On Quantitative Software Quality Assurance Methodologies for Cardiac Pacemakers.

Embedded software is at the heart of implantable medical devices such as cardiac pacemakers, and rigorous software design methodologies are needed to ensure their safety and reliability. This paper gives an overview of ongoing research aimed at providing software quality assurance methodologies for pacemakers. A model-based framework has been developed based on hybrid automata, which can be configured with a variety of heart and pacemaker models. The framework supports a range of quantitative verification techniques for the analysis of safety, reliability and energy usage of pacemakers. It also provides techniques for parametric analysis of personalised physiological properties that can be performed in silico, which can reduce the cost and discomfort of testing new designs on patients. We describe the framework, summarise the results obtained, and identify future research directions in this area.