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:*
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* 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* Includes a DFSS case study
describing the development of a new device* 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.
General
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