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Quality Improvement of Medical Wire Manufacturing Process

Summary: Medical wires are used in cardiovascular devices. Therefore, the wire drawing process is extremely critical in terms of creating high-quality products. However, with the possibility of hundreds of different process levels, implementing experimental design and analysis in the wire drawing process is very challenging. This article presents a case study of a Six Sigma based quality improvement framework for a wire drawing process at a U.S.-based medical wire manufacturing company. The study results show a major improvement in the predictability of the model with significant increase in R² value.

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  • Topics: Continuous Improvement
  • Keywords: Biomedical, Case study, Six Sigma, Manufacturing process, Manufacturing, Process improvement, Quality improvement (QI), Medical devices, Design of experiments (DOE)
  • Author: Nepal, Bimal; Mohanty, Sankalp; Kay, Lawrence
  • Journal: Quality Engineering