Strategy for the Development of a Surgical Robot-Case Studies and Regulations

Abstract

Many innovative surgical robots have been invented and developed. However, for the successful development of a surgical robot and its commercialization, appropriate and effective strategies are required. In this paper, the authors review a number of surgical robot systems in order to give insight into such strategies to reader. A summary of the functions and history of Robodoc, Da Vinci, Arthrobot and KaLAR are presented, as well as the governmental regulations in the United States on the surgical robots. By these case studies, it is clear that the cooperation between innovative robotic engineers and dedicated surgeons is necessary for the development of surgical robot. In addition, it would be safe to build a robot for a surgery which already conducted routinely by manual in the early stage of development. With an easier target, the development cycle will be shortened and shortages of funds will be prevented. Once a solid surgical robot platform is developed, the target of the robot should be surgeries that have clinical relevance and technical challenge together. Moreover, due to the conservative feature of governmental regulations on medical devices, production of a surgical robot will be limited to a small number of companies that accumulate experience in this field. Thus, the coming years will be a most important time for the commercialization of surgical robots.