The Technology:
The spine implant sector is one of the fastest growing segments of the medical device industry. At current growth rates the total market for spine implants is expected to exceed $10 billion within five years. The lead products in this market are fusion devices and artificial disks, which act to correct or replace portions of the spine which are damaged or degenerated. The most common causes of spine problems are trauma and age-related degeneration.
Researchers at the University of Tennessee Health Science Center have developed the first testing system that can accurately reproduce the motion and loading of a human spine. Current testing devices are only able to apply a limited range of motion and/or forces, which is insufficient to generate data that truly predicts how an implant will perform in vivo. The capabilities of this system were recently recognized by one of the industry-leading device companies, who contracted with the researchers to generate data to support an FDA regulatory application in response to the new requirements that biomechanical testing data be provided along with the clinical data. A related use for this system will be to rapidly test the performance of new device designs, leading to shorter R&D times and better performing spine implants.
Related publications:
• Memphis Business Journal – June 15, 2007
• Spine. 33(13):E400-E406, June 1, 2008
• J Biomech. 2013 Apr 26; 46(7):1369-75
Benefits:
• Shorten R&D time – Test more designs/prototypes in vitro, without having to wait for lengthy animal models.
• Reduce R&D expenses – Eliminate faulty designs prior to animal testing.
• Strengthen FDA applications – Generate the best biomechanical data for inclusion in regulatory filings.
The Inventors:
Dr. Denis DiAngelo is a Professor of Biomedical Engineering and Imaging at the University of Tennessee Health Science Center. His research interests center around the development of improved testing methods to simulate physiologic motion and loading of human joints. In collaboration with industry and surgical leaders, his biomechanical evaluations of surgical techniques and medical devices identify those interventions which can improve the treatment of musculoskeletal disorders.
Dr. Brian Kelly is an Assistant Professor of Biomedical Engineering and Imaging at the University of Tennessee Health Science Center. His research focuses on applying robotics with advanced control systems to the field of biomechanics, specifically for the design and evaluation of implanted spine devices. A frequent collaborator with the leaders of the medical device industry, he has evaluated several of the leading spinal implants and spine surgery techniques.
Patents:
• Issued US patent – 7,895,899
Reference: PD 05033