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.

• Preface xiAcknowledgment xiiChapter 1 Introduction: Additive Manufacturing for Medical Devices 11.1 Additive Manufacturing for Medical Devices – An Overview 11.2 Additive Manufacturing for Medical Devices – The Benefits and Drawbacks 21.3 Additive Manufacturing – Market Size for Medical Devices 4References 5Chapter 2 Current and Future Applications of Additive Manufacturing in Orthopedics 72.1 History of Patient- Specific Orthopedic Devices 82.2 Additive Manufacturing Market Size and Share 82.3 Current Uses of Additive Manufacturing in Orthopedics 102.4 Future Applications 142.5 Conclusion 16Table of Figure 16References 16Chapter 3 Types of Additive Manufacturing Technologies 193.1 Background and History of Additive Manufacturing Technologies 203.2 Seven Types of Additive Manufacturing Technologies 213.3 Additive Manufacturing Technologies with Medical Device Applications 423.4 Future Medical Applications of Additive Manufacturing Technologies 44Tables of Figures 45References 46Chapter 4 Design Considerations 494.1 Stages of Orthopedic Device Design and Development 494.2 Design Criteria for Orthopedic Devices 534.3 Additive Manufacturing Design Considerations 55Table of Figures 60References 60Chapter 5 Materials 635.1 Material Savings: Get- To- Fit 635.2 Recycle and Reuse 645.3 Material Properties for Orthopedics 655.4 Metals 685.5 Polymers 725.6 Ceramics 735.7 Conclusion 74Table of Figure 74References 74Chapter 6 Process Validation (IQ, OQ, PQ) 776.1 Introduction to Process Validation 776.2 IQ and Equipment Verification 796.3 Operational Qualification 846.4 Performance Qualification 876.5 Process Validation Summary 89Table of Figure 89References 89Chapter 7 Postprocessing of Additive Manufactured Orthopedic Implants 917.1 The Need for Postprocessing for Additive Manufactured Orthopedic Implants 927.2 FDA Guidance and ASTM Guidelines 927.3 Postprocessing Methods 937.4 Conclusion 98Table of Figure 99References 99Chapter 8 Facility Requirements for Metal Additive Manufacturing 1018.1 Introduction 1028.2 Facility Location and Power 1028.3 Equipment and Infrastructure 1038.4 Metal Additive Machine Selection 1048.5 Powder Handling and Storage 1068.6 Quality Control Equipment 1078.7 Operator Training and Safety 1088.8 Fire Suppression Systems 1098.9 Emission Control and Environmental Regulations 1098.10 Medical Device Regulations and Regulatory Compliance 1108.11 Conclusion 111Table of Figures 111References 111Chapter 9 Powder Reuse and Testing 1139.1 Introduction 1149.2 Material Selection 1149.3 Raw Material Storage and Handling 1169.4 Powder Analysis 1169.5 Powder Reuse 1189.6 Combining Virgin and Reused Powder Batches 1209.7 Conclusion 121References 121Chapter 10 Final Inspection – Lot Release Testing 12310.1 Regulatory Compliance 12310.2 Visual Inspection Techniques 12510.3 Nondestructive Testing 12610.4 Destructive Testing 12710.5 Emerging Technologies 12910.6 Conclusions 129References 130Chapter 11 Regulatory Filings 13311.1 Creation and Evolution 13411.2 Quality Management Systems 13611.3 US and EU Device Clearance/Approval Schemes Compared 14211.4 US Regulatory 14211.5 EU Regulatory 14611.6 Additional Considerations for Additively Manufactured Devices 150Table of Figures 151References 152Chapter 12 Device and Material Enhancements 15312.1 Surface Coatings 15412.2 Osseointegration- Improving Characteristics Possible with AM 15712.3 Antibacterial and Antimicrobial Characteristics Possible with AM 15912.4 Looking Ahead 160Tables of Figures 160References 160Index 163