Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness

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Wiley, Apr 25, 2008 - Medical - 528 pages
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The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle

Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide:

  • Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology

  • Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design

  • Provides a detailed, step-by-step implementation process foreach DFSS tool included

  • Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry

  • Includes a DFSS case study describing the development of a newdevice

  • Presents a global prospective of medical device regulations

Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.

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Medical Device Design Quality
Design for Six Sigma and Medical Device Regulation

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About the author (2008)

Basem S. El-Haik, PhD, is the CEO and President of Six Sigma Professionals, Inc. ( in Canton, Michigan, and the author of many bestselling books on Design for Six Sigma. Dr. El-Haik is well known in the DFSS domain and has been a featured speaker at many technical conferences. He has seventeen years of experience in contemporary design and quality engineering methods and has trained, certified, coached, and monitored over 600 belts (Green Belts, Black Belts, and Master Belts) in DFSS and Six Sigma in both tracks: product and service (transactional).

Khalid S. Mekki is a Quality Manager at Baxter Healthcare Corporation, where he has served in various capacities since 2001. He is working toward his PhD in industrial engineering at the University of Illinois at Chicago. Khalid holds a master's degree in mechanical/quality engineering and a bachelor's degree in mechanical engineering. He has led and completed numerous Design for Six Sigma projects.

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