Every reporter: Yue Qi Every internship reporter: Lin Zichen Ke Yang
Ya Health is now common in workplace and shopping malls, and news that young and young employees have died suddenly. In the fast -paced modern life, people’s health needs effectively monitoring and early warning, and smart watches may be the most convenient carrying tools at present.
On December 23, Huawei launched a smart watch Watch D to support blood pressure measurement and ECG collection. At present, it has been registered through the second category of medical device through the State Drug Administration. Also in December, the National Bank Apple Watch finally supported ECG detection function. Prior to this, there was also news about the National Bank Apple Watch online ECG function.
In the smart watch market with a market size of 20 billion US dollars, the steps of technology giants have just entered the field of electrocardiogram. Other smart watches on the market have already started business for severe diseases such as myocardial infarction.
Recently, the patent dispute between Xueyang Technology and Fosun entered the file and pushed two myocardial infarction warning watches to the front. On the e -commerce platform, more smart watches selling for more than 1,000 yuan for small and medium -sized brands are also claimed to achieve myocardial infarction warning through AI.
How much is the accuracy rate of early warning? How to establish a data model? Is it medical basis? Why don’t Apple and Huawei do this business? The chaotic health warning watch market leaves too many problems. After interviewing professional doctors and employees, “Daily Economic News” reporters learned that compared with clinical medical equipment and regular medical examinations, the information given by the early warning watch is for reference only, and the credibility needs to be a question mark.
Behind patent dispute:
There are demands and blue oceans, no giants end
The war of smart watches in the field of health is becoming more and more intense.
On November 12, Xueyang Technology’s official WeChat public account “Anton Early Warning Center” issued an announcement of rights protection, saying that Fosun’s “Star Guard” was suspected of plagiarizing Xueyang Technology’s core product “settled”. “Annon” and “Star Guard” are smart watches with health early warning functions launched by two companies. From the perspective of advertising words, the two watches are collectively collecting user heart rate, blood pressure, blood oxygen, etc., through “big data analysis”, combined with “artificial intelligence modeling” to perform cardiovascular, hypertension, myocardial infarction risk and other diseases Early warning services.
The patent dispute between the Anton and the Star Guard has no results, but the fierce war of health warning watches was pushed to the front.
At the same time as the longevity era is approaching, the scale of sub -health and chronic diseases has continued to expand. Health management has become a key battlefield for smart watches/bracelets. The characteristics of the 24 -hour personal monitoring data are considered to be the most suitable for the science and technology giant to enter the medical field. one. Smart watch giants such as Apple, Huawei, and Samsung have already promoted the layout of the health medical market early.
“If you review the past and look at the future, you may ask a question, that is,” What is Apple’s biggest contribution to human beings? ‘The answer to this question is medical health. “In 2019, Apple CEO Cook Once saying that.
Before Apple Watch was released, Apple co -founder Jobs was still fighting with cancer. Under his authorization, Apple established a biomedical engineering team of about 30 people to develop blood sugar monitoring functions. Exploration in the medical field.
Image source: Daily Economic News (Data Map)
In addition to their own medical teams, cooperation with hospitals is also a path. Huawei and 301 Hospital, Huamei Technology and Peking University First Hospital, OPPO and Huazhong University of Science and Technology-Tongji Hospital are jointly explored the application of smart watches in disease management.
After the health data monitoring function is continuously improved, the next stage must be a disease warning. This is an area with huge clinical needs and market demand. According to the People’s Daily Online, about 80%of white -collar workers in my country are in a state of excessive fatigue. Among the people who died early in the age of 30 to 50, 96%died of fatal diseases caused by excessive fatigue, of which 80%were sudden cardiac death.
It takes a few thousand yuan to get a disease warning a few hours or longer. From the perspective of demand, this is bound to be a huge market. However, at present, the layout of mainstream manufacturers on the health field is still staying in record data and identifying physical conditions. The use of data to establish models and early warning is delayed. The biggest obstacle is that the accuracy of equipment early warning cannot be guaranteed. Early warning products can basically not achieve 100%warning, and products endorsement by technology giant brands, if the early warning rate does not reach 100%, there will be missed reports on a certain user. It is self -evident that this is also an important reason why few giants are willing to get involved.
An executive of a medical device listed company also said that accuracy is the main reason why many large companies are unwilling to get involved in the early warning business. “Mainly there are risks. If people have problems, the product does not have warning. This is a medical accident. (It is necessary) to compensate a lot. So the key is that the warning is not allowed.” Or based on the consideration of brand risks, the technology giants are also both in consideration of brand risks. Health early warning products are not launched, and some small and medium -sized brands are still in the battlefield in this battlefield.
In the name of protecting life:
There is AI, there is a Chinese medicine, and the accuracy has no clinical trial data
At present, the market that can be found in the market is mainly based on early warning myocardial infarction and stroke.
This is indeed based on scientific theory. According to the Cardiovascular Cardians of the Central South Hospital of Wuhan University, myocardial infarction (myocardial infarction) and cerebral infarction (ischemic stroke) are due to the rupture of atheroscopy and activating the coagulation mechanism, which leads to the formation of fatal thrombosis, blocking blood vessels caused. Then, by detecting the biomarkers that caused the rupture of the plaque, you can warn the risk of myocardial infarction and cerebral infarction. Blocks increase the possibility of ulceration.
Earlier, Xueyang Science and Technology executives introduced in an interview with the media that their R & D team analyzed the rules of 10 major categories of heart rate diseases and 14 major types of blood pressure diseases through analysis of heart rate, blood pressure, and blood oxygen curve. Examination of threatened pathological model.
Picture source: Photo Network 400073771
According to reporters, watches that claim to be able to conduct disease warnings on the market are relatively similar, that is, by analyzing the rules of various indicators before the disease, establish a pathological model in the cloud, and then detect physical data related data to establish personal data to establish individuals. Exclusive models, abnormal body indicators are the basis for its early warning.
Search on a “myocardial infarction warning” and “watch” keywords on an e -commerce platform, and can search for more various watch products. Most of them have not mentioned the brand name in the homepage of the product, and the price is above 1,000 yuan.
A shop named “Gainens Flagship Store”, which is sold in the store mainly three watches called “Gainens”. A smart watch priced at 2998 yuan claims to be able to monitor blood sugar, blood pressure, blood oxygen, electrocardiogram, and body temperature in real time. At the same time, it can achieve severe diseases such as myocardial infarction and coronary heart disease. The customer service claims that the watch is based on traditional Chinese medicine, blood imaging, blood flow change and biomechanics as the theoretical basis. However, the customer service is vague about the data indicators of the reporter in questioning the early warning.
At present, watches that claim to have disease early warning functions on the market roughly include the “settled” smart watch developed by Xueyang Technology, the “ultra -micro” AI life warning watch released by the ultra -micro health, and the “Hundreds of Pretty” healthy warning released by the century -old health. Watches and “Star Guard” smart warning health watches released by Fosun. These products claim that the disease warning that can be achieved is basically concentrated in cardiovascular and cerebrovascular diseases.
In the promotion information, most of these products indicate that they have filled the market gaps and achieved industry changes. For example, the “ultra -micro” AI life warning watch “heart rate, blood oxygen accuracy, and blood pressure accuracy rates are above 90%. According to the industry veteran, the technical breakthrough of ultra -micro -micro -AI life warning watch is also a major research and development result in the industry “; Wuhan Jiu Le said he was” the world’s first automatic, all -weather ultra -intelligent life warning system and health and sports management service platform. “
Aside from these dazzling publicity, the accuracy of early warning is the lifeblood of a early warning product. At present, it is difficult to verify the accuracy of disease warning. For this key issue, many brands may provide data that cannot be verified, or they can directly avoid it.
The customer service of the Flagship Store and the customer service of the Baiqiao flagship store stated that the accuracy of its own products is more than 99%, and “there is no missed report.” But this data is not from scientific rigorous clinical trials. Song Junliang, the product manager of Xueyang Technology, said that at present, the accuracy of the risk of early warning of the warning of the warning watch and the risk of stroke can reach 99%, and the accuracy of early warning tumor risk is more than 97%. These accuracy is based on consumer feedback data.
More brands choose the accuracy of the product’s early warning. Star guard’s customer service only stated on the issue of early warning accuracy that long -term wearing data will become more and more accurate, without further accurate data. The customer service of the Jiu Le technology corporate store also said that there is no statistics for the time being.
Some employees of the smart watch industry told the reporter of “Daily Economic News” that at present, health warnings should be analyzed whether they are healthy after wearing product collection data. The process of data collection actually depends on the accuracy of the data. At present, the industry still cannot reach accuracy that can accurately early warning. Earlier, the company launched its own intelligent security watch, the main function is to measure the heart rate and answer the phone.
Because accuracy is difficult to verify, these products are also blank in clinical trials. At present, many watches that claim to provide disease warning, none of the big tests that have undergone clinical trials. For example, Ma Jianfei, CEO of Xueyang Technology, told reporters that the company will also have medical device -level products in the future. The setting up warning watch is currently consumer electronics.
However, in the e -commerce publicity information, the reporter did not find a reminding “non -medical device -level product” reminder. The company only mentioned in the APP’s personal information protection guidance. ” Clinical judgment on behalf of medical professionals “.
The effect that cannot be verified:
How far is smart watch from medical treatment?
Among the many functions covered by wearable devices, health management may be the most demand and the most revolutionary function.
However, it is difficult to conduct clinical trials such as early warning watches, which has also caused a wearable health warning product that truly meets medical -grade requirements in the industry.
In July 2020, Professor Xu Yawei, the Cardiac Center of the Tenth People’s Hospital Affiliated to Tongji University, developed the world’s first “acute myocardial infarction warning system based on wearable 12 -lead ECG equipment and artificial intelligence early warning software”. This early warning The algorithm already has the verification of international authoritative journal papers. It mainly cooperates with technology companies to use clinical ECG to build STEMI (acute myocardial infarction) artificial intelligence reading algorithms. The artificial intelligence algorithm is more advantageous than doctors.
Photo source: Photo Network 401120602
However, this internationally recognized breakthrough also proves the feasibility of artificial intelligence technology in the early warning of critical illness, but the current related technologies still stay in the clinical research stage.
Why is the clinical verification of wearable early warning watches so difficult?
The possible reason is that the first is that medical products must bear legal responsibility. At present, all wearable health warning equipment, whether the accuracy of its own accuracy meets the medical grade and has doubts, the technology company dare not test the water easily; It is clear that it also brings difficulties to the registration approval of the product.
The most intuitive reality is that there is no precedent for disease early warning products in the type of medical device registration approval. Similar to this, the domestic first certificate of cancer early screening products lasted for 7 years. At present, there are only two approved products in the world. The first certificate of this cancer early screening was approved by hundreds of millions of dollars in clinical trials, with thousands of samples.
The country is already actively promoted for the registration application of artificial intelligence medical devices. In 2018, the General Office of the State Council issued opinions on promoting the development of “Internet+medical and health”, which clearly states that “mobile medical demonstrations based on artificial intelligence technology, medical and healthy equipment Screening and active intervention.
The design of clinical trial solutions for myocardial infarction and stroke warning is also a big problem. Among them, it is not difficult to understand. A doctor who has studied the field explained that even if the test can spend money to find 1,000 people to regulate the early warning watch and track the effect of the early warning, but the result of the long -term tracking of these 1,000 people is likely to be the result is likely that it is likely to be the result of the results of these 1,000 people. It is difficult to find a patient with myocardial infarction and strokes in 5 years, which cannot achieve the effect of scientific verification.
Ma Jianfei said that medical device -level products need to go through the clinical trial period and are a market under different use scenarios.
Another smartwatch industry practitioner told reporters that he agreed that the overall wearable product early warning industry is a good direction, and his company also has the willingness to layout, but at present, there is no action because the amount of data cannot be established accurately. Early warning model.
The reporter noticed that most of the currently layout and attempts of smartwatch early warning functions are technology companies, not medical companies. In the future, who can be the first to make wearable health warning equipment? Lu Zhibing believes that large technology companies have advantages in the field of wearable medical equipment. In addition to the technical level, the current awareness rate of technology companies in social groups is significantly higher than that of medical companies, and it is also easier to promote in the market.
However, Lu Zhibing said that domestic wearable equipment is in a rapid growth period, with a large number of products, but the homogeneity is more serious and the function is relatively single. If you want to become a real medical -grade wearable equipment, you need There are new highlights. In addition, most of the accuracy and professionalism of wearable medical equipment products are still lacking, and some difficulties need to be overcome. For example, improve the accuracy of data collection and improve the feedback mechanism; strengthen security management to avoid leakage of personal information.
“Strengthening innovation awareness and reducing homogeneous products. At present, the commonality of domestic wearable monitoring equipment is still a lack of products with breakthrough innovation.” Lu Zhibing said. Ma Jianfei also believes that the birth of a mature wearable medical equipment requires many conditions and capabilities, such as a strong artificial intelligence algorithm team, profound medical clinical knowledge, and many years of experience in wearable equipment manufacturing.
(Intern Gao Miaosen also contributed to this article)
Reporter’s notes ｜ Early warning life is dangerous, not to be verified afterwards
With the normalization of the new crown epidemic, personal health management has received unprecedented attention, and the diagnosis and treatment of the disease has continued to move forward, and consumer medical products represented by health warning watches ushered in unprecedented business opportunities.
However, the combination of consumption and medical care has brought many problems, and excessive publicity is the most intuitive one. On the e -commerce platform, there are many watches that claim to be able to early warning, but when they talk about the accuracy of early warning, the customer service may be silent, or directly say “you know it if you buy it.” Some companies also directly stated that the accuracy of the early warning of the product was based on consumer feedback data.
Born in the name of protecting life, the early warning rate is required to verify after the incident? This is very contradictory. It is explained that the target customers of health warning watches are healthy people, and there is no need to obtain registered medical device documents outside the hospital. However, there are also people in the industry that the process of data collection cannot reach the accuracy of early warning diseases.
This is the fact that the true and false health warning watch markets are difficult to distinguish. The large factory has just begun to increase the medical attributes, but the small factory claims that it has “filled the market gaps and realized industry change.” The clinical verification of the early warning watch is long, but in the face of consumers, various manufacturers should maintain basic honesty.
Intern reporter: Lin Zichen Ke Yang Reporter: Yue Qi
Edit: Liang Yan
Vision: Chen Guanyu
Capture: Liang Yan Ma Yuan
Daily Economic News