Medical Device Design for Six Sigma
A Road Map for Safety and Effectiveness
2. Auflage Mai 2008
560 Seiten, Hardcover
Wiley & Sons Ltd
Kurzbeschreibung
This Design for Six Sigma (DFSS) and risk management book provides the framework for identifying, assessing, and controlling risks that may be present in products, processes, projects, and operations through an algorithm of design using the six-sigma thinking, tools, and philosophy. The algorithm will also include the mathematical derivation for Six Sigma capability upfront, enabling design teams to change concepts that are not safe and effective upfront.
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.
Preface.
1 Medical Device Design Quality.
2 Design for Six Sigma and Medical Device Regulation.
3 Basic Statistics.
4 The Six Sigma Process.
Appendix 4A: Cause-and-Effect Tools.
5 Medical Device Design for Six Sigma.
6 Medical Device DFSS Deployment.
7 Medical Device DFSS Project Road Map.
8 Quality Function Deployment.
9 DFSS Axiomatic Design Method.
Appendix 9A: Matrix Review.
10 DFSS Innovation for Medical Devices.
Appendix 10A: Contradiction Matrix.
11 DFSS Risk Management Process.
Appendix 11A: Robust Design Failure Mode and Effects Analysis.
11A.1 Parameter Diagram.
11A.2 Robust Design FMEA Elements.
12 Medical Device Design for X.
13 DFSS Transfer Function and Scorecards.
14 Fundamentals of Experimental Design.
Appendix 14A.
14A.1 Diagnostic Plots of Residuals.
14A.2 Pareto Chart of Effects.
14A.3 Square and Cube Plots.
14A.4 Interaction Plots.
15 Robust Parameter Design for Medical Devices.
16 Medical Device Tolerance Design.
17 Medical Device DFSS Verifi cation and Validation.
18 DFSS Design Transfer.
19 Design Change Control, Design Review, and Design History File.
20 Medical Device DFSS Case Study.
Glossary: DFSS Terminology.
Appendix: Statistical Tables.
References.
Index.
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.
