Take advantage of Canada, eh YES!! 0% Tariff, IMDRF, and, and, and... Stephanie Grassman, MedTechXperts LLC

Right? Okay, good. So, yeah, I was talking to Sean about what we could talk about and stuff on Friday, and I said, you know, it's… there's so many interesting developments, and… I said, okay, let's talk about this whole situation that we find ourselves in. So, my… my title of my talk is Take Advantage of Canada A, And of course, yes, this situation has changed to the better since September 1st, and I'm going to go more into detail. Oops. So, just to mention, my presentation is just for educational purposes only. It doesn't replace the legal text of legislation, standards, or guidance documents.

It's my personal opinions. And I'm a subject matter expert in the medical device regulations, but I'm certainly not a custom tariff lawyer, customs broker, import specialist, and so on and so forth. I just want to make that clear for everybody. Just a quick presentation of my firm. We support med tech companies in regulatory affairs, quality management, audits, Engineering, clinical evaluations, Investigations. And we bring together a network of employees and partners with 20-plus years of work experience in the MedTech area. And our motto is Supporting Expediating Market Access and the Success of You and Your Medical Device.

So, to me, who the heck am I? I'm a Canadian, and also Swiss, and the Managing Director of MedTech Expert since 2016. I've worked internationally in a quality management environment, For over 30 years? I've had different varying roles, as you can see. Also varying expertise as well. And as a Canadian, I got all my education, actually, in Canada. So I have a Master of Science of Biomedical Engineering for the University of Calgary, and a Bachelor of Science in Mechanical Engineering. And I've been living in Switzerland since 1998, so you sort of frame this whole presentation.

So why I want to talk about this topic? Well, we have tariffs that have been imposed by the United States. There's a lot of countries that are struggling with the circumstances right now. In my particular case, because I'm in Switzerland. Swiss manufacturers are scared. Some are even actually holding back their stock. And… you know, based on a lot of meetings I've gone to, there's lots of concern, and we don't know what to do, yeah? That was always the statement in different meetings that I've gone to. I thought to myself, there's got to be another way. Soap. I just want to put out the question to the crowd. Who's affected by this tariff situation? Is anybody noticing changes in projects or situations that they want to share?

Was everything hunky-dory and wonderful?

I personally have noticed and have gotten comments from many, many people that the uncertainty, around the tariffs and many other things simultaneously has led to a market slowdown and a delay in projects by many, many companies, and they're saying, well, maybe Q3, well, maybe Q4, well, maybe Q1 of next year. And it's affecting, I think, a lot of the people on this call in terms of being consultants, being service providers to the med tech industry. That's… where I see the biggest slowdown is in the tangentially related businesses. Any thoughts, comments from anyone else?

Yeah, I've had the same… I've got a client in the, that does haptic glove tech, for disabled people, so it's not really a full-blown… medical device, but they're working with, well, I suppose it is, with, heart patients, right? People that had stroke. They've rerouted and redesigned their entire global supply chain. to not finish the goods in China, just get components. And, restructured the entire, manufacturing or assembly process, if you would, and they're bringing that, actually, and trying to assemble them. They're a startup, so the volumes are not high. They're trying to actually do it in the U.S. and Florida.

And they're not having a good time. So they bring in pieces, and they're not bringing in the whole product, and trying to, and actually they're routing them through… European country. So, China to Europe, Europe to the US, to get different set of taxes. And then assembly in the US. And a non-medical device company made… a product made in India for the tariffs. I've actually opened up a 3PL for them in Mexico and Guadala. So… tariffs… I'm doing a lot of work in the tariff space, global supply chains.

Anyone else?

Yeah, we, we've… had a… we had a pre-sub meeting with, the FDA in, 2024, but right now we've completely deprioritized the U.S. market, you know, We got… the nice thing is we got a lot of other things to focus on, but, and we're not dependent on… on that, but, it's… There's a… there's a phrase, ends with show, I can't remember the first part of it, but, I…

Don't go there.

No, no, no, no.

Thank you. Anyone else care to comment? Okay.

Hey, this is Maya. Yeah, we're certainly seeing some, much higher, duties and taxes to have to pay. Our headquarters is located in Denmark, and our products are made in Denmark, and then we ship them over here, and, yeah, it's… it's a lot more than it used to be, so yeah, it's definitely… I mean, we're starting to look into possibly producing here in the U.S. as well, I guess partly to… I guess, get around, or avoid that, the tariff, issue. And also just for, I guess, for… ease and, and yeah, quicker shipping, but that's, you know, it's kind of a big project to get started, and it might take a little while, so, so yeah.

Right, and with the uncertainty as to how this is going to shake out, I think that a lot of companies are like, well, I don't want to make that huge investment just to see all this reversed in a month, so that's kind of the situation. Stephanie, you want to continue?

Yeah. Oh, can I say something?

Yeah.

Sure.

So, as you know, we are… Devil Medical, we're representing, you know, over 140 foreign manufacturing companies. We're doing their importation for the U.S, so I'm well pleased to know what's going on right now, because we've been dealing… with this since the beginning. I think it's not a right idea to, you know, to start manufacturing in the US, because as you said, you know, it could change in one month. With the new election in midterm, it could change the power also. So it means that maybe the president will have less power in a year and a half with the new, midterm election. So we tell our customer, don't panic, you know, let's wait and see for now, but most of them, what they did, they shipped more product before the tariff hits. So we have two warehouse in Miami, so we have… for us, that was a good thing, because, you know, we can charge more, because they have more product.

One of the big E, issues is that when people try to say, oh, we're gonna reduce the transfer price to the distributor, so you're gonna offset that 10%, or the 15%, or the 20%, well, this is illegal, so you cannot do that. If custom caught you doing this. they could fine you. So, don't do that, you know? You could do it if you had a written document that says that before that, you know, the tariff hits, you have that agreement between the manufacturing company and the distributor to reduce by 10%. But be very, very careful, because if they see that, you know, that discount equaled the tariff.

it's illegal, so don't do that. And, we… on 148 customers, I say probably maybe only 5 of them decided to hold back and wait. Most of them, they just continued to do their business.

eating.

up, you know, the 10-15%, because they have enough margin there, you know, to do it, knowing that it could change, also. So… and you need to be in good contact with a good custom broker in the US, because that's how you get your right information, because even if the president says something. It's… it doesn't mean it's going to go in effect right away. It could take weeks, you know, before Customer and Border Protection get the information and transfer that, you know, to make it effective.

Can we move on with the presentation and then circle back to discussion towards the end? I want to make sure that she gets time to present her idea, okay? Fantastic. Thank you. Thank you so much.

Okay, so I have a next question. Does anybody know what the tariff rate is for Switzerland coming to the United States? I think it's an interesting question, because when I went around in the internet, there was a whole bunch of different rates. Does anybody know? I'm sure Stefan knows. Sure he knows. But, just everybody else.

I think it's north of 30%.

Okay, I'll give you the answer right now. So, here we go, oh no! So, we have a 29% Trump tariff on there. And you can sort of see a comparison, with Canada at the time, that this was, actually published on CNBC. So, yeah, so we're reeling from this tariff situation, yeah?

Why is it so high for Switzerland? I don't understand.

maybe he's frustrated that he's not getting… I don't know, maybe he's frustrated that he can't eat Swiss chocolate anymore? I don't know. Who knows?

That may be the best answer so far.

Okay, well…

the logic, so…

Yeah, but I want to explain to you why it's so important for Switzerland here. The United States is our biggest export destination, and I didn't actually know that until it was published. Yeah? So I think that's really quite interesting. But on the same regard, Swiss companies are also world leaders in U.S. investment. We're such a small country, but we provide a lot of investment into the United States. It's something that we should maybe consider in the background as well as we go forward here. And a lot of people are saying, well, we should use this as a bargaining chip, you know? Switzerland should use this as a bargaining chip, as some of the Swiss politicians were saying at the moment. But anyways, that's politics. Let's keep going here.

Okay, so… I was discussing this with Sean, you know, let's… we gotta just throw out all the solutions, open up the discussion, see what we can do, and you know, I looked at Canada-US, free trade, right? The situation is that there is a free trade agreement that was written a few years ago. That enables cross-border trade of goods with select medical devices which have a certificate of origin, which would qualify for 0% tariffs. So, most of this… statements within the Free Trade Agreement. I'm just going to use Free Trade Agreement to represent the Kuzma and the Usma. It's actually the same agreement, it just has a USA name and a Canadian name to it.

Those things have been re-established since September 1st, 2025. And the discussion of easing tariffs between Canada and the U.S. is ongoing, because the U.S. is the primary partner for Canada, so it's important. So, the qualification for preferential tariff treatment They have to qualify for the rules of origin. The US importers have to claim this tariff preference. And they have to do it with, with a certificate at the time of claim. The goods also have to be accompanied by this certificate of Orange, which is required according to the Free Trade Agreement. And just a summary of, sort of, the step-to-step to arrive at that is you first have to find out

how you're… device or product qualifies, you first had to find out the HS Code. And that is a harmonized coding system for products around the world. You have to determine if the product meets the rules of origin. You have to compile the certificate of origin. Provide it to the importer, and you have to be ready that it has… it's going to be verified. You need to also keep records. for at least 6 years after exporting it. So everything that's associated with your certificate of origin should be kept. So, what is a certificate of origin? Who's familiar with the concept, and what is the definition of certificate of Origin for medical devices?

Nobody? Okay, I'll continue. Internationally, there's no harmonized definition of certificate of origin. But it is fundamental in determining the duties and charges that are applicable to imported goods. On both sides of the border. And of course, these free trade agreements, I forgot to mention, also include Mexico. But I'm just concentrating on the US and Canada. And each good is classified, as I said, prior to these HS codes. And using the HS codes, you find out if it has… what is the qualification? That is required to call it an originating good. So I'm just gonna show you, some…

Examples of how to define those codes. I just took, dental implants. Went into the Canadian tariff finer. There's also US as well, which you can look at. I left a link on these next two slides. And I decided to go with dental implants, and this is the kind of coat that comes up. And you can give this code in. And then find out what the situation is. So that's just a blow-up of what you saw on the previous screen. So it says it's tariff-free, and I'll go into that later, what does… what do you have to do in order that it's duty-free? And the analogous information you also find on the USA site, as you see on the web link below, you can look at that after the presentation.

So you can also, if you don't believe what you saw on the US site in the… And on the Canadian site, you can give in the same HS code on an international site, and as you see here, I know… I apologize, it's small font, I couldn't get it any better. It says 0%. But of course, there's, there's, conditions, stipulated with it. It has to have a certificate of origin, yeah? It has to qualify for one. So, conditions for 0% tariff. Now, I don't want to say it's for all medical devices, I just found it for some. This following definition. And this is sort of the definition of what has to, exist in order for it to qualify. I don't want to go into how these things are defined, like the regional value content.

Net cost. All these definitions are freely available for you to look up. And of course, it's not just easy like this, yeah? There's also applicable requirements associated with it. There's a whole… The Free Trade Agreement is a rather lengthy document, and there's a lot of conditions and a lot of considerations that you have to take into account. And that's why I say also, for certainty, you should really consult the experts, maybe get an advanced ruling on it. And find out if it qualifies for the rules of origin, and also determining how to market as well. So this is just… I copied out the text, yeah, associated with the dental implants, which I previously showed you.

And, as I said, the definitions you can find here. Do you want to consult that after the presentation? So, if you want to write a certificate of origin for this free trade agreement, these are the things that you have to specify. Now, there is no template for this. But there's just these required elements that have to be defined on that, and it has to accompany the good as well. And it… they don't specify with what it has to accompany, it could also accompany an invoice as well. I'm not going to read through it, you can take a look at it after. The presentation meeting today. considerations. There's lots of considerations. This isn't… I just took a little bit of a snapshot of what you need to consider, right?

You need to really see and check and double check if it really qualifies as an originating product, right? And you need to determine its market. Also, as I said, maybe consider doing an advance ruling, right? With the USCBP. It reduced the risks of delays, disputes, extra duties paid at the border. He has buyers peace of mind, of course, and they can claim a preferential tariff. rate more confidential, confi- with confidence, more with confidence. That's at least what's reported on the Canadian site with regards to this free trade agreement. But you also have to consider that the importer has a lot of obligations that have to be considered. So, yeah, I just took one of them, right? So, you know, you get into trouble if this is not the case, right? I just marked in blue as an example.

And this is why it's really important to consider an importer with experience with medical devices. Yeah? So that he makes sure that he doesn't lose the originating good status of the good, right? Because you want to have… you want to have 0% tariffs, you don't want to have fines or other… other problems of paperwork or extra documentation. So, just on to the next topic. Just Canada as itself, right? We're really open for business. I can say that as a Canadian. There's a number of free trade agreements, there's also, agreements with sharing technology between different countries. And the Government of Canada is very actively involved in free trade negotiations with other countries. They also do some, trade fairs, they go around the world doing trade fairs.

What also vouches for the Canadian environment is that the new Prime Minister, Mark Carney. was the 8th governor of Bank of Canada, and the 120th governor of the Bank of England, so he's very familiar with commercials. Goods passing through financial situations, financial institutions. And I think he's not gonna do a misstep. like someone who wouldn't be so deeply involved. And of course, the professional organizations for medical devices are also supporting a 0% tariff environment. That helps the whole process along.

I understand that AdvaMed lobbied pretty heavily on behalf of this 0% tariff for medical devices, is there? Yeah. Yeah.

Yeah, that's true. Yeah.

Have they, really? I'm not.

They have, they have. They joined together with MedTech Canada, and they really had a group. There was actually a presentation at one of the congressional hearings, I think about a year ago, or… yeah, when Trump came in? A few… I think at the beginning, about February. There's actually… I think you can go onto YouTube and you can see how the… the main… one of the main guys, top-level management of that medical device association, gave a presentation and said how important it was. I don't remember the date, Stefan, otherwise I'd tell you. But they did. They really publicly Made it known that it's not a good situation to have tariffs on medical devices.

Anyways, other selling points for Canada. There's a lot of public audiences for business. It's really business friendly. There's also… Canada's in a good political position as a member of G7. It's a very… I mean, I always call it multicultural and diverse population.

This also enables, clinical investigations that are done in Canada to be… the data to be used in other.

Places around the world. And what I also really treasure is the business-friendly conditions of Health Canada. Health Canada is really actively involved. They were at the MedTech Canada meeting this year, and we're actively involved in presenting the positions and discussing with a lot of stakeholders how to improve the system. And for me, it's one institution, one interpretation, harmonized procedures, interpretation of regulation. That makes it really much easier than the European system, with many, many interpretations of regulation, and we're still interpreting it. It hasn't stopped. The other thing is that Health Canada is a member of the IMDRF,

And that means that they also recognize the MDSAP certificate to prove QMS compliance. And they use IMDRF reliance, vigilance, reporting codes, and also essential principles. What's also I find really nice is that if they don't make a regulatory decision about the manufacturer, establishing license within 120 Calendar days? that the person who's applied gets a 25% credit on the licensing fee, and that would be nice in Europe, because some of these… some of the applications are going, you know, what is, 12, 18 months, 24 months? It's kind of ridiculous. But anyways. Just a short, short summary of what the IMDRF represents. They're really looking at harmonization and convergence of the regulation internationally.

And there are success stories, right, with IMDRF. They have vigilance AE terminology that has not even been adapted by the EU. They have their MDASAT program supporting QMS compliance. They have essential principles, and what I like the most is the reliance, and the reliance is where you, acknowledge or recognize, the other country's regulation for medical devices. So, for example, Canada recognizes, you know, the FDA, and it shortens up the process and the cost associated with getting the medical device onto the market. And within 2 weeks, there's gonna be a meeting at the IMDF again And it's taking place in Southport, Japan.

And, I'm lucky enough I'm gonna be able to participate. So, just to give a little bit of overview of the IMDRF members. And so, if, you know, getting medical devices onto market, if you're one of these countries and you want to get them to one of the other countries, you have an expedited, market access, which you can really take advantage of. Okay, I'm going a little bit away from Canada now, I'm just looking at other possibilities. Open up the discussion here. As I said. This free trade agreement between the United States and Canada is not just between these two countries, also with Mexico. And they also have a certificate of origin.

Similar to what I showed you before. As someone mentioned at the beginning of the meeting, we need to consider maybe supply chains and reorganizing them, and I guess, that has been confirmed by one of the participants. And, of course, the politics behind the country has to also be considered, you know? How… is it a country that the U.S. prefers or doesn't prefer? China is not really the best place to… manufacture the medical device and bring it to the United States. There's of course other free trade agreements the US has that might be interesting to consider the whole, supply chain process. Of course, the product can also fall under the carnate, that's where you temporarily take a product into the U.S. market, maybe for a Congress or meeting, or the Nairobi Protocol, which I'll get in later.

Of course, you can always submit a request for clarification on the HS code, or if it qualifies for the originating definition.

Stephanie?

Yep.

Edward has his hand up. Oh, okay. Edward, do you want to say something?

Yeah, yeah, I didn't want to disturb your flow, but real quick, before we get into all these other ones, have you got an explanation of the time that it would take to do this Canadian route that you're talking about? Just out of curiosity. And the other question I have is, I… again, like, for our little company, we don't have FDA approval yet, so I… I'm presuming that what you're… all those things are… are… require that these are products that already exist, and… are no longer going into the market, so the FDA thing I know would be a separate thing, but I presume you're talking about stuff that's already approved for sale into the U.S, right?

Yeah.

Elsewhere?

Yeah, also prove elsewhere. So, medical devices that are on the market in other markets around the world. Like, if I go back to, these countries here, right? If I go to Australia. I can send this to you after the meeting. If you go to Australia, for example, they recognize the FDA, They recognize the EU, for example, and they show you what they still have to look at in order to get your medical device to market. But it speeds things up, and it makes it actually a lot cheaper, right? So it's not just FLAS isolates the U.S. market market access. If you have market access in any of these other countries, you come into the market quicker in the countries that are here in blue.

Because they, they coordinate and, and acknowledge the medical device regulations of the other country, to a certain extent. Not a full extent, but to a certain extent.

I would love to line up a call with you after this, and… because I don't want to monopolize everything, so… Sure, sure, sure. That's quite interesting to learn, okay?

Sure. And it'll be interesting to see what's gonna happen, about this whole tariff situation, so I'll be in Sapporo in Japan in two weeks' time. I'll just go back here. Oh. Is that good? Is there anybody else holding their hand up, Sean? I didn't see that before, so… Okay. I'm just gonna go into… I was… at the last one, I was talking about the Norovie protocol, and this is… These are products for handicapped people. So blind, permanent, chronic, physically, mentally handicapped. These are duty-free according to the Nairobi protocol. This is, I left you a web, site that you can look up with regards to these products to get more information.

There are exceptions, though. To this, possibility. And that is if a person has an acute or transient disability, so if something goes away, it's not permanent. Eyeglasses, dentures, cosmetics don't fall underneath this, therapeutic diagnostic articles as well. And medicine, and drugs. So, I just left you a few websites to take a look at what the tariff situation is, the rules of origin between the countries. As I said, this is not a simple thing. The free trade agreement is very, very lengthy. There's lots of stipulations, lots of conditions, lots of requirements of importers, and what they have to fulfill and what they should not be doing, yeah?

You know, if an importer does something wrong, it could be that you lose your 0% tariff situation, or you get fines on top, so it's, as I said at the very beginning of my talk, I'm not an expert in importing. So, as I said, you can make a request. On classification rules? And this is the address? Yep, mad. We have to sum it all up and say, hey, it's a very fluid situation, it's not over till I'll let you fill out the blanks here. And this is sort of a capture of some of the news articles recently, so we don't know what's going on. We just have to hold onto our hats, try to find solutions. have active discussions like we have here today. Find solutions. There's a lot of real know-how in this talk today, a lot of senior people, and I'm sure we can help each other out to try to find a solution to the problem.

And I'd like to thank you.

Thank you.

Do we have any attorneys on the call?

Yeah. I'm not a lawyer.

S? Hi!

Hi, Elizabeth Ann?

Yes, I'm… yeah, right, I'm, aged. lawyer, European medical device store.

What is your thought on all this?

Everybody, I'm very confused. It never seems to be the same twice. I'm very cautious, and I am advising clients not to make any quick decisions. Things keep changing. It is concerning for us. Most of my clients are actually American, wanting to do business in the EU. So it's a little bit back, opposite to what we've been discussing. But, I would be… I wouldn't take any… Rapid decisions at the moment. This is my advice I've been giving clients. Because, you know, you have a decision one day, and the next week, we've got a different one, and a different tariff rate, and then they're withdrawn, and then they're reintroduced. It's causing, quite a lot of heartburn to our clients.

In fact, Michelle put a comment on… Michelle Mitchell put a comment on that she heard this morning on the news that they may be renegotiating the tariffs with Canada. So, I…

Well, it is up for discussion in 2026, so for next year, because the agreement is for 36 years, I think, but every 6 years, something like that, they have to sit down and talk about it again. So, I think that's what's coming. They, they kind of… my mind, in my mind, they're gonna, get rid of the USMCA. At all, you know, because… now they're kind of tight with it, because it's Trump, actually, who signed the previous one, so now he wants to get rid of it, but he's the one who signed it, you know, the last time. So, yeah, they're right, you're right, you know, they're gonna…

Discuss it, but they… it's up for discussion anyway in 2026.

So… I think Michelle heard that the White House is actually considering renegotiating the tariffs with Canada now.

No, I think that's not what I meant. I think they are re-evaluating the USMCA agreement to see what they can do. So, I think that's what I really meant to say.

Thank you for the clarification. Sorry.

You know, from my perspective, I have another client that is just rolling with the punches. Luckily, volumes are not too high, so… also a startup, I work with a lot of startups, and they actually put their clients, the end customer. on notice, I think they've got a little tagline that says, you know, current pricing. And… because you can't… a business can't just wait, right? So, some people who've been able to stockpile have stockpiled, and I saw that a lot with some exercise equipment companies. But on the other hand, I'm also seeing companies that say, hey, today's price is this, you know, subject to fluctuations and changes.

And they're doing pretty well. They're just rolling with the punches. Because business really can't stop, so…

I heard that a Swiss company, I think it was Lint, is holding back their whole supply for the USA till things calm down, but I… I read that, sort of, in passing in the newspaper, so they're keeping their stock and bringing it into Canada instead of into the United States at the moment.

Yep.

And I think what's also what's very confusing is that for many years, you know, there was no tax on medical devices. If you look at Chapter 90, where all medical devices fall, most of them, and Chapter 30, there were no taxation on medical devices. So now, you know. why people are so confused. They think that now there's a… there's a tariff on medical device. It's not a tariff on medical device, it's a tariff on the country. So, if you look at the chapter 90, like you show, you know, it's still 0%, You know, but, you know, the tariff on the contrary oversees that, and it's like, nope, you know, it's adding up, you know, to that tariff.

And what's more challenging right now is, see, they got rid of the minimus. rule, so that meant everything that was under $800 before was just going under the radar at Custom and with the FDA. Now. they have to do a formal entry of those products, so it's adding more work for, custom and for the FDA. It slows down the process, at the border, so… That said, you need to have a commercial invoice, a good importer, like you said, that knows what they're doing, because that could have a huge impact. Product can get stuck at custom, and just deny entry and ship back, you know, to the, to the shipper.

As a practical example of this, the Belton Authorities have… or the Belgian Postal Service has decided to stop Exporting. to the US are supporting the export of any product, any product, to the US of a value of less than $800. So you've got the choice of a very expensive career, or nothing. It's a bit of a shocking, step, but it's… and I would expect that other member states in the EU will take the same step. Yeah. Anybody who finds the state… the State Postal Service.

But even DHL, FedEx, and UPS, they're not set up with the staff right now to that overload of shipment that they need to do a formal entry. We just don't know how it's gonna go.

I guess the people with storage facilities are laughing at the moment, huh?

Everybody's laughing at us.

So in terms of…

Swiss are not… Swiss are not laughing, they're just eating the chocolate that can't be delivered.

And looking at their watch to see when it's gonna finish this thing.

Actually, on CNBC, they had an article, and they said that all the rich people in the United States are now going on holidays to Switzerland to get their expensive watches. They're not bothering, you know, getting it in the United States. It was… I thought it was quite interesting. So it helps tourism, yeah? Maybe Switzerland should have a tourism ad with, you can get your expensive watch in Switzerland, come and see us.

So, has… has anyone actually experienced any price increases due to the tariffs, either for your medical device business, or for parts, or for, imports, or for clients? Like, I mean, has anybody seen any real impact? Absolutely.

Absolutely. We had to redo pricing.

We import, you know, medical devices from South Korea. And we tried to negotiate with the, you know, the manufacturing company, pricing, and this is new, you know, the tariff is on you, just pay it. So, yeah. We have to increase our pricing to hospital, which is a very difficult situation, because we have a contract with hospital, it's set up, so it's difficult to negotiate, because there's no… that's not my problem. So we, as a distributor, an importer, we have to E that tariff, because we're not… we're not able to pass it on. to the, the hospital. And even I had a discussion with the VP at Medicaid, and she says, you know, I asked her the question, so are you going to transfer more money to the hospital when you pay, you know, for a procedure? And she says, no, we don't get more money from the government to increase our transfer payment to hospital, so…

Very interesting. Very good point, thank you. Anyone else? clients, Yourself? Anything? Problems?

That's for sure a very interesting topic, so thank you, Stephanie and Sean.

Sure. I have some…

For providing your… Sean, if I can just say thank you, Sean, Stefan, for being on the call today, because, you know, I know that you're an experienced importer and distributor, and also have storage facilities, so I appreciate your comments to this whole theme. I think it helps the conversation move forward. Thanks.

I'm passionate about it sometimes.

Yeah.

So, let me give you some previews of what's coming up while we're, you know. sitting here. Next week, we are going to have, Michael Kanya from MedDevo, and he is going to be, showing, discussing the EIFU, which is, instructions for use, not indications for use. So, in the US, we use IFU for indications for use, and in Europe, they use it for, instructions for use, and in mid-July, there was legislation passed in the EU, I think July 15th or something like that, which said that for all medical devices, they can go to electronic instructions for use, as long as they're intended for the provider or the hospital clinician, not

a lay user. So, when they're not for a lay user, they're able to go to this, which, if you think about the 27 language requirements in the, in the EU, and the fact that, Companies just weren't changing the instructions for use because of the onerous… they were sort of stockpiling changes. to them, and then… and then doing bulk updates rather than… But now, moving to electronic format, they… they still require that paper be printed on demand. But, the, the requirement has changed, and so he's gonna be talking about,

how this can work in favor, but also the systems that need to be in place in order to effectuate this kind of change, and take advantage of it. I… when I think of the environmental impact alone, I… I get a smile on my face. And so that's a nice thing. I don't have my notes in front of me. On the 19th. Everybody's been moving around on my calendar. Let's see, on the 26th, Clarimed, KSim from ClareMed is gonna be presenting on human factors, which I've been learning a lot about recently, human factors usability, and really, what I've come to understand is that the sooner that you start.

The less it's gonna cost you later on, because once you get into lockdown mode on your design, and you discover that it's not highly usable, and that, you're… you're gonna find yourself in serious, serious trouble. So please show up for that, and then, the 19th… Pardon me. My, my brain is just… fried. And, because it's Friday. But, so yeah, those are the… some of the… some of the events coming up. Then, in early October, Robert Buxtall is going to be presenting on the state of the art, and that promises to be, exceptionally informative, so please show up for that. If anybody remembers who's speaking on the 19th, feel free to put it in the notes, because I'm an idiot. And,

But, yeah, there we go. Please support each other, Please riff our business to one another. Please make an attempt to reach out to the other people that are on this call, and remember to join, MedTech Leading Voice Exchange. at MLVExchange.com. It's an exciting group, and… From a personal perspective, I hired 3 new employees, who are starting on Monday, and, so we are going to have a new dedicated community manager. So look forward to more communications, more updates, and,

much more active community. I'm also considering moving the community to Slack, and off of Kajabi, because I'm starting to hate Kajabi. But that is another story. Any, comments for Stephanie before we go today? Closing remarks?

I just want to ask, you know, if… a lot of people going to Medica in Dusseldorf in November. Maybe we should, you know, plan something, get together, if people are going.

I do not have plans currently.

No.

But, I will look into it.

I haven't decided yet, Stefan, but if I do, I'd love to meet up. I missed you last time.

Great. Well, thank you, everyone. Looks like you get 12 minutes of your day back.

Thank you, Sean.

Hello, everyone.

Thanks, Stephanie.

Thank you, Sean.

Have a great weekend. Thank you, Sean, as well, from my side.

Thank you, Stephanie. Great presentation. Thank you. Very interesting.