Front Cover -- Medical Device Design -- Copyright Page -- Contents -- Preface -- Acknowledgements -- 1 Introduction -- 1.1 What Is Design? -- 1.2 The Design Life Cycle -- 1.3 Medical Devices Definitions -- 1.4 Summary -- References -- 2 Classifying Medical Devices -- 2.1 Introduction: Why Classify? -- 2.2 Classification Rules -- 2.3 Classification Case Study -- 2.3.1 EU Classification -- 2.3.2 USA Classification -- 2.3.3 Special Cases -- 2.4 Classification Models -- 2.5 Classification and the Design Process -- 2.6 Summary -- References -- 3 The Design Process -- 3.1 Design Process versus Design Control -- 3.2 Design Models -- 3.2.1 Pahl and Beitz, and Pugh -- 3.2.2 Divergent-Convergent Model -- 3.3 Managing Design -- 3.3.1 Common Design Management Models -- 3.3.1.1 Serial Design -- 3.3.1.2 Ad Hoc Feedback -- 3.3.1.3 Concurrent Design/Concurrent Engineering -- 3.3.1.4 Collaborative Models -- 3.3.1.5 Holistic Models -- 3.3.1.6 Which Model Is Best for Me? -- 3.4 Cross-Reference with Regulatory Requirements -- 3.5 Summary -- Tasks -- References -- Further Reading -- 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 -- 4.5.1 New Product Procedure -- 4.5.2 Clarification/Product Specification Procedure -- 4.5.3 Detailed Design Procedure -- 4.5.4 Design Verification/Validation/Evaluation Procedure -- 4.5.5 Design Changes -- 4.5.6 Control of Documents -- 4.5.7 Risk Assessment Procedure -- 4.6 Implementing a Procedure -- 4.7 Summary -- References -- 5 Developing Your Product Design Specification -- 5.1 Introduction -- 5.2 Developing the Statement of Need (or Brief) -- 5.2.1 Identifying the "One Thing" -- 5.2.2 Formalizing the Statement of Need -- 5.3 The Product Design Specification (PDS) -- 5.3.1 Essential Elements of a PDS -- 5.3.1.1 Customer.

5.3.1.2 Regulatory and Statutory -- 5.3.1.3 Technical -- 5.3.1.4 Performance -- 5.3.1.4.1 Biomechanics -- 5.3.1.5 Sales -- 5.3.1.6 Manufacturing -- 5.3.1.7 Packaging and Transportation -- 5.3.1.8 Environmental -- 5.3.1.9 Summary -- 5.4 Finding, Extracting, and Analyzing the Content -- 5.4.1 Focus Groups -- 5.4.2 Regulatory Bodies -- 5.4.3 Immersion -- 5.4.4 Libraries -- 5.4.4.1 Standards -- 5.4.4.2 Journals and Learned Publications -- 5.4.4.3 Books -- 5.4.4.4 Librarians -- 5.4.5 Technical Literature -- 5.4.5.1 General Trade Magazines -- 5.4.5.2 Catalogs, Fliers, and Trade Literature -- 5.4.6 The Internet -- 5.4.7 Conferences and Symposia -- 5.4.8 Others -- 5.5 Summary -- References -- 6 Generating Ideas and Concepts -- 6.1 Introduction -- 6.2 The "Engineer's Notebook" -- 6.3 Creative Space -- 6.3.1 The White Room -- 6.3.2 Personal Space -- 6.4 Generating Concepts/Ideas -- 6.4.1 Radial Thinking -- 6.4.2 Inversion (or Word Association) -- 6.4.3 Analogue -- 6.4.4 Brainstorming -- 6.4.5 Discretizing -- 6.4.6 Morphological Analysis -- 6.4.7 Research -- 6.4.8 We Have Ideas! -- 6.5 Selecting Concepts and Ideas -- 6.5.1 Morphological Analysis -- 6.5.2 Criteria Assessment -- 6.5.3 Weighted Criteria Assessment -- 6.6 Summary -- References -- 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) -- 7.5.1 Fault Tree Analysis -- 7.5.1.1 Ishikawa Diagram -- 7.6 D4X -- 7.7 Six Sigma -- 7.8 Summary -- References -- 8 Design Realization/Detailed Design -- 8.1 Introduction -- 8.2 The Process to Design Realization -- 8.2.1 Macro Project Plan -- 8.2.2 Assemble Design Team -- 8.2.3 Micro Plan -- 8.2.4 Delivery of Subprojects -- 8.2.5 Delivery of Overall Design -- 8.2.6 How? -- 8.3 Assemble Your Detailed Design Team.

8.3.1 DHF Considerations for the "Lead Designer" -- 8.3.2 Phases of a Team -- 8.3.3 Design Meetings/Design Reviews -- 8.4 Design Calculations -- 8.4.1 Computer-Aided Analysis -- 8.4.2 Computer-Aided Analysis Disciplines -- 8.5 Materials Selection -- 8.5.1 Formalizing the Selection Process -- 8.5.2 PDS -- 8.5.3 Precedent -- 8.5.4 Research -- 8.5.5 Regulatory Bodies -- 8.5.6 Standards -- 8.5.7 Materials Search Engines -- 8.5.8 Advisory Bodies -- 8.5.9 Consultancies -- 8.5.10 Animal Products -- 8.5.11 Biocompatibility -- 8.5.11.1 Scope -- 8.5.11.2 Definition(s) and Standards -- 8.6 Computer-Aided Design -- 8.6.1 Cloud Computing -- 8.6.2 Document and Revision Management -- 8.6.3 Collaboration -- 8.6.4 Reverse Engineering -- 8.6.5 Engineering Drawings -- 8.6.6 Part Numbering -- 8.6.7 Tolerances -- 8.6.8 Sign Off -- 8.6.9 Rapid Prototyping (RP) -- 8.6.10 3D Visualization -- 8.7 D4X -- 8.7.1 Design for Manufacture (DFM) -- 8.7.2 Design for Assembly (DFA) -- 8.7.3 Design for Disassembly (DFDA) -- 8.7.4 Design for Sterilization (DFS) -- 8.7.5 Design for Environment/Sustainability (DFE) -- 8.8 Design for Usability (DFU) -- 8.8.1 Ergonomics -- 8.8.2 Man-Machine Interface -- 8.8.3 Design for Desirability -- 8.9 Summary -- References -- 9 Evaluation (Validation and Verification) -- 9.1 Introduction -- 9.1.1 Clinical Trial or Clinical Evaluation: What Is the Difference? -- 9.1.2 Why Do an Evaluation? -- 9.1.3 What Is in an Evaluation? -- 9.1.4 Relationship with the PDS -- 9.1.5 Method of Demonstration -- 9.2 Risk Analysis -- 9.2.1 Identifying Risks/Hazards -- 9.2.2 Assessing Level of Risk -- 9.3 Criteria-Based Evaluation -- 9.3.1 In Vitro/In Vivo -- 9.3.2 Accelerated Life Tests -- 9.3.2.1 Vibration -- 9.3.2.2 Cyclic Loading -- 9.3.2.3 Static Loading -- 9.3.2.4 Humidity and Temperature -- 9.3.2.5 Normal Use -- 9.3.2.6 Cleaning and Sterilization -- 9.3.3 Calibration.

9.3.3.1 Sensitivity -- 9.3.3.2 Range -- 9.3.3.3 Repeatability -- 9.3.3.4 Reproducibility -- 9.3.3.5 Resolution -- 9.3.3.6 Linearity -- 9.3.3.7 Summary of Calibration -- 9.3.4 Surface Evaluation -- 9.3.4.1 USB Microscopes -- 9.3.4.2 Commercial Optical Microscopes -- 9.3.4.3 Profile Projectors -- 9.3.4.4 Hardness Testing Machines -- 9.3.4.5 Scanning Electron Microscopes (SEM) -- 9.3.4.6 Atomic Force Microscopy (AFM) -- 9.3.4.7 Beam Profile Reflectometry (BPR) -- 9.4 Computer-Based Evaluation -- 9.4.1 Animation -- 9.4.2 Dynamic Simulation -- 9.4.3 Finite Element Analysis -- 9.4.4 Computational Fluid Dynamics -- 9.4.5 Caveat -- 9.5 Value to "Healthcare" Analysis -- 9.5.1 Distinct Health Benefits -- 9.5.2 Stating Clinical Benefits -- 9.6 Clinical Studies and Clinical Trials -- 9.6.1 The Hypothesis -- 9.6.2 Investigation Specification -- 9.6.2.1 Study Types -- 9.6.3 Relationship with Ethical Committees -- 9.6.3.1 Informed Consent -- 9.6.4 Relationship with Regulatory Bodies -- 9.6.5 ISO 14155 and EC-FDA Guidelines -- 9.6.6 Analysis of Data -- 9.6.6.1 Outliers and Missing Values -- 9.6.6.2 Correlation -- 9.6.6.3 Averages and Confidence Limits -- 9.6.6.4 The Student t-test -- 9.6.6.5 Multivariant Analysis -- 9.7 Literature Review -- 9.7.1 Conducting the Review -- 9.7.2 Format for Literature Review -- 9.8 Format for Formal Clinical Evaluation Report -- 9.9 Summary -- References -- 10 Manufacturing Supply Chain -- 10.1 Introduction -- 10.2 Identifying Potential Suppliers -- 10.2.1 Samples -- 10.2.2 Initial Audit -- 10.2.3 Contractual Arrangements -- 10.2.4 Approved Supplier Register -- 10.2.5 Suggested Procedure -- 10.3 Packaging -- 10.3.1 Sterile Packaging -- 10.3.2 Nonsterile Packaging -- 10.3.3 Packaging Testing -- 10.3.4 Storage Considerations -- 10.4 Procurement -- 10.4.1 Supply Chain Glossary -- 10.4.2 Costing -- 10.5 Summary -- Further Reading.

11 Labeling and Instructions for Use -- 11.1 Introduction -- 11.1.1 The Rules -- 11.2 Standard Symbols and Texts -- 11.2.1 CE Mark -- 11.2.2 Nonsterile Device -- 11.2.3 Single Use Item -- 11.2.4 Sterility -- 11.2.5 Use by Date -- 11.2.6 Lot Number/Batch Number -- 11.2.7 Catalog Number/Part Number -- 11.2.8 Consult Instructions for Use -- 11.2.9 Prescription Only -- 11.2.10 Manufacturer Details -- 11.2.11 Date of Packing/Manufacture Date -- 11.2.12 EC Representative -- 11.3 Labeling -- 11.3.1 Outer Packaging Labels -- 11.3.2 Patient Labels -- 11.3.3 Bar Codes -- 11.3.4 Security Labels -- 11.3.5 Crossover of Symbols between USA and EC -- 11.3.6 Translation -- 11.3.7 Position of Labels -- 11.4 Marking -- 11.4.1 Company Identification Mark -- 11.4.2 CE Mark -- 11.4.3 Part Number and Lot Number -- 11.4.4 Size -- 11.5 IFUs and Surgical Techniques -- 11.5.1 Instructions for Use Leaflet -- 11.5.1.1 Nonsterile Items -- 11.6 Surgical Technique -- 11.6.1 Assembly and Disassembly Instructions -- 11.6.2 Warnings and Contraindications -- 11.6.3 Production of the Surgical Technique -- 11.6.4 Document Control -- 11.7 Declarations -- 11.7.1 Declaration of Conformity -- 11.7.2 Declaration (or Certificate) of Cleaning and Sterilization -- 11.8 Translation -- 11.9 Summary -- References -- 12 Postmarket Surveillance -- 12.1 Introduction -- 12.2 PMS and Its Role in Design -- 12.3 Tools -- 12.3.1 Process Control Chart -- 12.3.2 Reliability - Bathtub Curve -- 12.3.3 Weibull Plot -- 12.3.4 Measles Chart -- 12.3.5 Pareto Analysis -- 12.4 Using Your Existing Contacts -- 12.4.1 Early Adopters and Key Opinion Leaders -- 12.4.2 Focus Groups -- 12.4.3 Courses and Conferences -- 12.5 Vigilance -- 12.6 The Good, the Bad, and the Ugly -- 12.7 Summary -- References -- Further Reading -- 13 Protecting Your IP -- 13.1 Introduction -- 13.2 Types of IP Protection -- 13.2.1 Patent.

13.2.1.1 Filing.