ABSTRACT
In Chapter 1 we mentioned that there has been tremendous focus on Six Sigma initiatives by many different companies in various industries over the past few years. This Six Sigma effort has resulted in improved product and process performance, improved supply chain performance, and so on, thereby clearly signaling that this approach can be used to achieve strategic business objectives. Most of the publications and books in the Six Sigma area, though good at explaining both technical and business aspects, are focused on applying this methodology for manufacturing or transactional processes. There are only a limited number of publications that focus on applying Six Sigma to design and develop products and associated manufacturing processes. To our knowledge, there are no books that specifically focus on applying Six Sigma to medical device design and development.
