This compelling reference provides readers with all the critical information related to developing high quality spinal stabilization implants. Emphasizing fundamental science and core biomechanical principles, the book navigates through every critical step of product development including ethical and regulatory issues, appropriate product testing and analysis, and product approval and reimbursement considerations. The authors showcase the principles they describe with real world case examples and prepare readers for trouble spots with pitfall warnings throughout. Stressing practical applications, both clinically and commercially, this is a must-have resource for anyone venturing into the complicated terrain of spine implant development and testing
Part I: Fundamentals. Anatomy and Biomechanics of the Spine. Bone Biology of the Spinal Column and Biomechanics of Bone Tissue. Biomechanics of Rigid and Motion Sparing Systems for the Cervical Spine. Biomechanics of Rigid and Motion Sparing Systems for the Lumbar Spine. Biomaterials and Biologics Used in Spinal Instrumentation. Smart Technologies for the Spine. Part II: Business of Implant Development: From Design to the Regulatory Process. Ethical Issues Related to Research and Product Development. Product Design from Concept to Market. Financial and Legal Issues. Intellectual Property: The Basics for Spinal Implants. The United States FDA Regulatory Process From Start to Finish. International Regulatory Considerations. Part III: Product Testing and Analysis. Standardized Testing of Spinal Implants. Designing a Biomechanical Test for the Assessment of Spinal Kinematics. Designing Viable Animal Studies. Designing a Clinical Study for an IDE. Finite Element Analysis to Evaluate Implant Design. Biomechanical Assessment of Spinal Implants Using Cadaveric Tissue. The Basics of Wear Testing and Particulate Characterization of Wear Debris. Part IV: Product Approval and Reimbursement Considerations. Post-Market Approval and Implant Launch: An FDA Perspective of What Happens Next. Reimbursement Considerations Affecting Medical Devices: The Backbone of Spinal Implants.