DESIGN FOR HIGH RELIABILITY - MEETING THE GOALS OF HIGH YIELD AND REDUCED FIELD FAILURES DURING THE MEDICAL PRODUCT DEVELOPMENT PROCESSAuthors: Chris Rozewski and Michael Tendick
Company: Plexus Technology Group
Date Published: 5/19/2004 Conference: Medical Electronics Symposium
By applying Design For Six Sigma methodologies the joint team set reliability objectives early in the design process aimed at realizing a robust product with high manufacturing yields, minimal process variation, and high availability in the field. Through a combination of clearly defined product and lower-level design requirements, rigorous design analysis, milestone driven, in-depth design reviews, and relentless testing, the joint team successfully met its six sigma objectives enabling GEMS-IT to launch a highly accepted product that continues to exceed market forecasts.
This paper details the tools and techniques used to implement a successful Design For High Reliability medical device development project. It additionally focuses on the unique requirements when collaborating with an outside supplier who must adapt to the OEM’s internal processes, culture, and development environment to serve as an effective extension of the OEM’s internal team. Manufacturing process yield and field failure data are presented to quantitatively demonstrate the effectiveness of the approach.
Key words: Six Sigma, design for reliability, FMEA, DFM, DFT.
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