Designing Security into Life-Critical Devices: Where Innovation Meets Regulation

Описание: As healthcare becomes increasingly connected, cybersecurity is now as critical to patient safety as the devices themselves. In this episode of Exploited: The Cyber Truth, host Paul Ducklin sits down with RunSafe Security Founder and CEO Joseph M. Saunders to explore how medical device manufacturers can design protection into every phase of product development—from concept to deployment and beyond.

Joe discusses how medical device manufacturers are aligning innovation with evolving FDA and CISA cybersecurity expectations, embedding secure-by-design principles, and redefining engineering culture to treat security as part of product quality and not just compliance.

Listeners will learn

• Why Secure by Design is critical for building safe, resilient medical devices from the start
• How FDA guidance has pushed manufacturers to treat cybersecurity as part of product design and is reshaping compliance in healthcare
• What a Software Bill of Materials (SBOM) is and why generating it at build time gives the clearest picture of software risk
• Why openness about software components helps reduce risk, even when it feels counterintuitive
• How standardizing development practices makes devices safer, lowers costs, and leaves more room for innovation


For those developing life-critical devices or managing medtech risk, this episode explores how building security into every stage of design and development protects patients and sustains innovation in connected care.