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

Area of Science:

• Medical device development
• Virtual Reality (VR) therapy
• Human-Computer Interaction

Background:

• Numerous virtual reality (VR) systems are approved as therapeutic medical devices for both clinic and home use, enabling remote patient monitoring.
• While most current VR systems are non-immersive, the rise of affordable head-mounted displays (HMDs) fuels interest in immersive VR therapies.
• Immersive VR, particularly HMD-based systems for at-home use, introduces unique safety risks that necessitate a structured risk management approach.

Purpose of the Study:

• To demonstrate a comprehensive risk management process for a generic immersive VR system intended for remote patient monitoring during at-home therapy.
• To identify applicable regulations, standards, and guidance documents for therapeutic VR medical device development.
• To establish generic requirements for immersive VR systems for home use and remote monitoring, considering both patient and clinician perspectives.

Main Methods:

• Review of relevant regulations, standards, and guidance for therapeutic VR medical device design.
• Predicate analysis and user story generation to define system requirements for patients and clinicians.
• Application of Failure Modes and Effects Analysis (FMEA), adapted for medical device risk management, to identify potential risks.
• Proposal of risk control measures based on the FMEA findings.

Main Results:

• Identification of specific risks associated with immersive VR systems for remote, at-home patient monitoring.
• Development of a generic set of user requirements for patients and clinicians.
• Proposal of a systematic risk management framework, including risk control measures.
• Demonstration of how FMEA can be applied to immersive VR medical device risk analysis.

Conclusions:

• Many VR therapeutic applications will be regulated as medical devices, requiring adherence to design and risk management standards.
• Early integration of risk management principles and relevant standards can accelerate the development of safe and effective immersive VR therapies.
• A structured risk management process is crucial for mitigating the unique challenges posed by immersive VR for remote patient monitoring.