Medical Device Assembly Yield Improvement: Application of Quality Foundations

Abstract

Quality foundations application is not a new concept for medical device, manufacturing, and service industries. The key quality concepts have origins from the quality pioneers named as “gurus” Joseph Juran, Deming and Crosby. There are some key principles which many companies apply as part of project development and implementation. This article, as a final design project, presents the application of quality foundations on a yield improvement project for a catheter assembly line, where the customer survey scores were 48% out of 100%. The combination of voice of customer to achieve customer satisfaction, quality foundation tools application, and lean manufacturing concepts integration resulted on a yield improvement of 4%, and customer survey score of 60% due to the implementation of a new re-design UV fixture in order to reduce significantly the defect know such as coil damage. Keywords — Catheter, DMAIC, VOC, Yield.