High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care

Citation: High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care (Feb. 2009).

Overview
This report presents the perspectives of the senior scientists of the NITRD Program’s High Confidence Software and Systems (HCSS) Coordinating Group (CG), with input from experts from other federal agencies, on the R&D challenges, needs, and strategies for developing and deploying the next generations of high-confidence medical devices, software, and systems. HCSS agencies whose missions are not medical device-specific have found it beneficial to partner in this area because medical device research challenges are similar, if not identical, to those within their purview. Digital technologies are increasingly being assigned high- level control over the monitoring, sensing, actuation, and communications of medical devices— often with human life in the balance. Through this report and associated HCSS-sponsored national workshops, the HCSS agencies are seeking to illuminate fundamental scientific and technical challenges that must be addressed before we can design and build high-confidence devices, software, and systems that operate flawlessly from end to end. The report authors sought to paint the landscape of the evolution of medical device technology and the federal investments that have benefitted medical device R&D over time.

The authors noted a number of key findings:

•	Today’s medical device architectures are typically proprietary, not interoperable, and rely on professionals to provide inputs and assess outputs; “families” of such devices also tend to be stove-piped and not interoperable with other “families” of devices. •	In the frequent circumstance that a patient is connected to multiple devices at once, such as in an operating room, clinicians now must monitor all devices independently, synthesize data, and act on their observations, which can be affected by stress, fatigue, or other human factors. •	Medical device architecture is beginning to include wired and wireless interfaces to facilitate networked communication of patient data. But ad hoc efforts to aggregate data across devices designed to operate separately can lead to unintended or accidental results. •	The growing interest in such capabilities as home health care services, delivery of expert medical practice remotely (telemedicine), and online clinical lab analysis underscores the central role of advanced networking and distributed communication of medical information in the health systems of the future. Increased R&D focus on the specialized engineering of networked medical device systems is needed. •	Neither past nor current development methods are adequate for the high- confidence design and manufacture of highly complex, interoperable medical device software and systems (“intelligent” prosthetics, minimally invasive surgical devices, implants, “operating room of the future”), which in years to come will likely include nano/bio devices, bionics, or even pure (programmable) biological systems.