Market approval processes for new types of spinal devices: challenges and recommendations for improvement.

BACKGROUND

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.

OBJECTIVE

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.

METHODS

In this paper, two cases of market entries of spinal devices are presented and evaluated to illustrate these deficiencies.

RESULTS

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.

CONCLUSION

We have provided recommendations to enhance spinal implant regulation and improve and ensure the patient's safety and the future of spine surgery.