clinical wearables

clinical wearables

The market for wearable technology is growing rapidly. With more than 30 percent of adults in the United States using the devices, the global market is ready exceed $380.5 billion by 2028. As the market evolves, wearable devices are expected to become more personal, powerful and stylish. And we’re starting to see wearables move from fitness devices to health devices. However, many device manufacturers overlook the most important aspect for consumers who want to use their devices for health purposes: improved device accuracy and FDA approval.

Wearable technology first hit the market in the early 2000s in the form of pedometers, sleep trackers, and general wellness devices. These do not include the wide variety of features currently available such as heart rate, body temperature or activity level monitoring. They were not intended to serve a medical application and there was certainly no focus on whether they provided users with accurate data in all circumstances. This is a reality that continues to be true today – the majority of devices currently on the market are still inconsistent in terms of the accuracy of the data they provide to users. This presents a challenge for consumers who assume the data is accurate or “close enough” as they use the data to better understand their health or potentially raise concerns with their doctor. Until wearable technology companies position themselves as medical device companies, these devices will continue to fall short when applied in medical settings.

Wearables companies tend to avoid seeking FDA approval for several main reasons. First, they see themselves as consumer device manufacturers, not medical device companies, so they don’t organize to make medical devices. They often do not hire employees with medical product development experience, nor do they create the infrastructure that can support the development of such a device. Second, it is expensive to go this route. It can often take longer to develop, iterate, test, and refine your product to the specifications needed to obtain FDA clearance. Some manufacturers have blurred the line between wellness and medical devices by seeking FDA approval for a specific feature of their device, with Apple and FitBit receiving FDA clearance for ECG monitoring and atrial fibrillation detection. This type of mixed device approval—where aspects of the technology have permission but not the device as a whole—will only continue to muddy the waters as consumer devices enter the medical device landscape.

There are significant data privacy benefits for consumers when using an FDA-cleared wearable device, as the protection of personal medical data (protected health information, or PHI) was mandated by the agency with the introduction of health portability and accountability. Insurance Act (HIPAA). With consumer data and privacy concerns at the forefront, especially when it comes to women’s health, consumers can rest assured that their health data is treated with the same level of security as their medical records. As consumers better understand their right to medical privacy, they will have higher expectations for wellness wearables that are not bound by data privacy regulations. When FDA clearance is granted, it will communicate a seal of approval, which means that privacy controls are in place that prevent access to an individual’s PHI without their authorization.

There is significant opportunity for medical wearable device manufacturers in telehealth and virtual health visits, which have reached new heights during the pandemic. Convenience and accessibility appeal so much to patients and practitioners that the telehealth market is stabilizing at a rate 38 times higher than pre-pandemic levels. Consider that 80 percent of the residents of the United States live in what are considered health deserts. They can be in rural areas and inner cities, and that means FDA-approved medical-grade wearables have the ability to really help detect potential health problems and provide healthcare professionals with data about a patient’s specific situation. without having to travel for medical care.

The lines between consumer and medical devices will continue to blur as the market evolves. For companies looking to enter the wearable medical device arena, my advice is to take the best of both worlds and develop a product that offers what you would expect from a medical device in terms of accuracy, reliability, data quality and FDA approval. Then combine that with what you would expect from a consumer device – aesthetic appeal, comfort, usability and cost effectiveness. Bringing to market high-quality, reliable devices that consumers trust and want to use not only raises the bar for other players, but also helps maintain a healthcare environment that is more accessible and equitable for people across the world.

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