The recent need to self-isolate brought by COVID-19 has made telework options a necessity for workers in nearly every industry. Even physicians and other healthcare providers are finding themselves relying on telecommunications to care for their patients. With this massive shift taking place, medical providers must adapt to continue providing high-quality care.
A method for accomplishing this is for healthcare providers to rely on telemedicine and medical device developers to assist them by creating new technology that fulfills needs that may arise as virtual conditions become the norm. Business isn’t conducted as usual as we aren’t in “usual” times. Our ability to innovate in science and technology has always been our norm and now is the time to continue pushing forward. While developing medical devices can be difficult when operating in a virtual atmosphere, it is not only necessary but can have some distinct benefits that can be carried beyond the current pandemic period.
Telehealth and Telemedicine
Although many medical providers are moving into telework for the first time, the framework for telehealth and telemedicine has existed and been in use for several years. An important thing to note is that telehealth and telemedicine refer to different things. Telehealth refers to services that support the delivery of healthcare, such as occupational therapy and other ancillary disciplines. Telemedicine, on the other hand, refers to the direct delivery of care from a physician. Dr. Mary Beth Privitera, Research and Human Factors Principal at HS Design and author of Applied Human Factors in Medical Device Design, points to the practice of stroke specialists evaluating patients in rural areas via telemedicine as an existing example of the practice being used successfully in years before the coronavirus outbreak. This model of care wherein rural areas can tap into specialized stroke teams to direct care impacts patient care daily. It begs the question, why haven’t we adopted it earlier in other areas of care?
Within this practice of medicine, there are three primary methods of monitoring a patient’s health. In one approach, results or information is recorded and then forwarded to the interested party, much like going to an imaging center and having the results forwarded to your primary care physician. Another approach uses remote monitoring directly through a targeted medical device and/or video observation which enables providers to closely observe patients and provide further care. The third approach includes remote monitoring of medical device readings, as in the case of a neurologist monitoring the EEG signals in an ICU. In this example, the EEG recordings are recorded in the cloud and viewed from any location via a secure connection albeit from the physician’s phone, tablet, or computer. These practices are already increasing in use and will only continue to do so the longer social distancing remains a necessity. According to Dr. Privitera, telemedicine, along with teleresearch and telehuman factors, are here and here to stay.
Challenges to Development
With the current need for new medical technology rising by the moment, adapting to telemedicine and long-distance research and design is the current top priority for medical device developers like HS Design. In doing so, developers face many obstacles related to testing and access to clinical care. To keep the development pipeline moving, extra steps must be taken to acquire the necessary feedback on products and special efforts must be made to ensure that these results follow FDA Guidances. Noting that FDA Guidances relevant to medical devices have strict requirements as to the environment, setup, and recording of usability studies, particularly the final human factors validation. Although there is nothing in FDA guidance that forbids this being performed in a virtual situation, it can be the case that results may become negatively reviewed in that the study was not performed under the capabilities of full observation by the human factors team. To conduct a human factors validation study in a virtual environment, the approach should be pre-approved. On this, HS Design Principal Tor Alden states, “With this being the case, we maintain the need to help our clients work with the FDA and figure out a way to keep the process moving.”
Yet, receiving FDA approval is by no means the only challenge facing developers when attempting to design and test products. Sometimes, only two or three prototypes of a particular product can be produced. In these cases, the best course of action for usability testing may be to ship a single prototype to different people consecutively to receive all necessary results. This can take a considerable amount of time and generally needs to be planned for in advance. Some products are simply too large to reasonably prototype and ship. For physical products, in particular, real interaction with the product is key to development. Anything that limits the ability to get products into the hands of users for testing poses a serious risk of blocking the pipeline at a time when it is more imperative than ever that it remains moving. Yet, the requirements of usability testing is consistent globally.
Adapting and Overcoming
There is, however, some good news to speak of in this regard. For example, formative usability tests that precede the human factors validation can be readily conducted virtually. Many products, like user interface designs or instructions for use, can be analyzed virtually in the matter of a simple conference call. Physical prototypes can be shipped for evaluation and observations can be conducted in the form of virtual touchstone tours. Dr. Privitera points out that the FDA is also adapting to the new circumstances and are sympathetic to developers at this time. Virtual observations and testing can sometimes enable better access to rural areas than traditional traveling in-person experiences. Yet, more adaptations are necessary to fully transition to a model that can support telehealth and telemedicine operations as well as research and development sans physical interaction.
Realizing this, HS Design has devised several strategies with which to confront the obstacles of this transition. One such strategy is “Touchstone tour development kits,” which are kits sent to providers for contextual inquiry in hospitals. These kits are plug-and-play, meaning that the providers need only follow the included instructions and turn the recording device on for data to be collected. Instructions for use are another arena in which improvements have been made. According to Tor, IFUs have historically been left to the end of the development process. New practices have necessitated IFU development earlier as they impact the overall usability of a device and are part of the user interface. Perhaps most intriguing of all HS Design’s current proposed solutions is augmented or virtual reality, which Tor comments they have used in the past to make simulated prototypes of larger devices. Eventually, he explains, AR/ VR equipment might be sent to users for them to test these prototypes in a virtual and simulated environment.
Looking into the future, Tor suggests that the recent move to telemedicine and teleresearch is “a natural step” and that these recent changes are subject to growing pains the same way any large shift is. He and Dr. Privitera predict that the two primary challenges facing the industry will be maintaining the human touch that comes with a physical presence, missing in virtual environments, and supporting the medical community in their willingness to lean on technology to fulfill their clinical responsibilities. However, the potential benefits of this shift are being shown already and can be reaped through proper adaptation. HS Design is well-prepared to perform these adaptations and assist their clients in doing the same.