Wearable health technologies

There are several key areas in which consumer and clinical-grade (also referred to as medical-grade) wearable health technologies differ:

This is the first and biggest differentiator. If the device intended to help diagnose or monitor health problems, or the manufacturer wishes to make claims of medically accurate data, it would need to be submitted to the FDA for clearance or approval. Many of the consumer devices such as basic fitness trackers avoid the need for FDA clearance thanks to a 2016 FDA guidance that the agency will not enforce medical device regulations as long as the device is marketed for "wellness" purposes only and poses little risk to users. There are some exceptions, such as newer smart watches from Apple, Samsung and Fitbit which sought and received FDA clearance as Class II medical devices for their ECG capabilities.

In the US, regulatory approval for these devices is overseen by the Food and Drug Administration (FDA). There are three classes of medical devices that are regulated, simply referred to as "Class I, II or III", and the requirements for regulation vary. Class I products have the lowest risk and include items such as bandages or dental floss. Class II are seen as intermediate risk and include many wearable devices such as the Apple Watches with ECG capabilities. Class III devices are the ones that have the highest risk and include implantable devices such as pacemakers. As consumer-oriented device manufacturers such as Apple continue to move further into the medical space with their wearables and software it is likely there will be much more involvement from the FDA.

While the consumer health wearable market is considerably larger at the moment, research firm Frost & Sullivan sees a lot of growth potential for new companies entering the market and focusing on creating clinical-grade wearable health devices and developing the accompanying software. The key reasons for this being; the usefulness to healthcare providers in providing accurate and actionable data, a lack of competition in the space, and insurance companies paying for devices for patients.

While most of the attention at present is given to the consumer devices, in recent years there have been some significant developments when it comes to clinically tested and validated wearable healthcare devices such as:

Anybody who needs to regularly monitor their blood pressure is aware of how inconvenient it can be to find a suitable time and place to take a reading, and even popular wireless devices require certain conditions to be met. These generally include finding a quiet location, being seated with the monitor at a heart height, and the inconvenience of carrying the device itself. Two new Class II devices are now available from medtech company Biobeat Technologies to make this process easier for users. The BioBeat cuffless monitor comes in two form factors, one a familiar watch form, and the second as a disposable wearable patch. Both take continuous blood pressure, heart rate, and blood-oxygen levels with medical-grade accuracy that can be shared with medical professionals in both home and clinical environments.

The Philips Biosensor is a single-use wearable patch that monitors a patient’s vital signs every minute and can last for up almost 5 days. This technology has proven to be particularly useful in the case of the Covid-19 pandemic where it was used to monitor patients who did not need to be on breathing support.

The Temp Traq single-use wearable patch transmits a user's temperature continuously for up to 72 hours via low-energy Bluetooth. As with the Philips Biosensor, it has proved particularly useful during the Covid-19 pandemic as a way to monitor not only patient temperatures but workers in critical industries so that spikes can be detected early and measures can be taken to reduce the risk of infection to others.

As well as these, there are new wearable devices in late-stage development that have the potential to improve many lives. These include wearable artificial kidneys that can replace the need for users to be attached to large dialysis machines, giving them the freedom to maintain much more active lifestyles. A new wearable patch called ADAMM allows continuous monitoring of asthma symptoms, and can share the data with healthcare providers, providing the possibility of better management of this chronic illness that affects around 300 million people worldwide.

Like with any rapidly evolving technology, the growing market in both consumer and medical-grade wearable health devices is not without some concerns, such as accuracy of the data collected, the ability for healthcare providers to make use of the data collected, and the ownership and security of the data itself.

At the consumer level, wearable devices allow users the ability to have a better awareness of basic health metrics, and in some cases, even have the ability to save lives. Clinical-grade devices are helping to transform healthcare, by allowing patients to self-monitor from their homes, reducing the need for in-person doctor visits. With around 30% of the adult population in the US using wearable health devices, and the predicted growth of the market, it is clear that they are here to stay.