Dedication
Preface
Acknowledgements
Chapter 1. Introduction
1.1 What Is Design?
1.2 The Design Life Cycle
1.3 Medical Devices Definitions
1.4 Summary
References
Chapter 2. Classifying Medical Devices
2.1 Introduction: Why Classify?
2.2 Classification Rules
2.3 Classification Case Study
2.4 Classification Models
2.5 Classification and the Design Process
2.6 Summary
References
Chapter 3. The Design Process
3.1 Design Process versus Design Control
3.2 Design Models
3.3 Managing Design
3.4 Cross-Reference with Regulatory Requirements
3.5 Summary
Tasks
References
Further Reading
Chapter 4. Implementing Design Procedures
4.1 Introduction
4.2 Review of Guidelines
4.3 Overall Procedure
4.4 Audit /Review Procedure
4.5 The Design Process
4.6 Implementing a Procedure
4.7 Summary
References
Chapter 5. Developing Your Product Design Specification
5.1 Introduction
5.2 Developing the Statement of Need (or Brief)
5.3 The Product Design Specification (PDS)
5.4 Finding, Extracting, and Analyzing the Content
References
Chapter 6. Generating Ideas and Concepts
6.1 Introduction
6.2 The “Engineer’s Notebook”
6.3 Creative Space
6.4 Generating Concepts/Ideas
6.5 Selecting Concepts and Ideas
6.6 Summary
References
Chapter 7. Quality in Design
7.1 Introduction
7.2 Optimization
7.3 Design of Experiments/2k Factorial Experiments
7.4 House of Quality
7.5 Failure Mode and Effect Analysis (FMEA)
7.6 D4X
7.7 Six Sigma
7.8 Summary
References
Chapter 8. Design Realization/Detailed Design
8.1 Introduction
8.2 The Process to Design Realization
8.3 Assemble Your Detailed Design Team
8.4 Design Calculations
8.5 Materials Selection
8.6 Computer-Aided Design
8.7 D4X
8.8 Design for Usability (DFU)
8.9 Summary
References
Chapter 9. Evaluation (Validation and Verification)
9.1 Introduction
9.2 Risk Analysis
9.3 Criteria-Based Evaluation
9.4 Computer-Based Evaluation
9.5 Value to “Healthcare” Analysis
9.6 Clinical Studies and Clinical Trials
9.7 Literature Review
9.8 Format for Formal Clinical Evaluation Report
9.9 Summary
References
Chapter 10. Manufacturing Supply Chain
10.1 Introduction
10.2 Identifying Potential Suppliers
10.3 Packaging
10.4 Procurement
10.5 Summary
Further Reading
Chapter 11. Labeling and Instructions for Use
11.1 Introduction
11.2 Standard Symbols and Texts
11.3 Labeling
11.4 Marking
11.5 IFUs and Surgical Techniques
11.6 Surgical Technique
11.7 Declarations
11.8 Translation
11.9 Summary
References
Chapter 12. Postmarket Surveillance
12.1 Introduction
12.2 PMS and Its Role in Design
12.3 Tools
12.4 Using Your Existing Contacts
12.5 Vigilance
12.6 The Good, the Bad, and the Ugly
12.7 Summary
References
Further Reading
Chapter 13. Protecting Your IP
13.1 Introduction
13.2 Types of IP Protection
13.3 Keeping Mum
13.4 Talking with Partners
13.5 Summary
References
Chapter 14. Obtaining Regulatory Approval to Market
14.1 Introduction
14.2 Class I Devices
14.3 Higher Classifications
14.4 FDA Process
14.5 EC Process
14.6 Getting to Market
14.7 Summary
References
Appendix A. Useful Websites
FDA Medical Devices
Appendix B. Tables
Appendix C. ISO 14971 Annex C Pre–Risk Analysis Questionnaire
Appendix D. Generic Codes for Class I Medical Devices (MHRA)
FDA Class I and II Exempt Devices
Appendix E. Basic Materials Properties for Materials Selection
E.1 Density
E.2 Stress and Strain
Index
