Nearly half of adults in the United States suffer from hypertension. Left untreated, this condition can lead to heart attack and stroke, two leading causes of death. Despite this risk, less than 25% of hypertension sufferers have the condition under control(1).
For decades, doctors have not been able to offer any effective solutions for hypertension management outside of drug therapy, which has a low adherence rate. This has led to a high degree of skepticism from patients and doctors alike concerning hypertension management solutions. But this tide is showing signs of changing.
Digital health solutions and connected devices have the potential to redefine hypertension management expectations. Early studies have already shown the amazing results these devices can produce. And there is still a great deal of opportunity in this market for innovative medical technology companies to take advantage of. Given the size of the customer base and the cost of managing complications associated with hypertension, this market promises rapid growth as technology advances.
Hypertension Monitoring and Treatment
Hypertension is defined as sustained systolic blood pressure levels above 130mmHg or sustained diastolic levels above 80mmHg. About half of hypertension sufferers are considered stage 2, with levels consistently hitting numbers above 140mmHg.
According to the CDC, nearly 35 million Americans require medication to control their condition but are not taking it. Caring for hypertensive patients and the comorbidities associated with the condition costs over $131 billion per year.
Many of the challenges associated with treating hypertension stem from a lack of effective monitoring options. Blood pressure readings taken in the doctor’s office are often skewed by “white coat syndrome” and rarely represent the average blood pressure level for that patient. Measurements obtained using home monitoring cuffs tend to be more accurate but still only represent a snapshot of a much larger picture.
Wearable connected devices have the potential to dramatically change hypertension monitoring and, thus, improve the management of the condition for better patient outcomes. Unlike home monitors, wearables have the potential to record hundreds of pressure readings per day, providing a full picture of the user’s blood pressure patterns. This would allow caregivers access to the data necessary to identify markers that signify a negative cardiovascular prognosis, including abnormal blood pressure variability and masked hypertension.
Combining wearable blood pressure devices with other sensors and monitors has the potential to further increase the usability and clarity of data and identify risk factors long before damage to the cardiovascular system and other organs occurs.
Current Connected Device Applications
The first blood pressure-measuring smartwatch received FDA approval in late 2018. Since then, we have seen a number of wearable devices utilizing similar sensors hit the market. Today, consumers have many choices in what form their connected blood pressure monitor takes.
Mobile Connected Blood Pressure Cuffs
The first advancement in hypertension monitoring, connected blood pressure cuffs, has gotten sleeker and easier to use in recent years. Most of these devices are now wireless and come with a companion smartphone app that allows users to share data with their care team and review measurements in multiple forms, including trend graphs.
Mobile-connected blood pressure cuffs have the advantage of allowing users to take their blood pressure at home to avoid “white coat syndrome.” Many recent releases are small and portable enough to be used outside the home as well. But, unlike other options here, these bulky monitors are not meant to be worn continuously and only provide readings when the user activates them.
Still, these devices have shown a lot of promise to help those suffering from hypertension. One popular connected device and heart monitoring platform, Hello Heart, helped reduce blood pressure for 84% of stage 2 users, according to a study published in JAMA.
The launch date for the long-anticipated Apple Smartwatch blood pressure monitoring function has been pushed back to 2024. But many other companies in this market, including YHE, Omron, and Samsung, have cracked the code on wearable blood pressure monitoring devices.
The first devices in this market utilized pressure bands similar to blood pressure cuffs to measure pressure readings only when prompted or scheduled. Newer iterations utilize photoplethysmography (PPG) to sense blood pressure using light fluctuation. These devices have the ability to measure blood pressure readings throughout the day without being prompted.
Data from both types of watches can be accessed via the watch screen or a connected smartphone via the associated app. Many are also connected to healthcare portals so doctors can make treatment decisions based on the patterns and irregularities detected.
Similar in design to smartwatches, but with a slightly different appearance, are connected blood pressure monitoring bracelets. These sleeker, lighter-weight devices utilize PPG sensors to collect blood pressure data and transfer it directly to the connected mobile application. Because they don’t have a screen, they are more discrete and often more comfortable to wear.
Despite their smaller size, they have the potential to gather just as much data with the same accuracy as larger smart devices.
The newest player in the realm of blood pressure monitoring wearables is the smart patch. These devices stick directly to the skin and transfer readings to connected smart applications. Consumer access to these products is not yet available, but Biobeat’s chest-worn smart patch has received FDA approval for specific applications. Other patch options are still in trials but include many interesting multi-sensor devices that hold a lot of promise for clinical and consumer use.
Opportunities for Connected Devices in Hypertension Monitoring
Despite the range of connected device and wearables options currently on the market and set to launch in the near future, there are still a ton of opportunities in this niche. MedTech companies that are able to improve on current options, integrate advancements in machine learning, and explore other innovations in this area are certain to gain a foothold in the hypertension monitoring market.
Enhancements to Accuracy and Reliability
Factors including improper device placement, cuff size or band tension, body position, and user movement all affect the accuracy of the readings taken by blood pressure monitoring wearables available today. Movement during blood pressure readings, especially, can introduce motion artifacts that affect accuracy and skew data. Beyond user interference, factors such as ambient temperature, noise, electromagnetic interference, and device battery level can introduce errors in readings.
Companies looking to enter this market can position themselves above the competition by investing in advanced technologies that can overcome these problems with accuracy and reliability. Advanced sensors that are less affected by movement and ambient conditions can produce more consistent, reliable data. Designing the wearable to reduce inaccuracies due to tension, improper placement, and other factors will also be important.
Integrating Advanced Algorithms and Machine Learning
Utilizing AI and machine learning in wearable medical tech is a relatively new field, but one that is taking off fast. Any company looking to launch in the connected device market needs to incorporate these advanced technologies into their product.
Machine learning algorithms can be used to analyze large datasets of blood pressure measurements collected from wearable devices. By identifying patterns and correlations within the data, these algorithms can improve the accuracy of that data and identify abnormal variations and trigger alerts for users or healthcare professionals. Companies should employ supervised learning methods, such as regression or classification algorithms, to develop models that accurately estimate blood pressure based on various sensor inputs.
Machine learning can also enable individual calibration and personalization of wearable blood pressure devices. By collecting data from individual users over time, algorithms can adapt and fine-tune the device’s performance for each user. This approach accounts for variations in physiology, such as arterial stiffness, and improves the accuracy of measurements. Additionally, these algorithms can be trained to detect and compensate for motion artifacts during blood pressure measurements, allowing for more accurate data interpretation.
Innovations in Sensor Technology
The vast majority of wearable blood pressure sensors on the market today utilize photoplethysmography sensors to measure arterial pressure. The downside to this sensor approach is that these devices require calibration with a blood pressure cuff. Apple’s Smartwatch utilizes photonics-based sensors, which do not require calibration. However, the company has faced setbacks with this technology.
Companies looking to build superior devices may need to look to alternative sensing capabilities including multisensor approaches. ECG and pulse wave-based sensors both have the ability to estimate blood pressure when paired with AI algorithms. Bioimpedance and ultrasonic sensors collect data that is highly correlated with and indicative of blood pressure levels and could be utilized in these types of wearables. Microneedle, optical coherence tomography, and graphene-based sensors all show promise in producing accurate blood pressure measurements.
Advancements in Usability and Design
Smartwatch-style wearables continue to be a lucrative approach to blood pressure sensors. But even here, there is room for improvement. Reducing the size of the watch and the sensors inside it would make them more appealing to users. And improvements to non-sensing characteristics, such as battery life, charge time, and range, would also make them more marketable than current devices.
While smartwatches may be the optimal delivery method for consumers, patients with hypertension or advanced heart conditions may prefer a less cumbersome monitoring device. Here, smart patches seem to offer the most promise. These wearables are more discrete and often more comfortable than other options.
Integration of Additional Health Parameters
We’ve spoken before about the importance of interoperability in connected devices. As technology advances, we are seeing more wearables trend toward multifunctionality, not just in what applications they connect to, but in what data they provide. Many connected blood pressure devices currently on the market already include monitoring of other cardiac data, such as heart rate, ECG, blood oxygen level, and calories burned.
Companies looking to enter the market can continue to build on this trend by including sensors and functionality to collect data on stress levels, sleep patterns, body mass index, blood glucose levels, medication adherence, and more. In addition to building multifunctionality into the wearable itself, developers need to prioritize interoperability with other sensing devices when building their software and connected applications.
Challenges and Considerations
As an emerging market, there are many opportunities for innovative MedTech companies to create connected devices for hypertension monitoring and management. But with these opportunities also comes many challenges that need to be overcome and considerations that require attention.
As with connected devices used to treat and monitor other chronic conditions, developing blood pressure monitoring wearables requires special attention to data security and privacy. Companies must implement appropriate encryption, secure data storage, and comply with data protection regulations to safeguard user information. Wearable devices meant to treat, diagnose, or monitor medical conditions are subject to regulatory compliance and must meet applicable requirements beyond data safety. In order to meet many of these regulations, manufacturers must prove the accuracy and reliability of the data produced.
On the user end, companies face many challenges in producing a device that will be accepted and utilized by the target market. Not only must the device appeal to the intended users, but companies must design user-friendly interfaces, include clear instructions, and provide adequate support to enhance user experience while encouraging compliance with recommended measurement protocols.
Finding Success in the Hypertension Monitoring and Treatment Market
Advancing the use of wearable blood pressure measuring devices to monitor hypertension has the potential to significantly reduce the number of deaths associated with this disease. Having access to the frequent measurements and real-world data produced by these types of devices could change how hypertension is treated and greatly improve outcomes for millions of people.
With so much potential, it’s not surprising that this market holds huge opportunities for MedTech companies that can utilize advancing technologies to create more accurate, more user-friendly, multifunctional devices with advanced sensors. But even with so much potential, there are notable challenges and considerations that come with creating SaMD and wearable devices for this niche.
Having a partner like Sequenex, a company that has decades of experience developing software for the connected device market and working to meet regulatory requirements, is one way to ensure these challenges do not stand in the way. With our expertise in developing innovative wearable sensors, data analytics, and predictive algorithms, we offer comprehensive solutions for medical technology and software companies hoping to break into growing markets just like this one. Connect with us today to find out how we can help you plan, develop, and launch your hypertension-monitoring wearable device.