A week later, Lu Tingfeng was discharged from the hospital.
As soon as he arrived at the company, he held a brief weekly meeting, then took his laptop and went straight to the president's office.
This week, although he was lying on the hospital bed to rest, his mind was not idle. He was as inspired as a diabetic incontinent. He came up with many good ideas while trying them out. As soon as he came back, he would show off his skills and realize them one by one.
Wei Kang was deeply pleased to see him bouncing around and looking like a good man again: "It's good that you're fine. You should learn a lesson in the future and don't make yourself so tired. By the way, I just want to tell you something." "
Lu Tingfeng immediately sat upright and listened attentively: "Mr. Wei, please speak."
Wei Kang mused: "Now the hardware is almost complete, and the subsequent software adaptation is also constantly improving. Next, we need to go to the Food and Drug Administration to apply for registration of medical devices. We must hurry up on this matter."
There was hesitation on Lu Tingfeng's face, and he hesitated to speak: "Mr. Wei, we have discussed it internally and are a little unsure whether to register the whole device or just the software."
"Based on the actual situation of approved wearable medical device applications, most smart wearable products are applied for the device as a whole, and only a few are applied for independent software."
"But if we apply as a whole device, it will be very troublesome to cooperate with manufacturers in the future, because every time they launch a product, they need to obtain medical device registration."
"You must know that the production and sales threshold of medical devices are relatively high. Manufacturers must have relevant production licenses, and product listings also need to undergo strict approval. After listing, they must also perform adverse event monitoring responsibilities."
"For consumer electronics manufacturers, this is equivalent to adding a lot of trouble, because smart wearable products that are not medical devices do not require any marketing approval."
"Similarly, medical devices cannot be advertised casually. All publicity must be reviewed before being released, and the requirements are very strict. After smart wearable products that are not medical devices are put on the market, they face much simpler regulatory requirements. Sales channels and advertising There are very few restrictions.”
"In this way, if it is a manufacturer with average strength, it may not be too enthusiastic, and the product cycle will be very long. It is estimated that the market will need to be developed for a period of time. Only when the potential of a big hit can be seen, manufacturers will continue to follow up."
Wei Kang thought for a while and then said: "This concern is very reasonable, so let's apply for the Longtu APP independent software. This should meet the registration requirements for medical devices."
"The intended use of registered wearable medical devices currently on the market is mainly to collect and record monitoring data, but most of them cannot achieve automatic analysis or diagnosis functions."
"Our products not only collect data with higher accuracy, but more importantly, they can analyze and diagnose the data. This is our biggest selling point."
"Our hardware can only collect data, but not for medical purposes. Longtu APP is just the opposite. In this way, it can circumvent hardware supervision, and manufacturers will not have such concerns and can launch it freely. Any smart wearable product.”
"Only after installing the Longtu APP can you have medical functions and provide consumers with detailed monitoring data and diagnostic results. In this way, the hardware collects data, the software analyzes the data, the software and hardware are decoupled, and the flexible use is beneficial to us. , manufacturers, and consumers, it is more beneficial to each other.”
Lu Tingfeng suddenly realized: "It's high, it's really high, President Wei is wise. In this way, we can treat it as an amateur consumer electronics product, but it can provide professional-level medical and health services, which is simply a dimensionality reduction blow."
He said proudly: "If my friends have any objections, I can tell them the cruel truth. It's not that we are too strong, but that they are too weak. This is what consumer electronics products should do."
Whether smart wearable products are medical devices depends on whether the intended use of the product has medical purposes.
Therefore, companies have the freedom to choose product positioning, and smart wearable products can appear in the consumer market through different marketing channels.
In addition, the domestic definition of medical devices includes independent software, that is, software (APP) that runs on smart wearable products for medical purposes, and can also be registered separately as medical devices.
In summary, smart wearable products can be applied for as a whole as a device or the software contained therein, to achieve the goal of obtaining medical device registration.
So Wei Kang's idea is totally fine. It solves the trouble of registering electronic devices as medical devices. It lowers the difficulty and threshold of a professional-level function through software, making it a daily consumer-level function.
This is undoubtedly an industry revolution and a great progress in innovative technology.
Soon, the mobile version and smart wearable version of Longtu APP were officially ready, and as independent software, they applied to be registered as a second-level medical device with the Provincial Food and Drug Administration.
Medical devices are mainly divided into three categories: medical equipment, medical consumables, and household medical devices.
In China, it is divided into three categories for management according to the degree of risk.
Category 1 medical devices have the lowest risk and are generally auxiliary products, such as stethoscopes, surgical instruments, scrapers, tongue depressors, surgical gowns, gauze bandages, masks, etc.
Class II medical devices have medium risks and are generally in vitro products that require strict management, such as medical suture needles, non-absorbable sutures, blood pressure monitors, thermometers, electrocardiographs, microscopes, biochemical analyzers, hearing aids, condoms, etc.
The third category is high-risk devices, which generally have to enter the human body and are subject to particularly strict management, such as implantable pacemakers, intraocular lenses, hemodialysis devices, implant materials, cardiovascular stents, anesthesia machines, and dental implants. Insertion materials, absorbable sutures, syringes, etc.
Most of the medical devices on the market are Class I and II medical devices. Class III devices can basically only appear in hospitals and are operated by doctors, far away from ordinary people.
All work was progressed in an orderly manner under the leadership of Lu Tingfeng.
As employees of Sanqing received sports bracelets distributed by the company one after another, relevant posts on the intranet were flooding the screen every day, and discussions were heated.
"The bracelet saved my life. Today I was wearing the bracelet at work, and suddenly I received an alarm message. It turned out that the bracelet monitored my 24-hour electrocardiogram, found paroxysmal atrial fibrillation, and recommended that I seek medical treatment immediately."
"To be honest, I have always felt that I am in good health and have nothing wrong with me. If it were not our company's product, I would not have cared about it at all. But because of the lessons learned from my colleagues, I did not dare to be careless at all and went to the hospital for a checkup immediately. Suddenly, paroxysmal atrial fibrillation was diagnosed.”
"This was the first time I heard this term. I didn't feel anything at the time. But later I asked the doctor about it and learned about the dangers of this disease. I couldn't help but be shocked."
“During atrial fibrillation, due to the loss of the contraction function of the atrium, blood is prone to blockage in the atrium and form thrombus. If the thrombus breaks off, it will flow to all parts of the body with the blood, leading to cerebral embolism, stroke, hemiplegia, and limb arteries. Embolism may even require amputation in severe cases, which is really scary.”
"Paroxysmal atrial fibrillation cannot be detected during routine physical examination due to uncertainty, and long-term dynamic ECG monitoring is required. Fortunately, I wore the bracelet for several days, and its sensitivity is very high. Only with the function of 24-hour dynamic monitoring of the electrocardiogram can I detect my condition, otherwise once a blood clot forms, the consequences will be disastrous."
This is not the only case. There are hundreds of cases among the company's 20,000 to 30,000 people, either the employees themselves or their family members.
They all claimed that they received the alarm from their bracelets and did not ignore the distress signal sent by their bodies, so they treated them in advance and avoided aggravation of the condition.
Generally speaking, when any condition worsens, there is a process in which the body will send out some distress signals.
It is impossible to jump from 0 to 1 immediately without any accumulation process.
For example, before a heart problem occurs, palpitation, shortness of breath, paroxysmal pain in the chest, palpitations, and chest tightness are common symptoms, but they often disappear quickly. In fact, these are the body’s signals for help.
Many people either didn't notice or didn't take it seriously, and ignored this information, which led to the continuous accumulation of diseases, quantitative changes leading to qualitative changes, and finally the accumulation became difficult to recover, thus missing the best period for treating the disease.
As the saying goes, disease comes like a mountain, which means that when the disease accumulates to a certain extent, it suddenly breaks out with great force and worsens instantly.
If early warning can be issued and people pay attention to it, many tragedies can undoubtedly be avoided.
This is why prevention is better than cure.
The popularity of the bracelet within the company remained high, and soon someone posted screenshots of some posts online.
Because it was related to Sanqing's new product, it immediately aroused a great response and was widely spread by netizens.
In Langbo, Bihu and Toutiao have all become hot searches.
"Is it true or false? It sounds a bit too mysterious."
"The news leaked from Sanqing's internal forum. It should be true. And it seems that they distributed it to their employees. If it's not good, they probably won't use it on their own employees."
"Sanqing is going to enter the medical device market? But the first product is a smart bracelet, isn't it a bit... not professional enough?"
"Upstairs, let me tell you. Do you want to say that it's a bit low? Isn't smart bracelets something only produced by mobile phone manufacturers? Sanqing should make professional wearable ECG monitors. Right, right?"
"Actually, I have used a professional wearable dynamic ECG monitor. The market for this device is actually huge and it is more popular abroad. Domestically, the market is a mixed bag. Many products have been withdrawn from the market because they cannot meet the demand for medical data. Only Very few products have been clinically approved. I suggest patients in need to buy foreign brands to ensure quality."
"It's wrong of you to say that. Are you secretly insinuating that Sanqing's equipment is unprofessional? If I want to buy it, I have to support domestic products. When Sanqing's bracelets come out, I will go there immediately and buy one for my parents. .”
"Haha, there is a shepherd dog upstairs. I won't say more about who it is. Apart from anything else, Juwei now has a smart watch with a medical-level blood pressure detection function. It has passed clinical trials and obtained Class II certification. Medical device registration certificate. Now Sanqing has released an electrocardiogram detection bracelet. Aren’t these all domestic products? Do you have to lick foreign products?”
"Yes, foreign products are actually not that good. Do you think I want to promote domestic products? No, in fact, I want to say that in the field of smart wearables, all products are garbage, and none of them are useful."
“Let’s talk about the smart watch Fitbit Sense I have used. This one is very popular abroad. It focuses on health monitoring and provides various health monitoring functions such as stress management, heart health, arterial blood oxygen saturation, and skin temperature. It has a built-in electrodermal activity The sensor can intelligently determine whether you are sick or stressed by the detected health status. It also looks good, much like the iWatch made by fruit.
I bought this because I have health anxiety issues. Every time I feel heartburn or abnormal heartbeat, I go to see the EKG reading, which reassures me and makes me believe that I am healthy.
However, this damn Fitbit Sense's EKG is so inaccurate that if I move too much during the scan, or if my heart rate gets too high or too low, I can't get a reliable reading and tell me that I don't have a health problem.
I was having as many as 20 electrocardiograms every day, but I didn’t know it was inaccurate. The watch kept showing that I was normal, even though I was out of breath and my heartbeat was pounding. This had to make me suspicious of it. .
Damn, after a workout, I had severe chest pain and had to go to the hospital for a checkup. The results showed that I had ventricular tachycardia caused by arrhythmia. The doctor said that if I were late, I would probably die suddenly. When I came back that day, I smashed the old watch and threw it in the trash can.
So I say all this just to express my agreement with the person above. Indeed, the smart wearable devices here are all rubbish, and none of them can play a role. Now I am very doubtful whether this bracelet from Sanqing is also garbage? "
"I guarantee with my personality that this Sanqing bracelet is definitely not the glamorous bitch on the market, but a genuine professional device."
"Why do you say that upstairs? The Wolf Warrior filter is too big."
"Just because I am a user of this bracelet, and because of it I was diagnosed with myocardial infarction."
"Ah, boss, is there still a pendant on your leg? Can you lend it to me? A programmer in the company died suddenly last week. I'm really scared. Please save my life, boss!"
"This thing can only call the police and ask you to go to the hospital. If you feel uncomfortable, it is the same as going directly to the hospital for a check-up."
"Stop arguing, I just want to know, where can I buy it?"
"Just wait, medical devices won't be approved and put on the market in three to five years."
Netizens were so noisy that they were all a bit doubtful.
There are too many smart wearable watches on the market, and none of them can achieve true professional-level medical purposes. Most of them can only be icing on the cake, detecting some functions that are not painful or itchy, but are not very accurate.
If it really involves their own health, no one dares to count on these electronic toys.
As for professional-grade portable monitors, unless they are confirmed patients, no one is willing to stick several electrode pads on their chest 24 hours a day to prevent sudden death.
However, fans of Sanqing still have blind confidence in Sanqing. They feel that no matter how bad the products produced by Sanqing are, they will not be much worse. Even if they are not as good as professional equipment, there is still no problem in killing other products on the market.
They called Sanqing Group one after another and asked when they could buy this bracelet?
The enthusiasm of netizens was very touching, so Sanqing Group officially issued an announcement.
Announced the successful development of the portable monitor module and Longtu APP health monitoring function.
Instantly, it caused a shock throughout the entire network.
(End of chapter)
