
Medical Device Design
Innovation from Concept to Market
Description
Key Features
- 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
Readership
Table of Contents
Chapter 1. Introduction
1.1 What Is Design?
1.2 The Design Life Cycle
1.3 Medical Devices Definitions
1.4 Summary
ReferencesChapter 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
ReferencesChapter 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 ReadingChapter 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
ReferencesChapter 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
ReferencesChapter 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
ReferencesChapter 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
ReferencesChapter 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
ReferencesChapter 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
ReferencesChapter 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 ReadingChapter 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
ReferencesChapter 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 ReadingChapter 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
ReferencesChapter 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
ReferencesAppendix 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
Product details
- No. of pages: 538
- Language: English
- Copyright: © Academic Press 2019
- Published: October 26, 2019
- Imprint: Academic Press
- Paperback ISBN: 9780128149621
- eBook ISBN: 9780128149638