My consulting practice focuses on the engineering safety of connected medical systems—especially where interoperability intersects with electrical safety, essential performance, and system-level risk. I work with teams to identify hazards that emerge when components are integrated (e.g., unexpected states, timing and synchronization issues, alarm behaviors, network degradation, and responsibility boundaries between devices and systems), and to build practical strategies to mitigate them.
With over 35 years and 1500 safety consults at FDA/CDRH supporting regulatory review, research, and standards activities, I bring a “standards-aware” approach grounded in how evidence is generated and evaluated. My work spans IEC 60601 and related standards (IEC 60601-1-10, Physiologic Closed Loop Control), ISO 80601-2-61 (pulse oximeters), AAMI 2700 (Integrated Clinical Environment), physiologic closed-loop control, and vital sign monitoring—helping teams align design, risk management, verification/validation, and documentation into a coherent safety case for interoperable systems.
Connected medical devices don’t become “interoperable” simply because they exchange data. True interoperability requires clear definition of intended use across systems, explicit interface assumptions, and engineering evidence that device–device and device–network interactions remain safe across normal operation, abnormal operation, and foreseeable misuse. I help manufacturers translate interoperability goals into concrete, testable claims and documentation that hold up to real-world clinical context.