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



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

Basem El-Haik, Khalid S. Mekki

ISBN: 978-1-118-21041-3 September 2011 528 Pages

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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.



1 Medical Device Design Quality.

1.1 Introduction.

1.2 The Essence of Quality.

1.3 Quality Operating System and the Device Life Cycle.

1.4 Evolution of Quality.

1.5 Business Excellence: A Value Proposition.

1.6 Summary.

2 Design for Six Sigma and Medical Device Regulation.

2.1 Introduction.

2.2 Global Perspective on Medical Device Regulations.

2.3 Medical Device Classifi cation.

2.4 Medical Device Safety.

2.5 Medical Device Quality Management Systems Requirements.

2.6 Medical Device Regulation Throughout the Product Development Life Cycle.

2.7 Summary.

3 Basic Statistics.

3.1 Introduction.

3.2 Common Probability Distributions.

3.3 Methods of Input and Output Analysis.

3.4 Descriptive Statistics.

3.5 Inferential Statistics.

3.6 Normal Distribution and Normality Assumption.

3.7 Summary.

4 The Six Sigma Process.

4.1 Introduction.

4.2 Six Sigma Fundamentals.

4.3 Process Modeling.

4.4 Business Process Management.

4.5 Measurement Systems Analysis.

4.6 Process Capability and Six Sigma Process Performance.

4.7 Overview of Six Sigma Improvement.

4.8 Six Sigma Gose Upstream: Design for Six Sigma.

4.9 Summary.

Appendix 4A: Cause-and-Effect Tools.

5 Medical Device Design for Six Sigma.

5.1 Introduction.

5.2 Value of Designing for Six Sigma.

5.3 Medical Device DFSS Fundamentals.

5.4 The ICOV Process in Design.

5.5 The ICOV Process in Product Development.

5.6 Summary.

6 Medical Device DFSS Deployment.

6.1 Introduction.

6.2 Medical Device DFSS Deployment Fundamentals.

6.3 Predeployment Phase.

6.4 Deployment Phase.

6.5 Postdeployment Phase.

6.6 DFSS Sustainability Factors.

6.7 Black Belts and the DFSS Team: Cultural Change.

6.8 Summary.

7 Medical Device DFSS Project Road Map.

7.1 Introduction.

7.2 Medical Device DFSS Team.

7.3 Medical Device DFSS Road Map.

7.4 Software DFSS ICOV Process.

7.5 Summary.

8 Quality Function Deployment.

8.1 Introduction.

8.2 History of QFD.

8.3 QFD Fundamentals.

8.4 QFD Methodology.

8.5 HQQ Evaluation.

8.6 HQQ 1: The Customer’s House.

8.7 HQQ 2: Translation House.

8.8 HQQ 3: Design House.

8.9 HQQ 4: Process House.

8.10 Application: Auto 3D.

8.11 Summary.

9 DFSS Axiomatic Design Method.

9.1 Introduction.

9.2 Axiomatic Method Fundamentals.

9.3 Introduction to Axiom 1.

9.4 Introduction to Axiom 2.

9.5 Axiomatic Design Theorems and Corollaries.

9.6 Application: Medication Mixing Machine.

9.7 Application: Axiomatic Design Applied to Design Controls.

9.8 Summary.

Appendix 9A: Matrix Review.

10 DFSS Innovation for Medical Devices.

10.1 Introduction.

10.2 History of the Theory of Inventive Problem Solving.

10.3 TRIZ Fundamentals.

10.4 TRIZ Problem-Solving Process.

10.5 Ideal Final Result.

10.6 Building Suffi cient Functions.

10.7 Eliminating Harmful Functions.

10.8 Inventive Principles.

10.9 Detection and Measurement Concepts.

10.10 TRIZ Root Cause Analysis.

10.11 Evolution trends in Technological Systems.

10.12 TRIZ Functional Analysis and Analogy.

10.13 Application: Using Triads to Predict and Conceive Next-Generation Products.

10.14 Summary.

Appendix 10A: Contradiction Matrix.

11 DFSS Risk Management Process.

11.1 Introduction.

11.2 Planning for Risk Management Activities in Design  and Development.

11.3 Risk Assessment Techniques.

11.4 Risk Evaluation.

11.5 Risk Control.

11.6 Postproduction Control.

11.7 Summary.

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.

12.1 Introduction.

12.2 Design for Reliability.

12.3 Design for Packaging.

12.4 Design for Manufacture and Design for Assembly.

12.5 Design for Maintainability.

12.6 Design for Serviceability.

12.7 Summary.

13 DFSS Transfer Function and Scorecards.

13.1 Introduction.

13.2 Design Mapping.

13.3 Design Scorecards and the Transfer Function.

13.4 Transfer Function Mathematics.

13.5 Transfer Function and Optimization.

13.6 Monte Carlo Simulation.

13.7 Summary.

14 Fundamentals of Experimental Design.

14.1 Introduction.

14.2 Classical Design of Experiments.

14.3 Factorial Experiment.

14.4 Analysis of Variance.

14.5 2k Full Factorial Designs.

14.6 Fractional Factorial Designs.

14.7 Other Factorial Designs.

14.8 Summary.

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.

15.1 Introduction.

15.2 Robust Design Fundamentals.

15.3 Robust Design Concepts.

15.4 Application: Dynamic Formulation.

15.5 Summary.

16 Medical Device Tolerance Design.

16.1 Introduction.

16.2 Tolerance Design and DFSS.

16.3 Worst-Case Tolerance.

16.4 Statistical Tolerances.

16.5 Taguchi’s Loss Function and Safety Tolerance Design.

16.6 High- vs. Low-Level Requirements’ Tolerance Relationships.

16.7 Taguchi’s Tolerance Design Experiment.

16.8 Summary.

17 Medical Device DFSS Verifi cation and Validation.

17.1 Introduction.

17.2 Design Verifi cation Process.

17.3 Production Process Validation.

17.4 Software Validation.

17.5 Design Validation.

17.6 Summary.

18 DFSS Design Transfer.

18.1 Introduction.

18.2 Design Transfer Planning.

18.3 Process Control Plan.

18.4 Statistical Process Control.

18.5 Process Capability.

18.6 Advanced Product Quality Planning.

18.7 Device Master Record.

18.8 Summary.

19 Design Change Control, Design Review, and Design History File.

19.1 Introduction.

19.2 Design Change Control Process.

19.3 Design Review.

19.4 Design History File.

19.5 Summary.

20 Medical Device DFSS Case Study.

20.1 Introduction.

20.2 DFSS Identify Phase.

20.3 DFSS Characterize Phase.

20.4 DFSS Optimize Phase.

20.5 DFSS Verify/Validate Phase.

20.6 Summary.

Glossary: DFSS Terminology.

Appendix: Statistical Tables.



"The book is well-written and the authors use well versed descriptions, easy to read figures and tables, and industry-related examples and case studies to explain what can be very complex concepts and processes. This book would be a valuable resource for anyone in the field of medical device design." (Doody's Book Reviews, October 2008)