Abstract

[This abstract is based on the authors' abstract.] A case study follows the development, manufacture, and release of a Mammotome (R) ST Breast Biopsy System at Ethicon Endo-Surgery, Inc., a Johnson & Johnson Company. Practical tools used in a systematic process to improve reliability of new products enabled Six Sigma levels of customer satisfaction. Using the concept of "Proactive Reliability," the product development team created a highly reliable device by consistently applying many reliability tools to seek out product design weaknesses, correct the design flaws early, then confirm their results. The focus of the study is on the Proactive Reliability process. Specific examples of how the process was successfully used on the Mammotome ST System Holster development are provided.