XR in Healthcare: Can promises be kept?

Photo by Andrea Piacquadio from Pexels

Recently, I was on a panel with Cambridge Wireless, and one discussion kept popping up was about XR as a medical device. We often see beautiful photoshopped images and reports showing how powerful VR is in treating patients remotely. I get reminded of one such advertisement of TIM(telecom Italia) that wants to show the power of 5G (see video below). All this hype leads to disappointment when we do a reality check on the claims of XR in healthcare. All this sounds amazing and really hopeful, however is it safe for the patient which is essential for any medical device? Can the marketing claims be backed up realistically via clinical evidence?

But first, we must start at the basics of medical devices, ‘What is the intended use of XR application?’

If we analyse the market, here are few ‘categories’ where XR products are positioned along the value chain of healthcare and they may or may not be a ‘medical device’.

1. Process improvement: This category includes training, operations, warehouse, marketing within healthcare. XR to assist in warehouse operations & quality control can applied without any implications to patient safety. Hence they may not need to be regarded as a medical device. If you consider training, given their application area in healthcare, they should have ideally controlled group studies (non-clinical) done to show significant improvement over traditional/control methods of training. Why is this device or mode of training better?
2. Diagnostic & therapeutics including Digital Therapeutics (DTx): Now this is an area that impacts patients directly.

• Intended use: First, one needs a clear and intended application of XR as a medical device. For example a meditation application can be a wellness app but if the intended use and indications for use as a mental health therapy such as CBT, then it has to go down a certification route of a Regulatory Authority.
• Safety: When XR is used in remote solutions such as Telemedicine and DTx, patient safety has to be taken into account. User (patient/clinician) experience has to be designed carefully considering space around the user, and using sensible cues such as spatial audio, and movement within the designed XR experience. Questions such as where does the responsibility lie if there is a sudden battery failure or the patient falls during a remote session is important to clarify from a legal and insurance point of view. Manufacturers of medical devices are liable and so are XR medical devices.
• User Interface: Similarly, UX and UI for medical devices is designed in a distinguished manner compared to consumer devices. If a medical XR application is used for therapeutics such as for treatment of tremors due to Parkinson’s, the application must be designed to be usable for target population and not general users. Too often the UI/UX does not consider that vulnerable population may not be able to access such solutions easily unless accessibility tools are inbuilt. Here voice UI and gestures designed for the population could be meaningful. A lot of research is being carried out on designing good user experiences & interfaces in XR by specialists researchers. The outcomes of these research must be applied and evaluated for specific applications in healthcare by considering the target patient population group.
• Data storage & interoperability: As with any other software application, we must talk about data storage and privacy. There are specific regulations around storage and processing such as GDPR/Data Protection Act. However in addition when it comes to medical device (both software & hardware), need to be interoperable with Electronic Health Record(EHR) otherwise islands of data will be created. Is the EHR able to store the data from XR applications such as in VR therapy or possible VR surgery (lets imagine this is happening) as seen in the advertisement. How and where would this valuable data be stored? What is the quality of data and how is that identified? Ownership of that data also needs to be thought by XR healthcare providers. If a startup is considering to be an XR as a health device not integrated to the EHR, how can a patient request access to her data? What happens when the XR company dissolve? These are key questions that will need to be addressed and be a well documented part of your organisation’s processes.
• Regulatory: From a regulatory point of view, software apps on phones, headsets and even webpages may qualify as a Medical Device and is considered Software as a medical device (SaMD). Until very recently, SaMD regulations have been less right and often many apps could claim self-certification route of Class I Medical Device with no external evaluation. However medical device regulations in Europe are changing from this year onwards (delayed to 2021 due to Covid-19) and companies can no longer self certify route. This means that SaMD will need to be inspected and certified by Notified Body before filing with Regulatory Authority. Startups will need to consider the time and costs for such inspections which are significant for startups and seeking a medical device classification can open up new risks to companies. Those who already have been self-certified will now need to upgrade to ensure their compliance. The new upcoming companies can no longer launch rapidly and need to plan for validation & certification in their market access plan. Post-market clinical studies will also be required and reports provided to the Competent Authorities on a regular basis which was not a requirement before.

In summary, a number of challenges need to be overcome before rolling out XR experiences in a medical category. Until then we still need to watch unrealistic portrayal of XR medical devices with a big pinch of salt :)