EQMS AND ETD BUILT FOR DIGITAL HEALTH featuring MIGUEL AMADOR

Oh!

Morning Sean.

Good morning!

Now, at 1 point I think at one of the calls you said that you do the fish on Christmas Eve.

Yeah, yeah.

Are you Italian?

Siso nataliano.

Oh, okay. Very good.

Yeah, yeah. I spend like 3 months a year in Italy.

No kidding.

Yeah.

That's nice whereabouts.

From.

Nice.

Mostly usually Rome.

Is that your heritage.

So only 2 of my great grandparents are Italian. I'm I'm Irish and Italian.

That's a common typical combination. So.

But definitely the Italian side won. So I've never been to Ireland. I've been. I've been to Italy at least 40 times. I don't know.

That's great! And you and you actually spend you spend months there.

Yeah, yeah, I like to work from there.

That's beautiful. Very good.

Yeah.

Well, you can fool me with your last name. So.

Yeah. Well, that's the funny thing about my name is that it doesn't sound Italian at all.

Yeah, even if even your 1st name you could you could pass for a lot of other things in Italian.

Right. My brother's name is Lucian, like Luciano.

Yeah.

Yeah, without the O.

Is there an Italian word for Sean?

Giovanni.

Oh, really. Okay. Gotcha.

It's just Irish for John.

Okay.

Just deleted somebody, he'll rejoin more sorry. I'm just getting the hang of this yeah. promote panelist I haven't seen. Yeah. So I'm just promoting people to panelists. If you want to decline. That's fine. but everybody's joining now. So It's you know, a couple a couple of minutes till can you hear that noise in the background, or is that muted.

No, we don't hear that.

Oh, that's good, because we're having stumps ground in the yard.

Oh!

We had some big trees taken down because they were getting dangerous. And yes, that's the situation. Oh, so if anybody would like to be promoted. They can just raise their hand or something. But I don't see.

Hey, Rick, I see you're wearing a red shirt.

Well, it's it's not a patriots thing. It's just our Kansas City or.

Well, but today is national. Today is national red, wear red day for heart disease.

Oh, I had no idea.

Yeah, yeah. That's why I'm wearing my red tie.

Every time I find out about a special day or a holiday, I put it down on my calendar for next year.

7, th February 7.th Every year.

Cool. I love it.

But chicken.

Well, good.

Thanks, man next week, of course, for for Valentine's day.

Yeah, that. Well, I think people know about that one, Joe. Very good.

Have you? Have you already picked out something nice for the long, suffering Mrs. Domino.

Absolutely already done.

Is that right?

Yes, yes, absolutely.

Will you give her a gift.

Of course.

How about Mrs. Stockton? Does she expect anything?

The the one thing she not to do is don't take her out to eat on Valentine's day. It is a madhouse.

Yeah, that's amateur night.

So we're talking. We're talking flowers, card candy stuff like that. And just basically anything else she wants.

What about you, Bruce? We don't know who's in your life. Anyone to celebrate us.

Say that again. I couldn't hear you, Joe.

I say, we don't know about your life. Who's who might you celebrate on Valentine's day if I.

Oh, my wife, we've been married about almost 11 years. Of course it's not the 1st marriage for either of us, but we we actually have 2 dances planned one the night before, and then one on Valentine's day.

What kind of dance.

Country country western type, stuff.

Wow!

Handle.

Yeah, it's it's important to us because we both love to do it. We've always done it even long before we met each other, but sadly, it's it's my only form of exercise. So we're pretty robust.

One more form of exercise more than I do. So where do you live?

Sorry.

Where do you live?

We're actually outside of Albuquerque, New Mexico.

Oh, okay. Been there a long time.

Yeah, actually, about 25 years.

So Rick is a fellow Southerner.

I'm sorry I couldn't.

Mr. Stockton, here is a fellow Southerner.

Whereabouts Rick.

Well, I'm over in San Antonio, but I've got an aunt who lives outside of Albuquerque.

Oh, wow!

Oh, yeah. and so well. Gosh! She moved back to Nashville already. I think she still lives out in Albuquerque.

Oh, oh! And we see each other online more than anything else. And and the guy that suggested that I join in this group Paul d'souza. You know he lives in New Mexico as well, but he's about 3 h drive from us.

Ron, can you co host me? Please.

Oh, yeah, that was the thing that you said you were. Gonna remind me to do every week.

Okay.

Currently.

That I shouldn't forget. Yeah. Yeah. And then promptly forgot.

Good.

You are now co-host.

I am. Thank you. Now. I can help you with that people into the.

Oh, thank you. So a number of people have declined. If you don't want to be live. That's fine just decline, Joe might, and you again. But don't take it personally.

So you might get a little annoyed. Stop asking me. But What I would do is I encourage everyone to accept, even if you choose not to come on camera, you can be a panelist and have your camera off. but at least then you'll be able to speak. and we'll be able to chat with you. We can't send a private note back and forth with folks who choose to stay as attendees. So that's another reason why I like to invite people up.

Do it all the time. Do my makeup on here, and.

Now I know that you were putting your makeup on. That's not something I have ever shared with the entire audience.

Oh, I have many times cause you tried to bully me and put my camera on.

Yeah. But then you write me saying I'm not ready yet.

I'm from the South. So it's big deal.

Alright. I think most on the panel will agree that you don't need the makeup, but.

So are you doing the promoting? So I don't have to.

I will. I know I just kind of got cornered into this makeup conversation.

Okay? Well, you do the promoting, and I'll do the chit chat. How's that sound?

So I think we should at least acknowledge our speaker, who's been very like watching us all talk with one another. He's like I thought I was the.

Good morning!

To not not planning to speak about, make medical devices, but so we can go to cosmetics. Probably the next sessions.

Now I definitely assumed that you spoke Spanish, but from where do you hail? There are many.

Step, and I we 500 years ago, we divided the world in half in half with the Spanish, so of more consideration. and because Portugal and Spain are 2 separate parts of the world.

Wonder. do most Portuguese people just get fed up with people coming in and talking Spanish at them, and like it's a different language.

No.

Portuguese speaks Spanish.

We are small countries, so we speak Spanish easily, because we being small, we are like I grew up with listening English from the us seeing soap operas from Brazil, TV cartoons from Spain the other day. We have a client in Italy. Okay, I said. Speak Italian. I'll I'll get half. I'll be managed to understand what you're saying. So we are quite. We are the flexible people. So when people come to Portugal to visit even see old, old people trying to change language, trying to understand. If you speak French or Spanish, they don't speak any of them, but they'll try to pick your language as much as possible, so.

Now, Eddie, you're European now. How many English languages do you speak.

According to my English wife, I don't even speak English, so you know.

So 0.

Yeah, pretty much.

Nikhil, how many languages do you speak.

Oh, yeah. So I I brought here small presentation.

Before you do. I just have to ask him, how many languages do you speak, sir?

I speak 4 languages, but out of which 3 are Indian dialects. So, apart from that, the 4th one's English.

And Feynman. How many languages do you speak.

Sorry I'll be speaking. It's 2 or 3 German, Dutch, and English. a little worth of French, so I can ask the way, but if they then answer in a very quick dialect, I'm totally lost.

Okay, well, let's turn our attention to our Portuguese guest who's here to entertain and educate us today. Miguel, what will we learn today? What's our? What do you want us to take away today?

Let me just brief you my presentation again. I I know that you may be already, quite used to see a lot of softwares and platforms being presented here to the group. I promise I'm not here to sell you anything in particular. Speaking with Shan. I we were speaking about this challenge of digital health medical devices, software as medical advice. And I wanted to bring a bit based on the work we are doing, not what we are doing at that we are the best platform. All this kind of conversation that I think, is not anything. But why? Why are we doing that? And why does it fit on the different kind of challenge of the regulatory world that I think all of us are so. It's a bit of this that I want to to bring you in as a discussion. I'll be based a bit on what we are doing now as as a digital platform.

But I'll promise the point is not to sell you to convince you of anything we are doing. I want mostly to convince you why we are doing those kind of things, and why, we'll see more and more of these tools being critical for the work we do. Just to start to give you a bit of of overview of who we are at compliant. We are team based in Portugal, but totally remote. So we have people in in, in in Brussels, in Latvia. People. We work with people all around Europe.

We're working with Celia. We love her. She's a she's a premium person, is she? Gonna I know she just had a child. Is she gonna join us today? Maybe.

No, no, she but she's in here in the office listening in, so she's she smiles with your comments. So she.

Oh, you're in an office now.

Yes, yes, yes, I'm just. I have to ask. You're not husband and wife, and you work. We are so.

Well, come on that. How I can't believe I had to probe like that. Bring the baby on.

Oh, she's sleeping now. She's sleeping now.

I don't care. Wake the child up.

She's sleeping. Well. Promise, then.

Oh, yeah. What about.

Right, maybe by the end of the presentation, and for God's sakes, yes, your wife has to come on. Otherwise we're just going to erase this whole presentation.

Okay, okay. So I'll say to join the the events on the link. But yeah. So so, bringing a bit on the team, we have been working with digital health, me personally, more on the business side for a lot of time. So helping startups to to get navigate these worlds. Sally, becoming also expert on this digital health space. And and we found out that the work as regulatory people do is quite boring on fixing things that does not make a sense in the digital world as today, as the as the knowledge around the medical device increase, especially when computers start creating knowledge that we need to process and a bit. On contrary, we've been working quite on this journey of digital health. We've been working with dime the past year on mapping.

How can you use the same evidence, or have a similar pathway to go to different countries around the world and and bring a bit of more clarity on the path for digital health around the world. We are doing a really interesting project. And I'll tell you I'm focusing on this because I think it's quite different from what many others are focusing is, how can you bring us digital solutions, eqms, solutions to universities? So when a Pg student or master student is doing already something that may become a medical device down the roads. We are not losing 10 years of data, because only when they do a spin off

and they get 5 million of investments. They they, they have a regulatory person and get into into a Qms solution. And we are losing so much data the way. And we are having this challenge of of bringing this additional solution for the Dutch universities. And we'll expand to other universities in Europe. And hopefully in the Us. Also, can we help on collecting data from from day? One of a project? We have been also working with different networks. working with providers. So we are quite trying to to help everyone navigate this challenge of getting a medical device as a software software, as medical device approved in into the markets. And truly we rarely see most of the teams, most of the people focusing on what is key. That is, how do I make a product of quality.

How do I make sure that the safety and the risks of my device are taking into consideration because they get so overwhelmed on filling out paperwork to please FDA or notified body that it becomes. We forget, as engineers that we are building a product that is critical and should be safe and of quality, and especially with software, because this mentality was not something that was driven. Most of the people in the software worlds. But the truth is that even on the software sides regulation is increasing oversight, and we are still having this clash, and in Europe we see it is much more than probably you are seeing now in the Us. Naturally, that is AI software medical advice

that is being developed by people that were used to to make prototypes of a software have bugs and have someone complain, and they fix the bugs when someone found it out. And now we need to tell them that you need to test things at the points that if there is a bug there, you cannot even put it in the market. You need to have to have fixed it before. And this is a change of mentality that's That probably was not a big issue before. But when we look to the investment of AI that the majority is in healthcare. If you just look to the number of of recalls for medical devices from FDA, and how majority of them. They are coming from software. More and more software is definitely the main source of risks that we see now. And

and what is for us, the challenge with software. And then we see with software, it's not that it's more complicated than doing most of the other medical devices. Is that truly, you never have a finalized product. You are every month you are releasing a new product every month you may be releasing, but something that may not be a medical device today. But tomorrow may be a medical device, and this boils down to some to to this clash with regulations when you start having more and more regulations. And and being European, we love to regulate things right? And and this is just a summary of European regulations. So Federal law to compare with the Us that covers the device size. So AI

medical devices you can be both. You have all liability attached to it. Then you have a bunch of regulations about data spaces. So yeah, creating data, how you access data, how you train a model with data. All of those kind of things have regulations, then personal data. data, privacy, all these aspects your device needs to comply regardless. If if it's just a medical device or not, then cyber security is cyber security that a hospital needs to comply, that need to ensure that every device that they put on the hospital complies with those kind of regulations. And honestly. we can complain a lot about the regulatory aspect of Europe. That is too much. But if you go to our engineering roots and biomedical engineering routes that

all those requirements are justified in 90% of them. It may be too much paperwork in some cases, but in general, how can you justify that those things are not required. So that's that's what would bring us to this kind of challenge of how do we manage this complexity? How? How do we look to the medical device, not at something at the regulatory things is something. Okay, let's let's let's speak with Michelle or other kind of experts. When we already have our amazing device. And we just want to go through FDA because we have no doubt that our device is amazing. And it's a challenge in software that a lot of the things you do early on really impact the results of what you're doing. I often say to to

to researchers of AI at the universities that 80% of the work that you are doing will go to garbage because you are not following basic data management procedures. That means that the model that you are created needs to be recreated with proper. in the proper way, to be deployed in in a hospital. and we connect this kind of challenges with more and more paperwork. So these are some statistics of of of FDA, of of the size of a 5 10 k. So we came to this world where where we are just creating more paper for the Regulator to see more paper, and I think many of the solutions that we are seeing out there coming up is, how can you use AI to create the paper quicker?

So honestly, what that lead is that we can even create more paper. And we're just increasing the paperwork about our products. And this is an old way of doing things. It makes sense. When there was not much paperwork. Even FDA today. Or, let's say, last year we're discussing how to use AI to streamline the revision of of paperwork. So we'll end up with these walls. If we just focus on doing things the old way, especially these digital health solutions or creating paperwork with AI for someone to read the paperwork with AI, and and and that's where we we, we are pushing, and many are also pushing for let's ditch documents and move focus on data. I think FDA is doing a good work on that sense or was doing. Let's always be careful with with what will happen from now on. But on, on

on stopping to have like a big technical augmentation. Pdf, like we have in Europe, or was previous submissions to have a more structured data of inputs, outputs. And and the point here is that we came to a challenge. And and was the motivation to create complier is, how can we create an ecosystem that really drives around data where we can communicate data between the stakeholders. And we can allow AI and machines to work with humans in that data. This is an overview of an initiative from the Iso of the smart standards where these are the level of

smartness, let's say, of the standards, so the standards themselves. But if you think about the technical augmentation, we can also see the parallels between the 2 worlds where we are still today in what is okay, let's not just have a Pdf file as a standard. Let's have something that the machine can read without Ocr to a point where we'll have a new standard coming up. and our in our team will receive tasks of things that need to change, that our team will have notes where I think they need to review on the technical documentation and where they will receive information because the machine was able to process and control what needs to be done.

and many. And if you think in the world that we'll see more and more a lot of our work being done by AI agents, how a lot of the regulatory work can be done automatically by AI agent, because there was a a new standard that poses some new requirements that can be done by AI agent that we we do not need to be in the loop, or doing all the steps in the way. We can just be on the loop along the way. And this is a bit. a bit of the of the vision that left. Let let us okay, let how can we create the software that helps to build on these new perspective of the world and not just trying to digitize the old way of doing things. And this bill boils down on connecting what is, how can you build a knowledge based

of of a software? And and and realizing that this knowledge base start being created, that's probably at university by Pg. Students before they even. There is a spinoff of the university. If you think about more deep tech kind of medical devices, and then it's a continuum of collecting data that we need to keep structure, that we need to keep collecting, and we'll move probably from stakeholder to stakeholder through the value chain, and then, when it arrives to a hospital and the hospital needs to assess that kind of compliance, it needs to have more automated ways to check the compliance along that journey, and when we speak about hospitals, it's because I don't believe regulators will be able to keep up

with all the regulation eventually will depend a lot on the relationships between entities, organizations. How can we communicate trust through the regulatory work and not just filling out paperwork for pleasing FDA officer. Yeah. So in this sense, this is the mission of complier and why we are focusing on building digital tool for this future of regulatory compliance, we see the need for digital health. The work that is done from more traditional medical devices is still hard. It can benefit a lot from digitalization. But digital health is not sustainable without it. If we do not bring a new level of digitalization, of managing this data, what we see is that there is a compromise.

It's just overwhelming that even auditors just don't check most of the things. Most of the things just pass because you, as a human being, you are not able to go through all the small details, all the small regulations. And this is a bit what we try to to to go around. It's not not how to decrease regulations. How can you make regulation more digestible for people? And this is a bit before jumping a bit. What we are doing as a solution. I just wanted to stop here with some of these gaps and hurdles that we felt along the way, and we see along the way that start from the beginning of the project, where most of the people do not know which regulations apply to them, and and just fixing this hurdle.

and and I remember some of the past sessions that you were discussing, some of you asking about, how can I guide someone? What they need to do with a certain level in some of the platforms. Just this is a big need that we found out.

I'm Miguel, allow me to interrupt. I've been.

I think Trap can probably have a bit of discussion at this stage.

I'm I'm very honest. I haven't listened to a word you've said in the last 10 min, because I have been chatting nonstop with your wife. I'm so excited to see her, and in that time I have learned that you have 20 people at your company which shocked me. and that I was like, Okay, you have investors. No, you're bootstracked. And I'm like, Okay, are you guys independently wealthy? No, not right now, not certainly with your newborn, and that in Portugal salaries are typically low. So your overhead isn't that bad, and that you are bootstrapping and funding this with your own money, but also that you and she have clients as a consultancy, and that the product that you're sharing with us today is not yet on the market.

I just think that that element would be interesting for a lot of entrepreneurs on this call that because I'm thinking, like, Wow, you guys just had a kid. And you're both in this. And so where's the stability? I would be very, very frightened to do what you're doing. So you're brave. I'll give you that. See that if you want to come off mute and talk to this a bit, I think that'd be interesting for folks. How you guys talked about this and say, so we doing this. I know that at your last company you did similar work. I'd be interested in like the conversation, Miguel. I don't know where you were before this. How you guys said this is the right thing for our family.

I think. Yes, please do.

Maybe maybe I can start Miguel feel free to jump in so we can do a little bit backwards. So to where this the idea for complair came from. So I was working before at Pic med I was doing regulatory affairs work, and we felt the pain that regulatory affairs people do, especially later times where it were paper based. Everything was, I mean. it's difficult to do all the work manually. Plus. I was learning a lot for just the company. And we knew that in Portugal and overall, especially for Software and AI, there was still not yet many people in that field. So it was. Miguel also comes a little bit from the regulatory field. I was doing a Phd. More focused in

more in the Miguel. Help me here.

Yeah, so so I've been working before coming to digital health on on the wild west of stem cells. And how we regulate these kind of innovations that you are that you cannot approve. Simply, I remember when I was speaking with Pharma, and biotech companies have no clue where the cells were were having inside the body. So how can I ensure that 1010 years from from injection they were not causing cancer in the brain, they have no clue where the cells were going. And and this brings a bit on this kind of challenge of AI like if you really try to ensure everything is 100 safe, then we don't have anything. But you have benefits. You are seeing benefits so regulating these innovations, something that was passion. And and again, we created completely full time. First.st I was. I've been working with the Ei

with European ecosystem of startups, so I know almost every startup in Europe quite connected with ecosystem. So it it makes easy for us to Bootstrap, because we don't start in Portugal. Simply, okay, try to to sell from Portugal. We have clients from Romania, from Estonia, from from big 500 companies, from the Us. That came from this network that we already had before. So I'll.

That stem cell work you did. Are are you with that company at all anymore?

No, no, no, it was part of my Phd. Studies. So so I was. I was doing some work with Mit back then, on this.

Completely. Now you just casually dropped my Phd. At Mit. I mean what? Come on.

I was like, who's this guy, Sean?

Is introducing us to, and then I have to pry to learn that not only are you Celia's husband, which is more important than the Phd. But that you just casually worked on stem cells, know everyone in Europe and went to Mit.

Yeah. But again, does not make the challenge easier to to fix.

Challenge any easier. You still have to market the product. But apparently so, how many ongoing consultancy jobs do you guys have while you're also developing a product to launch.

So I I was checking the numbers we have around 50, 20 clients at the same time.

Doesn't. This is not adding up. You are servicing 20 clients. You have 20 employees working on software development to launch, and you have a newborn.

No, our team is half consultants, so we have some here on that join, like Erlene, is also one of the rising stars in the fields working with us, and we also.

Applause for these people on camera. I mean, really, that is.

You know, plus for that.

Are you in the office?

Things.

We also have you in the in the list. I was seeing Maggie Oliver that is doing her Phd. With us on regulatory science, so she's even more brave because doing a Phd. In this field is even for the bravest. But yeah, but in a nutshell, I think what? And I think this group discussion about regulatory, improving things is what drivers in the end, when they did the jump, we don't feel that anyone is our competitor in the end. There's so much thing to be done. If any of us can really help creating more awareness, simplifying things helping each of their clients to become a better product. We are helping so many more, so many people. So I think we, I really like this work as community more than just feeling that we are competing, and and that makes easy easy the risk. Because in this, in the in the I

I was commenting mission, we don't do much advertising per se like. Probably you can. This kind of events can be a bit of advertising for some reason, but usually there is so many companies entrepreneurs, innovators a bit lost in these fields that I wish to have more expert people to recommend to many of the times. So we don't need to 20 people, but the 20 projects at the same time.

Before we put your slides back on and again I've already admitted that I haven't listened to a word you said. Can you help me understand? What what are you doing that you feel no one is doing? There's plenty of software out there. So what do you feel is missing from everyone that you need to develop your own thing.

So as I was explaining in my my part. But I'll be. I'll come back for you, and is that we? We are in the business that we are managing knowledge. And we need to manage this data across different areas. And it's the connection between this knowledge that allow us to bring the world of AI inside of healthcare. So having AI system or software that is really focused on my Qms or my data privacy or my technical documentation, or my post-market surveillance is too scattered to be really causing impacts, because that means that we will never replacing the brains of cellular. And many of here that are the brains of the companies that know where in that paper something is when you need to change. And this is kind of connecting that we felt. Okay, we see a lot of software that help

to to do documentation. By the way, we started completely before Chatgpt. So there was, no, I think I'm not sure if green light Guru was launching AI solution by then, in 2010, through 2021, but none of the other. AI solutions existed. But by then

What was your insight then, or were you were you aware enough that it was coming, and you were building and waiting for this piece to be dropped in, I mean.

Yes, yes, yes, of course, our roadmap was. Let's let's get a lot of clients. Let's get a lot of data and then learn from the data how things connect with each other and build AI. Now, we have these fundamental models that know much more than we do many of the times. They are just pretty good liars, so we need to be careful, because they, when they don't know, they pretend really well, they that they know, but they know a lot a lot more than probably much of our clients. So how can we help now? We are able to help them to do a quality of work that, together with humans, can really expedite a lot of the journey. The challenge we see with is the health. And that's that's where on the difference is that nobody's looking to the full vertical. So we are many times trying to to solve.

I do post-market clinical follow-ups or do Pms studies. How do I bring AI to fix that? My kind of job? But how things are interconnected. For instance, we we are working with some some partners that are building these tools with AI for literature, research, literature to review. How can we provide them? The keywords. So to be able to search because we know the products. And we can drive people.

That are acutely interesting to me, and I I kind of knew this before. But you've said it in a crystallized way. I've not heard before, and that is that when Chat Gpt or its equivalent doesn't know the answer they make shit up to make like they know the answer, Do you? Are you aware of any safeguards being built so that Chat Gpt can be mature enough to say, I don't know. Let me get back to you as opposed to giving us bad information? That's question one question 2 is. isn't there some kind of industry leader in this space that has a lot more money and a lot more resources than you, I mean. Rick writes. Build a better mousetrap. The world will be the path to your door. But

isn't someone else trying to do the same thing? You are like. Why, why do you believe that you can do it relative to some? I don't even know who the players are. Some big player trying to do what you're doing.

So. I I think we have touching 1st on the AI topic. And again, that's what I was saying. We do regulatory science. We have multiple project that that we are working with our clients, how to develop AI validation methods and how we develop AI models for healthcare, that then we can also apply to these fields, and many of those concerns the same concern. How do? How do I give a wrong diagnostic to a patient ends to be also. How do I give a wrong risk to? To, to a manufacturer to be put on? And and and this is a level of work that that we, we understand that we need to work on that sides.

And the beauty of this is that the big players like Google Openai, they are focusing on the big models. They are the internet of the New age. So they are building the servers. They are building the connections. They are building the browsers. They are not building the apps, the specific apps that will be that need need to bring this knowledge. So with that way, you rule out the big players. those big tech players. This is not their their fields. This needs to come from us. So from who is expert in the field, in the in the terrain, who is doing regulatory work and understands what are the hurdles? Those are the ones that can build this niche

models that are really tailored to our practice, and in that sense there is also something on our story that we are a bit different from. Probably many of the big players out there is that we are not selling to big Med Tech. We are not selling to big pharma. Those have different challenges that we are solving the digitalization of big companies is a big challenge for anyone to sell to. We are working with universities from day one. And and when we go through the product. I'll highlight this kind of challenges. How do I convince the Phd students to document risks?

These are our challenge. And and I don't see anyone at this stage focusing on these kind of challenges. We there are many building tools for the risk risk managers for the risk engineers for the quality assurance people, but those those are just part of the story in the end. Those are the people that suffer a lot because someone didn't do their job before. And this is what we do understood. That we need to fix is, how can we fix the collection of data when it's generated? And that is how we convince someone to use a tool that is not built to build rockets and go to the moon when they just need to collect some risks

during their Phd work. And and this is an angle that's that we believe that's that we don't see others looking into it. They are fixing issues for many of us on our specific rules, not the the ones that don't want to listen about regulatory.

Michelle, you had your hand raised.

Oh, yeah. So this is he got at the heart of why, I generally don't recommend Eq. Message because they were not designed for medical devices. They were not size companies. They were a giants of like automotive, like aerospace, like all those things. And they're like, oh, all these things can be shoved onto medical devices. And then they impose controls that were not needed. And they didn't have controls that were needed. And it just created chaos. And I also like, have a adversity to the word agile.

because it means that we are anti documentation. and we do not generate anything that the FDA wants to see, because the FDA still wants to see a document come out of an Eqms. And so few can do it.

Agile is anti documentation.

Oh, oh, for sure, Luke is gonna describe it. Yep. Oh, as a as a regulator, I've never gotten what I needed to put in a submission from an agile process. I'll just say that.

No, I I agree with the agile is only useful in the in the in the proof of concept phase of of of a device or a product. Then you can do quick things. But the moment you start with design controls, you're you're you're you're into a change management. And that kind of stuff now. But but I was triggered by the by the slide where you made the comparison between a medical device and software as a medical device because it would add so many loops. But isn't. Doesn't that stem from the general behavior of programmers to white code and bring it out very fast without checking it. First, st I mean in in I know a company in the Netherlands that make an hospital information system that's huge.

And they were very successful. And I said, Well, bringing a medical device to market is a lot harder than a bit of software. And then he said, Yeah, but listen to this. There are always changing regulations from the from the government. There are always people wanted to have extra features, this and extra things there, and he said. What our strongest point is is that we have built such a system that we can verify and validate our software that we can, if you, if we have to stop now, we have validated in 2 weeks. And it's these are huge systems. So that that is the biggest advantage of how they make their their their software. So with software as a medical device or AI is a medical device.

If if at 1st there would be much more emphasis on what you build, you have to validate and and and verify it. You have validation and verification. In the beginning. You, you invent something you already must think, and how can I verify and and validate it? And then I don't think you have that much loops in your in your development process.

Yeah, if I can bring it. I think I can touch in 2 points that are relevant to this discussion. First, st more than the speeds of of things. And one thing we discovered, and we only work with digital health. And what we discover is that when someone comes to us is my device, a medical device, and I know more. Michelle. Here. I don't know who's more in the audience. Does this work daily on helping someone to understand. If they are a medical device or not, I cannot assume just what they tell me. I need to consider all the scenarios of what they may be building. because my client as usually startups the moment they start speaking with a doctor, they may quickly go from what is not a medical device today to a medical device in 2 weeks, because they just add a new feature.

And this new feature is probably only 5% more than the rest of things. But more than just the jalit constant releases is is because you need to maintain multiple scenarios that still exists inside the company. Probably only when comes to the to the markets next month, but you may have it, it reappearing as a medical advice later on. And and this journey touch on the second point, what you're saying is, how do I educates the Pg student? How do I educate the software engineer that is rushing to launch their product because they feel this drill, this. Okay, I need to deploy this on on understanding that there is this traceability of things, and we struggle so much on on like with gyro on. We have clients that took one year

just to implement basic implementation of things in gyra. And and it's a bit of our control because those tools are not well were not built for traceability, while if I show to someone, here is your requirements. you need to have a test in the end to close this loop, it creates more the mentality of the basic principles of of traceability, of, if you have a requirement, you need to have a test in the end. And then it builds up that many of those tests today with the software, they are automatic. They are. You need to connect to the codes. The documentation may be generated by the codes directly as they run things, and you leave part for humans to to check part of those humans that now can be done with AI, many of the cases. And this is a bit of the challenge that we are trying to build a bit for these worlds, because, of course, traceability is the backbone of every Qms. That does not work only with documents, also work with data.

But but the point is I I think you. You point. How can you bring this education to the, to to early on? How can we really educate people that do not know what is traceability, or at least they don't understand the power of traceability. And and keep it as simple as as them, because before they go to the big Eqms solution that Michelle was mentioning. They need to have a light version of it, but they are already building data that needs to feed, to feed to more complex systems. Down the roads.

Fair enough I have. I read you off script. Go ahead and bring your slides back, and

No, no.

Thank you for indulging.

Okay, I promise that you are. I was not here to sell our solution. So I think this is.

Want to hear about it, so please re-engage us with the presentation.

Is, is the vision of of the world that's honestly, the more the more that can also help to build this, the best, we are not sure.

By the way, that Carolina is a member of your team. Just quickly, Carolina, if you come off mute, how did you discover them? Are you a doctor? getting your doctorate?

No, no! I worked before at Sgs notified body, and I was giving a class at university. My previous university, and my teacher told me about Complier that there was a startup in Portugal doing more or less the same as I was doing at Sgs. And I decided to just send an email, see if we can introduce myself to Miguel. And at the same day I had the job offer in my email. So we had a meeting. And yeah, it was just a click. And since July that I'm working for for complia.

Very nice. Well, good luck in your young career. Okay.

Thank you.

Please continue.

It's not every day that that you can have someone coming from a notified body to a startup. Usually they are the ones stealing people from startups. So is is good.

And yeah, and we we usually don't hire people on the same day. It was our fastest hire for sure. But yeah, we didn't want to lose her.

Yeah. Yeah. So let me, just, I'll explain a bit of the pieces of the things that we're doing in our platform. And again. Why, we're doing that. That's that for me, I think. And and again. we are not sure that this will be the solution. We are not sure that this will will fix the the issues that I mentioned. We are trying to take a take into into it. And and and that's that's the purpose of of what we are building is is to to try to solve this complexity in a simple way, and that is the hardest thing to do. In in in the end. so in in a nutshell. We are bringing together with the with this, what you can call electronic ums.

electronical technical documentation system alongside with these products and strategy definitions. So how can we help someone to understand what regulations apply to them if they need to be a medical device, if they are not a medical device, do I need to comply with AI act? So everything that goes around these to health solutions. So not just for medical devices. And that builds collaboration. insight, so collaboration within the team, but also collaboration across organizations. And and and and just just before our session. We are having a session on AI on the AI Act in Europe, and I was having someone asking, Can we use Chat Gpt for our medical device.

and I said, Yes, you can. As long as they have the documentation that you are required to provide for your medical advice, and, as far as I know, Openai does not provide that technical documentation on how they train the data, how they do a lot of the stuff. And this bows a bit on this idea, on this perspective of the digital health worlds, where things are so interconnected between different entities that we need to think about documentation and data, not within how I, as a big company, I manage different departments. But how do I really have a technical documentation that starts at the university goes probably gets some parts from Openai.

goes to a startup and then is acquired by a big Med Tech company. And through that journey that data needs to support compliance requirements along the way. So, we have a focus, of course, on how can we help people to classify if a medical device this in Europe is a big challenge, especially for software. We did a thesis just on how to improve the framework to classify a medical device. We are deploying AI to help to reply to those questions. So we so we can do it at scale. So imagine that every student at university may understand, if their product may be a medical device or not, as you can understand, I'll not be able to Bootstrap, if that's my work.

As a consultants have to charge 10 years per hour to be able to to do so. So our, how can we scale this, this initial support? So tell me about your products. We we guide you through reply to questions based on with AI, and in the end you get you. You get an answer of your medical advice or not that then you can discuss with a human with an expert. But but expedite all that process. If you want to interrupt and make any question, let me know. I'll just go through some of the features, and leaving the best to the ends. I think that some of the others are more like we need to have that, because otherwise you cannot replace other Qms. But a bit on the end. I left the things that we want to to

to really do differently. But at this stage

We go as your marketing friend, I'll offer unsolicited counsel on this slide, for example, it's pretty, but you're using so much white space and the screen. I would sooner take off the logo, take off future. I take off everything other than the screen, because I can't make out what any of those boxes say in the future.

Bye. Good point. But he he!

Now, what you can do is take it off this pretty way, and just show us the whole slide and make it bigger, so we can see what's in the middle. Thank you. That's better.

Yeah, yeah. But but you know, not going in much detail. Here is mostly how we how we try to structure the information through data in data slots. So what are requirements? What are risks? Not not playing with documents already. So the the goal is how we document data, not how we document how we do a documents in the end in focus on the data, because the data we'll translate in the document for FDA in a different format will translate to to different purpose in different formats. And and we want to organize these across data formats. The big hurdle that we are having and and sharing with you. Here is we. We need standards around

data structure for regulatory, and that is still start to be built in some. FDA is trying to do that with their stars. There is some discussions out, how, what is the composition of Internet purpose? And so on. But I think.

The regulatory bodies themselves don't have standards. So how are you supposed to build standards for them?

That's that's what I'm saying. This is something we don't aim to solve. But we will see this transition happening in the future. Where will be easy for me to migrate my data to FDA, because we have a standard way of communicating regulatory data of a medical device. Until then very much in your space, Michelle. May I ask you to come back on camera.

And ask of the team questions that are relevant to how you might use a product like this, because this is well out of my wheelhouse like this screen, for example. Do you know how you would use it, or why you would use it? Michelle lot.

Well, this is fascinating, because I have a new client that has got a interesting AI project that may or may not be a medical device. But when we're getting into this Ehr data export, that's a big deal with the 21st century cures in the Us. So it's interesting to see, like some of these things that I'm working through right now from a whole different regulatory perspective, you know, kind of being built in.

Good.

Back a few slides or refresh my memory. A few minutes ago I was gonna comment on something you said, and I can't remember now, because I am of that age.

What was was on this slide, or a previous slide before.

No.

Is it on the the screen before where he showed another picture of the product that one.

No.

So the previous slide. This was before we we are speaking.

Okay.

One conversation.

Talking about something.

You stay on camera because I

Yeah, but but but but for for the sake of time, I'm just going through some of these initial features in in a bit more like an overview of things again again, this shouldn't. These are saying this is not novelties. for sure. This is how we look into that, and making sure that you can keep track of of the full journey, of what is being done. What I wanted to show here on on the slides that I hope, is a bit more zoom here. That makes it easier to to see is that we are bringing. We face this challenge when we start working with universities is okay. We have this big fancy. We can collect every data about your medical device. But what do I need to see when I'm at the concept phase.

Imagine, Michelle, okay, you only want to know, what is this a medical device or not? I just want you to provide me this information. I don't want to to see all the rest of the things. I don't want to overburden this Pg. Student that come to.

It will do the classification for you like if you are a medical device or not like, or if you're a Cds Cdx.

This is one of this is one of the features of classification helping to classify. What I I was bringing here is is, how can we? How can we have different lenses to look to the same Eqms. So we can have a light version for those of concept phase. They don't need to fill a lot of things yet, but at the same time we can.

I'm gonna completely interrupt. Andre, are you okay? Okay? Sleeping is one thing. You just look unwell, like we're alarmed. I'm alarmed. Come off off mute, and assure us that you are okay.

I'm fine. I'm just fixing my watch.

It's in your watch.

How embarrassing for all of us.

Please continue to fix your watch, Miguel. Sorry to interrupt.

No problem, no problem. So.

My conferences either. So we already have an issue with Andre.

I. I was bringing more in this point of the guidance because of the the key challenge and and what we we are building with our clients. And and these use cases. How can we keep this simpler, not not aiming to have a simple platform that that does not do most of what what we do. But how can we keep it simple to the, to the correct, to the to the stage, that the user is. And that's that's the tricky. So we need a platform to evolve with the user and not have the user move from platforms because they evolved. And and this is a bit of the tricky of what we are trying to to have a mechanism that allow people to. Okay. You don't need to care about risk at this moment. This is not the stage. You are focus on this, and we can guide them at this stage.

But yeah. And and another thing, when we go into documents, and Michelle was saying, we still need. We still need live in a in a, in a wall of documents. And and here there is a lot of solutions that help you to create documents in a more automated way out of data. Our take on here and actually was the main motivation for Complier platform when we created this? Why the hell we have that on the documents. what what rule or or good guidance justify that paragraph? Why do I need to do management reviews every year? Where is the rule that says that I need to do so? And if you work with clients as consultants. They question everything that you ask them to do until you show them the rule that they need. Okay, this is by law. We need to do so.

So we felt that we had to bring this knowledge base, this knowledge graph of the product also to the knowledge around the products. And how can we pinpoint to specific points, or why you're collecting the risks? Why, this paragraph is like this to to not only, but the regulation standards and so on. Yes, Michelle.

Is that like, is this like a end to end solution? So like, it's got everything from initial design development, like user needs all the way through design and then into commercialization, like the activities that you have to do in commercialization. So it's like the whole package.

Yeah, that that's all saying that that is data. But that is data for someone that concept face. They don't need to care. And if you show them that they have 20 menus to go through. they get overburdened. So how can we show? Okay, at this stage focus on that when you're ready in the market. Then other data pieces appear.

So. Was that a yes, yes, yes, yes, yes, yes.

Was nodding with my head. But I was bringing this. This knowledge graph is something that we felt that nobody was tackling is, how do I bring the knowledge of what I need to know? Why do I need to do certain things to the point where I wrote something? Because this is the challenge of How do I come back to certain things? And and what we see in the industry is that we have a lot of artifacts from big companies. And I think, Michelle, you speak about it some of the times that. Okay, why do we have this procedure? Nobody knows why we we someone.

Exactly exactly, and that I see a lot of software companies. They're just chasing the enterprise because as soon as they get funded. And this just happened to green Light, Guru especially. They get private equity, like all the regulations and the stuff that actually matters is out the window. It's all about like, did you get enterprise client? So also just happen to Basil systems, and that's all that they're after is the enterprise. And the enterprise does not really understand the regulations anymore.

So this, actually, I forgot to pinpoint. We are bootstrapping because we want to avoid to bring investors in, because the moment you bring investors. They want to to to Siemens and and the big guys. And and and you can look to many of our competitors. The big guys can call it. They are not tailoring to the same clients that we are, because if you.

Good for you only.

Shopping is a struggle. I would prefer to have 10 million in the bank and and focus on product development. But at this stage we. We try to balance bootstrapping. building things with our clients and and building a software that can tailor to to to a new world. I'll not say that it's not something. We'll get more money than the others. It's just at the point that is really hard to convince us why you are not selling to Siemens and solving Siemens issues. When when we try to solve a Phd.

Lot of people that threw millions of dollars into trying to customize their product. For like a big company like you said, like millions, millions and millions, just for this one installation, and no other client wanted that. And so once they made the money off that one installation, it was just a subscription after that. you know, and and they could have spent the millions like making their product actually do what needed to do, not what Siemens thought of how design controls worked.

So I'm gonna interrupt for a second and because a lot of people are jumping off the call, so I wanted to highlight a couple of things. One, this kind of interaction that we're having. And the idea that we've, you know, presented a software company which is tailored to the smaller enterprise. or the smaller Device company is is really essential. I would like to underscore how you can collaborate each of you with Miguel and Company. Complier. And I'm gonna put his email address in the shot.

And you can also interact with Celia on Mdg premium.

In Celia, on Mdg. Premium.

So.

I invite you to collaborate with them? And to form a connection. It may be that you have clients that could use this product. It may be that you could use this product. It may be but it it's definitely worth exploring further. And I'm sorry that we're running out of time. But this is fascinating, so we'll have to have them back.

And do you have something.

No? Well for me this is interesting. But it's not me. It's my team who actually need to connect with you guys, the folks who actually know things about technical files. As Michelle knows, I know very little.

That's been already.

Well as of today. We have, just extended an offer that's been accepted for our I think this will be our 8th employee and have sales commenced. As a matter of fact, we are shipping 5 boxes to 3 countries next week.

And each box contains what.

15 devices, so a year supply for each person, or 3 months for 5 people.

Think I knew you before you became really rich.

We're not there yet.

I know, but that's why I need more.

Yeah, no. And we had one of our devices most recently was used. It's supposed to be for 30 days, and the urologist said, it's not working.

Stop talking at.

It was no, we put a notice. We put a notice.

Stop.

We put a notice.

Should I cut off his mic? Michelle.

Yeah.

Actually this interesting part of Michelle on the metaph space. I remember organizing some webinars with Pharma, and we couldn't have even the comments on, because if there is any comment it will be a big issue with within the company, and I never saw the company, especially small ones, to care about social media monitoring of yeah. Cool point, it's interesting how same rules for the 2 different industries

I just have Ed's best interest at heart. I don't think anybody else would have told Ed. I talking.

And I appreciate it. Michelle.

It is pretty cold, though I'll just say that like you, you can say is, it was pretty cool.

Yeah, no, it was me, too. Now, what would be the best thing to come out of today's conversation. Are you looking for beta testers. What! What could a group like this do for you? Most.

No. So so definitely. So we'll be focusing on 2025 to to said, I'm not here to sell. We went to better, because.

We got not selling. We got it, but.

You.

What do you need most.

So we'll be launching our platform a a better version by the end of of next month. So those that wants to give feedback. Try, say, okay, this is, we really want to fine tune the usability to make sure that we keep things as simple as possible. 2 things complicated. I think everyone here knows how to do it. The complex parts, how this is fully complex, but how to put it simple, we really need to build it with people. So if you have people in your team that's feel this struggle. And I think most of people feel the struggle. We'll love to have inputs to understand. How can we keep this again? Not customized to you like Michelle was saying. Not that the purpose, but really makes sense that this makes sense to be used.

When this is fully functional, what will your clients stop doing? What will this replace in their current routine?

This will replace their Eqms solution. So they do not need to trying to fit things on gyro to to implement flexibility. They do not need to to move.

Virtual Qms. And paper.

Yes, so, and they did stop using paper so and.

See, are you? You're not a panelist, but I can have you talk a major thing available. If you want to ask your question on camera, or, if you need me to read it, Stephanie.

I'll do. I'll do it without camera. Stephanie Grassman here. I just came back from holiday so apologies that I'm not on camera. I just have a question with regards to electronic signatures I've had in the past where one of manufacturers submitted the technical file and had added my signature to the technical file. This was a previous customer of mine, and then I've got a deficiency report, and I was asked to address all the deficiencies. So I said, This is not my my work. And then they said, Well, your signatures here. And then I got passed on the Microsoft word document, and my signature had been copied into the technical file and like into the clinical evaluation. Have you looked at electronic signatures? For for me? It's really important.

That's broad.

My signature doesn't get copied into something. That I haven't done.

No, that's a good point. Because definitely one thing that our clients will stop using and caring is about this electronic signatures and move to to FDA compliance signatures that will shew the voids what happened to you, because your signature will never appear in our platform, or a stamp of approval by you if if someone does not have your password and your login, and and definitely the the old way, most a lot of companies when they just have a print copy of a signature and is in the document. It's really easy to do this kind of frauds without any kind of control. But yeah, definitely that is part essential part of of

of the platform definitely.

Thank you.

When.

You describe it? Part 11 FDA. Part 11. Compliance, that is, is something we need to have.

You have a sense when you are fully functional. what kind of price point you're looking at.

So the pricing is actually something we're experimenting because we want to attach pricing to value and not users. How that should play around is not yet fully clear. How can we capture the value of using the platform? And I see values.

Oh, so you're gonna try to not make it. A number of people that are actually on the.

That is stupid. You want collaboration in your.

Exactly exactly, because then people like don't put people on it that need to be on it, because they only have so many seats.

Or they'll just use different people the same. The same account, which also is not the purpose.

Yeah.

It does not make sense.

Someone to put in.

Like the Stephanie's question just now.

Okay, so the company has a license. Can you give us a sense? I I don't know what it is relative to what they're presently paying for their Qms solutions. Can you argue with parity? Higher, lower, but.

The the cost of software is low. So we we, the point is, how much how much does it make sense to be sustainable. and that help us because we don't need to please investors. And that's why we try to avoid investors as much as we can for that purpose. And and then the second point is that there is a new way of working with these platforms where you are working with AI agents. We are working with automations, and for us make more sense to embed this kind of helpers around the platform that you pay for when he needs. But we have a basic level of things that you can do without even paying. And we will be doing that with universities like.

yeah, it boils down what Michelle was saying, how, what kind of pricing schemes that actually do not promote compliance because people avoid it later on, before they have money, or they don't bring their team because they're paying for users, and that's why. How can we attach to to the value for me will be perfect if I just get paid if they get approved by FDA. They pay much more than probably pay for the other Qms. But at least we are lines only if I help them they get paid is a bit of still things that we are exploring. How can we go away from the more typical software as a service payment scheme that many solutions have so pricing wise, we can always be cheaper than the others. That is not the issue. We just want to make sure that we we share the value with with our clients.

Smart.

This is new shaping one. You're 15 min past the hour. Do you have a closing clock for us?

I have for them. So one of the best pieces of advice that I got was, Get them using the product, and the money will come. I think, that you should focus on usage. I think that you should focus on getting people hooked on the product, getting them, loving the product, getting them evangelizing about the product. And the money will come. So focus on usability, focus on utility.

Sounds like. There they are!

Yeah.

I mean our our 1st clients clients from consultancy. Some of them are waiting for for for the platform, so they'll be our our 1st users and hopefully our eventually send the ones that will be telling good things about about the platform. And then from from there we can evolve into selling these, not as a within the service, but as a as a product by by itself. Exactly how yeah, like, Miguel was saying, still trying to better understand the pricing and.

Copy what everyone does. So it's not that we have no clue that we don't have. We could not say something that will be objective. But I think a bit of our challenge of innovators in this field is, how can we not go in the same path that everyone goes.

I'm putting in the chat for everyone. An article I wrote a long time ago called You Make me blush. and it is my prescription for how to get the best testimonials. But when it does come time for someone to maybe say something nice. That's that's something that you can do next week. We have Kevin talking about finding the right Med tech opportunities at the right time. And then the week after Fan, favorite Michelle Lott returns in her glory with Rene to talk us to us about commercialization pitfalls. And if I'm not mistaken, you just held a webinar on that topic, and how did that go.

We did. We had great feedback, a lot of questions, and people seem to appreciate the perspectives that we shared. And so Renee and I were 2 halves of a whole.

Or.

As well to like everything that you need to bring a medical device to market except for regulatory. No, no, except for reimbursement. Sorry I'm regulatory except for reimbursement. Me and Rene check all the boxes together. It's just.

Part was is that at the end of it she launched a program called a Lean launch Pad, which is specifically designed for startups and offers a a set consulting price per month. So it's basically consulting as a service. And you're able to access this at a set fee which makes your development predictable. And so that this is ideal for any small company that's like, we need some help. We don't need help all the time. We're not ready to hire yet, you know, and the response has been fantastic. So we're getting ready to go.

We? We had people sign up immediately. That's wild.

We created a landing page for it. I'll share the landing page. With the group.

Parching. Is it a? Is it like a subscription? Michelle.

A little bit.

A little bit like a subscription or a little bit of money.

Both both, and so like you can sign up for a discount for a longer period of time, but it can be month like month to month if you want it, or you get a discount if you like. Sign up for 3, 3 months. So, and then you get access to me to Rene, to our clinical person, to like all our above compatibility, like who whoever you need for what you're doing, we can plug in for that fee, for, you know, 2 HA month.

And

And then on top of that, you get like an office hours, and like a general question, you know, that would be.

Nice.

For the group.

Good luck with that for those of you who are Mdg. Premium members Celia has promised that she will post a picture of their daughter in baby pictures. The rest of you. Sorry. Just wanted to bet.

What about? What about pet pictures? Do you have dogs or cats?

You can do that absolutely. I think we still have a pet look.

Should have a channel.

It's not as it's not as there aren't as many members in the Pet Lovers group, but you are certainly welcome to continue to share pictures of.

Let's say they have a officer role at the company. Right? Not not, you know. Professional pets like yours. Right.

That's.

You're not on your c-suite. Is that what you're saying?

Yeah, so, only.

Pets are actually pets instead of your bosses.

You're the only person I know that has her pets on the Executive Committee.

They're taskmasters. I'll tell you that.

I bet they are. This was.

You guys did a great job.

Today.

Celia and Miguel.

And a nice surprise slipping in the wife part there that I had no idea to expect so lovely to see you, Celia. And really great wishing you a lot of success. And I know you guys are on little sleep and you're doing a lot. You're welcome here any Friday to join us, perhaps at least 2 weeks from now, when Michelle returns in her glory. It's been a while since we've had her as featured guest. Sean, I need at least 15 min to recharge, and then let's you and I reconnect and talk about 10 x, and by the way, next week. Valentine's day is the last of the early bird days for those of you who are planning to come to get in at the discount.

Sean, thank you for coordinating this today, and thank you all for joining. We will see you next week. Goodbye, for now.

Alright!

Thank you, Miguel.

Thank you.

Thank you all.