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The wearable health technology market is expected to be one of the largest and fastest growing markets in the next decade. Wearable health technologies have the potential to disrupt a number of parallel markets and, at the same time, significantly reduce health care costs. Cost savings are driven by better processing and resource management.

Consumer-centred health care

Health care is transforming into a patient-centric, consumer-driven model. The traditional inefficient and costly model: a person seeks medical help from the doctor – the only source of information and the doctor makes decisions based on fragmented medical history or medical records. The rich datasets available generated by wearable technologies now put patients at the center of care. Consumer-led healthcare will change patient care journeys, pushing the industry to grow and collaborate in new ways, both with patients around their own health and with partners and innovators. Handheld devices will primarily support people leading healthy lives, then diagnostic and therapeutic capabilities will follow, driven by the user themselves at the point of care.

Responsibility

Digital technologies and data combined enable more holistic EHR, medical education, clinical experience, and experience building a more holistic medical picture at the micro and macro level. This changes the distribution of data and accountability with the patient as the point of care and engaged in medical decisions. At some point, clinicians will collect data from their patients’ wearable devices and sensors as part of routine care.

Regulators

As the capabilities of wearable devices grew, the FDA considered how to regulate the new technology. Originally, wearable devices were not considered medical devices unless they claimed to treat specific diseases or conditions. However, as wearable device technology advanced, the FDA regulated some new features.

For example, Apple released an ECG feature on its watch to detect atrial fibrillation. Since it was intended to detect atrial fibrillation (an irregular heartbeat), Apple could not classify the feature as a general wellness device and the feature had to be approved by the FDA.

WellDoc’s diabetes platform, for example, has been approved by the FDA as a digital therapeutic. What makes it a therapeutic tool compared to an information tool compared to a diagnosis? Welldcoc Diabetes tracks blood glucose levels like any other blood glucose meter. In the traditional monitoring model, a patient will review their blood glucose data and then decide how to adjust their insulin dose accordingly. In the Welldoc model, the Welldoc platform tells the patient exactly how much insulin to inject. This changes the paradigm from the patient/doctor making the dosing decision to the technology platform making the dosing decision (to achieve clinically tested results). This “dosing decision” makes the platform a therapeutic device and not a monitoring device, which in turn requires full therapeutic approval from the FDA.

As the impact of biosensors and syn-bio grows in the wearable platform, regulators will need to consider devices and their software in many categories; diagnosis, medical device, digital therapy and quite simply therapy. Although the FDA may exercise its regulatory power over the clothing industry, a more permanent solution will likely require updates to the Food, Drug, and Cosmetic Act, which could slow market growth.

Repayment

Reimbursement has taken some time to catch up with digital technology innovation in general, but as cost-benefit arguments begin to revolve around the use of resources and labor, payers will drive change through reimbursement. Good data analysis and AI will be able to demonstrate that the hardest part is changing old models of health care delivery and delivery.

Additionally, as therapeutic benefits increase, reimbursement will also increase, but this will require significant investment in good quality clinical trials and pharmacoeconomic studies. This, in turn, will require strong pharma/biotech-like leadership and management spearheading new innovative ventures.

Privacy

Beyond regulatory and reimbursement challenges, there are additional new legal dynamics for manufacturers bringing their smart wearables to market. These mainly concern the confidentiality and security of the data processed. New levels of detail and information about an individual will be available through data collected by new devices, leading to new levels of privacy concern. There will be additional legal requirements regarding the application of the device, such as liability in case of malfunction, professional regulations of medical users and data processed.

Market opportunity

With such wide application across a number of markets, we’ve seen some pretty dramatic differences in wearable health tech predictions. It is clear that these differences depend on the aspects included. We believe a reasonable estimate is around $17 billion in 2020 with projected growth at a compound annual growth rate (CAGR) of around 28% from 2021 to 2028 to reach well over $100 billion.

A greater focus on health and wellness and a growing elderly population will see fitness, remote monitoring and personalized medicine as key growth areas, but the arrival of more therapeutic applications will significantly accelerate growth .

Although some of this development work is still in its early stages, the potential value for the market is clear. Ziylo has developed an innovative technology platform, which could be a key element in activating the next generation of insulin, capable of reacting and adapting to blood glucose levels, thus eliminating the risk of hypoglycemia – des dangerously low blood sugar levels – and leading to better metabolic control for people living with the disease.

Ziylo was acquired by Novo Nordisk in a deal worth $800 million.

What is clear is that wearable health technologies will be highly disruptive as their impact will ripple across many market sectors – from healthcare delivery to diagnostics to therapeutics. The key to successful investment is understanding precisely which technologies, market sectors, and regulatory factors will ultimately drive market growth.

Photo: exdez, Getty Images