Abstract
BACKGROUND: Robot-assisted minimal access surgery (MAS) reduces blood loss, recovery time, intraoperative and postoperative complications and pain. However, uptake of robotic MAS remains low, suggesting there are barriers to its use. To overcome these barriers, a new surgical robot system, Versius, was developed based on the needs and feedback of surgeons and surgical teams. METHODS: The surgical robot prototype was designed based on observations in the operating room (OR) and previous interviews with surgeons. Formative studies with surgeons and surgical teams were used to refine the prototype design, resulting in modifications to all components, including the arms, instruments, handgrips and surgeon console. Proof-of-concept cadaver studies were used to further optimize its design by assessing its usability during surgical procedures. RESULTS: Feedback led to the development of a novel, mobile design with independent arm carts and surgical console, linked by supported serial or parallel connections, providing maximum flexibility in the OR. Instrument tips were developed based on surgeons' preferred designs and wristed at the tip providing seven degrees of freedom within the patient. Multiple handgrip designs were assessed by surgeons; of these, a 'game controller' design was rated most popular and usable. An open surgical console design allowing multiple working positions was rated highest by surgeons and the surgical teams. CONCLUSIONS: This surgical robot system has been developed using feedback from end users throughout the design process and aims to minimize barriers to robotic MAS uptake. Additionally, these studies demonstrate system success in the surgical procedures it was designed for. The studies reported here, and further studies of the Versius Surgical System, are intended to align with IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework guidance.