At present, medical-grade smart wearable devices are widely concerned, and a number of domestic startups have targeted the category of "smart blood pressure watches", and "Research and Intelligence" is also one of them. Accurately measuring blood pressure through airbag compression is not a problem for traditional mercury sphygmomanometers and upper-arm electronic sphygmomanometers; but shrinking the airbag to the size of the watch wristband and accurately transmitting pulse pressure has become the technical key to testing similar products.
"The double airbag patented smart blood pressure watch BP Doctor MED (medical grade) developed by R&D and development is currently in the stage of type inspection, and it is expected that next year's Q2 can get the NMPA medical device class II certificate; at the same time, CE filing and FDA certification are also being carried out simultaneously." Sheng Yibing, founder/CEO of the company, introduced to 36Kr. In 2019, R&D Intelligent began to develop smart blood pressure watches, using the "oscilloscopic method" as a technical path, that is, transmitting blood pressure fluctuations in arterial vessels through the air sacs, and calculating systolic and diastolic blood pressure.
There are 270 million people with high blood pressure in China, and Sheng Yibing and the team hope to make new products to help this population manage chronic diseases. In her view, wearable medical devices must have both medical-grade precision and thinness and appearance value, so that users are willing to wear them for a long time.
Therefore, while making the airbag narrow and light, ensuring the stability of the air pressure output has become one of the problems they have to solve. The deformation state of different materials will affect the signal transmission, and if the material cannot achieve linear deformation stably, it may cause distortion of the original signal, which in turn will affect the accuracy of the measurement results. In addition, smart blood pressure watches need to expand and contract many times in a long life cycle, and the durability requirements are also very high.
"In order to find the right material for this airbag, we found hundreds of suppliers and tried hundreds of materials. Finally, the engineer and the supplier worked together to make the process improvement, and the airbag was made, and the thickness was 3 mm. In terms of accuracy, the error interval for BP Doctor MED to measure blood pressure is plus or minus 5 mm Hg," Sheng Yibing said.
Enterprise image: BP Doctor MED disassembly diagram
In addition to airbags, many miniature components also require original design and customization. For example, the micro gas valve, the "gas valve" itself is a very mature component, but it needs to be made the size of a soybean, and has the properties of pressure resistance, high temperature resistance, and tens of thousands of functional life, and there is no ready-made product on the market. R&D visited a number of different types of production enterprises, looking for parts that meet the needs of solenoid coils, magnetic wafer silicone injection, gas valve cores and other parts to assemble and produce miniature air valves. "For example, silicone injection, the size accuracy of the injected silicone particles needs to be within 0.01 mm, and in research and development, this mold alone will be scrapped 2 sets."
After overcoming a number of technical difficulties, R&D currently has 8 invention patents, 9 utility model patents, 3 appearance patents and 1 PCT patent.
In terms of user interaction, R&D conducts interface and functional design for middle-aged and elderly groups. "For the elderly, a one-button blood pressure measurement mode is designed, and it is equipped with a large button to facilitate the operation of the elderly. In addition, no matter what state the watch is in, long press this button for 2 seconds, you will directly enter the blood pressure measurement mode. The technical person in charge of Research and Intelligence introduced that for middle-aged people, mainly considering that their work is busy or the original manometry equipment is too large to measure blood pressure in real time, and real-time blood pressure measurement and daily prompts are designed.
Crowdfunding in early 2020
According to Camel, head of the research and intelligent market, in early 2020, the company launched a crowdfunding campaign on the overseas crowdfunding website Indiegogo, and raised $580,000 with the BP Doctor Pro product. In June 2020, the products were released in the United States and other places. It can be seen through the query that there are still foreign users who use the website to feedback the experience and optimizable details of the product use process to yanhe intelligently.
In terms of production capacity, the first generation of blood pressure watch PRO has been fully mass-produced, and the medical-grade product MED is in small batch trial production, and it is expected to achieve mass production next year. In October this year, the BP Doctor Pro of the kenwa blood pressure watch has begun to be sold in China, priced at 1998 yuan / piece, and promoted through the combination of online e-commerce and offline experience stores. In addition to the direct stores of Tmall and JD.com, the distribution agency model is the mainstay. In addition, Camel said that it will try to carry out more content marketing to convey the value of wearable smart blood pressure meters through the valuable health science of users.
The company provided the picture that BP Doctor MED is applying for a class II medical device certificate
At present, R&D intelligence has completed the Pre-A round of financing, and it is expected to launch a new round of financing in the first half of next year. According to the "China Hypertension Prevention and Treatment Guidelines 2018", the awareness rate, treatment rate and control rate of hypertension in China are 51.5%, 46.1% and 16.9% respectively, and there is still a lot of room for improvement in the process and effect of chronic disease management.
Recently, Huawei has launched the first "wrist ECG blood pressure recorder" WATCH D, and the product has obtained a class II medical device certificate. Through this wearable device, people with hypertension can measure and record blood pressure at any time; continuous blood pressure data of patients will also provide doctors with better clinical reference to assist in the treatment and control of hypertension.