Correct-by-design Software Is Fundamental to High-confidence Devices

Software is a fundamental and integral part of many medical devices. While the doctor who performs an operation must be licensed, the developers who create the software used in these devices undergo no such licensing. For this reason it is especially important that designs which can be subjected to rigorous analysis be produced prior to software development. Such designs are fundamental to effective and efficient testing, analysis of systems-of-systems, and risk determination and mitigation. This paper identifies challenges and potential research directions to address these concerns.