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Leading the Future in Product Development

Medical Devices Design For Six Sigma (MD DFSS)

In Medical Devices Design For Six Sigma (MD DFSS) we detail how to integrate appropriate design methodologies upfront in the device design process.

MD DFSS addresses design vulnerabilities that result from poor quality and design engineering practices. In the context of MD Design For Six Sigma, the major design vulnerabilities are be categorized as:

  • Conceptual vulnerabilities that are established due to the violation of design principles , and
  • Operational vulnerabilities are created as a result of factors beyond the control of designer called "noise factors". These factors, in general, are responsible for causing a device's functional characteristic or process to deviate from target values. Controlling noise factors is very costly or difficult, if not impossible.

MD DFSS helps companies shorten lead-times, cut development and manufacturing costs, lower total life cycle cost, and improve the quality of the medical devices to Six-Sigma level. MD DFSS provides comprehensive and complete process with real-world examples and:

  • Reviews concept and design methods such as Pugh Controlled Convergence approach, QFD methodology, parameter optimization techniques like Design of Experiment (DOE); Taguchi Robust Design method, Failure Mode and Effects Analysis (FMEA), Design for X, Multi Level Hierarchical Design methodology and Response Surface Methodology
  • Covers contemporary and emerging design methods, including Axiomatic Design Principles, Theory of Inventive Problem Solving (TRIZ), and Tolerance Design
  • Provides a detailed, step-by-step implementation process for each DFSS tool included
  • Covers the structural, organizational, and technical deployment of DFSS within the medical device industry
  • Presents a global prospective of medical device regulations
  • Can be customized to include Computer-Aided Reliability (CAR) and Computer-Aided Robust Design (CARD)

Providing both a roadmap and a toolbox, this is a hands-on approach for medical devices product development practitioners, product/service development engineers and architects, MD DFSS and Six Sigma trainees and trainers, middle management, engineering team leaders, quality engineers and quality consultants.

To know more, contact us @: or (734) 765-5229.