2nd Edition
by Basem El-Haik (Author), Khalid S. Mekki (Author)
The first comprehensive guide to the integration of Design for Six Sigma principles in the medical devices development cycle
Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness
presents the complete body of knowledge for Design for Six Sigma
(DFSS), as outlined by American Society for Quality, and details how to
integrate appropriate design methodologies up front in the design
process. DFSS helps companies shorten lead times, cut development and
manufacturing costs, lower total life-cycle cost, and improve the
quality of the medical devices. Comprehensive and complete with
real-world examples, this guide:
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Integrates 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
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Covers contemporary and
emerging design methods, including Axiomatic Design Principles, Theory
of Inventive Problem Solving (TRIZ), and Tolerance Design
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Provides a detailed, step-by-step implementation process for each DFSS tool included
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Covers the structural, organizational, and technical deployment of DFSS within the medical device industry
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Includes a DFSS case study describing the development of a new device
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Presents a global prospective of medical device regulations
Providing
both a road map and a toolbox, this is a hands-on reference for medical
device product development practitioners, product/service development
engineers and architects, DFSS and Six Sigma trainees and trainers,
middle management, engineering team leaders, quality engineers and
quality consultants, and graduate students in biomedical engineering.
