PRESENTATIONS AT MPMD 2008: The Evaluation of Orthopedic Medical Devices For Safety and Efficacy: Testing & Regulatory Strategies for Spinal Implants

摘要

Dr. Ferrara's presentation was based on the fact that spinal implants are now designed to enable motion, and not just remain a static implant. This "Era of Motion" means that implants must withstand many more and different stresses than before. One of the first steps in implant development is Proof of Concept/Feasiblity Testing. This involves FEA Modeling, then small sample mechanical tests, then pilot animal studies and pilot cadaver studies.