During the design and development of their medical device, manufacturers should consider the following elements in addressing cybersecurity:
Medical devices capable of connecting (wirelessly or hard-wired) to another device, to the Internet or other network, or to portable media (e.g. USB or CD) are more vulnerable to cybersecurity threats than devices that are not connected. Manufacturers should employ a risk-based approach when determining the design features and the level of cybersecurity resilience appropriate for the device. A Cybersecurity Bill of Materials (CBOM) can be a critical element in identifying assets, threats, and liabilities.