Medical Extended Reality Conference
Advancements in Technology, Applications, and Regulatory Science
October 24-25, 2023 | Bethesda, MD
#MXR2023
Join FDA, Industry leaders and MDIC in this exciting two-day regulatory science conference! #MXR2023 will bring together leaders in Augmented/Virtual/Mixed reality (AR/VR/MR) who are focusing on healthcare applications. Learn about technological advances, current medical applications, drivers of innovation and adoption, and recent regulatory advances in the field of medical extended reality (MXR).
Agenda at a Glance
Click + to expand to see the session description and speaker info.
Day 1 (Tuesday, October 24, 2023)
7:30 a.m. - 8:00 a.m. Breakfast/Registration
Speakers:
- Jennifer Waters
- Jithesh Veetil
8:00 a.m. - 8:15 a.m. Welcome
Speaker:
- Andy Fish
8:15 a.m. - 9:00 a.m. Opening Session: Developing the MXR Ecosystem
Speakers:
- Marc Griswold, Case Western Reserve Univ (invited)
- Peter Yang, De Novo Program Lead, Team Lead, FDA/CDRH/OPEQ/ORP/DRP1/TRP1A, FDA (invited)
- Chris Harner, OHT6 Medical Officer FDA (invited)
What progress has been made since the FDA Public Workshop on MXR in 2020? What are the big challenges that we face today and how we can work together to resolve them.
9:00 a.m. - 10:00 a.m. Regulatory Presentation: Current thinking on ongoing challenges in regulating MXR devices
Speakers:
- Laurence Coyne, FDA
- Chris Harner, FDA
- Michel Janda, FDA
- Lisa Kinnard, FDA
- Alex Beylin, FDA
- Ian Broverman, FDA
10:00 a.m. - 10:30 a.m. Coffee Break
10:30 a.m. - 11:30 a.m. Technology Panel: XR Hardware in Healthcare
Speakers:
- Lucas Fernandez, Reality Labs
- Grace Hwang, Microsoft
Moderator:
- Patrick Shironoshita
Hardware manufacturers share clinical uses of XR and the evolving ecosystem.
11:30 a.m. - 12:30 p.m. Lessons from the Field
Speakers:
- Jennifer Silva, Director, Pediatric Electrophysiology, Professor, Pediatrics and Biomedical Engineering, Washington University SOM
- Dr. Charles Martin, Vascular and Interventional Radiologist Cleveland Clinic
Moderator:
- Vangelis Lympouridis
MXR industry discusses recent technological developments, product improvements, standardization and regulatory efforts and remaining challenges.
12:30 p.m. - 1:30 p.m. Luncheon Keynote
Speaker:
- Michael Uohara, CMO Microsoft
MXR is a powerful technology that can enhance healthcare. Michael Uohara will present some of the use-cases for MXR in healthcare, such as training, patient engagement, collaboration, and visualization. He will also discuss the opportunities to scale MXR to address real healthcare challenges, such as accessibility, affordability, and quality. He will share some of the best practices and lessons learned from implementing MXR solutions in different healthcare settings. He will also highlight some of the future trends and directions for MXR in healthcare, such as personalization, integration, and innovation.
1:30 p.m. - 2:30 p.m. - MXR Clinician Perspective
Speakers:
- Brad Pua, Associate Professor of Radiology in Cardiothoracic Surgery (Cornell)
- Keith Horton, Interventional Radiologist (Georgetown)
- Brad Wood, Chief of IR (NIH)
- Amitabh Varshney , University of Maryland
Moderator:
- Sara Murthi, University of Maryland
Discover pioneering research, design, and innovation in Medical XR through visionary projects and groundbreaking advancements in clinical use.
2:30 p.m. - 3:30 p.m. - Panel Session: The MXR Clinical Product Development Cycle
Speakers:
- Mina Fahim, MediView
- Michael Southworth, SentiAR
- Vangelis Lympouridis, Enosis CEO
- Karly Yoder, GE Healthcare (invited)
- Phil Radcliff, GE Healthcare (invited)
Moderator:
- Jonathan Wakim
The journey of existing MXR devices and best practices in regulatory compliance, user-centered design, clinical trials, and commercialization.
3:30 p.m. - 3:45 p.m. Refreshments & Coffee Break/Poster Presentations/Demo Hall
3:45 p.m. - 4:15 p.m. FDA Digital Health Session: Augmented Reality and Virtual Reality Medical Devices: Perspectives from FDA Digital Health Center of Excellence (DHCoE)
Speakers:
- Annie Saha, FDA/DHCoE
4:15 p.m. - 4:45 p.m. NIH Session
Speaker:
- Leonardo Angelone
National Institute on Drug Abuse (NIDA) activities with start-up medical device companies using virtual reality for pain management.
4:45 p.m. - 5:45 p.m. Clinical Innovation Panel
Speakers:
- Patrick Littlefield, Deloitte (invited)
- Oliver Fleig, BrainLab
- Lars Riedemann, Heidelberg University Hospital
- Doug Billing, Deloitte (invited)
- Kyle Maddock, Apptek
Moderator:
- Jack Xu
5:45 p.m. - 6:00 p.m. Close-out Day 1
6:00 p.m. - 7:30 p.m. Networking Dinner (Exhibit Hall)
Day 2 (Wednesday, October 25, 2023)
7:30 a.m. - 8:00 a.m. Breakfast/Registration
Speakers:
- Jennifer R. Waters, Project Manager (MDIC)
- Jithesh Veetil, Senior Director, (MDIC)
8:00 a.m. - 9:00 a.m. FDA Session: Advancements in MXR Regulatory Science
Speakers:
- Ryan Beams, FDA
- Chumin Zhao, FDA Staff Fellow/OSEL
- Ed Margerrsion, FDA/OSEL (invited)
FDA/Office of Science and Engineering Laboratories (OSEL) on Advances in MXR Regulatory Science, including current research, regulatory science tools, and future challenges.
9:00 a.m. - 10:00 a.m. Clinical Trial Design for MXR
Speakers:
- Luana Colloca, University of Maryland
- Alex Cadotte Regulatory, MCRA (invited)
- Gretchen Nelson Clinical, MCRA (invited)
- Susan Persky, FDA
Challenges and innovative approaches for clinical trial design in Medical XR. Discuss strategies for rigorous evaluation, patient engagement and regulatory compliance.
10:00 a.m. - 10:30 a.m. Coffee Break
10:30 a.m. - 11:30 a.m. Image Quality, Standards, and Testing Methods
Speakers:
- John Penczek – Hardware/Standards, NIST
- Glenn Raudins, MediView
- Jeff Bail, Vicarious Surgical
Landscape of current testing methodology ensuring performance, image quality, safety, and user experience in MXR and identification of remaining challenges.
11:30 a.m. - 12:30 p.m. Human Factors: Panel Discussion (Best Practices and expectations for usability testing
Speakers:
- Dr. Ali Dhanaliwala, M.D., PhD, University of Pennsylvania
- Mary Beth Privitera, University of Cincinnati
- John Rice, Eclectic Behavioral Science, Modeling and Simulation
Moderator:
- Marc Egeth, Medical Device Human Factors
Discuss Human Factors and Human-centered design in MXR. Explore usability, safety, user experience considerations, and risk mitigation strategies in product development.
12:30 p.m. - 1:30 p.m. Lunch - Keynote Speaker: Bridging Imagination and Evidence: Advancing the Science of Medical Extended Reality
Speaker:
Brennan Spiegel, Cedar-Sinai Hospital
The field of MXR is rapidly expanding, with exponential growth in peer-reviewed papers over the past decade. However, there remain opportunities to enhance the rigor of MXR research. In this talk, we will review a framework for how to systematically develop and assess MXR applications in partnership with multidisciplinary teams and end-users. We will discuss examples where patient feedback led to significant changes in software, review trial methodologies for examining the efficacy of MXR therapeutics and examine approaches for human-centered design in MXR. We will end with recent examples using this approach to develop and test applications that combine VR and AI to support mental health, alleviate gastrointestinal symptoms, and help manage addiction.
1:30 p.m. - 3:00 p.m. Training, Education and Simulation
Speakers:
- Kunal Chaudhary, Managing Scientist at Exponent
- Shweta Daga, Director of Regulatory Affairs at Align Technology
- Rishi Reddy, University of Michigan
- Danny Goel, PrecisionOS
The transformative potential of MXR in healthcare training and education through simulation and specialized instructional design.
3:00 p.m. - 4:00 p.m. Clinical Deployment & Operationalization: Lessons from the field
Speakers:
- Anne Bailey, Director, Clinical Tech Innovation at U.S. Department of Veterans Affairs
- Caitlin Rawlins, Veteran Affairs
- Mark Zhang, AMXRA
- Joe Morgan, Waya Health
MXR deployment, scalability, and operationalization successes and challenges in a clinical setting.
4:00 p.m. - 4:30 p.m. Coffee Break/Poster Presentations/Demo Hall
4:30 p.m. - 5:30 p.m. MXR Monetization and Reimbursement
Speakers:
- Liesl Oldstone, Vice President, Health Economics and Market Access at AppliedVR
- Emily Holland, Senior Vice President at Capitol Hill Consulting
- Chris Davis Senior Vice President at Capitol Hill Consulting
Moderator:
- Heather Benz
Technology, systems integration, healthcare economics, payment and reimbursement as drivers for adoption.
5:30 p.m. - 6:00 p.m. Closing out session/Symposium Wrap Up
Registration Rates
| Category | Early bird Pricing | Regular Pricing |
|---|---|---|
| Industry (MDIC Non-Member) | $850 | $1,000 |
| Industry (MDIC Member) | $750 | $900 |
| Government/Non-Profit | $500 | $600 |
| Student/Post-Doctoral Researcher | $400 | $500 |
REGISTER NOW
Early-bird pricing ends September 8!
Who Should Attend #MXR2023
Medical device industry professionals
- Quality & Regulatory (QA/RA) professionals, including those who are responsible for regulatory and economic strategy or implementation of AR/VR/MR
- Technology experts that are making advances in the MXR space through new technology or use cases
Platform developers
Regulatory Affairs and policy professionals from industry and government
- FDA Review and research teams related to AR/VR/MR technology
- Government and private Payors as well as Reimbursement subject matter experts
- Government professionals that have direct input to standards and policies related to MXR
Healthcare professionals
- Early adopters of AR/VR/MR technology in their practice
- Those who have used AR/VR/MR but are curious to learn more
Patients and Patient Advocates
