FIGURE 1.

Computational test setups for physiological closed-loop controlled medical devices. (A) Fully computational testing uses computational models of the therapeutic delivery devices, sensors, and computational patient model. Initial conditions are set for the controller settings and patient, delivery device, and sensor models. Simulated disturbance profiles such as timing of injuries or other therapies are input to challenge the controller. The testing may be run within a single simulation environment. (B) Hardware-in-the-loop testing uses a computational patient model and one or more of the computational device models are replaced with the physical devices. This requires the use of actuator transfer mechanisms to convert therapy delivery device outputs to digital signals received by the computational physiological model and/or signal generators to convert the output of the computational patient model to signals that can be recorded by the patient monitor.