Applying SOFL to a Generic Insulin Pump Software Design

Abstract

Software embedded into medical devices demands a higher standard on its safety, as compared to most commercial software. One of the most important reasons is that the safety issue should be thoroughly investigated. In the United States, Food and Drug Administration (FDA) is entitled to scrutinize medical devices to ensure they are safe to the public before they enter the market. However, the review of medical device software has been quite challenging because not only the design of medical device software is complicated and error-prone but also the validation of the software system against regulatory requirements is notoriously difficult. Thus, some methodologies based on formal methods have been proposed to alleviate the pain faced by both software developers and regulators such as FDA staff. In this paper, we study how to use the Structured-Object-Based-Formal Language, which is called SOFL to develop a software system controlling an insulin pump, called the Generic Insulin Infusion Pump (GIIP). This case study facilitates the understanding of how SOFL can be applied to software systems related to medical devices in terms of the design and review aspects.