Introduction of new devices and technologies into a spine surgery practice: a review of processes and regulations.

The emergence of new devices and new technologies has led to signifi cant and important changes in the practice of spine surgery over the past decade. Spine surgeons are responsible for continuously learning about new implants, instruments, bone graft substitutes, and new procedures. Making informed decisions on the adoption of new technologies in spine surgery is an important challenge for all practicing surgeons. This article provides a systematic review of the processes involved in bringing new technologies and devices to market in spine surgery. It is intended to assist surgeons in building a knowledge base to evaluate whether the new options are appropriate for their patients and/or spine practice and to critically evaluate the processes of evidence development to facilitate informed decision making about new technologies.