How to improve the mechanical safety of a novel spinal implant while saving costs and time.

Abstract

Spinal implant failure is associated with prolonged patient suffering, high costs for the medical device industry, and a high economic burden for the health care system. Pre-clinical mechanical testing has great potential to reduce the risk of such failure. However, there are no binding regulations for planning and interpretation of mechanical testing. Therefore, different strategies exist. Mainly for novel implants an option is to start with a structured scientific literature search that forms