Advances in computing and displays have enabled a recent surge in low-cost mixed-reality devices, including augmented reality (AR) and virtual reality (VR). These new capabilities have resulted in substantial interest in the development of medical extended reality (MXR) devices. Clinical researchers and medical device developers have begun to leverage this nascent technology for surgery and interventional procedures, diagnostics, and therapeutics. While these applications present new opportunities, the adoption, impact, and longevity of MXR applications in medicine hinges upon the development of evaluation techniques, quantitative assessment of the effectiveness, and a clear understanding of the value added by MXR over current clinical practice standards.
Medical Extended Reality Device Workgroup
MDIC has established a medical extended reality device workgroup to develop an augmented/virtual reality implementation roadmap specifying open regulatory research questions and knowledge gaps that should be addressed to facilitate the integration of medical extended reality devices into healthcare and accelerate device availability to patients.
Examples of topics to be considered:
• Identification of and consensus on standard terminology
• Validation of characterization methods and specifications for head-mounted displays and other accessories used in medical extended reality devices
• Identification of pertinent quality control activities
• Evaluation of clinical validation approaches
• Suggested best practices for assessment of user interactions with medical extended reality devices
• Understanding evidence needed to support public and private payer coverage/cost/coding
The Medical Extended Reality Working Group is currently working on a Landscape Analysis Framework to support the safety and effectiveness of 3D-capable extended reality devices for surgical planning and procedures, including open and minimally invasive surgery. The framework will define terminology, identify safety and effectiveness considerations, testing approaches, and evaluate gaps for image quality, human factors, and identify approaches for demonstrating effectiveness of training. The group has completed the first phase of the framework and will be starting the second phase which includes an request for proposal for experts to evaluate the current analysis, review related literature, contribute relevant knowledge, and identify additional clinical gaps and challenges to ensure proper perspective. If interested, please review the request and respond.
Due Date: March 17, 2023
If you would like to join this collaborative effort, please fill out this form.