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U.S. Department of Health and Human Services

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Research Project: Mathematical Modeling and Simulation of Electronic Systems

Model-Based Engineering (MBE) is a product development technology that serves to reduce development errors and arguably costs when developing a medical device. This is, in part, because much experimentation and verification occurs in-silica without the need for full product implementation. Further, MBE technology can provide formal methods (mathematically) based test cases to drive verification and validation activities on “real world” device implementations.

Battery and power supply failures in infusion pumps can result in serious patient injury or even death. This project aims to develop a battery and power supply safety model for a Patient-Controlled Analgesic (PCA) infusion pump.

Such a model can become a reference standard for infusion pump manufacturers and reviewers when they evaluate these devices.

The project will develop a battery and power supply model consistent with PCA infusion pump designs and then integrate this model into the DESE PCA infusion pump safety model so as to evolve this model into a more realistic “real world” device.