title: Market approval processes for new types of spinal devices: challenges and recommendations for improvement.
abstract: Spinal pathology and related symptoms are among the most common health problems and are associated with high health care costs and productivity losses. Due to the aging population, these costs are further increasing every year. Another important reason for the increasing costs is the market approval of new technologies, such as spinal devices that are usually more expensive than the existing technologies. Previous cases of medical device failure led to concern about possible deficiencies in the market approval process.
  
  
  
  The objective is to provide an overview of U.S. Food and Drug Administration (FDA) regulation regarding spinal implants to delineate the challenges and opportunities that spine surgery currently faces.
  
  
  
  In this paper, two cases of market entries of spinal devices are presented and evaluated to illustrate these deficiencies.
  
  
  
  Spinal implant regulation is facing several challenges. New spinal devices should increase patient outcomes and safety at reasonable societal costs. The main challenge is to have a rigorous evaluation before dissemination, while still leaving room for innovative behavior that thrusts the healthcare practice forward.
  
  
  
  We have provided recommendations to enhance spinal implant regulation and improve and ensure the patient's safety and the future of spine surgery.
authors.affiliation: Department of Orthopedic Surgery, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Arno
authors.initials: A
authors.lastname: Bisschop
authors.affiliation: Department of Health Sciences, Faculty of Earth and Life Sciences, VU University, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands. maurits.van.tulder@vu.nl.
authors.forename: Maurits W
authors.initials: MW
authors.lastname: van Tulder
mesh_terms: D018795:Device Approval; D006801:Humans; D009983:Orthopedic Equipment / Q000592:standards*; D061214:Patient Safety; D019736:Prostheses and Implants / Q000592:standards*; D013122:Spinal Diseases / Q000601:surgery*; D014481:United States; D014486:United States Food and Drug Administration
keywords: Market approval; Spinal devices