IMRIS has successfully completed the human factors study for the SYMBIS surgical system – the validation used to support the product’s 510(k) submission to the US Food and Drug Administration (FDA).
“This is a significant step leading to our goals of merging intraoperative imaging with robotics,” saysIMRIS president and chief executive officer Jay D Miller. “By finding ways to enhance the vision and precision of surgery through technology, we are working towards improving the outcomes for patients with neurological disorders at lower costs for the healthcare system.”
Over the past eight years, the FDA has been actively working with companies to apply the science of human factors – understanding how humans interact physically and psychologically with a device – to medical device development.
The human factors study provided a neurosurgeon’s perspective on how well use-related risks were mitigated by the IMRIS design team, when the SYMBIS surgical system is used by neurosurgeons. The study physicians were asked to perform a planned simulated procedure without any outside intervention. Throughout the study, the subject’s interaction with the system was observed for any use-related errors.
“The human factors study was not only an opportunity for IMRIS to validate the performance of the SYMBIS system with real users,” Miller explains, “we also captured the voice of the customer on how surgeons perceive the current system, as well as the future clinical applications where robotics in neurosurgery can provide both clinical and economic value.”
The SYMBIS human factors study involved a diverse group of 18 neurosurgeons of varying demographics and range of neurosurgical experience. Subjects were recruited from nine leading neurosurgical centres in the USA – including three centres that do not currently have a VISIUS surgical theatre with intraoperative MRI (iMRI).
One of the study subjects, neurosurgeon William Broaddus of Richmond, VA, comments: “After working with the SYMBIS System as a human factors study subject, I see this technology as an exciting platform for major advances in neurosurgical practice.”