Generally speaking, the launch of new products, especially pharmaceutical products, must go through very strict approval. Approval of drugs must have data integrity from phase three clinical trials, and only after passing the review will trial operations be allowed.
Medical equipment is relatively loose. The US FDA stipulates that as long as the new equipment can perform the same function as the old equipment, it can be allowed to be put on the market.
However, after Parolilla came to power, he has begun to revise the regulations this time. However, the industrial chain involved in medical equipment cannot be shaken in a short time, so the new plan has not been fully implemented.
In this way, when Bai Ye's new products were sent to the FDA for testing, the technical staff of the FDA regulatory department reviewed various data, but the samples sent were scattered to several places. The first was the FDA, and the second was the SPOM Group.
Within the Mark Norman Experimental Center, the third copy went to the Ferno Group.
The FDA mainly reviews whether the relevant data of the item is accurate, such as various tests with reference to product parameters, as well as animal experiments, clinical trial-related test data restoration and approval. This process can actually be fast or slow, because Bai Ye's data is very
A complete set of inspections will probably only take a month.
Of course, it’s not uncommon for new products to be delayed until half a year!
Therefore, there are more things involved.
At this time, inside spom company, in Mark Norman's experimental center, a large group of top scientists gathered together, waiting for the data results.
The Mark Norman Experimental Center can be said to be the top experimental center in the United States. Because of the Spom Group, the testing instruments and experimental equipment here are top-notch in the world, especially in the fields of analysis and testing.
They take advantage of their technological leadership and have unique advantages in product research and development!
Today, Mark Norman invited his teacher, Nobel Prize winner, Mr. Fellman, as well as all the top scientific researchers in the group, and demanded that the items submitted by Bai Ye must be thoroughly studied!
This task is a small goal that Mark has set for himself.
He did not underestimate Bai Ye.
On the contrary, he gave Bai Ye enough attention.
It can be seen from the lineup of dozens of top scientists around him that Mark Norman cares about Bai Ye. It can be said that this lineup is already the most luxurious all-star.
The first thing they have to do is analyze. After breaking down the sample, they now have several difficulties to deal with and face.
First of all, what is covering the surface of cobalt-chromium alloy?
Secondly, how to cover the surface of cobalt-chromium alloy with this substance?
Finally, what are the flaws of this substance?
Focusing on these three questions, Fehrman began various experiments. They felt that as long as the physical and chemical properties of this substance were determined, other problems would be easily solved.
So, they used their current top-notch detection technology to decompose the substance, hoping to analyze it.
They show simulated blood environment, giving different degrees of acid-base corrosiveness, ionization environment, simulating destructive pathological environment...
Then, apply pressure to accelerate the progress of this destruction.
It is an environment equivalent to simulating the human body, except that the speed is accelerated in this environment.
Of course, this speed is not actually accurate. It is only controlled by the concentration of acid and alkali substances. In this way, some physical and chemical properties can be obtained.
Ten times the normal speed, converted into a very high concentration, but for a long time no one noticed the decomposition of this substance on the surface.
As time passed slowly, these people began to feel anxious.
Mark Norman said directly: "Switching speed, 20 times!"
only!
In such a high-concentration environment, there was no abnormality in the detection of various substances in the reaction box.
In other words, no new substances have been discovered yet.
Mark Norman was anxious at this moment.
"Continue to speed up, 100 times faster!"
In fact, this accelerated detection is not accurate, but they just hope to see some substances decompose to judge the resistance of this substance.
As time passes slowly...
Even Mark Norman's teacher Fehrman couldn't sit still.
He stood up and said directly to the operator: "Continue to increase, increase to 10,000!"
Are people around you dumbfounded?
Ten thousand?
Is this appropriate?
Is this different from direct strong acid and alkali?
And, is this going to be transgender?
What does the doctor want to do?
The operator knew that Fehrman was the real talker in the laboratory, so he directly increased it to 10,000 times. In this way, this environment was no longer a human simulation environment. Let alone people, even ants would disappear immediately if they entered.
Got it!
……………………
About an hour passed!
A bunch of people are disappointed!
Because there is no change in the reaction box!
This is equivalent to telling everyone not to waste their efforts, it is meaningless!
Extremely acid and alkali resistant!
This is the only conclusion everyone reaches.
Fehrman frowned, obviously dissatisfied with this conclusion, but still couldn't find an effective method.
what to do?
There is no point in dragging!
There is no direction to continue.
At this time, Fehrman said slowly: "Everyone goes back to rest and think about a plan each. We will continue tomorrow. Obviously, this item cannot be decomposed using conventional methods. We must think of his method. If this material can be broken through, for new
In terms of the company’s development, it is definitely a pioneering event!”
In fact, there was one thing in Fehrman's mind that he didn't say: This matter is too difficult!
However, difficulty does not mean impossible.
A Nobel Prize winner is no joke.
Thinking of this, Fehrman cut the sample into parts and took it home for further analysis and exploration.
And when everyone was about to leave...
A man suddenly said: "Well...doctor, actually...we seem to have overlooked something..."
At this time, everyone followed the sound and went out.
I saw a boy with black hair standing there, his voice seemed a bit timid.
Seeing the people around him looking at him, the boy felt anxious and nervous.
This person is no stranger. He is an intern in Norman's laboratory and a student in the Department of Chemistry at New York University. Among their current batch of interns, he seems to be the most inconspicuous one.
He is not a local NYU student, but an international student from China.
Fairman was already a little anxious, but when he heard the boy's words, he frowned and said, "I'm looking forward to your answer!"
When the people around heard what Fellman said, they all knew that Fellman was a little angry.
If a boy cannot come up with a constructive idea, the boy will be in trouble.