The future of wearable health tech

Consumer-centric healthcare will change the way patients are cared for, forcing the industry to grow and collaborate in new ways, both with patients involved in their own health and with partners and innovators.

The wearable health tech  market is expected to become one of the largest and fastest growing markets in the next decade. Wearable medical technology has the potential to disrupt a number of parallel markets, significantly reducing healthcare costs. Cost savings come from better care and better resource management.

Consumer-led healthcare

Healthcare is in the process of moving towards a patient- and consumer-centered model. The traditional inefficient and costly model: a person seeks medical help from a doctor, the only source of information, and the doctor makes decisions based on a disparate anamnesis or medical records. The abundant accessible datasets generated by wearable technology are now making patients the center of attention. Consumer-centric healthcare will change the way patients are cared for, forcing the industry to grow and collaborate in new ways, both with patients involved in their own health and with partners and innovators. Wearable devices will help people lead a healthy lifestyle first, followed by on-site diagnostic and therapeutic capabilities.

A responsibility

The convergence of digital technologies and data provides a more holistic electronic health record, medical research, clinical expertise, and the experience of building a more holistic medical picture at both the micro and macro levels. This changes the distribution of data and responsibility of the patient as a point of care and participation in medical decision making. At some point, doctors will be collecting data from sensors and wearables about their patients as part of routine healthcare.

regulators

As wearable device capabilities have increased, the FDA has grappled with how to regulate the new technology. Initially, wearable devices were not considered medical devices unless they claimed to treat specific diseases or conditions. However, as wearable technology has evolved, the Food and Drug Administration has introduced some new features.

For example, Apple has launched an ECG feature on its watch to detect atrial fibrillation. Because it was intended to detect atrial fibrillation (irregular heartbeat), Apple was unable to classify the feature as a general wellness device and the feature had to be approved by the FDA.

The WellDoc diabetes platform, for example, has been approved by the FDA as a digital therapy. What makes it a therapeutic, informational or diagnostic tool? Welldcoc Diabetes tracks blood glucose levels like any other glucometer. In the traditional monitoring model, the patient views their blood glucose data and then decides how to adjust their insulin dose accordingly. In the Welldoc model, the Welldoc platform tells the patient exactly how much insulin to inject. This shifts the paradigm from the patient/physician making the dosing decision to the technology platform making the dosing decision (for clinically validated results). This “dosing decision” makes the platform a therapeutic device, not a control device, and this, in turn, requires full FDA therapeutic approval.

As the impact of biosensors and synthetic biology on the wearables platform increases, regulators will need to consider devices and their software in many categories; diagnostic, medical device, digital therapeutic and simply therapeutic. While the FDA may use its regulatory powers on the wearables industry, a more permanent solution would likely require updates to the Food, Drug and Cosmetics Act, and this could slow market growth.

Return

It has taken some time for reimbursements to align with digital innovation in general, but as resource and labor cost-benefit cases begin to develop, payers will drive change through reimbursement. Good data analysis and artificial intelligence can show that the hardest thing is to change the old models of healthcare delivery.

Moreover, as the therapeutic effect increases, the cost recovery will also increase, but this will require significant investments in high-quality clinical trials and pharmacoeconomic studies. This, in turn, will require strong pharmaceutical/biotech-type leadership and management at the helm of innovative start-ups.

Confidentiality

In addition to regulatory and compensation issues, there are new and additional legal considerations for manufacturers selling their smart wearables. First of all, this concerns the confidentiality and security of the processed data. New levels of detail and human understanding will become available through the data collected by new devices, and this will raise new levels of privacy concerns. There will be additional legal requirements regarding the use of the device, such as liability for faults, professional standards for medical users, and data being processed.

Market Opportunities

With such a wide application in a number of markets, we have seen quite significant differences in the predictions for wearable medical technologies. Obviously, these differences depend on the included aspects. We think a reasonable estimate is around $17 billion in 2020, with a Compound Annual Growth Rate (CAGR) expected to be around 28% from 2021 to 2028 and exceed $100 billion.

An increased focus on health and wellness and a growing population of older adults will see fitness, telecommuting and personalized medicine as key growth sectors, but more therapeutic applications will accelerate growth dramatically.

While some of these developments are still in their early stages, the potential market value is clear. Ziylo has developed an innovative technology platform that could be a key component of the next generation of insulin, able to respond and adapt to blood glucose levels, thereby eliminating the risk of hypoglycemia (dangerously low blood sugar) and improving metabolism. control over the people who living with the disease.

Ziylo was acquired by Novo Nordisk for $800 million.

What is clear is that wearable medical technologies will be very disruptive as their impact will spread across many sectors of the market, from medical care to diagnostics and therapy. The key to successful investments is an accurate understanding of which technologies, market sectors and regulatory factors will ultimately drive the growth of the market.