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Consumer Health Technologies and FDA-Approved Medical Devices: A Promising Enigma

By Robert D Jensen

None of us likes to think of ourselves as “average.” However, in one way I discovered that I am, disappointingly, very much so.

Like roughly one-in-four Americans, I purchased a consumer wearable for my wrist and wore it daily thinking it would help me be healthier. I used this device to compete with others in my workplace in a “step challenge,” wore it to the gym to check my pulse, and only took it off for recharging.

Despite the auspicious start, I ultimately did what most wearable device purchasers do—I now use it far less than daily, and I’m not certain I could even find it today.

To say that technology has been crucial in advancing healthcare is an understatement. From robotics to miniaturized smart sensors, sophisticated health technology has given clinicians more capable diagnostic and treatment tools to respond to our care needs. Other advances that are nonspecific to healthcare (e.g., predictive data analytics, continuous connectivity) continue to influence care and care models even further.

So, what do consumer technologies and medical devices mean for us as consumers/patients, the clinical caregiver community, and health technology professionals? Let’s take a pragmatic look.

The Untapped Potential of Consumer Devices

Many of us were lured by the potential of consumer lifestyle devices to improve our health—and perhaps to make a bit of a fashion statement. Surely, knowing information like the number of steps we take each day, our heart rate, and calories burned would lead us to better choices and better health.
Unfortunately, our brains don’t work that way. I once asked Neil Stroul, PhD, a psychology and leadership coach, why our team did not seem to be responding to his feedback observations. His answer: “Awareness is the carnival booby prize.”

Applied to consumer devices, this means that just because we become aware of new data does not mean we’ll meaningfully change our behaviors to achieve different, more healthy outcomes.
Research supports Dr. Stroul’s assertion. A team led by Eric Finkelstein, PhD1 studied 800 Fitbit users in a randomized controlled trial, investigating whether the use of these devices with or without cash or charitable donation incentives would improve health outcomes (e.g., weight, blood pressure). They did not.

Another randomized trial by John M. Jakicic, PhD2 and a team of investigators found that the addition of a wearable technology device did not help overweight participants more than the standard behavioral weight-loss protocols. It seems that some wearables increase our awareness, but the outcomes are not what we assumed or hoped they would be.

But, before we abandon the promise of lifestyle devices as unfulfilled, we should take a broader look into how wearable health technology and its use is evolving towards beneficial health outcomes.

Clinicians can (and sometimes are) using wearable device data to inform patient diagnosis. While this may seem odd for a lifestyle device that is not approved by the FDA (US Food and Drug Administration), in some cases a physician may decide that potentially flawed information is better than nothing.

The first of such cases involved an emergency room patient who was suspected of having a heart attack. Data was retrieved from the patient’s phone that provided clinically valuable information to the clinical team during diagnosis and treatment. The insights were more complete than what the patient could provide on their own.

Another promising area for wearable devices is the management of chronic diseases. PricewaterhouseCoopers found that 28% of us have a “healthcare, wellness, or medical app” on our mobile phones. Two-thirds of physicians said they would “prescribe an app to help patients manage chronic diseases.”3

Again, while the addition of data may not be enough in and of itself, when placed in the context of a larger chronic disease management protocol, consumer apps may help patients.

FDA-Approved Medical Devices Show Remarkable Progress

A number of FDA-approved wearable and implantable devices are having a profound impact on health and are contributing to a changing health treatment model landscape. These include devices that monitor vital signs, facilitate telehealth, and even help manage attention deficit hyperactivity disorder.

I’ve seen the effect that these devices can have firsthand. A few years ago, some family friends discovered that their young son had diabetes. Like any parents, they were concerned about this newly discovered risk to their son’s health and what his life with this disease would be like.

Today, he wears a small insulin pump with a sensor on his back that monitors his blood sugar. He gets a bolus when he needs it and his parents get all the data recorded on an iPad. He’s able to have fun just like every other kid, and his parents are no longer worried. The medical device is a major part of that, allowing a child to enjoy a high-quality lifestyle.

The common denominator between these FDA-approved devices and lifestyle wearables are the sensors and, in some cases, the ability to respond based on that data. The health sector has especially benefitted from the ubiquitous miniaturization of microprocessors, improvements in connectivity, continuously dropping costs of data storage, and advanced large-scale analytics.
This has yielded several FDA-approved devices containing sensors of all kinds. They can be wearable, external ingestible, epidermal, blood sampling, or tissue embedded. Combining these developments with ever-increasing connectivity and data analytics can yield a broad range of benefits.

Predictive modeling, for example, can be used to identify patient population data patterns that can be proactively applied to patient care, avoiding detrimental health consequences and improving personal health monitoring outside of traditional healthcare settings. This preventive care and the notion of “continuous” care saves on the costs of traditional clinical settings while bolstering the diagnostic information available to care providers.

Leveraging Technology Towards a Healthier Future

Medical and consumer devices, combined with an understanding of behavioral change, may help us prevent and/or treat many of the costliest chronic diseases that we’re facing: cancer, heart disease, diabetes, respiratory disease, and others.

The Agency for Health Care Research and Quality (AHRQ) points to four most-influential behaviors related to these diseases: smoking, drinking, poor eating habits, and a lack of physical activity. None of the factors described by AHRQ come as a surprise. But new technology may represent a powerful tool to improve health through behavioral changes that are based on a more complete understanding of our environment.

Opportunity is growing every day with the potential for medical devices to have an even more profound influence on our personal health, the health of the population, and the healthcare of the future. While these technologies alone may fail to change health behaviors and outcomes, they can—in combination with a deeper understanding of human behavior—enable other techniques that are effective.

Behavioral change is clearly complex, as I learned after purchasing my own wearable device. But understanding it and the insights that these devices create in our environments can help inform better combinations of personal change that do lead to healthier choices and outcomes. With a groundswell of such types of successes, we can contribute to a shift away from the treatment of disease to encouraging and enabling wellness.


  • 1. Professor Eric A. Finkelstein, PhD, Benjamin A Haalund, PhD, Marcel Bilger, PhD, Aarti Sahasranaman, PhD, Robert A. Sloan, PhD, Ei Ei Khaing Nang, PhD, Prof Kelly R. Evenson, PhD. Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial.
    2. Jakicic JM, Davis KK, Rogers RJ, King WC, Marcus MD, Helsel D, Rickman AD, Wahed AS, Belle SH. Effect of Wearable Technology Combined With a Lifestyle Intervention on Long-term Weight Loss: The IDEA Randomized Clinical Trial.
    3. Robert Glatter, MD Wearable Technology and Digital Healthcare Strategies Should Shift Focus to Chronic Medical Illness

Robert D JensenRobert D Jensen

Pesident and CEO,
Association for the Advancement
of Medical Instumentation (AAMI)

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