Book description
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.
Basem S. El-Haik, PhD, is the CEO and President of
Six Sigma Professionals, Inc. (www. sixsigmapi. com) 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). basem.
haik@sixsigmapi. com
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.
