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A close-up look at Huawei’s first certified medical device

From lifestyle accessory to medical device

Huawei devices go from tracking fitness to monitoring patients’ vital signs

Making cell phones is one thing. Making smartphones and smart watches is another.

Medical devices? That’s a whole different business. But all three are part of a natural evolution for Huawei.

Huawei scaled the proverbial value chain, going from manufacturing low-cost cell phones for other brands to making some of the most sophisticated smartphones on the market.

Wearables inevitably followed. Today, the company’s wearables strategy is to help people live an active lifestyle through a combination of hardware, software and apps.

“For beginners, there’s the HUAWEI WATCH Fit or HUAWEI Band series, which have fitness tracking and personalized coaching modes,” said Rico Zhang, President of Smart Wearable and Health Product Line at Huawei Consumer Business Group.

“More advanced users can check out the HUAWEI WATCH GT Series, while advanced users or professional athletes can use specialized devices like the HUAWEI WATCH GT Runner series, which tells users the pace and distance run, and provides heart rate data, which it then uses to intelligently evaluate factors including running ability, training load, and recovery.”

Huawei wearable devices use TruSeen, the company’s proprietary health indicator monitoring technology. Seven years in the making, TruSeen, detects a wide range of physiological indicators, including heart rate, oxygen saturation, blood pressure, body temperature, and breathing rate. A newly upgraded algorithm quadruples the data processing capacity of the device, and improves the accuracy of its heart rate monitoring during a workout.

Huawei has always prioritized accuracy for its monitoring technologies. But when it decided to make the move from fitness tracker to medical device, the company had to meet new; and much higher; standards, for medical devices.

These standards vary by geographic region. For example, the Medical Device Regulation (MDR) governs the production and distribution of medical devices in Europe. It took effect in May 2021 and imposed much stricter requirements than the previous standard. For that reason, it has been hard, and sometimes impossible, for some manufacturers to get medical certification in Europe.       

Huawei’s first medical device

To ensure that Huawei’s new medical devices meet the highest quality   worldwide, the company has been working with partners to conduct “validation studies,” which establishing by that devices conform to user needs when used as intended. 

Although it had no previous experience with medical devices, has been able to reach its goal, even meeting the strict new standards that apply in Europe. In September 2022, the HUAWEI WATCH D was certified as meeting the MDR requirements by TÜV Rheinland, a German company that provides testing and certification for electrical and electronic products.  

“This was our first step towards making wearable medical devices and entering the healthcare market in Europe,” said Dr. Marcin Meyer, Head of mHealth R&D Huawei at the company’s research center in Grenoble, France. “The HUAWEI WATCH D is not only certified but has also been listed by the European Hypertension Organization STRIDE BP as a validated device for home blood-pressure monitoring.”

The results of the validation study of HUAWEI WATCH D were published in 2022. Professor Wang Jiguang, a professor at the school of medicine at Shanghai Jiaotong University, analyzed the data of 85 test subjects and proved that the device met all requirements.

Huawei is continuing its studies on Huawei Watch D in Europe, working with Professor George Stergiou, at the School of Medicine at the University of Athens in Greece. Currently, the HUAWEI WATCH D is certified for home blood pressure monitoring, but as a wearable device it has much bigger potential, which will be explored during the ongoing studies in Athens. 

The largest study done on a Huawei device was conducted in China and involved more than 3.2 million test subjects. The test, known as the Huawei Heart Study, looked at atrial fibrillation (AF), an irregular heartbeat that significantly increases the risk of stroke, heart failure, and other life-threatening complications.

The results of the study showed that the device facilitated screening for AF with greater than 92.8% confirmation of detected AF episodes, even for a low-risk general population. This was such a good result that the European Society of Cardiology 2020 guidelines for AF management use the Huawei Heart Study as a reference.

One might wonder whether monitoring by a smart wearable is necessary, given that AF patients can often feel their hearts beating irregularly. “We aim not only to detect AF, but also to predict it,” says Dr. Meyer. “Moreover, the patient doesn’t always feel the irregular heartbeats. And even if he does, it is hard to document a feeling with medical precision. With our dedicated App and the analytical capabilities of the cloud, you get quantitative data on the timing, length, and severity of the fibrillation. This allows remote monitoring of patients and reduces the overall cost of care by eliminating costly hospital stays.”

Partnering with medical researchers in Malaysia

Huawei smartwatches are also being validated for use as medical devices at the Universiti Malaya in Kuala Lumpur, Malaysia. Dr. Adina Abdullah, an Associate Professor in the university’s Department of Primary Care Medicine, is working with colleagues to supervise validation studies of the HUAWEI WATCH D in two main areas.

Blood pressure validation studies have been going on for the past two months or so. “We’re validating that the BP readings on the watch are the same as what you’d get in a doctor’s office,” says Dr. Adina who is a co-investigator for the project. “The university is always looking for partners, and initially, we worked mostly with companies that make medical devices. But in the last three to four years, we’ve started partnering with tech companies as well.” 

The second type of testing, which has not begun yet, will look at the possibility of using wearables to monitor the mood and stress level of healthcare workers, especially those who work with Covid patients. In this case, the watch gives the medical personnel early indicators that their stress levels are becoming dangerous levels of stress.

Huawei’s Watch D has function that lets wearers check their stress levels. “What we want to do is to ask, ‘How accurate are these measures?’” Dr. Adina says. “If the Huawei watch says my stress level is high, does that really mean I am stressed?” She and other researchers will create a protocol that checks the Watch D stress readings against those of a recognized tool, like the Short Form Health Survey 36 questionnaire (SF-36), which evaluates quality of life using eight dimensions, including emotional and mental health.

Professor Adina believes that, in the future, governments will need to make sure people have access to wearable technology. “It’s not acceptable that certain populations don’t get access to the Internet,” she said. Similarly, “It will not be acceptable to deny certain populations access to wearable technology, given the great benefits they would be missing out on.” 

She believes that “Wearables democratize the information – and the power – that doctors have. In past, the only way to know your blood pressure was to see a doctor. Now, you can take your blood pressure yourself. When we get patients in our clinic, and get them to start making choices about their health, they will be able to make informed decisions.”

She acknowledges that not everyone will find them beneficial or want to use them. But she believes wearables are here to stay. “I do believe in technology,” she says. “I don’t think it’s the Holy Grail, but it’s an amazing tool to have.”

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