As a result, it can be difficult to determine what network communications are happening, when they occur, and where they originate, making it harder to detect and respond to cyber threats.
Commercially available manufacturing equipment often does not meet national or international cybersecurity standards by default. This shortfall demands deliberate system design and configuration. Incorporating cybersecurity into standard industry practices, regardless of company size, will significantly reduce risks to the U.S. medical product manufacturing sector and its supply chain.
In its ‘Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing,’ white paper, the FDA identifies that there is a balance to be struck between creating an operational…
