Abstract: Over the past decade there has been considerable progress in the development of formal methods to improve our confidence in complex systems. Today the use of such methods in certain fields, such as hardware design, or nuclear power control systems, is de rigueur, with commensurate improvements in quality and reliability.
Regrettably, however, the use of formalism in the medical device domain is relatively sparse. This is due in large part to the perceived difficulty of using formal methods by ordinary engineers and domain specialists, and by the lack of training in how best to apply existing tools to solve the problems faced in that domain.
Over the past few years we have been developing educational materials to help bridge this gap. Specifically we have developed a course in formal modeling for practicing engineers. A core component of this effort is a set of exercises drawn from the medical device domain, which are used to
a) show how formal modeling can be used as an effective technique to improve quality and reliability of software-intensive systems
b) provide guidelines on selecting appropriate modeling approaches for the problem at hand
c) give students hands-on experience in modeling and tool-assisted analysis
In this paper we outline our use of medical device challenge problems in achieving these goals. We argue that such exercises (and the underlying concepts) can go a long way towards bridging the gap between theory and practice, and could be used more generally to improve the state of the practice in developing high-confidence systems, in general, and medical devices, in particular.