Developing Cyber‑Resilient Medical Devices: Key Insights

In this e-book, Pamela Gwynn, principal engineer at UL Solutions, shares core insights into the emerging challenges shaping cyber resilient medical devices. She highlights how home use conditions, AI, cloud based care and global regulatory variations are transforming expectations for safety, performance and cybersecurity.

“Maintaining clinical grade performance in the home environment is always a challenge, as manufacturers must account for greater variability.”

— Pamela Gwynn, principal engineer, UL Solutions

Key takeaways

• Home use environments introduce new risks such as unstable connectivity, inconsistent power and varied user behavior — all impacting cyber resilience.
• Wellness products increasingly function like medical devices, expanding exposure to cyberthreats across healthcare workflows.
• Global regulatory differences create compliance complexity, often requiring early navigation of national deviations.
• Simulation is becoming increasingly important for software as a medical device (SaMD) validation, supporting adaptive updates and cybersecurity related failure analysis.
• AI, cloud and telemedicine demand stronger data protection and availability, especially in remote care settings.
• The certification body (CB) scheme helps harmonize requirements, reducing redundant testing and strengthening security baselines.
• Local directives add risk, making early understanding of market specific expectations important.

Access guidance for designing resilient, connected medical devices for a rapidly evolving digital health landscape.