Using Modeling and Simulation in the Design of Closed-Loop Insulin Delivery System

The complexity of medical devices is rapidly increasing, enabled by innovations in technology. This same technology has enabled health care to expand from institutional environments to home care and mobile environments. Software plays a critical role in controlling these devices. It is essential that the dependability of these devices is assured because many of them are safety critical; i.e. can cause serious injury or death.

Modeling and simulation of device designs is emerging among medical device manufacturers as a technique to help address such challenges. Modeling and simulation has a long history of improving product quality by helping designers to detect defects that may be overlooked in a traditional software development workflow.

In this technical brief, we present a highly abstracted insulin infusion pump system as an example modeling exercise. A simulated environment of the glycemic system of the body, along with the insulin computation algorithm are modeled in Simulink and tested against various real-world parameters from clinical testing.

This paper was presented at Design of Medical Devices Conference, 2013.

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