Additive Manufacturing for Orthopedic Implants: Material and Process Selection, Validation Activities, and Regulatory Submissions (Additive Manufacturing Skills in Practice.) - Hardcover

Über die Autorin bzw. den Autor

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.

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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.