A prototyping process for medical devices and systems

This paper proposes a model-based and formal approach to the development of medical systems: formal modeling is used for system specification, design, and analysis; and interactive simulation, involving end users, is used for system validation. In this approach, the behavior of a medical device is modeled as a hybrid automaton, and concurrently, a realistic interactive graphic interface is developed. The behavioral model is translated into a logic theory, used to formally verify its correctness. The theory is also an executable model that can be integrated with the graphic interface. The resulting virtual device prototype is then simulated within a model of a clinical environment including the model of the patient and other devices. This approach results in higher dependability in patient care: formal methods lead to verifiability of the development process, and simulation allows validation of specifications and designs.