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Full Description
Offers a practical roadmap for successfully applying additive manufacturing to orthopedic implants
As additive manufacturing (AM) transforms the orthopedic implant landscape, professionals are facing a growing need for guidance that connects advanced manufacturing techniques with practical regulatory and validation requirements. Additive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities, and Regulatory Submissions delivers exactly that—a clear, concise resource designed specifically for engineers, designers, and regulatory specialists working at the intersection of innovation and compliance.
Written by seasoned professionals with deep experience in additive technologies, mechanical testing, and regulatory environments, this book walks readers through the critical steps involved in developing spine, hip, knee, shoulder, and other implant products using additive manufacturing. The content spans the full product lifecycle, from design and prototyping to process validation and FDA submission preparation. Key insights into various AM technologies and post-processing methods are grounded in real-world examples and case studies that illuminate common challenges and successful solutions.
Providing the essential tools for navigating a complex and rapidly evolving field, Additive Manufacturing for Orthopedic Implants:
Clarifies material selection criteria specific to different implant types and AM technologies
Explores the interplay between design freedom and regulatory expectations in patient-specific implants
Highlights common failure modes and risk mitigation strategies in AM orthopedic manufacturing
Addresses facility, inspection, and documentation needs to meet compliance and audit standards
Features decision-making aids, checklists, and process validation frameworks to support practical implementation
Demystifies the regulatory requirements specific to additively manufactured products
Integrating insights from multiple disciplines, including biomedical engineering, regulatory affairs, and quality assurance, Additive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities, and Regulatory Submissions is essential for professionals working in medical device manufacturing, particularly those developing orthopedic implants using additive technologies. It is also suitable for graduate-level courses in biomedical engineering, additive manufacturing, and medical device design.
Contents
Preface
Acknowledgments
Chapter 1 - Introduction: Additive Manufacturing for Medical Devices 6
1.1 Additive Manufacturing for Medical Devices - An Overview 6
1.2 Additive Manufacturing for Medical Devices - the Benefits and Drawbacks 7
1.3 Additive Manufacturing - Market Size for Medical Devices 9
References 9
Abstract 10
Keywords 10
Chapter 2 - Current and Future Applications of Additive Manufacturing in Orthopedics 11
2.1 History of Patient-Specific Orthopedic Devices 11
2.2 Additive Manufacturing Market Size and Share 12
2.3 Current Uses of Additive Manufacturing in Orthopedics 13
2.4. Future Applications 18
2.5. Conclusion 19
2.6. References 20
Abstract 21
Keywords 21
Chapter 3 - Types of Additive Manufacturing Technologies 22
3.1 Background & History of Additive Manufacturing Technologies 22
3.2 Seven Types of Additive Manufacturing Technologies 23
3.3 Additive Manufacturing Technologies with Medical Device Applications 48
3.4 Future Medical Applications of Additive Manufacturing Technologies 52
Table of Figures 53
References 53
Abstract 55
Keywords 55
Chapter 4 - Design Considerations 56
4.1 Stages of Orthopedic Device Design & Development 56
4.2 Design Criteria for Orthopedic Devices 59
4.3 Additive Manufacturing Design Considerations 62
Table of Figures 66
References 67
Abstract 67
Keywords 68
Chapter 5 - Materials 69
5.1 Material Savings: Get-to-Fit 69
5.2 Recycle and Reuse 70
5.3 Material Properties for Orthopedics 71
5.4 Metals 73
5.5. Polymers 78
5.6. Ceramics 79
5.7. Conclusion 81
Table of Figures 81
References 81
Abstract 82
Key Terms 83
Chapter 6 - Process Validation (IQ, OQ, PQ) 84
6.1 Introduction to Process Validation 84
6.2 Installation Qualification (IQ) and Equipment Verification 86
6.3 Operational Qualification (OQ) 89
6.4 Performance Qualification (PQ) 93
6.5 Process Validation Summary 95
Tables and Figures 95
References 96
Abstract 96
Keywords 97
Chapter 7 - Post-Processing of Additive Manufactured Orthopedic Implants 98
7.1 The Need for Post Processing for Additive Manufactured Orthopedic Implants 98
7.2 FDA Guidance and ASTM Guidelines 99
7.3 Post-Processing Methods 100
7.4 Conclusion 105
References 106
Abstract 107
Keywords 108
Chapter 8 - Facility Requirements for Metal Additive Manufacturing 109
8.1 Introduction 109
8.2 Facility Location and Power 110
8.3 Equipment and Infrastructure 111
8.4 Metal Additive Machine Selection 113
8.5 Powder Handling and Storage 115
8.6 Quality Control Equipment 116
8.7 Operator Training & Safety 116
8.8 Fire Suppression Systems 117
8.9 Emission Control and Environmental Regulations 117
8.10 Medical Device Regulations and Regulatory Compliance 118
8.11 Conclusion 119
Table of Figures 119
References 119
Abstract 120
Keywords 120
Chapter 9 - Powder Reuse & Testing 121
9.1 Introduction 121
9.2 Material Selection 122
9.3 Raw Material Storage and Handling 124
9.4 Powder Analysis 125
9.5 Powder Reuse 127
9.6 Combining Virgin and Reused Powder Batches 129
9.7 Conclusion 129
References 130
Abstract 130
Keywords 131
Chapter 10 - Final Inspection - Lot Release Testing 132
10.1 Regulatory Compliance 132
10.2 Visual Inspection Techniques 133
10.3 Non-Destructive Testing (NDT) 134
10.4 Destructive Testing 136
10.5 Emerging Technologies 138
10.6 Conclusions 138
References 139
Abstract 141
Keywords 141
Chapter 11 - Regulatory Filings 142
11.1 Creation and Evolution 142
11.2 Quality Management Systems 146
11.3 US and EU Device Clearance/Approval Schemes Compared 152
11.4 US Regulatory 153
11.5 EU Regulatory 157
11.6 Additional Considerations for Additively Manufactured Devices 162
Table of Figures 163
References 163
Abstract 163
Key Terms 164
Chapter 12 - Device and Material Enhancements 165
12.1 Surface Coatings 165
12.2 Osseointegration-Improving Characteristics Possible with Additive Manufacturing 169
12.3 Antibacterial and Antimicrobial Characteristics Possible with Additive Manufacturing 171
12.3 Looking Ahead 172
References 173
Abstract 174
Keywords 174
Index 175
