Physiological closed-loop control systems (PCLCS) automatically regulate physiological parameters, enabling widespread personalized treatments for diverse diseases. Medical device regulatory agencies such as the US Food and Drug Administration (FDA), have begun providing guidance to PCLCS device manufacturers with respect to designing disturbance and uncertainty scenarios, to conduct comprehensive stress testing under clinically relevant worst-case conditions. Due to their complexity, evaluating PCLCS through animal or clinical studies in all relevant scenarios is impractical. In this work, we discuss the development of a modular hardware emulation platform, which offers an efficient and cost-effective alternative for PCLCS assessment. The platform enables the simulation of any physiological system for which a mathematical model exists; the modular hardware architecture thus enables the emulation of faults, attacks, and the testing of countermeasures in either software, hardware, or cross-layer modality. We also present a case study for an artificial pancreas system (APS) that demonstrates the versatility of the platform in modeling - and countering - two different attack scenarios. Overall, this novel hardware emulation platform is a significant advancement for evaluating PCLCS, efficiently addressing security and reliability challenges in healthcare applications.
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