How to objectively evaluate the impact of image-guided surgery technologies.

PURPOSE:This manuscript aims to provide a better understanding of methods and techniques with which one can better quantify the impact of image-guided surgical technologies. METHODS:A literature review was conducted with regard to economic and technical methods of medical device evaluation in various countries. Attention was focused on applications related to image-guided interventions that have enabled procedures to be performed in a minimally invasive manner, produced superior clinical outcomes, or have become standard of care. RESULTS:The review provides examples of successful implementations and adoption of image-guided surgical techniques, mostly in the field of neurosurgery. Failures as well as newly developed technologies still undergoing cost-efficacy analysis are discussed. CONCLUSION:The field of image-guided surgery has evolved from solely using preoperative images to utilizing highly specific tools and software to provide more information to the interventionalist in real time. While deformations in soft tissue often preclude the use of such instruments outside of neurosurgery, recent developments in optical and radioactive guidance have enabled surgeons to better account for organ motion and provide feedback to the surgeon as tissue is cut. These technologies are currently undergoing value assessments in many countries and hold promise to improve outcomes for patients, surgeons, care teams, payors, and society in general.