Rebirth: Starting from Lighting Up the Tech Tree

Chapter 202 Regulatory Approval

After submitting the white paper, the wait has begun.

The third-party auditing firm was designated by the National Health Commission and was called the Huaxia Medical Device Safety Assessment Center. They sent seven people who stayed in the 402 laboratory and data center for two whole weeks. During the audit, Shen Yiming basically lived at the company, cooperating with their technical verification at any time. Every night he would send a message to Zuo Cheng, telling him which systems they had checked that day and which questions the other party had asked in particular detail.

One day, Han Lu came to Zuo Cheng and asked, "Are you nervous?"

Zuo Cheng said, "Don't be nervous. We've done everything we could; now we just wait for the results."

Han Lu said, "I'm a little nervous. Our commercialization plan is all set up, and if it doesn't pass the audit, it will all have to be postponed."

Zuo Cheng said, "If the audit fails, it means we have loopholes. Fixing those loopholes is more important than commercialization."

Han Lu sighed and said, "You're always like this, so unhurried."

Zuo Cheng said, "There's no use in rushing. Audit conclusions aren't reached through haste."

The audit report was released three weeks later, and Shen Yiming was the first to receive an email notification. He went straight to Zuo Cheng's office and said, "It's approved."

Zuo Cheng asked, "Any objections?"

Shen Yiming said, "There are two minor issues. First, the postoperative monitoring period in the surgical standards has been extended from seven days to fourteen days. Second, an annual audit mechanism needs to be added to the data security section. Everything else meets the requirements."

Zuo Cheng said, "We accept both options. An extra week of post-operative monitoring is a good thing, and an annual audit also benefits us; higher transparency makes it easier to gain trust."

Han Lu was already behind him and said, "So when will we get the approval?"

Zuo Cheng said, "Wait."

After waiting for one month and three days, the approval was finally granted.

The notification is an official letter from the National Health Commission, bearing its official seal. It approves the clinical application of 402 Technology's brain-computer interface medical device, specifically for the rehabilitation of motor function in patients with spinal cord injuries.

Han Lu scanned the official letter and sent it to Zuo Cheng, saying, "China's first approved brain-computer interface."

Zuo Cheng stared at the words without speaking. He put the original official letter into the drawer and locked it. The document was small, only one A4 sheet even with the official seal, but it signified the end of a long cycle and the true beginning of something else.

Shen Yiming messaged me in the afternoon, saying, "Have you seen the news?"

Zuo Cheng said, "Not yet."

Shen Yiming sent a link with the title: China's first private enterprise to be approved for clinical application of brain-computer interface.

The report, from Xinhua News Agency, was very formal, introducing the technical approach, clinical cases, and safety system of 402, and concluding that it marked a new stage in the clinical application of brain-computer interfaces in China.

Zuo Cheng finished reading the article and said, "The wording is more cautious than I expected."

Shen Yiming replied, "Being cautious is good; it shows they're taking this matter seriously."

That afternoon, Han Lu convened a meeting with the commercialization team, bringing out the previously prepared plan and pushing it forward point by point. The meeting room held over a dozen people, including representatives from business, marketing, and medical compliance.

She said, "The approval scope covers spinal cord injury patients, and the three hospitals we have currently signed agreements with are all within this scope. The first phase goal is to establish standardized operating rooms and rehabilitation rooms in top-tier hospitals and train neurosurgeons to use our equipment."

Someone asked, "How long does the training take?"

Han Lu said, "Professor Zheng's plan is two weeks of systematic training plus two surgical observations, and it will take about a month for the doctors to become proficient."

Someone asked, "Has the equipment price been set?"

Han Lu said, "Not yet. Zuo Cheng said he wants to wait until the first batch of production is complete, check the costs, and then set a price."

Halfway through the meeting, Han Lu paused the progress bar and asked Zuo Cheng, "Is there anything you want to add?"

Zuo Cheng said, "Two points. First, the hospitals we prioritize signing with must have complete neurosurgery and rehabilitation departments; they must not only be willing to cooperate, but also have the capability to provide excellent post-operative management. Second, we will subsidize half of the costs for the first batch of patients."

Han Lu asked, "Why the subsidy?"

Zuo Cheng said, "Because the first batch is the starting point for commercialization. The recovery results of these patients are our best example. If we serve them well, the market will open up on its own."

Han Lu said, "Okay, I'll add it to the plan."

After the meeting, Zuo Cheng stayed behind alone and reviewed the qualification documents of the partner hospitals one by one. The list of ten top-tier hospitals was distributed across Hangzhou, Shanghai, Guangzhou, and Chengdu. The number of neurosurgery beds, annual surgical volume, and rehabilitation department size of each hospital were clearly marked. He crossed out the three with weaker qualifications and asked Han Lu to re-select them.

Han Lu said, "You're being a bit too strict with your screening."

Zuo Cheng said, "The first batch must be strictly controlled. If problems arise, it's not just a matter for one hospital; it will affect the trust in the entire field."

Han Lu took the materials and said, "Then I'll look for more."

In the evening, Yu Ying came to pick up Zuo Cheng from get off work. She was waiting for him in the parking lot, and when she saw him come out, she said, "You got the approval today, are you happy?"

Zuo Cheng said, "I'm happy. But I'm even happier that the audit passed."

Yu Ying asked, "Is there any difference?"

Zuo Cheng said, "The approval document is the result, and the audit is the process. If our security system cannot withstand an audit, the approval document is meaningless. Now that the audit has been passed, it shows that what we have done is truly solid."

Yu Ying said, "You're overthinking it."

Zuo Cheng said, "That's something we should think about."

They got into the car, Yu Ying drove, and Zuo Cheng leaned against the window, looking at the plane trees along the roadside.

He said, "Kongkong, do you know what that means?"

Yu Ying said, "Brain-computer interfaces can now be officially used in hospitals."

Zuo Cheng said, "That's right. Zhang Wei was an isolated case before, but now we have a legal channel that allows more people to use this technology. Before, we were conducting experiments; now we're doing medical treatment. These two things may seem similar, but they are completely different in nature. If something goes wrong in an experiment, it's because the technology isn't mature enough. If something goes wrong in medical treatment, it's because you took responsibility for someone's life and failed to protect it."

Yu Ying paused for a moment, then said, "Then you'll be even more careful."

Zuo Cheng said, "I've always been careful. But now, that caution carries a heavier weight."

Yu Ying said, "The pressure has also increased."

Zuo Cheng said, "Yes. But this pressure is worth bearing."

After driving for a while, Zuo Cheng's phone vibrated. It was a message from Professor Zheng, which read: "The approval has been obtained. Now we need to let the results speak for themselves."

Zuo Cheng replied with two words: "Together."

Outside the window, the streets of Hangzhou slowly lit up with lights in the twilight. Many in this city are still unaware of what happened today, but for a small group, today is a true beginning. For those still waiting, the end of their wait is drawing near.

The first batch of 20 places has 2,000 people waiting.

Zuo Cheng knew very well that there would be more.