The objective of this research is to establish a new development paradigm that enables the effective design, implementation, and certification of medical device cyber-physical systems. The approach is to pursue the following research directions: 1) to support medical device interconnectivity and interoperability with network-enabled control; 2) to apply coordination between medical devices to support emerging clinical scenarios; 3) to ?close the loop? and enable feedback about the condition of the patient to the devices delivering therapy; and 4) to assure safety and effectiveness of interoperating medical devices. The intellectual merits of the project are 1) foundations for rigorous development, which include formalization of clinical scenarios, operational procedures, and architectures of medical device systems, as well as patient and caregiver modeling; 2) high-confidence software development for medical device systems that includes the safe and effective composition of clinical scenarios and devices into a dynamically assembled system; 3) validation and certification of medical device cyber-physical systems; and 4) education of the next-generation of medical device system developers who must be literate in both computational and physical aspects of devices. The broader impacts of the project will be achieved in three ways. Novel design methods and certification techniques will significantly improve patient safety. The introduction of closed-loop scenarios into clinical practice will reduce the burden that caregivers are currently facing and will have the potential of reducing the overall costs of health care. Finally, the educational efforts and outreach activities will increase awareness of careers in the area of medical device systems and help attract women and under-represented minorities to the field.
