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Should VR Headsets Be Considered Medical Devices?

Virtual reality is changing the digital industry by creating immersive and interactive environments. As VR makes headway into the medical space, the question becomes: Are VR headsets a medical device or just an entertainment hardware?

Virtual reality, or VR, is about to be everywhere. It’s the kind of invention science-fiction fans and technologists have been clamoring about for decades.

VR undoubtedly provides a wide variety of opportunities for escaping from boring old reality — but can it improve lives in a meaningful way? Could that impact ever become meaningful enough to qualify VR headsets as medical devices?

Makers of virtual reality hardware and software want to make their mark on medical innovation. Let’s take a look at the present definition of a medical device, and whether current or future VR technology might qualify.

Fig. 1

VR can benefit people suffering from some medical conditions. But should they be considered medical devices? (Source)

What Is a Medical Device, Legally Speaking?

Before we dive into the crux of this debate, it’s useful to define the key terms. The United States Food and Drug Administration (FDA) already provides a definition for the phrase “medical device”:

A wide variety of products qualify as medical devices in the eyes of the FDA:

  • Tongue depressors
  • Bedpans
  • Test kits and reagents
  • Some radiation-emitting equipment
  • Programmable pacemakers
  • Surgical devices and lasers
  • Ultrasound equipment
  • Other medical devices containing microchips
  • Diagnostic equipment for use in laboratories

What all these products have in common is that they are labeled and marketed for medical purposes. Under FDA regulations, these are products that may be used to prevent, detect, mitigate, or cure a known medical condition in humans or animals.

It also includes any device intended to influence the function or structure of a living body by any means other than chemical action. The European Union provides very similar directives and regulations for recognizing medical devices, as does the World Health Organization.

The intention here is to draw a solid boundary between devices and drugs. Most important to today’s discussion is the fact that, under section 520(o) of these FDA regulations, software applications do not qualify as medical devices.

The Case for VR Headsets as Medical Devices

Fig. 2

VR is still a relatively new technology, which could make classifying it tricky. (Source)

VR headsets are, of course, more than just software—and that makes their current place in the medical device landscape a little uncertain.

Nevertheless, VR technology has already demonstrated a considerable amount of potential in patient treatment, diagnoses, and physician training. There's clearly big money in this game already, too: an estimated $5 billion per year by 2023, according to research from Goldman Sachs. By 2025, the study says, electronic entertainment and healthcare will be the two most popular and valuable applications of VR, in that order.

What does the current landscape look like for VR in healthcare? So far, adoption among healthcare companies has been sluggish, and “killer apps” have been slow to materialize. Some of the companies singled out already as major players in this emerging markets are those with the billions required to research and develop the technology: names like Google, Oculus— owned by Facebook—and Microsoft.

With the above legal definitions of medical device in mind, what are the most compelling current applications for VR in healthcare? Here are several:

Physician training. Johns Hopkins, the University of Chicago and the University of Calgary are all early adopters of VR-based surgical training programs. In addition to providing safe and detailed environments in which to observe and take part in surgeries, the technology also provides the capability to fully immerse oneself in patient scans for a level of pre-surgery planning that wasn’t possible before.

Improving patient vision. Generations of conventional wisdom said television ruins our eyes—but VR headsets might just be able to help patients improve their vision. A company called Vivid Vision, which already has partnerships with 88 clinics, offers VR-based treatments for lazy eye, crossed eyes, and other sight disorders. Patients simply don their headset and play immersive games under supervision to correct the movement of their eyes.

Treatment for anxiety disorders. Mental health professionals see a lot of potential in VR programs from Psious and similar companies. The idea involves creating relaxing virtual spaces and deliberate, meditative, relaxation-focused exercises for patients to learn mindfulness and achieve better control over intrusive thoughts.

Physical therapy and patient rehab. VRHealth is a worldwide VR company with a presence in Boston and Israel. Its mission is to improve the effectiveness of current treatment models in physical therapy, pain management, problems with coordination, and even cognitive rehabilitation. The company has a presence in 30 healthcare locations in the United States. One of the advantages is that doctors can evaluate patients remotely, from the comfort of home.

Anxiety, panic disorders, and elder care. A VR program called jDome BikeAround seeks to help elderly individuals recover their motivation and confidence while navigating the outside world. While riding a virtual bike along virtual streets—lovingly rendered by Google Maps—elderly patients can rediscover places they used to visit and practice other forms of mindfulness and cardiac training.

Each of these is a real-world demonstration of the power of virtual reality in healthcare. The signs seem to point decisively to VR having real staying power and relevance in the lives of patients of all ages and conditions.

Do these products qualify as medical devices, though? Is there anything holding VR back from staking a lasting claim in the healthcare landscape?

The Case for Cautious Optimism

Fig. 3

Treating anxiety, use in physical therapy, and elder care are just a few ways VR can apply to medicine. (Source)

The first reason to advise caution—at least for now—is a two-pronged problem: a lack of quality content and a hesitation among healthcare system decision-makers to invest in the required hardware. In a survey, more than half of the respondents cited a lack of compelling, high-quality experiences as their reason for not bringing virtual reality into their healthcare systems.

Those are the first two hang-ups. The third is the high price tag and the poor ergonomics of VR headsets. Products like HTC Vive, Oculus Rift, and Samsung Gear VR hold promise, but they need additional product iterations to achieve the immersive environment patients expect, and the comfort and ease-of-use ailing patients deserve.

Let’s return to the original question: Should VR headsets be considered medical devices?

Having explored how several companies are already using this technology, or are planning to in the future, it's clear that the highest-profile VR projects in medicine today seem to qualify as medical devices under FDA and EU regulations and directives. These VR software applications, coupled with wearable hardware, provide fairly convincing tools for:

  • Correcting muscular problems resulting in poor eyesight using VR-based games
  • Evaluating a patient’s cognitive and physical abilities
  • Providing relief for a variety of mental health disorders
  • Helping patients approach soundness of mind and body through rehabilitation

It’s clear enough that if hardware makers continue finding ways to lower the price and raise the comfort of their headsets, and software makers keep furnishing evidence that their VR treatments deliver noticeable results in patients, VR in healthcare is here to stay.

There’s just one last question: How do regulatory bodies like the FDA handle the approval process for cutting-edge treatment modalities like these? Will they, as is the mission of many prominent voices in healthcare, help bring down the cost of treatment in both developed and developing nations?

Products from VRHealth boast both FDA approval and certification under ISO standard 13485. Early VR applications in surgical training found themselves subject to another ISO standard—ISO 13407—which covers human-centered design for interactive systems.

It was with the intention of facilitating safer innovation that the FDA recently outlined plans to modernize its approval process for new medical devices as well as iterations on existing ones.

The response from device makers has been mostly positive, with many expressing support for the longer approval and documentation process, as well as guidelines for more actively monitoring device performance in the real world vs. relying on complaints from patients.

VR technology in healthcare is fairly novel, but most of the pieces seem to be coming into place—including cautiously optimistic physician and patient interest as well as relevant and modernized guidelines from the FDA, ISO, and other consumer protection agencies.

SourceESB Parts Banner

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