Abstract
Safety and effectiveness are crucial quality attributes for insulin infusion pump systems. Therefore, regulatory agencies require the quality evaluation and approval of such systems before the market to decrease the risk of harm, motivating the usage of a formal Model-Based Approach (MBA) to improve quality. Nevertheless, using a formal MBA increases costs and development time because it requires expert knowledge and thorough analyses of behaviors. We aim to assist the quality evaluation of such systems in a cost-effective and time-efficient manner, providing re-usable project artifacts by applying our proposed approach (named MBA with CPN—MBA/CPN). We defined a Coloured Petri nets MBA and a case study on a commercial insulin infusion pump system to verify and validate a reference model (as a component of MBA/CPN), describing quality assessment scenarios. We also conducted an empirical evaluation to verify the productivity and reusability of modelers when using the reference model. Such a model is relevant to reason about behaviors and quality evaluation of such concurrent and complex systems. During the empirical evaluation, using the reference model, 66.7% of the 12 interviewed modelers stated no effort, while 8.3% stated low effort, 16.7% medium effort, and 8.3% considerable effort. Based on the modelers’ knowledge, we implemented a web-based application to assist them in re-using our proposed approach, enabling simulation-based training. Although a reduced number of modelers experimented with our approach, such an evaluation provided insights to improve the MBA/CPN. Given the empirical evaluation and the case study results, MBA/CPN showed to be relevant to assess the quality of insulin infusion pump systems.
Highlights
The treatment of diabetes usually requires the usage of insulin infusion pump systems
We present a partial formalization of a Coloured Petri Nets (CPN) because it is linked to different requirements in an assurance case-based specification using Goal-Structuring Notation (GSN)
We presented an Model-Based Approach (MBA) focused on CPN reference models of insulin infusion pump systems, aiming to assist manufacturers in assessing quality
Summary
The treatment of diabetes usually requires the usage of insulin infusion pump systems. As a safety-critical system, manufacturers should analyze the behaviors of insulin infusion pump systems to provide, at least, the minimum required guarantee of correctness [2]. Formal methods [3] play a significant role in verifying systems requirements and guaranteeing developed systems’ correctness, reliability, and safety. Regulatory agencies, such as the United States Food and Drug Administration (FDA), need effective means to evaluate the devices to certify the developed systems and assure each system’s safe behavior [4,5]. Formal methods can help develop dependable, safe, and secure systems and provide sound evidence for the required features to certify dependable medical systems
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