A Certification-Based Modeling Approach of Medical Cyber-Physical Systems: An Insulin Infusion Pump Case Study

Abstract

Medical Cyber-Physical Systems (MCPS) are safety-critical systems composed of hardware and software components that interact one each other and with the environment. Interactions of system and environment generate emergent properties that manufacturers should analyze to avoid hazard situations. The main contribution presented in this paper is a certification-based modeling approach of MCPS described by means of an insulin infusion pump case study. The modeling approach combines assurance cases in modular Goal Structuring Notation (GSN) and formal modeling tools to carry out a model-driven and goal-oriented requirements engineering. Assurance case models in modular GSN are specified along with requirements of an infusion pump system based on formal methods, and an Arduino prototype was designed during the case study. Manufacturers may reuse the approach as a source of safety and effectiveness evidence during a certification process.