Wearables and other digital health technologies are driving a more patient-focused, preventative approach to healthcare. Reducing inefficient healthcare practices through real-time monitoring and data collection, wearables and digital health technologies provide opportunities for personalized treatment for patients, lowering costs and improving care access and quality. Wearable device sales across the world are expected to reach $60 billion by 2025, so as the market grows, it is important to understand the roles of various wearables and digital health technologies as well as the impact they are expected to have on trends in the medical device industry moving forward.

Understanding Wearables and Other Digital Health Devices

The FDA describes digital health technologies as those using “computing platforms, connectivity, software, and sensors for health care and related uses,” which covers mobile health, health IT, wearable devices, telehealth, and personalized medicine. The FDA has also shared guidance for software as a medical device, artificial intelligence and machine learning in software as a medical device, cybersecurity, device software functions, health IT, wireless medical devices, and more. With improvements to wearable and digital health technologies driven by R&D, digital health categories are becoming more defined. Wellness wearables and digital health technologies have many similarities, though they provide different capabilities and benefits.

Wearables
75% of users feel that wearables increase engagement with their health. Many commonly known wearables include devices produced by tech companies for fitness and general wellness tracking purposes, such as the Amazon Halo band, the Fitbit, and the Apple Watch, which has an ECG sensor and can monitor blood oxygen levels. Garmin also produces Vivosport, which measures VO2 max and heart rate, targeting people who want to monitor their fitness. The Oura ring is another wearable used for observing sleep and vital sign health, and became well known for its use by NBA athletes during the COVID-19 pandemic. Currently, 30% of consumers in the US are regularly using wearables such as smart watches and fitness trackers, and 80% would wear smart watches to measure health data. These devices provide helpful information for people to better understand their general health and fitness, but many companies that produce wearables are starting to see opportunities in remote health monitoring.

The market for wearable devices for signs monitoring is expected to reach $980 million by 2024 with a 21.7% CAGR. The benefit of these wearable devices is that they are becoming smaller, more easily integrated into apparel, and new growth opportunities are available such as the ability for the devices to be implanted, as is the case for pacemakers and blood-sugar monitors. Phillips developed a wearable biosensor self-adhesive patch for patients to monitor movement, heart and respiratory rate, and temperature, which led to 89% fewer patients deteriorating into preventable issues like cardiac arrest, showing the real impacts of this technology. Also taking note of opportunities in wearables, Omron Healthcare developed a wearable blood pressure monitor watch called HeartGuide. While wearables provide sensors for health monitoring, other digital health technologies are impacting healthcare through different means.

Digital Health
Digital health technologies include anything from apps to track general wellness to apps with medical device functionality that help with diagnostics or assist other medical products. They can share real-time information with health care providers or enable users to monitor symptoms and health data. Medical devices like microscopes, ultrasounds, and blood pressure monitors may be able to plug in to a smartphone for mobile use, and images taken with smartphones can be shared with healthcare providers and used for diagnosis. This has improved automation and reduced time for symptom tracking and medication decisions for diseases such as COPD, asthma and diabetes, especially when paired with wearable tools such as sweat meters and oximeters.

Digital health devices enable clinical visits to be more efficient, with more information and transparency between patients and healthcare providers. Medical mobile apps as well as artificial intelligence or machine learning in digital health devices can also help with diagnosis and treatment decisions, helping personalize and improve the quality of healthcare through holistic data reporting. Validic is one company that is helping to connect digital health device data to applications and health IT systems, allowing healthcare providers to conduct remote monitoring — tying in with trends such as the rise of telemedicine over the COVID-19 pandemic. 

Impact on Trends in Medical Devices

As remote medicine continues to gain momentum, digital health technologies are likely to incorporate more wearable monitoring devices to provide better care personalization and promote preventative health tracking. Atrium Health has paired their MyAtriumHealth app with wearables such as the Fitbit to track health remotely, bringing medical functionality to wearable wellness devices. Additionally, among an evolving regulatory landscape, digital health technologies’ data collection methods can be better implemented for growth areas in chronic condition tracking, women’s health monitoring, and mental health support.

Wearables and digital health technologies will continue to be innovative resources to improve healthcare access, especially with the recent development of a new stretchable battery that uses human-generated heat as an electricity source to power wearable devices or wellness trackers. 5G will also improve diagnosis speed and improve data sharing capabilities for digital health devices. Both digital health devices and wearables should be designed for the consumer’s ease of use, but the main opportunity for growth is in data collection and sharing. Regulations for mobile health apps can be complicated, but the FTC has provided a tool to help companies determine whether their apps require oversight by the FDA, OCR, or FTC, through questions such as whether consumers need a prescription to access the app, whether health information is created or shared through the app, or if the app is for a HIPAA-covered entity.

With the ability of personalized data to make a significant impact on patient care by enabling “on demand” data and medical support, wearables and digital health devices are key opportunities for healthcare and will impact the trajectory of the medical device industry. Health apps and wearables for preventative care are estimated to help reduce healthcare system costs by almost $7B annually. Prescription digital therapeutics are also starting to gain traction for disease treatment, with reSET® as the first to receive FDA approval in 2017. However, use of health management mobile apps and wearable technology has dropped in the last two years, as data privacy and security concerns have grown. It is imperative that companies producing these digital health technologies and wearables need to consider how to approach consumer trust, optimizing a device that can be integrated into patient care seamlessly with strong security practices to encourage patient compliance, leading to higher quality, more effective care.

Contributions by Courtney Loughran