JMIR Publications

ABSTRACT

Background:

Numerous virtual reality systems have received regulatory approval as therapeutic medical devices for in-clinic and at-home use. These systems enable remote patient monitoring of clinician-prescribed rehabilitation exercises. However, most of these systems are non-immersive. With the expanding availability of affordable and easy-to-use head-mounted display-based virtual reality systems, there is growing interest in immersive virtual reality therapies. However, head-mounted display-based virtual reality presents unique risks that must be evaluated during the software development process to comply with international standards for medical device engineering.

Objective:

Following international standards for medical device development, the aim of this paper is to demonstrate a risk management process for a generic immersive virtual system for remote patient monitoring of at-home therapy. This paper primarily targets researchers and engineers unfamiliar with quality requirements for medical devices and provides an overview of software development and risk management processes.

Methods:

Regulations, standards, and guidance documents applicable to therapeutic virtual reality are reviewed. High-level requirements for a head-mounted display-based virtual reality system for home-use and 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 to comply with ISO 14971, is performed on the high-level user stories and a set of risk control measures are proposed.

Results:

Risk should be evaluated early when developing therapeutic virtual reality systems so that control measures may be integrated early in the design process. Errors in data quality and security can introduce risk to patients, which must be mitigated through appropriate control measures, including following industry standards and best practices. Immersive head-mounted display-based virtual reality introduces specific risks to patients that may require additional controls. Following appropriate human factors and usability engineering processes can help minimize the potential likelihood of harm.

Conclusions:

Many proposed therapeutic applications of virtual reality would be regulated as a medical device if they were to be commercially marketed. Understanding how to apply quality standards for software development and risk management can help expedite this transition, increasing the availability of innovative therapies that are safe and effective.