Application based reliability assessment and qualification methodology for medical ICs

Reliability assessment and qualification system has strong economic implications for both manufacturers and customers. The best system should have a good balance among cost of verification, market timing requirement, and acceptable risk that meets the targeted user´s application conditions and requirements. With the increasing use of innovative electronics in the medical applications, it becomes difficult to have a single reliability assessment and qualification approach to serve all applications. In this paper, we review the existing reliability assessment and qualification framework, and discuss their applicability in medical ICs. We will discuss the tradeoff and challenges in defining reliable medical IC products based on the application demands using a couple of medical IC examples.