8. A Model-Based Approach for Quality Assessment of Insulin Infusion Pump Systems

Insulin infusion pumps are safety-critical systems that require the approval of regulatory agencies before commercialization to prevent hazard situations. Nowadays, many recalls are reported for insulin infusion pump systems, motivating the usage of a formal model-based approach to improve quality. However, the usage of such approaches increases costs and development time. Thus, this study aims to assist the quality assessment of such systems cost-effectively and time-efficient. We defined a coloured Petri nets model-based approach and conducted a case study on the ACCU-CHEK Spirit system to verify and validate a reference model, describing quality assessment scenarios. We also conducted an empirical evaluation of the approach with 12 modelers to verify productivity and reusability. Using the approach, 66.7% of the modelers stated no effort, while 8.3%, stated low effort, 16.7% medium effort, and 8.3% considerable effort. Given such results, we developed a web-based application to assist modelers in re-using the proposed approach. The usage of the approach can decrease development time and thus costs, increasing confidence in quality attributes such as safety and effectiveness.