The Networking and Information Technology Research and Development (NITRD) Program, recently published the report “High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care”. NITRD is a formal interagency group within the Office of Science Technology Policy.
Prior to the digital age, medical devices were generally built using analog components in relatively simple design with relatively simple user interfaces and limited functionality. The primary method for controlling risk to patients was competent human interventions.
Over the last 20 years, designs for medical devices have evolved from analog to digital systems. Some of the more complex devices can have a million lines or more of code. Device life spans are shrinking due to more rapid innovations in enabling technologies and the demand for more robust systems.
Most devices contain embedded systems that rely on a combination of proprietary commercial-off-the-shelf and custom software or software of unknown pedigree components. These systems are highly proprietary and increasingly depend on software and designs and continue to rely on competent human intervention as the ultimate risk control measure. Embedded systems are becoming critical in medicine because they increasingly control the functions and communicate with the patients themselves.
To address the 21st century needs, NITRD’s High Confidence Software and Systems (HCSS) group held workshops with more than 100 experts to provide a forum for industry, research laboratories, academia, and the Federal government to come together to identify crucial challenges facing the design, manufacture, and the use of high confidence medical devices, software and systems. They identified promising research directions that could revolutionize the way that medical technologies are designed and built so that high confidence could be designed into the devices, software, and systems right from the start.
Key findings indicated:
- Today’s medical device architectures are typically proprietary, not interoperable, and rely on professionals to provide inputs and assess outputs
- When patients are connected to multiple devices at one time, 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
- Ad hoc efforts to aggregate data across devices designed to operate separately can lead to unintended or accidental results
- Growing interest in home healthcare services, 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
- Devices that will be used in the future will likely include nano/bio devices, bionics, or even pure programmable biological systems
According to the report, there is a need for rationally designed high-confidence medical device cyber-physical architectures, with a strategic focus on R&D in compositional modeling and design. An open research community of academics and medical device manufacturers is needed to create strategies for development of end-to-end, and engineering-based design and development tools. Certifying component devices is necessary but not sufficient.
The HCSS group recommends that R&D focus on high confidence networking and IT for the design, implementation, and certification of open medical technologies. In addition, barriers must fall among the relevant disciplines in order to understand holistic cyber-physical systems. Cooperation is needed between government, industry, and academia to develop standards and networking and information technology frameworks such as testbeds.
For more information or to download a copy of the report, go to http://nitrd.gov , email nco@nitrd.gov, or call 703-202-9097.
