Systems Integration of a High-Speed Surgical Drill with a Robotic Guidance Platform: Engineering Principles, Validation Methodology, and Clinical Impact in Robotic Spine Surgery

Abstract

The integration of high-speed surgical power tools with robotic guidance systems has unique challenges in surgical systems engineering that require co-design, co-development and concurrent engineering of its electromechanical, electrical‚ software and clinical validation aspects for the separate subsystems. We describe the engineering rationale and development methodology for the integration of the Midas Rex high-speed drill system (up to 75,000 RPM) into the Mazor X robotic guidance system for robotic-assisted pedicle screw placement in spine surgery. In addition to the new pilot hole geometry, the predecessor low-speed drill solution presented clinical risk in the form of robotic arm deflection under axial load, cortical bone skiving at the pilot hole entry site, and ergonomic concerns with performing a robotic procedure. The systems engineering process‚ including ICDs for multi-site program governance‚ biomechanical testing of the pilot hole‚ and design validation testing with practicing spine surgeons‚ culminated in integrated system FDA clearance in 2020․ The operational performance data obtained from the clinical validation showed that the robot's incorporation of the high-speed tool eliminated the need for the drill guide in the robotic workflow‚ reduced the number of workflow steps required‚ improved the ergonomics for the surgeon‚ and did not reduce the strength of the pedicle screw fixation․ The program shows a scalable, generalizable model for incorporating high-speed power tools into robotic surgical workflows beyond spinal instrumentation.