Saving Lives through Medical Devices

Abstract

The medical devices industry is a relatively new field which has been fueled by advancement of semiconductor, software, and biomedical sciences. The medical devices supply chain is geared toward building extremely robust products which can meet stringent regulatory compliance requirements and perform flawlessly in life-threatening situations. This industry is dominated by global giants who have a long history of producing devices which could be extremely complex and expensive to very high-volume products. The supply chain is quite mature in its processes in order to maintain the level of reliability, traceability and accuracy. The supply chain is delicate and risk averse as litigation and regulations play a dominant role in shaping the supply chain. This chapter discusses the manufacturing supply chain for medical devices. This is a high mix low-volume business where the price and purchasing decisions are determined by hospitals, insurances and not necessarily by the patients who are the end users. For a supply chain leader it’s important to understand both quality and regulatory aspects of the business as it plays a critical role in establishing commercial terms. Due to medical devices being a low-volume but high-mix business it often poses excess and obsolescence as well as shortage risk due to the long product life cycle. The challenges and opportunities for a medical device supply chain leader are also highlighted in this chapter.