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