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It’s all in the data: Consumer smartwatch vs. medical device

Typical consumer wearables have been designed to help encourage the general wellness of their wearers, and are increasingly beginning to advertise advanced health-tracking capabilities. On the other hand, advanced health monitoring devices have started to bridge the gap between medical and consumer because of their user-friendly design.

Researchers may wonder, what the real difference is between a medical and consumer wearable, and why not opt for the latter.

Consumer wearables are generally made to serve a broad range of functions outside health monitoring and may be focused specifically on a handful of health parameters, such as steps, sleep, and heart rate. In comparison, medical wearables come with a bigger suite of specialized digital biomarkers, such as electrodermal activity (EDA) and vital signs, alongside a wide range of sleep and activity biomarkers. Their high-frequency sensors are made to collect this data in larger volumes, with more accuracy and constancy.

This also means meeting high-quality regulatory and quality standards and undergoing extensive bench and usability testing. If a solution has FDA clearance in the USA and the CE Mark Certification under the European Union’s Medical Device Regulation (MDR), this demonstrates that it complies with stringent requirements to ensure patient safety, transparency, and accountability.

Another key difference is the access to raw data which is available with most medical wearables. Many consumer devices such as fitness bands and smartwatches tend to use black box algorithms, meaning that researchers have no way of knowing what their pre-processing methods are, whether they are accurate, and in turn whether their data is reliable too. These are all important considerations to consider if this is necessary for your study.

In their everyday use, consumer smartwatches tend to take snapshot metrics at irregular intervals, whereas medical wearables are designed with one main function in mind: measuring health data continuously.This ensures that researchers have consistent and accurate data for their analysis. If continuous data collection is activated with consumer wearables, it can have a huge toll on battery life, pushing it much below its consumer performance. Typical smartwatches may also have other built-in settings that compromise data quality, such as deprioritizing data and dropping pulse rate samples, in order to preserve battery life or to prioritize running an app that needs a lot of power to start up.

An important reason many consider using consumer wearables is due to their design. Consumer wearables are created for the consumer, so their design is generally slick and comfortable which can help boost participant wearing compliance. However, despite their complex functionality, medical wearables are now breaking into this space with a user-friendly look and feel for round-the-clock comfort.

TIMESPAN’s ART-CARMA project is using Empatica’s EmbracePlus wearable, part of the Empatica Health Monitoring Platform, to study the management of chronic cardiometabolic disease and treatment is continuity in adult ADHD patients. The project aims to understand the risks of cardiometabolic illnesses such as cardiovascular disease and obesity for adults with ADHD, and how their future health can be best improved through medication.

To find out more about Empatica’s solutions and how thousands of research partners and institutions, including NASA, are using their technology, visit their website.

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