Additive Manufacturing for Orthopedic Implants

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.

• PrefaceAcknowledgmentsChapter 1 - Introduction: Additive Manufacturing for Medical Devices 61.1 Additive Manufacturing for Medical Devices – An Overview 61.2 Additive Manufacturing for Medical Devices – the Benefits and Drawbacks 71.3 Additive Manufacturing – Market Size for Medical Devices 9References 9Abstract 10Keywords 10Chapter 2 - Current and Future Applications of Additive Manufacturing in Orthopedics 112.1 History of Patient-Specific Orthopedic Devices 112.2 Additive Manufacturing Market Size and Share 122.3 Current Uses of Additive Manufacturing in Orthopedics 132.4. Future Applications 182.5. Conclusion 192.6. References 20Abstract 21Keywords 21Chapter 3 - Types of Additive Manufacturing Technologies 223.1 Background & History of Additive Manufacturing Technologies 223.2 Seven Types of Additive Manufacturing Technologies 233.3 Additive Manufacturing Technologies with Medical Device Applications 483.4 Future Medical Applications of Additive Manufacturing Technologies 52Table of Figures 53References 53Abstract 55Keywords 55Chapter 4 - Design Considerations 564.1 Stages of Orthopedic Device Design & Development 564.2 Design Criteria for Orthopedic Devices 594.3 Additive Manufacturing Design Considerations 62Table of Figures 66References 67Abstract 67Keywords 68Chapter 5 – Materials 695.1 Material Savings: Get-to-Fit 695.2 Recycle and Reuse 705.3 Material Properties for Orthopedics 715.4 Metals 735.5. Polymers 785.6. Ceramics 795.7. Conclusion 81Table of Figures 81References 81Abstract 82Key Terms 83Chapter 6 - Process Validation (IQ, OQ, PQ) 846.1 Introduction to Process Validation 846.2 Installation Qualification (IQ) and Equipment Verification 866.3 Operational Qualification (OQ) 896.4 Performance Qualification (PQ) 936.5 Process Validation Summary 95Tables and Figures 95References 96Abstract 96Keywords 97Chapter 7 - Post-Processing of Additive Manufactured Orthopedic Implants 987.1 The Need for Post Processing for Additive Manufactured Orthopedic Implants 987.2 FDA Guidance and ASTM Guidelines 997.3 Post-Processing Methods 1007.4 Conclusion 105References 106Abstract 107Keywords 108Chapter 8 - Facility Requirements for Metal Additive Manufacturing 1098.1 Introduction 1098.2 Facility Location and Power 1108.3 Equipment and Infrastructure 1118.4 Metal Additive Machine Selection 1138.5 Powder Handling and Storage 1158.6 Quality Control Equipment 1168.7 Operator Training & Safety 1168.8 Fire Suppression Systems 1178.9 Emission Control and Environmental Regulations 1178.10 Medical Device Regulations and Regulatory Compliance 1188.11 Conclusion 119Table of Figures 119References 119Abstract 120Keywords 120Chapter 9 - Powder Reuse & Testing 1219.1 Introduction 1219.2 Material Selection 1229.3 Raw Material Storage and Handling 1249.4 Powder Analysis 1259.5 Powder Reuse 1279.6 Combining Virgin and Reused Powder Batches 1299.7 Conclusion 129References 130Abstract 130Keywords 131Chapter 10 - Final Inspection – Lot Release Testing 13210.1 Regulatory Compliance 13210.2 Visual Inspection Techniques 13310.3 Non-Destructive Testing (NDT) 13410.4 Destructive Testing 13610.5 Emerging Technologies 13810.6 Conclusions 138References 139Abstract 141Keywords 141Chapter 11 - Regulatory Filings 14211.1 Creation and Evolution 14211.2 Quality Management Systems 14611.3 US and EU Device Clearance/Approval Schemes Compared 15211.4 US Regulatory 15311.5 EU Regulatory 15711.6 Additional Considerations for Additively Manufactured Devices 162Table of Figures 163References 163Abstract 163Key Terms 164Chapter 12 - Device and Material Enhancements 16512.1 Surface Coatings 16512.2 Osseointegration-Improving Characteristics Possible with Additive Manufacturing 16912.3 Antibacterial and Antimicrobial Characteristics Possible with Additive Manufacturing 17112.3 Looking Ahead 172References 173Abstract 174Keywords 174Index 175