Preface xi
Acknowledgment xii
Chapter 1 Introduction: Additive Manufacturing for Medical Devices 1
1.1 Additive Manufacturing for Medical Devices â" An Overview 1
1.2 Additive Manufacturing for Medical Devices â" The Benefits and Drawbacks 2
1.3 Additive Manufacturing â" Market Size for Medical Devices 4
Chapter 2 Current and Future Applications of Additive Manufacturing in Orthopedics 7
2.1 History of Patient-Specific Orthopedic Devices 8
2.2 Additive Manufacturing Market Size and Share 8
2.3 Current Uses of Additive Manufacturing in Orthopedics 10
2.4 Future Applications 14
2.5 Conclusion 16
Chapter 3 Types of Additive Manufacturing Technologies 19
3.1 Background and History of Additive Manufacturing Technologies 20
3.2 Seven Types of Additive Manufacturing Technologies 21
3.3 Additive Manufacturing Technologies with Medical Device Applications 42
3.4 Future Medical Applications of Additive Manufacturing Technologies 44
Chapter 4 Design Considerations 49
4.1 Stages of Orthopedic Device Design and Development 49
4.2 Design Criteria for Orthopedic Devices 53
4.3 Additive Manufacturing Design Considerations 55
Chapter 5 Materials 63
5.1 Material Savings: Get-To-Fit 63
5.2 Recycle and Reuse 64
5.3 Material Properties for Orthopedics 65
5.4 Metals 68
5.5 Polymers 72
5.6 Ceramics 73
5.7 Conclusion 74
Chapter 6 Process Validation (IQ, OQ, PQ) 77
6.1 Introduction to Process Validation 77
6.2 IQ and Equipment Verification 79
6.3 Operational Qualification 84
6.4 Performance Qualification 87
6.5 Process Validation Summary 89
Chapter 7 Postprocessing of Additive Manufactured Orthopedic Implants 91
7.1 The Need for Postprocessing for Additive Manufactured Orthopedic Implants 92
7.2 FDA Guidance and ASTM Guidelines 92
7.3 Postprocessing Methods 93
7.4 Conclusion 98
Chapter 8 Facility Requirements for Metal Additive Manufacturing 101
8.1 Introduction 102
8.2 Facility Location and Power 102
8.3 Equipment and Infrastructure 103
8.4 Metal Additive Machine Selection 104
8.5 Powder Handling and Storage 106
8.6 Quality Control Equipment 107
8.7 Operator Training and Safety 108
8.8 Fire Suppression Systems 109
8.9 Emission Control and Environmental Regulations 109
8.10 Medical Device Regulations and Regulatory Compliance 110
8.11 Conclusion 111
Chapter 9 Powder Reuse and Testing 113
9.1 Introduction 114
9.2 Material Selection 114
9.3 Raw Material Storage and Handling 116
9.4 Powder Analysis 116
9.5 Powder Reuse 118
9.6 Combining Virgin and Reused Powder Batches 120
9.7 Conclusion 121
Chapter 10 Final Inspection â" Lot Release Testing 123
10.1 Regulatory Compliance 123
10.2 Visual Inspection Techniques 125
10.3 Nondestructive Testing 126
10.4 Destructive Testing 127
10.5 Emerging Technologies 129
10.6 Conclusions 129
Chapter 11 Regulatory Filings 133
11.1 Creation and Evolution 134
11.2 Quality Management Systems 136
11.3 US and EU Device Clearance/Approval Schemes Compared 142
11.4 US Regulatory 142
11.5 EU Regulatory 146
11.6 Additional Considerations for Additively Manufactured Devices 150
Chapter 12 Device and Material Enhancements 153
12.1 Surface Coatings 154
12.2 Osseointegration-Improving Characteristics Possible with AM 157
12.3 Antibacterial and Antimicrobial Characteristics Possible with AM 159
12.4 Looking Ahead 160
Tables of Figures 160
References 160
Index 163
