Research Project: Studies of the Properties and Characteristics of Interoperable Systems
DESE’s research efforts focus on the challenges and benefits of interconnecting medical devices, from different manufacturers, into a seamless network, commonly referred to as the medical device plug-and-play initiative. Achieving the safe interoperability of these devices requires a paradigm shift; as medical devices which heretofore have been the end products in the medical device marketplace (or vertically integrated into a system by a single manufacturer) could now become components in a larger multi-vendor system.
CDRH scientists and engineers are playing a leading role by focusing attention on key safety and effectiveness considerations, and participating in the development of standards to ensure a level playing field. In addition, engineers are addressing the regulatory concerns of CDRH by determining how to apportion responsibility for system performance among the various component vendors. This challenge requires the judicious application of systems engineering principles to augment CDRH’s traditional regulatory models. Systems composed of medical devices that interoperate in the single-patient-care environment can be divided into three components: 1) devices (sensors and actuators) that deliver therapy and make measurements, 2) a network architecture that connects the devices, and 3) a mechanism to program applications using the interoperability architecture. The behavior at the interfaces and the characteristics of each component must be understood in order to assure the safety and effectiveness of the system. Thus, robust test methods need to be developed that exercise the functions of the system in order to assure its performance and safe operation. Many of these test methods will be based on real-world clinical scenarios; hence we need a way to capture the clinical workflow, translate it into a computer language, and play it back to the system under investigation. We are working to prototype systems of systems to explore both the safety and effectiveness issues and bring clarity to their regulatory pathways.
DESE plays a key role in the project management/leadership of a team creating a virtual interoperable system to disseminate common hazards and create a test regulatory submission, as well as in the determination of the technical content. The team, composed of industry, academic and regulatory engineers and clinicians from around the world, has selected and documented a use scenario that is targeted to exercise the engineering and clinical complexities of interoperable systems without crossing into premarket approval. The team has developed definitions for interoperable functionality that can be used by FDA when considering intended use. Hazard and risk analyses at each level are being developed and made public as a baseline (starting point) for subsequent system development by industry.