Early reliability evaluation of a biomédical system

Early reliability evaluation for safety-critical applications is crucial, since it may allow to spot critical parts of the design and to introduce suitable countermeasures. In some domains it is common to adopt a design flow exploiting a high-level description of the system behavior and architecture; out of this description, suitable tools then automatically generate the software (and eventually the hardware) needed to perform the required tasks. This paper describes an enhanced version of such a design flow in which reliability is also considered and evaluated. The model of a pacemaker is developed and used for early estimation of its robustness with respect to a subset of the possible faults. The paper highlights why it is important to take into account the environment the target system is designed to interact with (in this case the heart), thus making possible to identify the most critical faults, based on the severity of their effects.