{"product_id":"additive-manufacturing-for-orthopedic-implants-material-and-process-selection-validation-activities-and-regulatory-submissions-hardback-9781394215218","title":"Additive Manufacturing for Orthopedic Implants; Material and Process Selection, Validation Activities, and Regulatory Submissions (Hardback) 9781394215218","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eAdditive Manufacturing for Orthopedic Implants\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eMaterial and Process Selection, Validation Activities, and Regulatory Submissions\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eMeredith Price Vanderbilt (Author), Dawn Abens Lissy (Author), Brian McLaughlin (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9781394215218, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eHardback, published 3 March 2026\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e176 pages\u003cbr\u003e26.7 x 19 x 2.8 cm, 0.522 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003cb\u003eOffers a practical roadmap for successfully applying additive manufacturing to orthopedic implants\u003c\/b\u003e \u003c\/p\u003e\n\u003cp\u003eAs 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. \u003ci\u003eAdditive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities, and Regulatory Submissions\u003c\/i\u003e delivers exactly that—a clear, concise resource designed specifically for engineers, designers, and regulatory specialists working at the intersection of innovation and compliance. \u003c\/p\u003e\n\u003cp\u003eWritten 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. \u003c\/p\u003e\n\u003cp\u003eProviding the essential tools for navigating a complex and rapidly evolving field, \u003ci\u003eAdditive Manufacturing for Orthopedic Implants:\u003c\/i\u003e \u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eClarifies material selection criteria specific to different implant types and AM technologies\u003c\/li\u003e \u003cli\u003eExplores the interplay between design freedom and regulatory expectations in patient-specific implants\u003c\/li\u003e \u003cli\u003eHighlights common failure modes and risk mitigation strategies in AM orthopedic manufacturing\u003c\/li\u003e \u003cli\u003eAddresses facility, inspection, and documentation needs to meet compliance and audit standards\u003c\/li\u003e \u003cli\u003eFeatures decision-making aids, checklists, and process validation frameworks to support practical implementation\u003c\/li\u003e \u003cli\u003eDemystifies the regulatory requirements specific to additively manufactured products\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003eIntegrating insights from multiple disciplines, including biomedical engineering, regulatory affairs, and quality assurance, \u003ci\u003eAdditive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities, and Regulatory Submissions\u003c\/i\u003e 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.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003ePreface xi\u003c\/p\u003e \u003cp\u003eAcknowledgment xii\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 1 Introduction: Additive Manufacturing for Medical Devices 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Additive Manufacturing for Medical Devices – An Overview 1\u003c\/p\u003e \u003cp\u003e1.2 Additive Manufacturing for Medical Devices – The Benefits and Drawbacks 2\u003c\/p\u003e \u003cp\u003e1.3 Additive Manufacturing – Market Size for Medical Devices 4\u003c\/p\u003e \u003cp\u003eReferences 5\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 2 Current and Future Applications of Additive Manufacturing in Orthopedics 7\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 History of Patient- Specific Orthopedic Devices 8\u003c\/p\u003e \u003cp\u003e2.2 Additive Manufacturing Market Size and Share 8\u003c\/p\u003e \u003cp\u003e2.3 Current Uses of Additive Manufacturing in Orthopedics 10\u003c\/p\u003e \u003cp\u003e2.4 Future Applications 14\u003c\/p\u003e \u003cp\u003e2.5 Conclusion 16\u003c\/p\u003e \u003cp\u003eTable of Figure 16\u003c\/p\u003e \u003cp\u003eReferences 16\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 3 Types of Additive Manufacturing Technologies 19\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Background and History of Additive Manufacturing Technologies 20\u003c\/p\u003e \u003cp\u003e3.2 Seven Types of Additive Manufacturing Technologies 21\u003c\/p\u003e \u003cp\u003e3.3 Additive Manufacturing Technologies with Medical Device Applications 42\u003c\/p\u003e \u003cp\u003e3.4 Future Medical Applications of Additive Manufacturing Technologies 44\u003c\/p\u003e \u003cp\u003eTables of Figures 45\u003c\/p\u003e \u003cp\u003eReferences 46\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 4 Design Considerations 49\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Stages of Orthopedic Device Design and Development 49\u003c\/p\u003e \u003cp\u003e4.2 Design Criteria for Orthopedic Devices 53\u003c\/p\u003e \u003cp\u003e4.3 Additive Manufacturing Design Considerations 55\u003c\/p\u003e \u003cp\u003eTable of Figures 60\u003c\/p\u003e \u003cp\u003eReferences 60\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 5 Materials 63\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Material Savings: Get- To- Fit 63\u003c\/p\u003e \u003cp\u003e5.2 Recycle and Reuse 64\u003c\/p\u003e \u003cp\u003e5.3 Material Properties for Orthopedics 65\u003c\/p\u003e \u003cp\u003e5.4 Metals 68\u003c\/p\u003e \u003cp\u003e5.5 Polymers 72\u003c\/p\u003e \u003cp\u003e5.6 Ceramics 73\u003c\/p\u003e \u003cp\u003e5.7 Conclusion 74\u003c\/p\u003e \u003cp\u003eTable of Figure 74\u003c\/p\u003e \u003cp\u003eReferences 74\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 6 Process Validation (IQ, OQ, PQ) 77\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction to Process Validation 77\u003c\/p\u003e \u003cp\u003e6.2 IQ and Equipment Verification 79\u003c\/p\u003e \u003cp\u003e6.3 Operational Qualification 84\u003c\/p\u003e \u003cp\u003e6.4 Performance Qualification 87\u003c\/p\u003e \u003cp\u003e6.5 Process Validation Summary 89\u003c\/p\u003e \u003cp\u003eTable of Figure 89\u003c\/p\u003e \u003cp\u003eReferences 89\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 7 Postprocessing of Additive Manufactured Orthopedic Implants 91\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 The Need for Postprocessing for Additive Manufactured Orthopedic Implants 92\u003c\/p\u003e \u003cp\u003e7.2 FDA Guidance and ASTM Guidelines 92\u003c\/p\u003e \u003cp\u003e7.3 Postprocessing Methods 93\u003c\/p\u003e \u003cp\u003e7.4 Conclusion 98\u003c\/p\u003e \u003cp\u003eTable of Figure 99\u003c\/p\u003e \u003cp\u003eReferences 99\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 8 Facility Requirements for Metal Additive Manufacturing 101\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 102\u003c\/p\u003e \u003cp\u003e8.2 Facility Location and Power 102\u003c\/p\u003e \u003cp\u003e8.3 Equipment and Infrastructure 103\u003c\/p\u003e \u003cp\u003e8.4 Metal Additive Machine Selection 104\u003c\/p\u003e \u003cp\u003e8.5 Powder Handling and Storage 106\u003c\/p\u003e \u003cp\u003e8.6 Quality Control Equipment 107\u003c\/p\u003e \u003cp\u003e8.7 Operator Training and Safety 108\u003c\/p\u003e \u003cp\u003e8.8 Fire Suppression Systems 109\u003c\/p\u003e \u003cp\u003e8.9 Emission Control and Environmental Regulations 109\u003c\/p\u003e \u003cp\u003e8.10 Medical Device Regulations and Regulatory Compliance 110\u003c\/p\u003e \u003cp\u003e8.11 Conclusion 111\u003c\/p\u003e \u003cp\u003eTable of Figures 111\u003c\/p\u003e \u003cp\u003eReferences 111\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 9 Powder Reuse and Testing 113\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 114\u003c\/p\u003e \u003cp\u003e9.2 Material Selection 114\u003c\/p\u003e \u003cp\u003e9.3 Raw Material Storage and Handling 116\u003c\/p\u003e \u003cp\u003e9.4 Powder Analysis 116\u003c\/p\u003e \u003cp\u003e9.5 Powder Reuse 118\u003c\/p\u003e \u003cp\u003e9.6 Combining Virgin and Reused Powder Batches 120\u003c\/p\u003e \u003cp\u003e9.7 Conclusion 121\u003c\/p\u003e \u003cp\u003eReferences 121\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 10 Final Inspection – Lot Release Testing 123\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Regulatory Compliance 123\u003c\/p\u003e \u003cp\u003e10.2 Visual Inspection Techniques 125\u003c\/p\u003e \u003cp\u003e10.3 Nondestructive Testing 126\u003c\/p\u003e \u003cp\u003e10.4 Destructive Testing 127\u003c\/p\u003e \u003cp\u003e10.5 Emerging Technologies 129\u003c\/p\u003e \u003cp\u003e10.6 Conclusions 129\u003c\/p\u003e \u003cp\u003eReferences 130\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 11 Regulatory Filings 133\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Creation and Evolution 134\u003c\/p\u003e \u003cp\u003e11.2 Quality Management Systems 136\u003c\/p\u003e \u003cp\u003e11.3 US and EU Device Clearance\/Approval Schemes Compared 142\u003c\/p\u003e \u003cp\u003e11.4 US Regulatory 142\u003c\/p\u003e \u003cp\u003e11.5 EU Regulatory 146\u003c\/p\u003e \u003cp\u003e11.6 Additional Considerations for Additively Manufactured Devices 150\u003c\/p\u003e \u003cp\u003eTable of Figures 151\u003c\/p\u003e \u003cp\u003eReferences 152\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 12 Device and Material Enhancements 153\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Surface Coatings 154\u003c\/p\u003e \u003cp\u003e12.2 Osseointegration- Improving Characteristics Possible with AM 157\u003c\/p\u003e \u003cp\u003e12.3 Antibacterial and Antimicrobial Characteristics Possible with AM 159\u003c\/p\u003e \u003cp\u003e12.4 Looking Ahead 160\u003c\/p\u003e \u003cp\u003eTables of Figures 160\u003c\/p\u003e \u003cp\u003eReferences 160\u003c\/p\u003e \u003cp\u003eIndex 163\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Mechanical engineering \u0026amp; materials [\u003ca title=\"See our other books on Mechanical engineering \u0026amp; materials\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Mechanical%20engineering%20\u0026amp;%20materials%20%5BTG%5D%22\"\u003eTG\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand 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