Medical wearables are making a significant difference in patient care, enabling continuous remote monitoring in the home. Over the past several years, consumer wearables for health and fitness monitoring like Apple Watch and Fitbit have changed the way people monitor their health, from tracking how many steps they walk daily to heart rate monitoring and, more recently, atrial-fibrillation detection. There have also been advances in sports wearables that help athletes improve their performance and monitor for injuries, all done by collecting and analyzing data from the sensors.
The next level of transformation in healthcare is medical wearables that enable the remote patient monitoring (RPM) of acute and chronic diseases. Since the Covid-19 pandemic, medical wearables have experienced wider adoption, providing healthcare professionals with a new way to monitor patients outside of the hospital environment.
The world of healthcare wearables was popularized by the consumer movement and
has since progressed to more serious uses of medical wearables, said Sam Liu, vice president of marketing at Vivalink, a digital healthcare solution provider. “During the pandemic, a lot of uses had to do with telehealth or remote patient monitoring, and that was largely using telemetry or video conferencing combined with certain types of medical wearables to start collecting data about the patient.”
But those types of monitoring conditions were still about maintaining health and chronic condition monitoring, and now it has moved into more serious acute monitoring, such as following a heart attack, where a patient needs to be monitored almost at a hospital-grade level, he added. “That requires a different approach to technology and uses of technologies.”
Hospital-grade wearables also require some kind of regulatory control like the FDA, and the devices themselves have to be very optimized to a patient’s physiology, Liu said. “For example, if you have a wristwatch that can track your activity and take a temperature reading, it is not going to be hospital-grade because of location and exposure to ambient temperatures. Hospital-grade temperature monitoring will have to be worn in a position on the body, such as under the armpit, where you can get an accurate measurement.”
Vivalink recently conducted a survey of healthcare providers and found that 93% of respondents are using RPM technologies across all cardiac rehab. The company offers medical-grade connected wearable technologies for RPM and continuous in-patient vital signs monitoring.
The survey also revealed that 68% of clinicians have conducted some level of home-based cardiac rehab, with 29% conducting more or the same amount of home-based versus clinic-based. The biggest driver behind the trend is post-myocardial infarction, otherwise known as a heart attack, indicating the importance of remote care in critical cardiac condition monitoring, according to the company.
Another recent Vivalink study showed a rapid increase in acute RPM and hospital-at-home programs. Eighty-one percent of clinicians surveyed said that they are currently using RPM for patients, compared with 20% in the 2021 survey. In addition, 84% said they plan to increase their usage in 2024 and 77% expect RPM-based care will outpace traditional in-patient hospital care within the next five years.
Liu said hospital-at-home is an emerging RPM segment in which hospital providers are treating the home environment as an extension of the hospital.
Cardiac is one of the top applications driving it, but it can be for any kind of serious or acute condition that requires the clinicians to still monitor the patients very carefully after being treated at the hospital for an acute condition, he said.
Continuous monitoring and RPM
One of the biggest benefits that medical wearables provide is the capability of continuously monitoring a patient’s vital signs, which were previously available only in hospital and clinic environments. The big trend now is hospital-at-home applications, in which patients are monitored remotely, in addition to chronic disease management, particularly for diabetes and cardiovascular diseases, enabling early detection and treatment.
Medical wearables are also getting more accurate and can be worn without a charge for a longer length of time. One example is Vivalink’s multi-parameter wearable electrocardiogram (ECG) patch with continuous 14-day live-stream capabilities. The ECG patch extends the duration for remote ECG monitoring with a single application of the patch, and the real-time streaming capabilities let clinicians remotely view a patient’s live ECG anywhere and anytime, the company said.
Continuous ECG monitoring may be needed after surgery and enables the healthcare provider to monitor a patient as if they were in the hospital or clinic to quickly develop a treatment plan for any abnormalities, such as arrhythmias.
Vivalink also offers a Biometrics Data Platform, which accelerates the implementation and time to market of RPM solutions. It offers a turnkey end-to-end solution comprised of a suite of wearable sensors, edge-to-cloud integration and advanced data management and analytics. The software platform is interoperable with mobile and web-enabled clinical applications, electronic health record systems and clinical trial management systems.
A hardware and software approach
Medical wearable platforms entail a range of technologies, including sensors, AI algorithms, networking communications, data processing and cloud services. They must also meet regulatory compliance, such as the FDA in the U.S. and the CE mark in Europe.
What are the biggest technology enablers? Liu said there is a lot happening in the areas of sensing and AI, and one reason there is a lot of focus on the sensor is that it is the data-collection point and it is also tangible, so it is easier to relate to. But it really should be about the data and what is being derived from the data, he said.
The data-acquisition supply chain starts with the sensors to data processing and then the diagnosis or the therapeutics coming out of that data analysis, he said. “It involves hardware, software, AI, the cloud and mobile technology—the entire spectrum of technologies to really make it happen.”
Vivalink’s platform includes proprietary medical-grade hardware and algorithms as well as networking technologies and cloud integration. Its software development kits are application-agnostic and allow customers to license algorithms for their specific applications.
The platform is comprised of medical-grade wearables and an edge gateway device, which can be a phone to collect the data that is then transmitted to the cloud, and software for data processing, Liu said. There is also the clinician portal or web portal, where a doctor or a nurse can track and monitor the patient remotely.
Vivalink’s differentiator is that its platform is uniquely designed for acute RPM, where acute conditions need to be continuously monitored for a specific duration, such as 24 hours or 14 days, with real-time monitoring.
For example, when a cardiac patient is discharged from the hospital, the clinician may want to monitor them for the next 14 days after their surgery, Liu said. In that timeframe, the clinician may get alerts that there is something going on and the doctor may want to see the patient’s ECG right now and live, he said.
Liu also noted that data processing happens at different levels. Because ECG signals are very sensitive to noise and movement, the processing starts with software to smooth out the noise from the ECG signals, so it transmits a cleaner signal. Once the clean ECG signals are transmitted to the cloud, they are analyzed for any kind of anomaly.
“Software is definitely playing an increasing role in healthcare and is used throughout the entire chain to make sure you have clean data,” Liu said. “All the knowledge for therapeutics and diagnosis comes from processing the data through software.”
AI takes it to the next level, enabling more information and analysis to be derived from the wearables.
In addition, the Vivalink platform allows any kind of digital healthcare company to quickly develop and deploy novel healthcare applications, typically software applications, but they do need to be able to integrate the hardware, the network and the cloud, Liu said. That is a lot of work to do themselves, so the development kit enables them to focus on their domain, whether it is cardiology, diabetes or oncology, without worrying about the intricacies of hardware, networking and the cloud, he added.
“If your company is trying to create a novel healthcare application for wearables, it is a challenge because you need to have software expertise, hardware expertise and networking expertise and the cloud, so there is a lot of expertise that you have to bring onto your team,” Liu said. “You can think of our software development kit or platform as the Amazon Web Services for RPM.”
Partnerships advance bio-signal monitoring
There is also a lot of collaboration in the industry among material, component and medical device manufacturers to advance the diagnostic capabilities and manufacturability of medical wearables for better patient outcomes.
DuPont recently announced a collaboration between DuPont Liveo Healthcare Solutions and STMicroelectronics (ST) to develop a new smart wearable device concept for remote bio-signal monitoring. The DuPont Liveo Smart Biosensing Patch prototype uses multifunctional microsensors and control electronics from ST embedded in a flexible patch design from DuPont.
The prototype leverages ST’s accelerometer, vertical analog front end, next-generation sensors with in-sensor AI, a microcontroller with Bluetooth module, ultra-low power management devices, firmware and algorithm support to create a board design that can analyze electrical and mechanical heart activity in full synchronization to extract multiple vital signs, ST said.
The partnership has yielded a broad range of medical patch technologies, including DuPont Liveo Soft Skin Conductive Tape 1-3150, a silicone-based thermoset adhesive for sensing and transferring electrical bio-signals, and Liveo Soft Skin Adhesives. It has also resulted in a smart biosensing patch technology toolbox for remote ECG and SCG monitoring.
The Liveo Soft Skin Conductive Tape technology can be used as a skin electrode for bio-signal–monitoring applications in single electrodes for short-term monitoring and medical wearable patches for long-term monitoring of seven or more days.
FLEXcon Global, a developer of adhesive coating and laminating, and Dawako Medtech, a medical device company, are collaborating on the development of new bio-imaging systems. The WBS Patch and WBS-US patch will be able to simultaneously acquire ultrasonic imaging and bio-signals.
The patches will leverage FLEXcon’s flexible adhesive, which will function as a disposable electrode array that can be used during musculoskeletal movement to provide information about the functionality, quality and quantity of the muscle. These measurements, together with PIIXMED, Dawako Medtech’s AI-powered platform, will help with the diagnosis of sarcopenia, clinical nutrition monitoring or physiological performance in sports medicine. They can also be used in oncology to help with the diagnosis of thyroid cancer.
Dawako Medtech said the patches provide real-time, non-invasive and continuous monitoring, which enhances diagnostic accuracy to improve patient outcomes.
The patches use different advanced flexible materials, including FLEXcon OMNI-WAVE and FLEXcon dermaFLEX, with different printing technologies to configure Dawako’s medical-grade adhesive patches in a simple and scalable way. The formal launch is expected in early 2024.
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