Additive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities,...

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Meredith Price Vanderbilt (Barkto Pavia LLP and Zengineer Consulting) Dawn Abens Lissy (Aurora Insights, LLC)

Additive Manufacturing for Orthopedic Implants

Name: Additive Manufacturing for Orthopedic Implants
Price: 140.95 AUD
Availability: PreOrder
ISBN: 9781394215218

Material and Process Selection, Validation Activities, and Regulatory Submissions

Meredith Price Vanderbilt (Barkto Pavia LLP and Zengineer Consulting), Dawn Abens Lissy (Aurora Insights, LLC), Brian McLaughlin (CTO & Founder of ALM Ortho)

$140.95

Hardback

Forthcoming
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English

John Wiley & Sons Inc
23 April 2026

Mechanical engineering & materials

Series: Additive Manufacturing Skills in Practice.

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.

By: Meredith Price Vanderbilt (Barkto Pavia LLP and Zengineer Consulting), Dawn Abens Lissy (Aurora Insights, LLC), Brian McLaughlin (CTO & Founder of ALM Ortho)
Imprint: John Wiley & Sons Inc
Country of Publication: United States
ISBN: 9781394215218
ISBN 10: 1394215215
Series: Additive Manufacturing Skills in Practice.
Pages: 176
Publication Date: 23 April 2026
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Forthcoming

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

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.