Additive Manufacturing for Orthopedic Implants
Material and Process Selection, Validation Activities, and Regulatory Submissions
1st Edition
Published on 3. March 2026
Book
Hardback
176 pages
978-1-394-21521-8 (ISBN)
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.
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.
More details
Series
Language
English
Place of publication
New York
United States
Target group
Professional and scholarly
Product notice
sewn/stitched
Cloth over boards
Dimensions
Height: 267 mm
Width: 191 mm
Thickness: 28 mm
Weight
522 gr
ISBN-13
978-1-394-21521-8 (9781394215218)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Meredith Price Vanderbilt | Dawn Abens Lissy | Brian McLaughlin
Additive Manufacturing for Orthopedic Implants
Material and Process Selection, Validation Activities, and Regulatory Submissions
E-Book
03/2026
1st Edition
Wiley
€71.99
Available for download
Meredith Price Vanderbilt | Dawn Abens Lissy | Brian McLaughlin
Additive Manufacturing for Orthopedic Implants
Material and Process Selection, Validation Activities, and Regulatory Submissions
E-Book
03/2026
1st Edition
Wiley
€71.99
Available for download
Persons
Meredith Price Vanderbilt is an attorney specializing in regulated medical product litigation at Bartko Pavia and the former Director of Consulting at Empirical Technologies. She is a biomedical engineer with extensive experience in FDA regulatory strategy, quality assurance, validation, and risk assessment. She holds RAC and CQA certifications.
Dawn Abens Lissy is the Founder and former President of Empirical Technologies Corp., a leading consulting and testing company for orthopedic medical devices. With over three decades of design, development, regulatory, and testing experience, she is a former FDA Entrepreneur-in-Residence and holds a patent for a spinal implant system.
Brian McLaughlin is the current Founder and CTO of ALM Ortho and the former founder and CEO of Amplify Additive, where he lead development of orthopedic implants using Electron Beam Melting (EBM) Additive Manufacturing technology. His background in biomedical engineering and clinical support gives him a unique perspective on merging technology with surgical applications.
Dawn Abens Lissy is the Founder and former President of Empirical Technologies Corp., a leading consulting and testing company for orthopedic medical devices. With over three decades of design, development, regulatory, and testing experience, she is a former FDA Entrepreneur-in-Residence and holds a patent for a spinal implant system.
Brian McLaughlin is the current Founder and CTO of ALM Ortho and the former founder and CEO of Amplify Additive, where he lead development of orthopedic implants using Electron Beam Melting (EBM) Additive Manufacturing technology. His background in biomedical engineering and clinical support gives him a unique perspective on merging technology with surgical applications.
Content
Preface xi
Acknowledgment xii
Chapter 1 Introduction: Additive Manufacturing for Medical Devices 1
1.1 Additive Manufacturing for Medical Devices - An Overview 1
1.2 Additive Manufacturing for Medical Devices - The Benefits and Drawbacks 2
1.3 Additive Manufacturing - Market Size for Medical Devices 4
References 5
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
Table of Figure 16
References 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
Tables of Figures 45
References 46
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
Table of Figures 60
References 60
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
Table of Figure 74
References 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
Table of Figure 89
References 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
Table of Figure 99
References 99
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
Table of Figures 111
References 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
References 121
Chapter 10 Final Inspection - 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
References 130
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
Table of Figures 151
References 152
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
Acknowledgment xii
Chapter 1 Introduction: Additive Manufacturing for Medical Devices 1
1.1 Additive Manufacturing for Medical Devices - An Overview 1
1.2 Additive Manufacturing for Medical Devices - The Benefits and Drawbacks 2
1.3 Additive Manufacturing - Market Size for Medical Devices 4
References 5
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
Table of Figure 16
References 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
Tables of Figures 45
References 46
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
Table of Figures 60
References 60
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
Table of Figure 74
References 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
Table of Figure 89
References 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
Table of Figure 99
References 99
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
Table of Figures 111
References 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
References 121
Chapter 10 Final Inspection - 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
References 130
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
Table of Figures 151
References 152
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