The rise of medical wearables in the 2020s

The rise of medical wearables in the 2020s

By Serina Cheung

While the 2010s will be known as the rise of the smartphone, the 2020s are poised as the rise of “wearables”. Electronic devices that consumers can wear, such as smartwatches, are considered “wearable technology”. The advancement of smartphones has allowed for technology to be intricately woven into many aspects of our daily lives. From asking Siri the weather to tracking our steps, mobile technology is a powerful tool to make everyday tasks easier. In recent years, wearable technology has found its place in society with a particular focus on health and fitness. Consumers are becoming increasingly health conscious with the desire to take ownership of their health. According to Accenture, the use of wearable technology in the U.S. jumped from 9% in 2014 to 33% in 2019.1 As the popularity of wearables surge, the 2020s look promising for the rise of wearable technology.

The first wearable technology to achieve mainstream success was the Fitbit, a simple wristband to track one’s steps throughout the day. Fitness smartwatches have now evolved into multi-functional tools that can track heart rate and detect falls. As of 2018, Apple leads the wearables market with the Apple Watch.2 In the age of big data, the Apple Watch allows an unprecedented amount of data to be collected in real time in an accurate and non-invasive manner. Apple has partnered with top academic medical institutions to launch studies relating to women’s, cardiovascular, and hearing health.3 This innovative approach to data collection allows research institutions to take advantage of the prevalent use of wearables. With each iteration of the Apple Watch becoming more and more health and fitness focused, Apple is inevitably tapping into the vast market for wearables. The massive success of the Apple Watch has not gone unnoticed, as Google recently acquired Fitbit as their venture into the wearables market.4

Smartwatches dominate the wearables market, however, there has also been an emergence of experimental health-focused wearables with promising applications:

  • The Cyrcadia Breast Monitor is a “smartpatch” for the breast that uses digital temperature sensors to detect abnormal circadian temperature patterns in breast tissue. This data is submitted to healthcare providers to detect early signs of breast cancer.5
  • Microsoft developed the Emma Watch, which uses small motors producing rhythmic vibrations to compensate for hand tremors. This technology is beneficial to those suffering from movement disorders such as Parkinson’s disease.6
  • The Philips wearable biosensor is a medical-grade device that discretely and wirelessly fits on the patient’s chest. It monitors key vital signs such as heart rate and respiratory rate, allowing physicians to continuously monitor patients’ health and be notified when intervention is needed.7

As new wearable technology makes accurate real-time monitoring and data collection easier, several promising applications for the future of the healthcare industry emerge. The remote collection of large amounts of health data allows for the establishment of patterns to train machine learning models. Wearables may have the ability to predict potential health problems before they fully manifest, allowing for early physician intervention and preventative measures. One of the most attractive features of wearables is the ability to collect physiological data in real time. The current routine of patients having their vitals taken at the doctor’s office represents a very narrow snapshot of a person’s physiology. Inferences can be made retroactively if these snapshots of a patient’s vitals are taken every few weeks, months, or years. However, frequent measurements may burden the healthcare system. Accurate and real-time measurements supplied by wearables produces denser datasets allowing for improved understanding of disease variability as well as characterisation of intra- and interpatient variability.

Real-time collection of data is also very useful for clinical and drug development trials. Most trials require patients to complete questionnaires at physical locations. However, if patients could electronically complete questionnaires using their wearables, this would improve compliance and timely collection of data, as well as reducing administrative burden.9 However, it is important to note that different modes of questionnaire administration, such as telephone-based, electronic, or paper-based self-report, introduces biases in the responses. Some of these biases include recall bias and social desirability bias and can have important implications for the validity of results.13 Physiological data collected during early stage clinical trials may identify early safety concerns allowing dosing adjustments to be quickly made. Towards the end of clinical development, several self-reported measures are made to identify adverse effects. Perhaps wearables could provide objective biomarker measurements of traditionally subjective, self-reported attributes such as pain, fatigue, and nausea.

Although the promising applications of medical-grade wearable devices in the healthcare system have garnered lots of attention, many challenges present themselves before wide mainstream adoption. For example, a recent study in France used wearables to remotely track and analyze patients with chronic conditions in real time. This study evaluated patients’ perception of the use of wearables and artificial intelligence (AI) in healthcare. Interestingly, only 50% of patients felt that the use of digital tools was beneficial, while 11% considered it a danger. There was distrust in using AI to help physicians predict outcomes and many felt that any decisions should remain a human task.8

Those who work on research and development in the pharmaceutical side may not be familiar with engineering devices. Conversely, the engineers working on the devices may not be familiar with the drug development process. The gap between the two industries may slow the progression of consumer friendly, health wearables. Notable non-medical grade wearables that have reached mainstream adoption include the Apple Watch and Fitbit. However, the Apple Watch is a consumer-grade, as opposed to a medical-grade wearable. Consumer-grade devices are FDA cleared, as opposed to FDA approved. FDA clearance deems a product to be substantially similar to another marketed device. However, FDA approval requires a more rigorous review. In other words, while the Apple Watch can provide some insight to one’s vitals such as heart rate, it is not meant to replace a trip to the doctor’s office.

The electronic collection of health data also raises concerns of privacy. More than one third of Canadians use health or fitness related applications on their phone, smart watch or tablet11. Canada is lagging in defining the governance of health data collection by medical devices and consumer-grade wearables.12 However, in the US, consumer-grade and medical devices are under different sets of regulations. Data obtained by medical devices require patient consent for collection and sharing. However, the data obtained by consumer-grade devices such as the Fitbit can be shared in a deidentified manner to third parties.9 Health data is worth billions of dollars to pharmaceutical companies. As such, companies need to attract consumers to consent to data collection to be sold to third parties. Technology companies need to be transparent with the type of data being collected and the option to opt out of third-party access to data. Currently, targeted marketing ads are becoming increasingly specific and personalized. Health data is another facet that marketing companies are using to further refine and reach their target audience.

Today, the idea of a smartwatch having the capabilities of a full-scale electrocardiogram is difficult to imagine. However, as these consumer-grade and medical-grade wearable technologies mature, remote patient monitoring using wearables alone may become a very real possibility. The potential of wearables has inevitably caught the attention of tech giants and pharma companies. With some of the world’s largest companies backing the R&D of wearables, a future of wearables reaching mainstream usage may be even closer than we thought.

IMS writer Serina Cheung is a 2nd year MSc student at IMS investigating treatments for castration-resistant prostate cancer under the supervision of Dr. Marianne Koritzinsky. In her free time, she is either planning her next vacation or being an avid consumer of Korean pop music.

 

 

 

References

  1. Accenture Study Finds Growing Demand for Digital Health Services Revolutionizing Delivery Models: Patients, Do [Internet]. Newsroom. Accenture; 2018 [cited 2019Nov7]. Available from: https://newsroom.accenture.com/news/accenture-study-finds-growing-demand-for-digital-health-services-revolutionizing-delivery-models-patients-doctors-machines.htm.
  2. Perez S. IDC: Apple led wearables market in 2018, with 46.2M of the total 172.2M devices shipped [Internet]. TechCrunch. TechCrunch; 2019 [cited 2019Nov7]. Available from: https://techcrunch.com/2019/03/05/idc-apple-led-wearables-market-in-2018-with-46-2m-of-the-total-172-2m-devices-shipped/.
  3. Apple announces three groundbreaking health studies [Internet]. Apple Newsroom. 2019 [cited 2019Nov7]. Available from: https://www.apple.com/ca/newsroom/2019/09/apple-announces-three-groundbreaking-health-studies/
  4. Fitbit to Be Acquired by Google [Internet]. Press Release Details. 2019 [cited 2019 Nov7]. Available from: https://investor.Fitbit.com/press/press-releases/default.aspx
  5. Cyrcadia Health. Core Technology [Internet]. Cyrcadia Health. [cited 2019Nov7]. Available from: http://cyrcadiahealth.com/core-technology/
  6. Project Emma [Internet]. Microsoft Research. 2017 [cited 2019Nov7]. Available from: https://www.microsoft.com/en-us/research/project/project-emma/
  7. Wireless Wearable Biosensor for Vital Signs Monitoring: Philips Healthcare [Internet]. Philips. [cited 2019Nov7]. Available from: https://www.usa.philips.com/healthcare/clinical-solutions/early-warning-scoring/wireless-biosensor
  8. Tran V-T, Riveros C, Ravaud P. Patients’ views of wearable devices and AI in healthcare: findings from the ComPaRe e-cohort. npj Digital Medicine [Internet]. 2019Jun14;2(1). Available from: https://www.nature.com/articles/s41746-019-0132-y
  9. Izmailova ES, Wagner JA, Perakslis ED. Wearable Devices in Clinical Trials: Hype and Hypothesis. Clinical Pharmacology & Therapeutics [Internet]. 2018Apr2;104(1):42–52. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6032822/
  10. Center for Devices and Radiological Health. Consumers (Medical Devices) [Internet]. U.S. Food and Drug Administration. FDA; [cited 2019Nov25]. Available from: https://www.fda.gov/medical-devices/resources-you-medical-devices/consumers-medical-devices#What_is_the_difference_between_Cleared_and_Approved_
  11. PwC Canada’s Consumer insights survey: The experience is pertinent to Canadian consumers [Internet]. PwC. 2019 [cited 2019Nov25]. Available from: https://www.pwc.com/ca/en/media/release/canada-consumer-insights-survey.html
  12. Canada H. Government of Canada [Internet]. Canada.ca. Government of Canada; 2018 [cited 2019Nov25]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-digital-health-technologies.html
  13. Bowling A. Mode of questionnaire administration can have serious effects on data quality. Journal of Public Health. 2005May3;27(3):281–91.