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Urgency Needed for Medical Grade Wearables


Primary barriers to wholesale adoption of wearables and digital devices are lack of consistent data quality and regulatory approval.

At the height of the pandemic, the FDA issued emergency use authorizations (EUA) to some manufacturers of remote monitoring and wearable devices. Considering the intended users – physicians, consumers, hospital systems– conducting a Mad Men-style, product-focus group to assess user feedback could have been useful. But time for such marketing indulgences didn’t exist, considering that lives were at stake.

With time’s passing, as more devices passed FDA scrutiny and were used in clinical trials and healthcare monitoring, research scientists and professional associations conducted their own brand of product focus groups. Surveys have emerged of patients, physicians, product engineers, all essentially asking the same questions: “Did you find the device useful, did it do what the manufacturer said it was supposed to, did you find value in it, what would stop you from using the device again?”

The collective answers: “Yes, but; sometimes; overall, not really; here is the list.”

Peer-reviewed studies that examined use, efficacy and efficiency of these tools found similar results. One example: a 2019 study found a smartwatch was excellent (96.1%) in detecting atrial fibrillation – ECG verified – but out of 650 devices, 101 of them transmitted unreadable signals.1

You might be tempted to utter an aphorism, like the one about hindsight and visual acuity or the need to quickly mend rips and tears. Keep all judgment in context, said Jennifer Goldsack, CEO, Digital Medicine Society, known as DiMe. These are addressable issues; soon, the digital medicine community will announce a plan to come up with solutions, she said.

Judgments notwithstanding, most physicians, said David L. Feldman, MD, MD, MBA, FACS, chief medical officer for The Doctors Company and TDC Group, will not use these devices without liability insurance. And before any insurance company grants malpractice protection, physicians will still be reluctant to use a device unless it saves them time. Said Feldman, “They are overwhelmed now with the volume of information. Now, add the Fitbit data from remote tools, how do they have time to interpret that?”

Getting technology up to user level involves more than writing a script. The professional instructions supplied with a remote QT interval monitor, given an EUA pass two months into the pandemic, was 42 pages long.

Reasons and findings

Two significant reasons lie behind the less-than-stellar survey and study results regarding device use and acceptance, Goldsack said.

The pandemic forced life-saving innovation at a dizzying speed, and timetables of device funding models were not set at a leisurely pace. Venture capital funding, which propelled tool development in the start-ups, she said, has “an aggressive timeline.”

“There was a rush to market with the best of intent,” said Goldsack. “Regulators couldn’t keep pace.” For its part, industry didn’t have the expertise for the most comprehensive thinking into which qualities and characteristics would appeal to device users.

Since then, studies and surveys have helped fill in those knowledge gaps. One 2020 survey of 4,551 US adults found 30% of them use wearable devices, and that those 30% were primarily comprised of white, educated, younger, healthier, wealthier men.2

A 2020 meta analysis of 41 studies, covering many populations and behaviors, listed 26 factors “relating to capability, opportunity, and motivation [that] appear to influence the uptake of and engagement with health and well-being smartphone apps.”A sampling: available user guidance, app literacy skills, well designed reminders, positive feedback, available rewards, and the app’s ‘perceived utility.’3

Molex and Avnet, large firms in the consumer electronics industry, surveyed 600-plus design engineering stakeholders last year. Those most interested in wearables were patients, at 61%, and the last, doctors and medical professionals, at 27% – insurance companies came in at 31%.4

Virtually all respondents said they considered the primary barriers to wholesale adoption are lack of consistent data quality and regulatory approval. If a device isn’t FDA approved, medical groups won’t use them.

That is correct; a 2022 AMA study found 85% of respondents said lack of liability protection was the most important reason they wouldn’t use remote devices. In that survey, 30% of 1,300 physicians said they used remote monitoring devices.5

Said Feldman: “The thing we worry about most is the diagnostic area. Missing a diagnosis is already a big problem.” He continued, “We advise doctors to be careful, they should really want to look through all this.”

The proposed fix

A research-grade medical digital device, said Pip Griffiths, PhD, project lead, DiMe, “has to be at that intersection where it is attractive and people want to use it.” Putting a monitor on an ankle to measure gait of a patient with progressive muscle degeneration, or asking a teenage girl with heart problems to wear a device on her chest, may be appropriate in terms of the level and accuracy of data they collect—but will people want to wear them? Research grade devices do not often offer that same attractiveness as a consumer product, she said, but the latter’s issue is that a wearable has a proprietary algorithm. “There are a lot of commercial devices that weren’t initially intended for research.”

Everyone, she said, has to take a step back.

DiMe intends to reach that attractive-but-useful intersection soon. DiMe is asking stakeholders in the digital medicine world to help figure out what exactly users want, and to come up with the methods to standardize those wants. DiMe and its army of volunteers have already established analytical and clinical validations and verification standards for biometric monitoring technologies, which it calls the V3 framework.

Now DiMe is forming a new project team of leading pharma companies, device companies, digital start-ups and product design experts to extend the V3 framework to address these challenges. Starting in March, this group of leaders in digital product usability, human factors, and human-centered design will collaborate for 8 months to extend the V3 framework to ensure that new digital products coming to market combine both performance and meet the needs of device users

Said Goldsack: “It is incredibly difficult to be sticky with these technologies.”

Christine Bahls is a freelance writer for medical, clinical trials, and pharma information.


  1. Dörr M, Nohturfft V, Brasier N, et al. The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):199-208.
  2. Chandrasekaran R, Katthula V, Moustakas E. Patterns of Use and Key Predictors for the Use of Wearable Health Care Devices by US Adults: Insights from a National Survey. J Med Internet Res. 2020 Oct 16;22(10):e22443.
  3. Szinay D, Jones A, Chadborn T, Brown J, Naughton F. Influences on the Uptake of and Engagement With Health and Well-Being Smartphone Apps: Systematic Review. J Med Internet Res. 2020 May 29;22(5):e17572.
  4. Diagnostic Wearables: The Future of Medical Monitoring. https://www.electronicproducts.com/diagnostic-wearable-devices-on-the-rise/
  5. AMA digital health study 2022 https://www.ama-assn.org/about/research/ama-digital-health-care-2022-study-findings
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