I can extract side effects

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 went straight to the president's office with his laptop in his hands.

This week, although he was resting on the hospital bed, his mind was not idle, and his inspiration was like a diabetes insipidus. He came up with many good ideas while trying them out, and he would show his skills and realize them one by one when he came back.

Seeing him alive and kicking and looking like a good man, Wei Kang was also very relieved: "It's good that you are fine, you have to learn your lesson in the future, 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 pondered: "Now the hardware is almost done, and the follow-up software adaptation is also constantly improving. Next, we will go to the Food and Drug Administration to apply for registration of medical devices, and we must hurry up on this matter."

Lu Tingfeng showed hesitation on his face, and he hesitated to say: "Mr. Wei, we discussed it internally, and we are a little unsure whether to register the whole device or just apply for software."

"Combined with the actual situation of the approved wearable medical device application, most smart wearable products are applied for the whole device, and only a few of them are applied for independent software."

"However, if we apply for the whole piece of equipment, 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 thresholds of medical devices are relatively high. Manufacturers must have relevant production licenses, and products must go through strict approval when they go on the market. After they go on the market, they must also perform adverse event monitoring responsibilities."

"For electronic consumer manufacturers, this is equivalent to adding a lot of trouble for nothing, 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 release. The requirements are very strict. After smart wearable products other than medical devices are launched on the market, the regulatory requirements they face are much simpler. There are very few restrictions."

"In this way, if it is a manufacturer with average strength, the enthusiasm may not be too high, and the product cycle will be very long. It is estimated that the market will need to be developed for a period of time, and the potential of the fire will be seen, and manufacturers will continue to follow up."

Wei Kang thought for a while, and then said: "The concerns in this regard are very reasonable, so let's apply for the independent software of Longtu APP, which should meet the registration requirements of medical devices."

"The intended use of registered wearable medical devices currently on the market is mainly to realize the collection and recording of monitoring data, but most of them cannot realize automatic analysis or diagnosis functions."

"Our products not only collect data with higher accuracy, but more importantly, can analyze and diagnose data. This is our biggest selling point."

"Our hardware can only collect data, but not for medical purposes. The Longtu APP is just the opposite. In this way, it can avoid hardware supervision, and manufacturers will not have this concern, and they can launch it freely. Any smart wearable product."

"Only after installing Longtu APP, can we have medical functions and provide consumers with detailed monitoring data and diagnostic results. In this way, hardware collects data, software analyzes data, software and hardware are decoupled, and flexible use is beneficial to us. , manufacturers, and consumers are more beneficial to each other.”

Lu Tingfeng suddenly realized: "High, really high, Mr. Wei is wise. In this way, we can completely 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 triumphantly: "If friends and businessmen have objections, I can tell them a cruel truth. It's not that we are too strong, but they are too weak. This is what consumer electronics products should do."

Whether a smart wearable product is a medical device depends on whether the intended use of the product has a medical purpose.

Therefore, enterprises have the right to freely choose product positioning, and smart wearable products can appear in the consumer market through different listing channels.

In addition, the domestic definition of medical devices includes independent software, that is, software (APP) that runs on smart wearable products to achieve medical purposes, and can also be registered as a medical device separately.

In a nutshell, smart wearable products can apply for the entire device or the software contained in it to achieve the goal of obtaining medical device registration.

Therefore, Weikang's idea is completely fine. It solves the trouble of registering electronic equipment as a medical device, and reduces the difficulty and threshold of a professional-level function through software, making it a consumer-level daily function.

This is undoubtedly an industry revolution and a great advancement in innovative technology.

Soon, the mobile version of Longtu APP and the smart wearable version were officially ready, and applied for registration as a second-class medical device with the Provincial Food and Drug Administration as an independent software.

Medical devices are mainly divided into three categories: medical equipment, medical consumables, and household medical devices.

In China, according to the degree of risk, it is divided into three categories for management.

Class I medical devices have the lowest risk and generally belong to auxiliary tools, such as stethoscopes, surgical instruments, scraping plates, tongue depressors, surgical gowns, gauze bandages, masks, etc.

Class II medical devices are moderately risky and are generally in vitro products that require strict management, such as medical suture needles, non-absorbable sutures, sphygmomanometers, thermometers, electrocardiographs, microscopes, biochemical analyzers, hearing aids, condoms, etc.

The third category is high-risk devices, which generally enter the human body and are subject to strict management, such as implantable cardiac pacemakers, intraocular lenses, hemodialysis devices, implant materials, cardiovascular stents, anesthesia machines, and dental implants. Injection materials, absorbable sutures, syringes and more.

Most of the medical devices that appear on the market are Class I and Class II medical devices, and Class III can basically only appear in hospitals and are operated by doctors, which are far away from ordinary people.

Under the leadership of Lu Tingfeng, all work proceeded in an orderly manner.

And as the employees of Sanqing received the sports bracelets distributed by the company one after another, related posts on the intranet were swiping the screen every day, and discussions were in full swing.

"The bracelet saved my life. Today I was wearing the bracelet at work, and suddenly received an alarm message. It turned out that the bracelet monitored my 24-hour electrocardiogram and found paroxysmal atrial fibrillation, and advised me to seek medical attention immediately."

"To be honest, I have always felt that I am in good health and there is nothing wrong with it. If it wasn't for our company's products, I wouldn't have cared about it at all. But because of the lessons learned by my colleagues, I didn't dare to be careless at all, so I went to the hospital immediately. Suddenly, paroxysmal atrial fibrillation was diagnosed."

"It was the first time I heard this term, and I didn't feel much at the time, but after I asked the doctor about it, I couldn't help being shocked when I learned about the dangers of this disease."

"In atrial fibrillation, because the atrium loses its contraction function, the blood is easy to stagnate in the atrium and form a thrombus. If the thrombus falls off, it will flow to all parts of the body with the blood, resulting in cerebral embolism, stroke, hemiplegia, and limb arteries. The embolism, which can even require amputation in severe cases, is really scary."

"Paroxysmal atrial fibrillation is generally not detected during routine physical examinations due to uncertainty. Long-term dynamic ECG monitoring is required. Fortunately, I have worn the bracelet for several days, and its sensitivity is very high. Only by monitoring the function of the electrocardiogram 24 hours a day can I discover my condition, otherwise once a blood clot forms, the consequences will be disastrous."

This is not the only case. With 20,000 to 30,000 people in the company, there are hundreds of cases, either the employees themselves or their family members.

They all claimed to have received the alarm from the wristband and did not ignore the distress signal sent by the body, so that they could be treated in advance and the aggravation of the condition could be avoided.

Generally speaking, any deterioration of the condition will have a process, and 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, there will be palpitation, shortness of breath, bursts of chest pain, palpitations and chest tightness as symptoms, but they often disappear quickly. In fact, these are the distress signals sent by the body.

Many people either didn't notice it, or didn't take it seriously, and ignored the information, which led to the continuous accumulation of diseases, quantitative changes led to qualitative changes, and finally the accumulation was hard to return, thus missing the best time to treat the disease.

As the saying goes, the disease comes like a mountain, which means that the disease has accumulated to a certain level, and when it suddenly breaks out, it will be violent and worsen in an instant.

If early warning can be issued and people's attention can be drawn, many tragedies can undoubtedly be avoided.

This is why prevention is better than cure.

The popularity of the wristband within the company remained high, and soon someone uploaded screenshots of some posts to the Internet.

Because it was related to Sanqing's new product, it immediately caused a great response and was widely spread by netizens.

In Langbo, the headlines and headlines are all on the hot search.

"Is it true or not? 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 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?"

"Upstairs, let me tell you for you, do you want to say, is it a bit low, smart bracelets are not something that mobile phone manufacturers only produce? Sanqing should be a professional wearable ECG monitor. Right, right?"

"In fact, I have used a professional wearable dynamic ECG monitor. The market for this product is actually very large, and it is more popular abroad. In China, the market is mixed. Many products have been withdrawn because they cannot meet the needs of medical data. Only Very few products have been clinically approved, and I suggest that patients in need should buy foreign brands, as the quality is guaranteed."

"It's wrong for 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 bracelet comes out, I will go right away and buy one for my parents. .”

"Hehe, the shepherd dog haunts upstairs. I won't say much about who it is. If nothing else, Juwei now has a smart watch with a medical-grade blood pressure detection function. It has passed clinical trials and obtained a second-class Medical device registration certificate. Now that Sanqing has released an electrocardiogram detection bracelet, aren’t these all the glory of domestic products, so we have to lick foreign products?”

"That's right, foreign products are actually not that bad. Do you think I'm going to push domestic products? No, in fact, I want to say that in the field of smart wearables, all products are rubbish, and none of them are useful."

"Talk about the smart watch Fitbit Sense I have used. This is very popular abroad. It focuses on health monitoring and provides stress management, heart health, arterial oxygen saturation, skin temperature and other health monitoring functions. It has a built-in electrodermal activity. The sensor, through the detected health status, can intelligently judge whether you are sick or under too much pressure, and the shape is also very beautiful, much like the iWatch made of fruit.

I bought this because I have health anxiety issues myself, and every time I feel something unusual like heartburn or racing heartbeat, I go for an EKG and it reassures me that I am healthy.

However, the damn Fitbit Sense's EKG is so inaccurate that if I exercise too much during the scan, or if my heart rate is too high or too low, it won't be able to get a reliable reading and then tell me there's no health problem.

I was doing up to 20 EKGs a day and I didn't know it was inaccurate, the watch kept saying I was fine even though I was panting and my heart was beating like a drum, it had to make me suspicious .

Your sister, after a workout, I had chest pains and had to go to the hospital for an examination. The results showed that I had ventricular tachycardia caused by arrhythmia. The doctor said that if I went late, I would have died suddenly. When I came back that day, I smashed this broken watch and threw it in the trash can.

So when I say so much, I just want to express my agreement with the upstairs. Indeed, the smart wearable devices present here are all rubbish, and none of them can play. Now I am very doubtful, is Sanqing's bracelet also garbage? "

"I guarantee with my personality that Sanqing's wristband is definitely not one of these coquettish and cheap products on the market, but a genuine professional equipment."

"Why do you say that upstairs, the Wolf Warrior filter is too big."

"Just because I am a user of this bracelet, and because it detected a heart attack."

"Ah, is there still a pendant on the boss's leg? Can you borrow it from me? The company just died a programmer last week. I'm really scared. Please save my dog's life!"

"This thing can only call the police and let you go to the hospital. If you feel uncomfortable, it is the same to go directly to the hospital for examination."

"Stop arguing, I just want to know, where can I buy it?"

"Wait, medical equipment, it won't pass the approval in three to five years, and it won't be on the market."

Netizens were arguing, and they were a little skeptical.

There are so many smart wearable watches on the market that none of them can be used for real professional medical purposes. Most of them can only be icing on the cake, and the detection of some functions that are neither painful nor itchy is not very accurate.

When it comes to their own health, no one dares to count on these electronic toys.

As for professional-grade portable monitors, unless it is a confirmed patient, no one is willing to stick a few electrodes on the chest 24 hours a day to prevent sudden death.

However, fans of Sanqing still have blind confidence in Sanqing, thinking that no matter how bad Sanqing’s products are, they will not be so bad. Even if they are not as good as professional equipment, it is still no problem to kill other products on the market in seconds.

They called Sanqing Group one after another, asking when they could buy this bracelet?

The enthusiasm of netizens was very touching, so Sanqing Group officially released a notice.

Announced the successful development of the portable monitor module and Longtu APP health monitoring function.

In an instant, the entire network was shocked.