ABSTRACT
One of the myths mentioned in Chapter 6 is that “using an up-front reliability engineering approach would add significant time and cost to medical device design and development.” Chapter 7 introduced a few reliability tools and techniques that can be used during the product design phase to dispel that myth. One of the key safety and reliability techniques, risk analysis, was explained in detail in Chapter 8. This chapter introduces other, more specific techniques that can be employed during the design phase of product development to help medical device companies build reliability into their products and not lose revenue due to increased warranty claims, downstream inspection, and so on. These techniques are presented as applying to three different types of systems: mechanical, electrical, and software. The primary motivation for this presentation is that these technologies are the ones that are predominantly deployed in medical devices. However, device manufacturers that deploy other technologies such as optics or drug-device combinations can also benefit by using the principles discussed in this chapter.
