Flex™ Robotic System
Farm collaborated with startup Cardiorobotics to develop the technology behind their innovative Flex™ Robotic System, a highly articulated, multi-linked “snake” robot that enables surgeons to replace certain complex, open-cavity surgical procedures with minimally-invasive procedures appropriate for difficult-to-reach areas of the human anatomy.
Initially created at the Carnegie Mellon Robotics Lab, the unique maneuverability of the robot is gained from its sequence of mechanical linkages, each containing a concentric mechanism that can be placed into a rigid or limp state. By employing a patented "follow-the-leader" movement strategy, the robot can be directed into almost any shape inside the patient through the relative orientations of its linkages.
This self-supported robot enables physicians to operate through circuitous paths and through a small, single-site access into the body. The section of the robot that enters the patient has at its distal end a multi-port head that can accept a variety of third-party surgical and interventional instruments and includes a video camera that allows the surgeon to fully visualize the surgical site during a procedure.
Farm began the project by transforming the client’s proof-of-concept breadboard into a fully operational prototype that was then tested in several animal surgeries. This process helped our team understand the behavior of the technology while revealing several opportunities to improve both the mechanical design and the usability of the device. Consequently, what had begun as a project to tweak a client’s design expanded into a deep development program that lasted almost a year.
Farm was responsible for all usability, mechanical, and systems engineering as well as DFMEA and risk/hazard analysis. Because patient safety was critically important, and because the device would require FDA approval, the program was conducted within Farm’s Quality Management System and tested under ISO 60601.
The device handed off to Cardiorobotics (now Medrobotics) was used for human surgical trials in Europe and South America. The success of that testing helped Medrobotics acquire the financing necessary for the commercial release of the Flex™ Robotic System in Europe, where it received a CE mark in 2014. Here in the United States, Medrobotics recently announced that it had received FDA clearance to market the Flex™ Robotic System, and is initiating a commercial launch in U.S. hospitals.
"The FlexRobotic System is the first and only robot-assisted surgical platform with a flexible scope cleared by FDA for use during transoral procedures."