LTR 74: AR/VR devices in MedTech

In this Let’s Talk Risk! conversation, Ritam Priya advises device manufacturers to engage early with the FDA through the Q-sub program. Applications of AR/VR in MedTech are growing rapidly, but the regulatory science is still evolving. There are many specific safety and performance concerns unique to AR/VR technologies used for medical purposes. Early engagement with the FDA can help in developing adequate plans for verification and validation of these devices.

Image quality, cyber-sickness, rapidly changing hardware and software technologies used in AR/VR applications, for example, are some of the concerns that need careful planning throughout design and development and in the post-market phase.

Listen to this Let’s Talk Risk! conversation with Ritam Priya, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:02:05 Introduction

00:01:30 Transitioning into a medical safety role from clinical practice

00:02:31 Overview of AR/VR applications in MedTech

00:06:15 Example of a recently cleared AR/VR based medical device

00:08:27 Image quality is a major concern for FDA in AR/VR devices

00:09:20 How FDA is advancing regulatory science for AR/VR technologies

00:11:18 Special safety and performance considerations for AR/VR devices

00:13:27 Audience Q&A and open discussion

00:31:11 Closing comments and key takeaways

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Suggested links:

LTR: A fast growing frontier: AR/VR driving innovation in MedTech.

FDA: Augmented Reality and Virtual Reality in Medical Devices.

About Ritam Priya

Ritam Priya is currently the Founder & Principal at Novarum MDRQ Consulting where she provides regulatory consulting services to MedTech clients in both pre- and post-market phases. She has over 20 years of experience in the medical industry, including leadership experience at top organizations. Her expertise includes regulatory requirements for marketing authorization of medical devices in major global markets including US, EU, UK, Australia and Canada. She holds a Bachelor’s degree in Mathematics, Computer Science and Economics, and an MBA in Strategy.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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