Spotlight On: Beyond IVDs and ventilators - medtech’s multifront battle against COVID-19

The role which medical devices are playing in the COVID-19 pandemic go beyond diagnostic tests and ventilators. From remote monitoring wearables to fluid management and blood purification systems, there are numerous opportunities for medical devices to be incorporated in COVID-19 management strategies. This article focuses on wearables and looks at examples of these devices used for managing both COVID-19-infected and non-infected populations. 

 

The highly contagious nature of COVID-19 could not present a better use case for digital technologies that enable health care to be delivered without contact, from a safe distance and not unduly overburden already-stretched health systems. Telehealth companies with services that allow physicians to conduct virtual consultations with their patients have experienced a surge in demand. For example, one of the biggest providers of such services in the US, Teladoc Health, reported on April 14 that it is now routinely providing in excess of 20,000 virtual medical visits per day in the US, representing a more than two-fold increase from just a month ago. 

Wearables help to take virtual health care one step further, using sensors to allow real-time and continuous monitoring of individuals’ health status in any settings and outside of (virtual or physical) face-time with physicians.  

Continuous temperature monitors (CTMs) that could track fevers caused by viral infections are being used both in hospitals, on COVID-19 patients, and outside the clinical setting to monitor high-risk, vulnerable groups. Companies like Blue Spark Technologies and LifeSignals are offering these CTMs as single-use disposable patches worn by patients while real-time data captured by the sensors in the patches would be transmitted to a cloud and the information accessed online by physicians. Blue Spark’s TempTraq system, which is currently being used and implemented in hospitals across the US, Europe and Australia, transmits the data to both patient- and physician-facing mobile apps as well as to hospital IT systems. 

LifeSignals’ BioSensor Patch 1AX is designed to not only record temperature but also respiration rate, ECG trace, heart rate and movement in real-time and the data are transmitted to the user’s phone. The 1AX, which is based on LifeSignals’ FDA-cleared cardiovascular monitorin g platform, is expected to be introduced to the market in the next few weeks and is intended for use for general population screening in home-settings, including those in quarantine and the elderly in care home facilities and other high-risk groups living on their own.

LifeSignals is also developing a second monitoring patch targeted for in-patient use and plans to launch this in June. The Biosensor Patch 2A captures, stores and streams clinical-grade vital signs data, including blood oxygen levels. The patch can be worn for up to five days. 

Other companies on track to bring out similar CTM patches to help fight COVID-19 include, among others, Alphabet’s Verily and Nemaura Medical, which has repurposed its continuous glucose monitoring (CGM) technology, sugarBEAT, for temperature tracking. The latter said its existing CE-marked CGM patch designed to measure blood glucose levels at five-minute intervals also contains a thermistor which measures skin temperature as an integral part of the device and plans to adapt the patch to just have the temperature-measuring function. 

Current leaders in the wearable continuous glucose monitor market, Abbott and Dexcom, have been deployed to fight COVID-19 too, but their products will not be repurposed. Instead, Abbott’s 14-day Freestyle Libre CGM Dexcom’s G6 10-day sensor are still being used to monitor glucose levels but have been authorised by the FDA for use on diabetic patients who are hospitalised because of COVID-19. Both the company’s sensors are worn on the back of the patient’s arm and it helps hospital staff quickly and safely with little or no contact. Patient’s glucose readings are taken from Freestyle Libre by taking a one-second scan of the sensor using a reader or a smartphone, while the G6 sensor wirelessly sends real-time blood sugar levels to either a Dexcom reading device or smartphone within a 20-foot range. 

Spry Health is looking to deploy its Loop system to monitor patients at home who are confirmed, suspected or at risk of COVID-19, as well as relieve healthcare resources by helping to triage potential cases and cut out on unnecessary trips to the hospital. 

Loop is a wrist-worn device that tracks heart rate, pulse-oximetry and respiratory rate, and it was FDA-cleared in April last year for physicians to remotely monitor patients with chronic diseases, namely serious respiratory conditions like chronic obstructive pulmonary disorder. 

These patients with underlying respiratory conditions are also at higher risk of becoming critically ill if they acquire the COVID-19 infection. “When we saw this health crisis coming and realised how much the health system overall was going to be overrun, we thought this is really where remote monitoring has a huge role to play by helping people stay at home as long as needed," said Spry’s CEO Pierre-Jean Cobut. 

What differentiates Loop from many other wearable-based remote monitoring systems is that it does not require the user to input any data into an app or to interact with a smartphone. It does not even require WiFi for transmission of data from the sensors in the wearable device. 

"People with COPD tend to be older; the vast majority of them are in their late 60s, 70s, or 80s and the tech savviness isn't necessarily there. Also in the US, they're typically going to be in rural areas so we made the choice to create a system that could be deployed very easily without having to rely on a smartphone, without having to rely on Wi-Fi...It is very, very simple from the patient side - if you know how to wear a watch, you know how to use Loop," Cobut told FirstWord MedTech. 

In addition to the wearable device, the system includes a docking station that serves as a charger for the wearable and also uploads all the physiological data captured by the wearable. The docking station has a 4G LTE chip which communicates the data to a cloud-based server and proprietary machine-learning algorithms then process the data and analyse it for early signs of deterioration. The insights that are delivered to the physician or patient’s care team are also designed to be clear and actionable, explained Cobut: "The physician or clinician nurse who is looking at the information will see their list of patients colour-coded red, yellow or green, so they can see on any given day who seems to be a risk and why."

The Loop Signal service that Spry launched last month in response to the COVID-19 crisis includes a nursing component to its management solution. "We realise that especially at a time like this, health systems don't have the bandwidth to properly monitor people at a distance, and so what we are proposing with Loop Signal is to implement an intervention protocol [agreed by and developed together with the healthcare system] into the programme. That way, the programme can help with the remote monitoring and triaging based on what intervention protocols suggest." Patients with signs of deterioration can then be contacted by telephone or treated remotely when possible. 

"That's really where a company like ours can have the most impact. You want to keep these vulnerable individuals isolated and not make unnecessary trips to the ER because any time they make a trip to the hospital, they could come in contact with somebody else who is actually sick.  So there's all kinds of reasons why you want to be able to promote this type of remote surveillance, and make sure that you're only getting them the care that they need - not more and not less."

Consumer fitness and health trackers are also engaged in the battle against COVID-19. Oura Health's smart ring is a relative newcomer to the consumer health wearables market, having been launched in 2018. The Oura ring is designed to monitor sleep and fitness activity and it is embedded with sensors that track body temperature among other vital signs. Last month, the University of California San Francisco initiated a study to try to identify the early onset of COVID-19 by using data captured by Oura rings that will be worn by over 2,000 San Francisco emergency medical workers. 

In addition to this study, UCSF is campaigning for all users of the Oura ring (Oura said in March that it has sold over 150,000 of the devices to date) to share their medical data and contribute to the university's efforts to develop a COVID-19 detecting algorithm. 

Similarly, Fitbit, one of the leading health tracker companies in the world, is collaborating with The Scripps Research Institute and Stanford Medicine to conduct research on how Fitbit data could help detect, track and contain COVID-19, as well as other infectious diseases. 

This new consortium - which is open to other institutions joining in - builds on research already underway by both Scripps and Stanford. Scripps' DETECT app-based research programme and Stanford’s COVID-19 Wearables Study aim to establish the validity of data - heart rate, temperature, sleep activity and other vital signals - collected from wearables in determining early onset of infectious diseases.

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