3 years after the jubilant success of the rocket launch,
Tsukuda Manufacturing was boosting their business thanks to their part in that achievement.
Now, introducing himself as Tsukuda's rival, appeared Shiina Naoyuki,
the president of Sayama Manufacturing who started his career at NASA.
And Tsukuda gets told by Zaizen that the procurement of the rocket engine valve
will be decided by competition from the next time.
In the meantime, Tsukuda Manufacturing gets an order to manufacture a prototype of a special valve
from Nippon Klein, a major manufacturer of precision instruments.
That valve was a key part of core heart, an artificial heart being developed by
Professor Kifune of Asia Medical University.
Shiina, who was scheming to
steal away the core heart business from Tsukuda Manufacturing,
headhunted a member of Tsukuda Manufacturing's Technological Development Dept., Nakazato Atsushi.
Furthermore, he had Nakazato steal the drawing of the altered core heart valve that
Yamazaki had personally designed on his own.
Just around that time, Mano Kensaku, a former employee,
came to introduce Professor Ichimura Hayato from Hokuriku Medical University
and Sakurada Atsushi, owner of a local business,
to entreat their cooperation to develop a prosthetic valve to be used in heart surgeries.
However, with dark clouds looming over the business with Teikoku Heavy Industries
in addition to the skepticism over developing medical devices
due to the recent incident with Nippon Klein,
Tsukuda Manufacturing did not have the time or money to spare to develop the prosthetic heart valve.
Gaudi
is my dream.
Please, President.
While visiting Sakurada's company in Fukui,
they learn that Sakurada's dedication to develop the prosthetic valve
comes from his feeling of atonement to his daughter who died of a heart disease.
Touched by Sakurada's feelings, Tsukuda finally makes up his mind
to participate in the development of a new prosthetic valve, the Gaudi Project.
Tsukuda Manufacturing will do everything within our power to tackle Gaudi.
3 days later
After the blood circulates the body,
it passes through the right atrium to the right ventricle and on to the lungs.
Right Atrium
Left Atrium
Left Ventricle
Right Ventricle
Then the left atrium receives the blood from the lungs and sends it to the left ventricle
which then pumps it to the aorta for systemic circulation.
What keeps the blood from regurgitating
is this heart valve, but
if there's a lesion here, blood doesn't flow properly.
This is where a prosthetic valve becomes necessary.
Appearance-wise, it's shaped like a ring.
The fact is, there are currently no prosthetic valves made in Japan.
We are totally dependent on those made abroad. However,
due to problems, such as size, with foreign-made prosthetic valves,
in many cases they are incompatible the Japanese physique, especially children.
For that reason, there are many patients who cannot be cured.
Our Gaudi Project is a valuable project to enable children suffering from severe valvular heart disease
to regain a healthy body and a future.
For the future of these children, please lend us your hand.
Ichimura Sensei, thank you.
Now then, let me announce the core members who will be working on this project.
First, from the Technological Development Department, Yosuke.
And Aki-chan.
Suzuki.
I entrust the development of the prototype to you three.
Yosuke, you're the team leader.
Me?
And on the administrative side, I'd like Ebara to be in charge.
I want you to support these three as a sub-leader.
You may say I'm being idealistic and laugh at me.
But this Gaudi Project isn't merely a business.
As an engineer
and a member of society,
I believe it's a mission that needs to be accomplished to save people's lives.
The development will probably require an enormous amount of time.
If you should get lost along the way, try to remember this mission.
To enable the children to smile and have a future,
let's work together and make this project materialize.
So this is the prototype of the prosthetic valve.
What's wrong with it?
We don't know.
We don't know why, but blood clot forms more easily with this.
A blood clot is a mass formed by platelets and fibrin in the blood that may be the cause heart attack or stroke
What we have to overcome is
a way to prevent blood clots from forming and biocompatibility.
Basically, it will be a repetition of trial and error.
As a matter of fact, there are three obstacles that must cleared for the Gaudi Project to be a success.
The first, as Tsukuda-san mentioned, is the technological obstacle.
And the second is the financial obstacle.
I'm doing what I can too, but
the parent company that's providing the money, Sakurada Tateami, has employees too.
The third obstacle is getting the approval.
The first obstacle we have to overcome is
a pre-review meeting with PMEA.
PMEA is the acronym for Pharmaceuticals and Medical Equipment Agency,
an independent agency in charge of reviewing drugs and medical devices.
Currently in Japan, there exists a system in which all medical drugs and medical devices
receive guidance from PMEA from the developmental stage
until the Ministry of Health, Labour and Welfare makes a final determination and gives approval.
If, at that pre-review meeting with PMEA, if we can get them to favorably perceive
our intent and contents of our development,
the subsequent reviews should also go well.
But if we get off to a bad start here, it may have a lasting effect.
And so, when it this pre-review meeting?
It's in 2 weeks.
Ichimura Sensei is also top-notch as a heart surgeon.
So there's no end to the throng of patients who come seeking his help.
But how did such an outstanding surgeon end up in Fukui?
Ichimura Sensei was the top disciple of Asia Medical University's Chief Heart Surgeon,
Professor Kifune, to begin with, and was expected to be his successor.
You mean Professor Kifune who developed that core heart?
Or so they say, but...
in truth, the idea of core heart was originally Ichimura Sensei's.
But Professor Kifune published it as if it was his own.
In other words, the mentor stole his disciple's invention. What a scumbag.
But Ichimura Sensei thought it would be better for him to step back
if that advanced the development of core heart and many patients could be saved.
So he quietly accepted it.
Professor Kifune had Ichimura Sensei forcibly transferred to Fukui,
and made core heart completely his own.
How tough that must've been for Ichimura Sensei.
Fukui Prefecture Hokuriku Medical University
- Good evening. - Good evening.
Long time no see, Ichimura-kun.
I had a sudden urge to see you. Are things going well?
Yes, thank you.
It's just that...I heard it through the grapevine
that you're having a hard time with your current research.
- Are you talking about the prosthetic valve? - Actually, I've been thinking for a while too
about making a new type of prosthetic valve.
Someone asked me to give you a hand since you seemed to be at an impasse.
And that's why I took the trouble to come all the way out here.
I thank you for your concern.
It's not like we're strangers.
We've been through a lot together, haven't we?
With a medical device, it takes a long time and
a lot of money to get it approved by the Ministry.
If I was to develop it, Nippon Klein said they'll sponsor me
in addition to joining the development team.
How about it? Don't you think it's a good deal?
Of course, I'll try to leave your name and the University
as the primary member of the development team.
If you think about the patients who are suffering from valvular heart disease,
if you think what is the the shortest path to implementation,
there's no better deal than this.
Come on, Ichimura-kun.
For the future of medicine,
let's work together again.
I appreciate the offer, but I'll have to refrain from accepting it.
It's my belief that the significance of this Gaudi Project is contingent
on seeing it through the end myself.
Here I am, going out of my way to bring you such a great offer,
but you're going to reject it, huh?
I truly appreciate the offer and I'm very grateful, but...
Gaudi is my idea.
Please spare me from going through the same thing I did with core heart again.
How dare he repay the Professor's kindness with ingratitude.
How much ruder can he get, that Ichimura.
What's so great about Gaudi.
The nerve, after I took the trouble to go all the way to Fukui.
Why bother with that anymore? Even without dabbling in prosthetic valve,
Professor Kifune, you have core heart.
No. There's a rare sweet business opportunity just lying there before our very eyes.
There's no way we can knowingly pass it up.
In order to secure development funds for core heart too,
I believe we should get our hands on everything we can get.
- But you know... - Let's wait.
Actually, with Toudou-san's help,
I checked out this company called Sakurada that's participating in Gaudi.
When did you...
Sakurada's development expense comes from its parent company, Sakurada Tateami.
Currently, opposition is growing within that parent company towards developing a medical device
that's not producing results.
If things remain unchanged and the meeting with PMEA doesn't go well,
the funding to Sakurada is expected to be cut off soon.
If Sakurada should pull out of the project,
wouldn't your suggestion become a real possibility?
I see.
Even if we don't do anything, he'll approach me first, huh?
Shiina-kun.
You're indeed a first-class businessman.
Your ability to see through things is really something.
What I learned at NASA.
That's...how to find the winning formula.
How to make adequate preparation in order to win.
That's all there is to it.
By the time you get to the negotiation table, the game is already decided.
Winners make winning happen.
That's my management policy.
Anyway, the main issue for improving the core heart valve is durability.
The realization of a 6-month, 180-day performance warranty.
Get that done as soon as possible. You got that?
Yes. Uh...
We're currently delivering prototypes with a 90-day performance warranty, right?
- To Nippon Klein. - Of course.
May I take a look at that existing product for reference?
No, there's no need for that.
I want you to come up with your own ideas for improvement
without being tied down to the existing product.
Very well. I'll make sure it gets done successfully.
I'm counting on you.
Ours is the leading group of engineers with the best skills and brains.
There's no comparison to Tsukuda Manufacturing, right?
Yes.
This is confidential, but Teikoku Heavy Industries' rocket engine valve
will be replaced by ours soon too.
Really?
If this core heart goes well,
I'm going to have you work on the rocket engine valve.
So I need to have you produce results as soon as possible.
There's no place for incompetent employees at our company.
GAUDI DEVELOPMENT PROJECT
Meanwhile, in preparation for the meeting with PMEA in 5 days,
Tsukuda Manufacturing's Gaudi Team of Tachibana, Aki, and Suzuki
was making the final push to develop the prototype of the prosthetic valve.
Working hard?
How's it coming along?
Please look at this.
This isn't bad at all. Looks like the problem of biocompatibility can be cleared.
Yes.
The remaining issues are the development of an open/shut mechanism and devising the operability,
- And... - It isn't working out at all.
It's the blood clot.
It's just a trace, but no matter what we do, blood clot forms.
If it's just a trace, perhaps it can be dissolved by medication...
That won't do. Patients can forget to take medication, and it has to be taken for the rest of their life.
We'll just have to find a way in the basic structure
to prevent blood clots from forming.
We don't have much time left.
We'll have to at least get on the right track before the meeting with PMEA.
Don't panic.
When you're developing something, there's bound to be a black box like that.
The part that can by solved by a mathematical formula is very easy.
But once you reach a certain point,
there's always something that can't be solved with logic.
You make it, test it, and make it again.
You may continue to be unsuccessful. But you know,
your own unique know-how can only be gained from that kind of effort.
Don't try to be smart about it. Get your hands dirty.
Intelligent guys try to get it done without getting their hands dirty.
But that's not how it works.
You don't use your head to make things.
Use your hands
and your heart.
Yes, sir!
This is excellent experimental data.
I think it's safe to say core heart will be able to progress to the clinical trial stage soon.
- Thanks in advance. - You can rest assured.
Oh, by the way, do you remember a guy by the name of Ichimura who used for work for me?
Ah, you mean that Ichimura Sensei who went to Hokuriku Medical University?
I heard that he's in the process of developing a prosthetic valve right now,
but it sounds like he's producing a rather shaky device.
So if you should get an application for a pre-review meeting...
Professor Kifune,
just between you and me,
we've already received the application in regards to that.
We are scheduled to have a meeting next week.
I see.
Well then,
can you warn the reviewing official in charge.
To exercise extreme precaution.
That won't be necessary.
The official in charge
is me.
That's all for the summary of the Prosthetic Valve Gaudi Project.
PMEA First Meeting
We are open to any questions or suggestions.
Please excuse me for being abrupt, but
are you really the only ones involved in this project?
What do you mean by that?
I'm sure you're all aware, but there's always a risk associated with a medical device.
If something should ever happen,
whether you folks can take the responsibility or not,
that's what we're worried about.
Setting Hokuriku Medical University aside...
- Sakurada-san. - Yes.
- You're a provincial business enterprise, right? - Yes.
And Tsukuda Manufacturing.
You're a small company located in Ohta-ku.
I hesitate to say this, but you're a mere nobody.
Developers of medical devices
must have the appropriate social foundation.
Even more so when it comes to a Class IV medical device like this
Class IV Medical Device - device that is highly invasive to the patient and may have a direct bearing on the life of the patient should a malfunction occur, such as pacemakers
This is not something that can be undertaken easily by
a small no-name company from nowhere.
- Takigawa-san. - What? Oh...
That was an inappropriate remark.
Well anyway,
without a more detailed cooperative framework, we have nothing to evaluate.
This new material, for which a patent is pending, was made with cutting-edge technology.
Tsukuda Manufacturing is producing rocket engine valves for Teikoku Heavy Industries
with technological capabilities that even major enterprises doesn't have.
Company like these are most befitting to develop
new advanced medical devices that the clinical trials are seeking.
Then um...
submit your financial statements.
Show us what kind of companies you are.
Neither one of you have offered your stocks to the public, have you?
You say they're good companies, but we have no details,
nor have we ever heard of the company name.
The company profiles of Tsukuda Manufacturing and Sakurada are detailed in the attached...
Anyone can fabricate paper documents like this.
Please submit something more official.
Listen carefully.
The essence of our review,
before we even get to "what" is being made,
is "who" is making it.
Oh, Ichimura Sensei.
As I recall, you used to work under Professor Kifune, didn't you?
Why don't you consult with Professor Kifune?
He would have connections with major manufacturers.
What's more, he has the proven track record of core heart.
If that's the case, we can move forward with our mind at ease.
Listen now.
I'm giving you this advice for your sake.
If any mishap should occur, the lives of many people may be lost.
Did you all come here prepared to take responsibility for that?
Do you really have the qualification to develop a medical device?
Think about that real carefully, and
then...come back again.
What's wrong with that reviewer in charge, Takigawa!
I can only think that he has malicious intent and prejudice towards us small business.
I'm sorry.
It's my fault.
I once heard that
this man called Takigawa is on friendly terms with Professor Kifune.
Then what. Are you saying that because you refused Professor Kifune's help,
he pulled strings so that we wouldn't pass the review to get back at you?
Probably.
He's just waiting.
- For me to come crawling back to him. - That's disgusting.
Sensei, is this really going to work out?
This is still the first round.
Now that it's come to this, let's start with clearing the peripheral obstacle.
- Do you have a plan in mind? - As a matter of fact,
I've submitted a new research paper to an academic journal.
If it gets published, more people will support the Gaudi Project.
Then PMEA won't be able to ignore us.
Then all we can do for now is pin our hopes on that.
Yes.
Hey. Can't you do something about that sighing at least when we're eating?
The bad luck's going to rub off on me. I have an important interview tomorrow, you know.
What's wrong with sighing? I have a lot on my mind.
Normally, doesn't a daughter worry more about her father?
Are you nuts! You're such a wimp.
Who, me?
All your Grandpa did was sigh too when things weren't going well at work.
Men are wimpier than you think.
Isn't Masahiko-kun like that at times too?
- You're right, he is. - Right?
So there's no end to it if you get mad every time at things like that.
I guess so.
Wait a minute.
Who's Masahiko-kun?
- Thanks for dinner. - Hey, wait a minute.
Who the heck is Masahiko-kun?
Her boyfriend, of course.
She's in the spring of her life, you know.
- How come no one's told me. - He's a very nice boy.
He's good looking, was raised abroad, and an excellent student.
He got a few job offers too.
But I guess he's not quite ready to be your successor.
Of course not! Wait a minute.
Mom.
- Don't tell me you've already met him. - He's been here several times for dinner.
What!
What do you mean? Tell me what part of that paper is outdated.
Please give me an explanation I can understand.
Who are these professors who are opposing it?
Please wait.
Hello? Hello?
What do you mean the research paper got canned?
Professor Kifune is the association president. Naturally, he must have a lot of say
- in the contents of the academic journal too. - Damn.
- Kifune again, huh? - Is Ichimura Sensei all right?
- He must be quite upset. - Actually, he said he has no time to be depressed.
He's already working on his new research paper.
Where does he get that strength?
Sorry for troubling you in regards to Ichimura's meeting.
Not at all. All I did was make the logical decision.
Those idiots from a small factory who don't know their place
overreaching into the field of medical device
is simply out of the question.
I couldn't agree with you more.
It's too bad Ichimura Sensei made the wrong decision at a critical time.
No matter how you look at it, the person he should turn to
is Professor Kifune who brought core heart this far.
Oh, by the way, Takigawa-kun, when will the clinical trial
- for that very core heart be approved? - Very soon.
I believe I can give you the good news at the next meeting.
We're also making further improvements
and a valve with increased durability is scheduled to be completed soon.
That's something to look forward to.
I'm counting on both of you.
- Oh, no. - What? It failed again?
You used to work at Tsukuda Manufacturing, didn't you?
- Then this should be a piece of cake for you. - I'm sorry.
Sayama Manufacturing Development Manager Tsukishima Naoto
It took some time to figure out the characteristic of the material.
It's the result at our company. Result. Results mean everything.
- Are you sure you understand that? - Of course.
You don't want to get removed from development and be in a miserable position like that, do you?
Oh, they're here for a site visit.
- Not bad. - Thank you.
Welcome to our factory.
If this core heart goes well,
I'm going to have you work on the rocket engine valve.
There's no place for incompetent employees at our company.
Hello.
Is it true Teikoku Heavy Industries is having a competition for the valve?
- Why do you know about that? - It's only natural I'd hear about it.
There are lots of people here who have connections with Teikoku Heavy Industries.
So? How's it going? Does it look like you can win?
Of course...is what I'd like to say, but
Sayama beat us once at Nippon Klein.
Good luck. I'll be rooting for you.
What's this all of a sudden. It's creepy.
Sayama's president came back from NASA, right? Everyone's talking about it.
Former member of JAXS, Tsukuda vs
President Shiina from NASA.
That this is a battle between us and NASA. So you can't lose.
Just because you're not involved. Aren't you enjoying this too much?
For me, the company's on the brink of life or death.
That's the way you chose to live, isn't it?
- It's your chance to show off to Rina for a change. - What do you mean for a change?
By the way, did you know? That Rina has...you know...
You mean Masahiko-kun?
- You knew? - But of course.
- Bye then. - Hey, wait...
Masahiko-kun...
Everything I've seen indicates a company that's growing rapidly.
I give it a rating of A.
Technological capability is also unparalleled for a mid-sized factory.
From manufacturing process, product quality, to personnel affairs,
- there's no problem with the management system either. - Thank you.
In other words, we're better than Tsukuda Manufacturing.
Can I assume that's what you're saying?
Tsukuda's just a small factory after all.
It can't compare to Sayama Manufacturing whose president has full knowledge of NASA's technology.
They just happen to own the patent for the valve system.
What we're striving for is the world's highest standard.
Strive to be the best in the world with all the parts and precision instruments we develop.
That's our motto.
I'm expecting great things from you, President Shiina.
With that secret plan you suggested, Sayama Manufacturing is sure to get the valve contract.
- President Shiina, see you. - Thank you for dinner.
Good night.
Are you sure it's okay? To make a promise like that to get business.
In order to win the business with Teikoku Heavy Industries,
it's only natural to lay a little groundwork like that.
Winners make winning happen. Perfectly.
This is a secret plan to achieve that end.
Be it core heart, Gaudi, or rocket engine valve,
I'm going to get my hands on all of them.
Excuse me...the existing valve for core heart that's being supplied to Nippon Klein...
May I take a look at it to use it as reference?
- What about Tsukishima-san's permission? - Yes. I got it of course.
If you're doing an experiment, you want a hand?
Sayama Manufacturing Technological Development Dept. Yokota Nobuo
Come to think of it, you used to work at the Development Department, right?
Yeah.
Even when I make it based on this drawing, it always ends up being unstable.
I want to see what the difference is with the delivered product.
Oh, no.
What happened here?
You're absolutely sure this is the existing product that's being supplied to Nippon Klein, right?
Yeah, I'm positive.
Does it mean this just happened to be a defective product?
- How's it going? - We changed the ring part to nitinol
and after repeatedly making minor adjustments, finally
we ended up with this prototype. I think it's pretty darn close.
It'll be fine. It will work for sure this time!
Failed again.
You guys go home for today. You'll be more productive when you get some rest.
I can't do it anymore.
I was really confident this time.
If this one doesn't work,
I don't know what more I can do.
Are we really
doing the right thing?
What do you mean?
Maybe
PMEA was right.
It was impossible from the start for a small company like us to develop an important medical device like this!
Tachibana's team was completely at a loss in the development the prosthetic valve
and in order to learn about the starting point of Gaudi,
they subsequently asked Tsukuda to take them to Fukui.
The first place Tsukuda took them was
Sakurada, which was co-located with its parent company, Sakurada Tateami.
President of Sakurada Tateami Sakurada Tsutomu
Sakurada-san.
Oh, hello. I'm sorry
I wasn't even there to greet you. I must've just spaced out.
That's all right. I'm sorry too for coming on our own.
- Not at all. - It's nothing special, but please take it.
Oh, thank you. You shouldn't have, but thanks.
Welcome, Tachibana-san, Kano-san, Suzuki-san.
Is this the machine that knits the special material for Gaudi?
It's impressive when you see the real thing close up.
Oh, I'll go have someone bring some tea. Excuse me.
Sakurada-san.
Did something happen?
Please tell me.
We're on the same Gaudi Team, aren't we?
I'm sorry, Tsukuda-san.
Actually, a little while ago...
At the main company, dissatisfaction with you is about to explode.
If there's no progress with the Gaudi Project,
the 50 million for this time is the last of our financial support.
I'm truly sorry.
This, after you took pains to join us.
At this rate,
in 6 months,
our funds will be depleted.
If there's no progress by that time,
I have no choice but to leave the Gaudi Project.
That can't be...
Gaudi needs your technological skills.
We can't possibly
tell this to those guys, can we?
I'll explain it to Ichimura Sensei and Mano-san myself later.
I'm sorry.
Keeping Sakurada's circumstances to himself,
Tsukuda visited Ichimura's hospital with Mano.
How is it? You feel better, don't you?
Yeah. Sensei, thank you.
Sensei, will Kiyoto be all right?
Of course. You don't have to worry anymore.
Oh, Tsukuda-san. Everyone.
Kids, our guests from Tokyo brought you presents today.
- Here you go. - What about this?
- Thank you. - Thank you.
I'm glad to see you all here.
- Sorry to bother you when you're busy. - Not at all.
Compared to you folks who've been working everyday without hardly sparing time for sleep,
this is nothing.
But we haven't produced any results yet.
That's to be expected.
Results can't be produced that easily.
I've lost count of all the setbacks I've had.
You must be a strong person, Sensei.
I'm not strong at all.
But you know,
how can I quit when I see all these smiling faces in front of me? That's all.
Sensei.
- This looks boring. - Hey, Keita!
That's why I told you, President. Kids don't get excited over castles.
Oji-san, you guys are making rockets, right?
A toy rocket would've been better.
Really? But you know, Keita-kun,
try making this. It'll be fun.
Putting little parts together like this
to make something big
is the basis of making things. Rockets are built the same way.
Please come watch that child's surgery tomorrow.
Fortunately, there was a prosthetic valve that fits Keita.
There's no danger to his life, right?
It isn't a real difficult surgery, but
there's always a risk with any surgery.
So all I can do is try my best every time.
Please come watch Keita fight for his life and root for him tomorrow.
Takahashi Keita-kun, 11 years old.
We will now perform the prosthetic valve replacement surgery of the aortic valve.
Let's begin.
Scalpel.
Forceps.
- Start heart-lung bypass machine. - Starting.
Clamp forceps.
- Total reached on flowmeter. - Stopping the ventilator.
Clamping aorta. Inject cardioplegic solution.
Injecting cardioplegic solution.
- Heart stopped. - Cutting the aorta.
Scalpel.
- How many minutes since the cardioplegic solution? - It's been 20 minutes.
- No. 16 A Valve. - Got it. A 16.
The valve is made in USA and it's the smallest one available.
But it's still a bit too big for Keita
so it has to be implanted in a different place rather than the usual, and
the incision will be bigger.
But in order for Keita to go on living,
using that is the only choice right now.
Keita said he wants to get better soon
and someday play soccer with the other kids in the ward.
But prosthetic valves that fit the other children
don't exist at the present time.
Being that they're kids, I'm sure they'd like to launch a rocket
or be a hero...
have big dreams like that.
But he just wants to play soccer with his friends.
Such an ordinary small dream like that,
the least we can do is make that come true, don't you think?
Hang in there.
Hang in there...
Okay. Flowdown.
Flowdown.
Remove clamps.
Backing up flow.
Start beating.
Start beating!
Heartbeat is back.
All right. Stop the heart-lung bypass machine.
Heart-lung bypass machine stopped.
Blood pressure going down.
Add another 5 gamma of dopamine.
Adding.
- Hang in there! - Keita-kun!
Keita, hang in there!
- Hang in there, Keita! - Keita-kun, hang in there!
- Hang in there! - Hang in there!
- Blood pressure's back up. - All right. He's okay now.
All right. All right!
I recalled what you said.
But this Gaudi Project isn't merely a business.
As an engineer
and as a member of society,
I believe it's a mission that needs to be accomplished to save people's lives.
If you should get lost along the way, try to remember this mission.
To save children like Keita-kun.
To take away the suffering and grief from those children.
That's what we're fighting for, right?
We're working for a wonderful cause, aren't we?
Yeah.
Mano-san.
Please tell Keita-kun.
That he'll definitely
be able to play soccer with his friends some day.
I'll tell him.
President.
I won't waver anymore.
Gaudi
will be perfected by our hands without fail.
After returning from Fukui, Tachibana and his team
resumed devoting their days to the project again.
And Tsukuda got the financial statements and other documents ready,
as tasked by PMEA at the previous meeting,
and once again, set out to face PMEA at the pre-review meeting.
PMEA Second Meeting
First of all, as instructed at the previous meeting, we've submitted detailed financial statements.
Yes, I see. Tsukuda Manufacturing and
Sakurada Co., Ltd.'s parent company, Sakurada Tateami,
are both wonderful companies that are performing very well,
- I can tell. - Yes, that's right.
Without their companies, this Gaudi Project would not be possible.
Is the development phase going well?
Yes. Based on the roadmap we showed you previously,
these young guys here are repeatedly conducting tests day and night.
- You must be having quite a difficult time. - Not at all.
When we think about the children waiting for this prosthetic valve,
- what we're going through is nothing. - Wonderful.
That's admirable. However,
this won't do.
- In what way won't it do? - With medical devices,
it's not about just manufacturing them.
If you develop a new medical device, you have to sell that to the whole world.
In order to do that, a license to manufacture and sell will be necessary.
- I assume you know that much, right? - Of course. However...
The major corporation that has that license to manufacture and sell
manages the large amount of money, carries out the clinical trial,
and ultimately has to file the application.
Does your company have that license?
You don't, do you? You need a large corporation
that has the capability to do these thing properly to back you up.
In the first place, it's impossible for you to develop something like a medical device.
I was thinking about finding a major corporation that would cooperate with us by the time Gaudi was complete.
Have you talked to Professor Kifune about it?
- No, I haven't. - I told you to last time, didn't I?
He has a lot of influence with major manufacturers of medical devices.
Companies like Nippon Klein, for example.
There's no credibility when you all you do is say "I was thinking about finding"
when you haven't even made any effort to do so. If you can't make the effort,
you should give up this project.
Anyway, we're getting nowhere talking like this.
Take this back with you once more and think about it real carefully.
Shall we go then?
Thank you for your valuable advice. It was very helpful.
Then will you be satisfied if we find a corporation like that?
You'll be satisfied if we find a major corporation with a license to manufacture and sell
to support us through the completion of Gaudi, right?
That's why I'm telling you to consult with Professor Kifune.
I'm grateful for your concern, however,
to a developer, the product is like a child.
The company we can trust and place that child in their care,
we'll find it ourselves.
Stop talking nonsense. There's no way you can.
If things could be accomplished with feelings like that, anyone can be a developer.
But where there's no feeling, there's no progress in technology.
That's what I believe.
In the first place, is the purpose of this PMEA to force businesses to give up their aspiration
to develop medical devices?
Or is it to lend a helping hand for the safety and development of medicine in Japan?
Which is it?!
That's of course...
the latter.
Then, won't you please
trust us a little bit more and lend us a hand?
Even if it's 1 percent, if there's a possibility,
we won't give up.
We're the only ones who can
perfect this Gaudi!