Using Medical Device Standards for Design and Risk Management of Immersive Virtual Reality for At-Home Therapy and Remote Patient Monitoring

Joseph Peter Salisbury

doi:10.2196/26942

Abstract

Numerous virtual reality (VR) systems have received regulatory clearance as therapeutic medical devices for in-clinic and at-home use. These systems enable remote patient monitoring of clinician-prescribed rehabilitation exercises, although most of these systems are nonimmersive. With the expanding availability of affordable and easy-to-use head-mounted display (HMD)-based VR, there is growing interest in immersive VR therapies. However, HMD-based VR presents unique risks. Following standards for medical device development, the objective of this paper is to demonstrate a risk management process for a generic immersive VR system for remote patient monitoring of at-home therapy. Regulations, standards, and guidance documents applicable to therapeutic VR design are reviewed to provide necessary background. Generic requirements for an immersive VR system for home use and remote patient monitoring are identified using predicate analysis and specified for both patients and clinicians using user stories. To analyze risk, failure modes and effects analysis, adapted for medical device risk management, is performed on the generic user stories and a set of risk control measures is proposed. Many therapeutic applications of VR would be regulated as a medical device if they were to be commercially marketed. Understanding relevant standards for design and risk management early in the development process can help expedite the availability of innovative VR therapies that are safe and effective.

Highlights

While a wide variety of approaches have been referred to as virtual reality (VR) in the literature, VR is popularly understood to include the use of a wearable head-mounted display (HMD) that creates a sense of being immersed in a virtual environment
Immersive VR offers the potential for greater ecological validity in therapy, allowing the brain to respond to stimuli similar to how it does in the real world [20,21,22,23,24]
The objectives of this paper are to: 1. Provide an overview of medical device standards that are applicable to the development of VR as a medical device (VRaMD) intended for home use and remote patient monitoring

Summary

Introduction

Virtual Reality as a Medical DeviceTherapeutic virtual reality (VR) offers tremendous potential to provide innovative treatments in a broad range of clinical areas, including mental health disorders [1] (eg, traumatic stress [2,3], anxiety disorders [4], depression [5], schizophrenia [6], eating disorders [7]), pain management [8,9], motor and cognitive rehabilitation of neurodegenerative disorders [10,11], traumatic brain injury [12], stroke [13,14], and cognitive disorders [15,16].While a wide variety of approaches have been referred to as VR in the literature, VR is popularly understood to include the use of a wearable head-mounted display (HMD) that creates a sense of being immersed in a virtual environment. Therapeutic virtual reality (VR) offers tremendous potential to provide innovative treatments in a broad range of clinical areas, including mental health disorders [1] (eg, traumatic stress [2,3], anxiety disorders [4], depression [5], schizophrenia [6], eating disorders [7]), pain management [8,9], motor and cognitive rehabilitation of neurodegenerative disorders [10,11], traumatic brain injury [12], stroke [13,14], and cognitive disorders [15,16]. While a wide variety of approaches have been referred to as VR in the literature, VR is popularly understood to include the use of a wearable head-mounted display (HMD) that creates a sense of being immersed in a virtual environment. For VR interventions that will be classified as a medical device, https://biomedeng.jmir.org/2021/2/e26942

Objectives

Methods

Discussion

Conclusion