Med device cybersecurity: Designing to expect an attack
Featuring: Garyld Miles, VP of operations and engineering, The Realtime Group
Per recent media reports, medical devices are considered vulnerable and easy to hack, which creates a new security threat that could ultimately lead to patient harm. Additionally, connected devices could compromise patient safety and patient data, and affect business profitability and brand reputation as a result. Since connected devices provide substantial benefits for patients and end users, the potential risks must be proactively managed at design time.
Our current complex cybersecurity threat landscape requires a complex design based threat mitigation approach, focused on prevention at the design level. FDA expectations for mitigation and prevention in the face of these new and numerous threats and vulnerabilities center on the FDA Premarket Cybersecurity Guidance, FDA Postmarket Cybersecurity Guidance, and UL 2900-1. This discussion will address methods of threat prevention through defensive design techniques.
About the speaker:
Garyld Miles, VP of operations and engineering at The Realtime Group brings 30 years of R&D experience in systems, embedded electronics, and software/firmware, most of which is in the medical device space. His background is in medical device compliance; mission critical, real-time embedded hardware and software product development, and has co-developed more than 80 medical device or industrial control systems. Current focus is systems engineering, usability, and regulatory compliance through application of requirements analysis, safety assessments, safety architecture, risk and hazard analysis, FME(C)A, FTA, and system and software reliability. This includes technical responsibility for CE Mark, FCC, UL, EMI/EMC, and other safety and environmental certifications. He is an active member of IEEE, is a Certified Software Quality Engineer (ASQ CSQE), and holds a BS in Computer Science from the University of Texas at Dallas.