This article is reprinted with permission fromChina News Weekly（ID: Chinanewsweekly）Author: Meng QianBlood oxygen meters are sold out.Many e-commerce platforms show that blood oxygen meters are “out of stock,” or require reservations for purchase, or customers must wait a long time for delivery after placing an order. Meanwhile, the prices of blood oxygen meters available on the market have skyrocketed, with reports of prices increasing from 88 yuan last year to 399 yuan this year, and some merchants even inflating the price of meters that originally cost a few dozen yuan to over a thousand yuan, attracting the attention of regulatory authorities.In this context, smartwatches and fitness bands with blood oxygen monitoring capabilities have gained significant attention, with sales on certain e-commerce platforms skyrocketing.Industry insiders point out that smartwatches and fitness bands have been equipped with basic monitoring functions such as pulse, heart rate, and blood pressure since their inception, and the introduction of blood oxygen monitoring indicates that many manufacturers are actively entering the medical technology field.However, almost all manufacturers emphasize that the aforementioned monitoring functions are only for “exercise monitoring and basic daily health checks, and do not meet medical standards.”
Unreasonable price increases for blood oxygen meters, smartwatches gain attentionUnder the pandemic, blood oxygen levels have become a “warning signal” for human health. The “Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Version 9)” indicates that a blood oxygen saturation level below 93% during rest is one of the indicators for determining severe COVID-19.Dr. Zhong Ming, Deputy Director of the Intensive Care Unit at Zhongshan Hospital affiliated with Fudan University, stated, “The first impact of respiratory diseases is on our blood oxygen levels. Normal blood oxygen saturation should be above 96% or 97%. If your blood oxygen saturation is below 95%, you need to be alert to the tendency for severe illness. Therefore, especially for high-risk groups, it is advisable to have a blood oxygen meter at home to monitor blood oxygen saturation at all times.”Recently, terms like “how terrifying is silent hypoxia” and “beware of silent hypoxia in the elderly” have frequently appeared on Weibo’s trending searches. In some hospitals, many severe patients have experienced severe hypoxia after contracting the coronavirus, with some elderly patients having blood oxygen saturation levels as low as 70%. However, these patients did not exhibit obvious symptoms such as difficulty breathing at the onset of their illness, a phenomenon known as “silent hypoxia.”Dr. Zhang Wenhong, Director of the Infectious Disease Department at Huashan Hospital affiliated with Fudan University, has publicly pointed out that to enhance the monitoring capabilities for the elderly at home, it is crucial to be aware of the “silent hypoxia” in older adults. He suggests that families with the means should purchase simple fingertip pulse oximeters or that community committees could distribute them to elderly individuals over 80 years old to monitor high-risk individuals for severe illness risk.Chen Qiulin, Deputy Director of the Health Industry Development Research Center of the Chinese Academy of Social Sciences, told China News Weekly that the public previously paid little attention to blood oxygen levels, but this pandemic has significantly increased awareness, leading to a rush to purchase blood oxygen meters.From ibuprofen to blood oxygen meters, the public has entered a buying frenzy, starting to invest in “medical devices.” According to publicly available data, on December 30, the CMS50D blood oxygen meter from Kangtai Medical sold 982,000 units on JD.com, ranking first in sales. Additionally, several other blood oxygen meters sold over 100,000 units. However, most of the top-selling blood oxygen meters are currently out of stock. Some merchants have raised the price of the Yuyue Medical blood oxygen meter, which previously sold for a few dozen yuan, to several hundred yuan, with some even priced at 1,380 yuan, raising suspicions of “price gouging,” prompting investigations by market supervision authorities.Consumers unable to purchase blood oxygen meters have begun to seek alternatives. Wearable devices such as smartwatches and fitness bands that support blood oxygen monitoring are also selling well. China News Weekly found that many smartwatches and fitness bands on major e-commerce platforms have shifted their selling points to blood oxygen monitoring features, resulting in a sharp increase in sales.According to data from Suning.com, in December 2022, sales of wristbands and smartwatches with blood oxygen meter functions increased by 330% compared to the previous year. OPPO has stated that under the current circumstances, the market performance of smart wearable devices is on the rise, with wristband products performing particularly well. Media reports indicate that analysts close to Huawei have noted that smartwatch sales have increased by over 100% in two weeks, with wristband products also experiencing growth.However, the reliability of blood oxygen monitoring results from smartwatches and fitness bands has become a focal point for the public.
Smartwatches cannot yet serve as medical diagnostic proof“I just ordered a fingertip blood oxygen meter a couple of days ago, and it will be shipped in five days, but the actual shipping time is uncertain,” said Cao Dong, who is facing a peak of COVID-19 infections in his city. He bought the blood oxygen meter mainly for his elderly grandmother. Cao Dong himself has been wearing an Apple Watch for a long time and regularly monitors health indicators.“In recent days, various panic over ‘white lung’ and COVID anxiety has prompted people to start monitoring related indicators,” Cao Dong said. For example, regarding blood oxygen values, based on past experiences, the Apple Watch and the health app on the iPhone can connect and automatically test multiple times throughout the day, “During instantaneous tests, the accuracy may not be guaranteed due to the wearing position, and sometimes it may show lower values, but because of the multiple tests, it will still show normal values.”In Cao Dong’s understanding, a healthy person should always show a normal value of 100; otherwise, it would not be recorded. Over the past two years, Cao Dong’s parents have also purchased Apple Watches and learned to use smartwatches to monitor health indicators, “I don’t check it too often, but I encourage my parents to pay more attention.” Currently, Cao Dong’s parents are recovering from an illness, having just recently reduced their fever. When asked if he worries about the accuracy of the monitoring values and the inability to assess the condition, Cao Dong mentioned that if pneumonia or other conditions arise, he would self-check based on symptoms, such as whether there is a persistent low fever.The popularity of blood oxygen monitoring features on smartwatches originated with the release of the Apple Watch Series 6 in September 2020. Apple’s public information indicates that users can “measure blood oxygen levels on demand directly from their wrist, providing insights into overall health status.” However, their official page also clearly states that the blood oxygen app is not intended for medical use and is not suitable for self-diagnosis; specific situations should be consulted with a doctor.Currently, mainstream smartwatches and fitness bands on the market generally support blood oxygen monitoring. OPPO has responded to China News Weekly, stating that the monitoring data and results from smartwatches are for reference only and are not intended for diagnostic or medical purposes, thus cannot replace medical device products. Most households cannot equip themselves with comprehensive medical monitoring instruments, so smartwatches serve as a supplementary means for users to understand their physical condition more conveniently.The statement that they “cannot serve as medical diagnostics” actually stems from the insufficient stability and accuracy of the monitoring. According to a foreign study, the average deviation of the Apple Watch Series 6 compared to medical-grade blood oxygen meters is about 1.2%; when blood oxygen levels are below 90%, the monitoring results deviate by less than 8% from medical-grade devices; for blood oxygen levels between 90% and 100%, the deviation is less than 6%.Zhang Bao, a partner at Rock Capital Medical Investment, told China News Weekly that professional blood oxygen meters use the transmission pulse oximetry method, with photodiodes and LEDs on opposite sides. The measurement calculates hemoglobin concentration and blood oxygen saturation based on the intensity of light transmitted through the tissue bed. They are generally clipped to the finger because the hemoglobin concentration in the finger is relatively high, while smartwatches use the reflective pulse oximetry method, with photodiodes and LEDs on the same side, collecting light reflected from different depths beneath the skin.He further pointed out that the blood oxygen monitoring results from smartwatches can only serve as a reference and do not reach medical-grade standards. Fundamentally, the monitoring from smartwatches is subject to many external interference factors. Unlike blood oxygen meters, which can tightly wrap the monitoring site, allowing all light to pass through the human finger effectively, the construction and wearing method of smartwatches create “gaps,” leading to significant interference with the light entering and reflecting back.Zheng Yi, President of the Shenzhen Smart Wearable Industry Association, told China News Weekly that fingertip blood oxygen meters use reflected light, and the monitoring position of the fingertip is relatively better than that of the wrist, resulting in higher monitoring accuracy. If the smartwatch (wrist) PPG (photoplethysmography) blood oxygen monitoring sensor is well-selected and the algorithm is well-developed, the monitoring of blood oxygen saturation can be relatively credible. He also stated that whether using fingertip or wrist blood oxygen monitoring, professional certification (such as medical device certification) should be required for reference, but whether there is hypoxia should also consider other symptoms.
Will consumer-grade products transition to professional medical-grade?In the past two years, influenced by the booming health market, the smartwatch market has shown a growth trend. According to iiMedia Consulting, the market size of smartwatches in China was 29.5 billion yuan in 2021, and it is expected to exceed 40 billion yuan by 2025. According to IDC’s “Quarterly Tracking Report on the Wearable Device Market in China, Q3 2022,” the shipment volume of smartwatches reached 10.8 million units in Q3 2022, a year-on-year increase of 1.8%, with adult smartwatches seeing a sales growth rate of 13.3%. The release of new smartwatches from brands like Huawei and Apple has significantly boosted the adult smartwatch market.“As the pandemic continues, people’s attention to health has become more acute,” said senior engineer Yuan Bo. Initially, the main application scenario for smartwatches was exercise, used to monitor sleep, heart rate, and other indicators. However, as consumer-grade products have proliferated, consumer acceptance of these products has increased, leading to issues of product homogeneity. At this point, “health” has become a differentiation factor.Manufacturers have begun to focus on obtaining professional medical device certifications, rapidly entering the medical health product and technology space. Since 2020, Apple has secured three FDA medical device certifications within three years, while Huawei and OPPO have also obtained multiple medical device certifications.“Our products have received Class II medical device certification from the Drug Supervision Bureau, which is not easy to obtain. It takes about two years, and the technology, from sensors to algorithms, must meet certain monitoring accuracy standards within allowable error ranges,” said Li Jiuchao, General Manager of Shenzhen Weiyi Technology Co., Ltd. He told China News Weekly that while there are many consumer-grade wearable products on the market, developing medical-grade products requires more technical research and development costs, product manufacturing costs, and the establishment of management systems and hardware facilities for medical device certification, along with ongoing operational costs, all of which require sustained financial investment. “However, the market return cycle for such products is long, and the return on investment is low, so only a few companies are willing to invest in applying for medical device certification.”Li Jiuchao’s company is currently focused on technology and product development, while value-added services (professional analysis, diagnosis, and intervention) are left to industry leaders. Currently, Apple, Huawei, Samsung, and even Google are building or acquiring related technologies to create digital health systems.Chen Qiulin pointed out that the advantage of products like smartwatches is that they can monitor human health indicators at any time, forming daily trend judgments that are of reference significance, but directly applying them to medical guidance is quite challenging. Future applications may be in health risk monitoring scenarios for home care, nursing homes, and care facilities, using warning functions to connect with family doctors, community doctors, and relevant medical institutions to effectively enhance the convenience of seeking medical care.He further noted that in the development of medical-grade products, wearable products face significant challenges, including insufficient integration with medical institutions, incomplete product access systems and regulatory frameworks, and a lack of a recognized payment model for commercialization, which currently mostly takes the form of bundled sales.(At the request of the interviewee, Cao Dong is a pseudonym)Reporter | Meng QianEditor | Hu YunOperational Editor | Wang Lin
