Back in 2002 as a doctor

But the company will definitely promote it to doctors and hospitals in order to drive up profits, drive up stock prices, and make shareholders happy. Everything is so reasonable.

You show your patients that they wouldn't be alive today if it weren't for this innovative product.

Human life expectancy doubled in 150 years because of innovation. "

When Huang Lao said this, his eyes were as sharp as a knife, and the old aura of his old age was gone. He seemed to jump on his own horse, holding a spear, and charged into the battle desperately.

"New technology does not mean innovation by itself!"

Huang Lao's deep voice echoed in the meeting room.

The new technique broke the technical barriers between disciplines, which is the most typical innovation, but he stood on the podium and told everyone that new technology does not necessarily mean innovation.

The high-level faces of the manufacturers are all ugly.

"Take Adv vamed and its member companies as an example." Huang Lao Youyou said.

The white-haired old man was silent and looked at Huang Lao solemnly.

"Over $2001 million was spent on lobbying in 2200. They lobbied so hard that the standards for device approval dropped year by year. Device companies sent out lobbying armies to influence FDA approval."

"Through rhetoric, through rhetoric, in hearings about how the company puts patients first, pursues optimal outcomes, and wants to ensure that new medical innovations reach patients. Help save lives and improve the human condition. Eliminate suffering and make the world a better place." good."

"These words are too much, so that you all believe it yourself? Do you believe that you are the angels sent by the gods to save the world?"

Huang Lao jokingly looked at the executives of the many manufacturers in front of him.

“I know that the medical device industry is very influential in Washington, and you have made hidden donations to covertly fund political campaigns. Medical device companies also fund think tanks and patient advocacy groups, all to lower the barriers to approval.”

"Technical approval experts who leave the FDA can work for many medical device companies with high salaries, which is what they 'deserve', you must think so."

"Regulation is not good. If you want to reduce regulation, you need to reduce countless regulations for every additional regulation. This reduction may apply to certain fields, but it cannot and should not be used for devices that are put into the human body. Do you know the side effects of those consumables? !"

Saying that, Huang Lao raised his hand.

Zhou Congwen took out a stack of materials from the trolley case and put it in the hands of his boss.

"Hip replacement surgery is the surgery you have been pushing for these years, right." Mr. Huang glanced at the senior management of those companies, "In order to reduce costs, you don't need to prove that the metal material is harmless to the human body, but choose metal cobalt."

"Cobalt is a shiny steel-gray metal with a melting point of 1493°C and a specific gravity of 8.9. It is relatively hard and brittle. Cobalt is ferromagnetic. It is comparable to iron and iron in terms of hardness, tensile strength, machinability, thermodynamic properties, and electrochemical behavior. Nickel is similar."

"But do you know that metal cobalt is used as a consumable for implantation in the body, what will happen to the human body after absorbing the cobalt element?"

As Huang Lao said, he shook the materials in his right hand.

"This is the data of patients with abnormal behavior after hip replacement surgery that I have summarized in the last five years."

A stack of materials rattled, like a gust of wind, like a torrential rain.

"Here, some patients started to have tinnitus after hip replacement surgery, and often repeated their own words over and over again; some patients had difficulty breathing, swollen lower limbs, and symptoms of heart failure; some patients developed Alzheimer's disease. similar to the disease."

"And this is all because of the 501K process that was introduced after the lobbying army convinced the FDA."

Huang Lao's voice raised, especially when he was talking about the 501K process, he was like an angry King Kong.

"Wow~" A stack of materials was thrown out by Mr. Huang, scattered like snowflakes.

In an avalanche, no snowflake is innocent.

At this moment, no consumables company is innocent.

"Certifying that its device is substantially equivalent to another device already on the market. This requirement is meant to be an exception and is essentially a loophole.

Sadly, this exception is now the rule.I am sorry to see that most devices are now regulated under this framework. "

"The reason for the approval of a medical device is that it is basically equivalent to a previous medical device. And the previous medical device is also approved because it is basically equivalent to an earlier device."

"Don't you think it's ridiculous! Among the consumables for hip replacement, cobalt is used instead of cobalt to reduce costs, and there are not enough examples to successfully enter the clinic. So far, nearly one million patients who need it have been implanted in their bodies. Cobalt element!"

"It's a carcinogen! It can cause Alzheimer's, it can cause heart failure, it can cause many fatal diseases!"

"And it, because of the damn 501K process, entered the clinic and entered the patient's body."

Zhou Congwen stood beside his boss silently.

He knew everything the boss said. In the time period of the previous life, this situation became more serious in the next ten years.

But I dare not say it myself.

Zhou Congwen was daunted by the huge capital group behind him and those black hands.

Being alone is the best choice, so Zhou Congwen chose to keep his mouth shut.

But after resurfacing, my boss said everything on such an occasion, pointing the finger at the capital behind the manufacturer and pointing at the FDA.

Brave!

Chapter 1493 I don't want this kind of thing to happen

"I think innovation is that we have something new. And we have good evidence to support it. We can prove the pros and cons of it very well."

"But the innovation I thought was definitely not what it is now!"

Huang Lao raised his head and raised his right hand, as if he was holding a spear, fighting the invisible dragon.

Brave, he is a real brave.

"I'm a cardiothoracic surgeon, and I'm just a cardiothoracic surgeon." Mr. Huang then emphasized, "Thoracoscopic surgery is a surgical method I like very much. Everyone knows that laparoscopic surgery can reduce the cost of surgery for patients. Trauma, shorter hospital stay."

"But in my opinion, a thoracoscopic operator needs at least 100-200 operations to practice to be competent for this kind of operation."

"And this is the level that can only be achieved under the operation of relatively high-level doctors."

"But I have never given up on the training of our domestic thoracic surgeons." Huang Lao put down his hands and said calmly, "In the past, operations were full of blood and internal organs. In the future, operations will be parts and data. This only exists in science fiction." What happened, but now it’s on the stage.”

"I like this kind of change very much, but the change must have a solid foundation!"

"A large number of new technologies are adopted, but the consequences are rarely evaluated. It's all about making money. This is what I don't want to see."

"Manufacturers of thoracoscopes sell to clinicians, only talking about minimally invasive, but rarely mentioning the risk of minimally invasive."

"You guys, when you go to the FDA with your thoracoscopy device, say you're going to have nine weeks of training for the doctors.

But doctors would not buy thoracoscopes if they knew that nine weeks of training would be required, so you performed two operations on pigs, and another doctor supervised by the side, saying that ten operations will be enough to operate the machine proficiently. "

"I reiterate again that thoracoscopic equipment can replace all previous surgical procedures, but it is definitely not something that can be used in the operating room and used on patients after only performing two operations on pigs!"

"Boss, calm down." Zhou Congwen comforted his boss, but instead of using Chinese, he communicated with the boss in proficient English, which was also for others to hear.

Mr. Huang glanced at Zhou Congwen and nodded. He put his hands behind his back and bent his back to stand aside.

Everyone was stunned, seeing Mr. Huang give up the stage to Zhou Congwen and the young man standing behind him all the time, they didn't know what was going to happen.

Especially Owada Fukaya, he seemed to have returned to decades ago in a trance, and once again saw the scene of Dr. Huang returning to his youth and standing on the world stage to single-handedly challenge the entire cardiothoracic surgery scene.

"The boss is talking about the past. As far as I know, the Da Vinci robot produced by Da Vinci Company is also the same." Zhou Congwen said loudly.

The replacement of roles did not give people a sense of stagnation.

It was Dr. Huang who spoke just now, and Zhou Congwen who spoke now, but everyone felt that only one person was speaking.

that role,

that boy,

that brave man,

It never changes.

"I have seen the promotional video and know that this is a new technology that can definitely be used clinically."

As Zhou Congwen said, he smiled slightly, raised his hands and twisted his flat hair, making rustling noises.

"Since the 90s of the last century, the three-year confidentiality period has passed, and military technology has begun to flow into the market. The Internet and related applications and development have been pushed by capital into a rapid wave, and a new era has begun."

"The economic crisis and the Internet bubble are inevitable products. I won't talk about it here. What I want to talk about is the Da Vinci robot, a device developed for frontline medical rescue."

"I'm very optimistic about its application, but as the boss said, at least 200 operations are required for doctors to master it. Before that, for example, training must be done."

"Unfortunately, as far as I know, the manufacturer's main purpose is to sell machines, but they do very little training."

"In retrospect, taking thoracoscopy as an example, I didn't really feel comfortable until I had done two or three hundred operations. In other words, I can be very proficient. Inexperienced people operating surgical robots will increase the number of patients. The probability of complications or injury."

"The promotion of new technologies is necessary and necessary, but the speed cannot be fast."

The smile on the corner of Zhou Congwen's mouth seemed to be carved, and he spoke calmly.

"Back to the topic, let's talk about mitral valve clips."

"This is a new device that my boss and I have researched. Is it useful? I believe that those of you who have watched the video and live broadcast of the operation know that its appearance is an epoch-making change in cardiac surgery and cardiology."

"It could redefine cardiac surgery."

"But!" Zhou Congwen raised his voice and glanced at everyone, "By citing the 501K process, the mitral valve clip can be used in 10 cases of surgery. This is something neither I nor the boss want to see."

"This is medical treatment. All implants have to go through long and rigorous research to find side effects and be as safe as possible."

"It has entered the clinic so soon, and when the cost is reduced, should the 501K process be used to replace the titanium-nickel alloy in the mitral valve clip with metal cobalt?"

The smile on the corner of Zhou Congwen's mouth was like a knife, piercing Lawrence's heart.

What this pair of masters and apprentices did seemed meaningless to Lawrence.

But they just did it, and they did it openly in front of countless doctors, in front of many manufacturers, and even in front of the spokesperson of capital.

Unscrupulous, rampant to the extreme.

How the 501K process is passed, Lawrence is very clear.

Not only medical devices, but even pharmaceuticals.

OxyContin, an analgesic drug, didn't that fellow Richard complete the work of the FDA step by step, and is pushing it to the clinic!

All of these are unspoken rules under the table, and now the old man and the boy have lifted the table called new technology, revealing the truth inside.

Lawrence couldn't figure out why Dr. Huang, who had always been supportive of new technology, would do this.

Although what Dr. Huang said was simple, popular, and easy to understand, and there was nothing incomprehensible, Lawrence still seemed to be dreaming.

Everyone in the meeting seemed to be strangled.

No one expected that Dr. Huang and Dr. Zhou would deal a fatal blow to the new technique they had just created.

If it were me, and I created a brand new surgery, an epoch-making surgery, I definitely hope that the sooner it enters the clinic, the better.

Because that represents prestige in academia.

No doctor would refuse to name a new procedure after himself.

But Dr. Huang and Dr. Zhou didn't seem to think so. They uncovered the harmony on the surface and exposed the ugliness under the table.

Chapter 1494 Although there are thousands of people, I will go

"New ones are not necessarily good." Zhou Congwen said frankly, "The boss means that after a long period of observation, the consumables used in the human body must undergo a series of modifications and corrections before they can be used clinically."

"It's like today's surgery, must it be a success?"

Speaking of today's operation, Zhang Youji's big die almost fell off and hit the foot.

He doesn't care about grand narratives, Zhang You only cares about whether he can get the number one in the world and whether he can appear on a world-class stage.

To be precise, Zhang You only cares about Xiao Que Xing.

If possible, Zhang You would press Zhou Congwen's mouth to tell this bastard to stop grinning.

But Zhang You couldn't help it. He stood aside and watched Zhou Congwen point the finger at the new technique that had won a complete victory today.

"The implanted mitral valve clip seems to be very successful, at least the intraoperative angiography proves this." Zhou Congwen said frankly, "The trauma to the patient is smaller than that of the previous operation, and the recovery is faster. After dozens of cases The short-term follow-up of patients and the analysis of data prove that it is indeed a very good operation."

"However!" Zhou Congwen raised his voice and said firmly and persistently, "What about the long-term? The cost of mitral valve clips for intervention is expensive, and most patients cannot afford it. Is it like hip replacement surgery to reduce costs and costs? What about doping the titanium-nickel alloy with metal cobalt?"

"Although the improved version of hybrid surgery can further reduce the cost, it is an implant after all. Without long-term follow-up, who knows what complications will arise."

"Lanke!" Zhou Congwen raised his voice and began to roll the roll.

Ranko's senior management was taken aback, they never expected that this young man would be so fierce.

There is no way for any individual to face an international giant like Ranko alone, even if he is Dr. Huang.

Owada was also inexplicably astonished, his eyes fixed on Zhou Congwen, as if he saw Dr. Huang who single-handedly challenged the entire academic world decades ago.

However, Dr. Huang was fighting against the cardiothoracic surgery community, which was a wrong procedure that was recognized by everyone.

Today, Dr. Huang and his close disciple are going to challenge a multinational giant company!