Medical Extended Reality (MXR) Regulatory Science of Surgical Applications

The MDIC MXR Landscape Analysis of Surgical Applications Workgroup is comprised of leaders in MXR, its medical applications, and assessment, who have set for themselves the ambitious vision to advance the safe and effective implementation and evaluation of MXR devices. They aim to accelerate the development of MXR devices across application spaces, with an initial focus on surgical planning and procedures, to the ultimate benefit of patients.

The group is a learning community that has come together biweekly for over a year to answer questions about the cutting edge of AR/VR devices today, how they should be assessed, what drives innovation and adoption, and future impact the devices will have on patient care and the digital transformation of health. The result of these discussions and a survey of the landscape is this framework report, which focuses on human factors and image quality topics as areas in which MXR devices have faced hurdles. By reviewing the state of the art in these disciplines and considering how it can be applied specifically to MXR devices, the Workgroup hopes to support manufacturers developing novel devices in answering fundamental regulatory science questions about the assessment of their devices. The Workgroup has also identified assessment challenges and knowledge gaps, which require continued effort across the ecosystem to address and pave the way for consistent, clear standards and scientific consensus in MXR testing.