Medical Device Design

Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.

This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design.

• Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation
• Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more
• Presents additional content around software and biocompatibility concerns

Medical and Biomedical Engineers plus medical and clinical professionals involved in medical device design, from concept to commercialization and FDA/regulatory approval

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 Case studies
2.7 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 Case studies
3.6 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
5.5 Case studies
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 Application to software development
7.9 Case studies
7.10 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
8.5.1 Bigger section on biocompatibility
8.5.2 Bigger item on "standard" materials (tables in appendix)
8.6 Computer-Aided Design
8.7 D4X
8.8 Design for Usability (DFU)
8.9 Software and embedded systems coding
8.10 Additive Manufacturing
8.11 Case studies
8.12 Summary
References

Chapter 9. Evaluation (Validation and Verification)
9.1 Introduction
9.2 Explanation of Standing Items
9.2 Risk Management (updated for new standard)
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 Need for contracts and SLA
10.5 Summary
Further Reading

Chapter 11. Labelling and Instructions for Use
11.1 Introduction
11.2 Standard Symbols and Texts
11.3 GUDID and identifiable markers
11.4 Labelling
11.5 Marking
11.6 IFUs and Surgical Techniques
11.7 Surgical Technique
11.8 Declarations
11.9 Translation
11.10 Case studies
11.10 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 The Design Dossier, Design History File and the Technical File
14.7 Getting to Market
14.8 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