Developing Medical Devices from Abstract State Machines to Embedded Systems - A Smart Pill Box Case Study.

The development of medical devices is a safety-critical process, because a failure or a malfunction of the device can cause serious injuries to the patients whom use it. The application of a rigorous process for their development reduces the risk of failures since validation and verification activities can be performed in a objective, reproducible, and documentable manner. In this paper we present an approach based on the Abstract State Machine (ASM) formal method. Starting from the model, validation and verification (V&V) techniques can be applied. Furthermore, by step-wise refinement, a final model can be obtained, which can be automatically translated to [inline-graphic not available: see fulltext] code. The process is applied to the smart pill box case study. Starting from the ASM model, we generate [inline-graphic not available: see fulltext] code for the Arduino platform after the application of V&V activities. Furthermore, we introduce regulation (IEC62304) and guidelines (FDA General Principles of Software Validation) that support the developer in medical software development. In particular, we explain how ASMs formal process can be compliant with them.