Abstract
Wearable devices have rapidly transformed from a novelty into a tool used for a multitude of different aspects of human health. From personal fitness trackers monitoring heart rhythm and blood pressure to military-grade training devices simulating battlefield wounds, wearables have spread across a large space of technology, and help promote wellness, clinical diagnoses, specialized medical training, and fitness motivation. These innovations, however, are beginning to outpace the regulatory measures currently in place and the institutional frameworks designed to govern the technology. As wearables grow more sophisticated in the coming years, a critical question arises: When does a wearable become defined as a wellness or medical device, and what standards are in place to determine what it classifies as? If this question is not properly answered, a consumer’s life may be at risk. Relying on unvalidated health features may make consequential decisions about their health when they have an undetected underlying problem. The two projects combined sit on opposite ends of this spectrum: one is an analysis of consumer wearables being regulated by the FDA, as it tries to clear the fuzzy boundary between wellness and medical devices, while the other explores developing a wearable training system that mimics hemorrhaging in the groin area in order to help medics and corpsmen prepare for a real-life scenario. The challenge these two projects face together is, as wearable health technology continues to advance, the systems that regulate it must evolve with equivalent pace.
Personal fitness wearables have recently cemented themselves as a cheap yet effective alternative to a personal fitness trainer. During the COVID-19 pandemic, gyms were closed and people were forced inside, so extra motivation was necessary to stay in shape and exercise on a daily basis, which is what digital health wearables provided. Once the pandemic protocols lifted and gyms opened, digital health wearables did not slow down, becoming even more popular in the years following. Wearables continue to add new metrics and data collection sensors to remain top contenders as technology continues to progress. As innovation of fitness wearables continues, so does the trend of wearables incorporating medical device features into their products. Companies such as Apple, Fitbit, Garmin, and WHOOP have incorporated an ECG feature into their devices, enabling users to check their heart rhythm for a specific irregularity, atrial fibrillation (A-Fib). This innovation required approval by the FDA as a Class II medical device, as the feature is intended to diagnose a health condition, which falls under FDA regulation. Other features that have been recently innovated have walked the line of FDA regulation or not. A recent example of this is WHOOP’s BPI (blood pressure insight) feature, which was marketed under no regulations. The FDA is in current conflict with WHOOP about this feature, and it remains to be seen whether the feature classifies as a medical or wellness device. Incorporating health features such as these blurs the line between medical and wellness devices, as the latter does not require FDA regulation, and is defined as a device that promotes a healthy lifestyle or motivates users to incorporate healthier habits into everyday life. This regulatory line needs to be more concretely drawn, or else users stand a worse chance of receiving inaccurate data pertaining to health concerns.
My technical report includes designing a human-wearable moulage to train wound packing for hemorrhage control. Uncontrolled bleeding is one of the leading preventable causes of death on the battlefield. However, current training relies on static manikins or moulage devices that lack real time, quantitative feedback. Trainees cannot reliably determine whether their packing technique used in training would actually control bleeding. It is noted by a retired Army medic that abdominal wounds are not packable due to the absence of a firm, bony structure for counterpressure. Also, hemorrhages to extremities are better treated with tourniquets. On the contrary, limb and junction wounds near the shoulder or groin are highly relevant training sites. This highlights the need for a wearable, upper limb-focused training device capable of simulating bleeding and providing objective feedback on packing performance. Our project group proposes to develop a human-wearable moulage system with integrated sensors to train medics in hemorrhage control by wound packing.
My STS research paper and technical report both include performing research on human wearable technology, but for different aspects of health. The STS report focuses on the regulations between wellness and medical devices, while the technical report focuses on using a wearable training device to prepare medics for deep wound treatment in battlefields. Both topics differ in their own regards, but pose an interesting unifying question: As wearable technology progresses and expands in health capabilities, how will it be regulated, and where is the line that the FDA must draw to foster innovation yet perform an adequate job of regulation to maintain the safety of the general public?
