Dawn Abens Lissy – författare

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 technologiesExplores the interplay between design freedom and regulatory expectations in patient-specific implantsHighlights common failure modes and risk mitigation strategies in AM orthopedic manufacturingAddresses facility, inspection, and documentation needs to meet compliance and audit standardsFeatures decision-making aids, checklists, and process validation frameworks to support practical implementationDemystifies the regulatory requirements specific to additively manufactured productsIntegrating 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.

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.