Case Studies

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  1. Modern DOE Doubles Medical-Device Production Rate at Half the Variation

    January 2019
    Engineers at a major medical device manufacturer used RSM to successfully model a key process for their flagship product. The RSM model then became the foundation for development of robust specifications to ensure quality at six sigma levels.
    Authors: Anderson, Mark
    Publication:
  2. Response Surface Methods (RSM) Achieve Design for Six Sigma (DFSS) Goals for Medical Device Manufacturing

    October 2008

    Engineers at a major medical device manufacturer used RSM to successfully model a key process for their flagship product. The RSM model then became the foundation for development of robust specifications to ensure quality at six sigma levels.

    Authors: Anderson, Mark
    Publication:
  3. Application of Design of Experiment (DOE) Techniques to Process Validation in Medical Device Manufacture

    February 2006

    This paper provides an overview of the application of DOE techniques during key aspects of process validation and discusses two practical examples from medical device manufacturing. The attendant benefits of this type of procedural approach to the medical device sector are considered. From the results obtained, it is clear that meeting process validation requirements can be taken as an opportunity to better understand and improve manufacturing processes. As such, DOE techniques are pivotal in effectively achieving these aims in a manner that provides for regulatory compliance.

    Authors: Dixon, D. et. al. for LOB
    Publication: Journal of Validation Technology
  4. Design of Experiments for Ruggedness Testing: Case Study on Paraffin Therapy Bath

    January 1999

    A version of this article appeared in Medical Device & Diagnostic Industry.

    Authors: Anderson, Mark J. & Anderson, Paul J.
    Publication: Medical Device & Diagnostic Industry

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