BEING US DISTRIBUTOR FOR FOREIGN MEDTECH COMPANIES featuring STEPHAN TOUPIN

You're muted, Steven.

Hey! How are you?

I'm good. How are you?

Good? Does this sound as good.

Yes, fun. Sounds fine.

So you're back in the Us.

Oh, yeah.

It's gonna be terrible. I I just can't imagine.

What?

What you went through with all that.

Oh, I should post the editorial that I wrote about it. Well, good.

I think in Dublin is that you? You go through custom there, you know, to yeah.

Only place that you go through customs in Europe, is it Dublin? And I didn't know that because I had never done it before.

Yeah, I did that.

So it's nice welcome to the Us. It's what. Yeah. So I was stuck in this area before that, waiting for them to call my flight and was in the wrong place. And that's how the whole thing got messed up. But really the problem started after I missed the flight, because then the 2 airlines couldn't agree on whose responsibility it was to fix the problem.

Yeah.

So. yes. So I read an article. Please just replace airport employees with chat. Gpt, it's a because because chat gpt, actually was the only thing providing any help or empathy to me. During this whole process every. all the people were just lying or saying things that were incorrect or just not not helping. Oh, very chat control. B. There it is. Let's see. So

Tiffany.

The employees were lying to you.

Well, there are either incorrect or misleading on purpose so, but or didn't know what they were doing. Do you know what I mean like, but they're all telling me that they can't help me when clearly they can. You can put me on another flight. You won't put me on another flight. Yeah, exactly. There's a difference. can't and won't. And the reason that they won't is because they feel like it's the other side's fault, right? So it's

Yeah. And sometimes it's because they're they don't want to do the work.

Well, there was this one guy there who was just so over his job. He had been doing it for 30 years that he was just yelling at me that I had to go back to American airlines that he he's like, Yeah, it's not our problem. And like screaming this at me, and I asked him why he was being rude. and then he told me that I was being rude, and I said, No, I'm the one who's stranded. not you. You're gonna go home to your family or your cat, or whatever I'm not, you know.

I'm very happy here. I've had 3 days of sunshine after 2 weeks of rain. So that's been pretty nice.

Where are you located?

Washington, out of Portland.

Oh, Washington, State.

Yeah, yeah.

But that's isn't that kind of normal for you guys to have so much rain.

We've been here 4 years, and that was the longest we've gone without some breaks in between. So maybe it's normal. But I just hadn't seen it.

Yeah.

Well come down to Miami.

No, I I lived in Homestead, south of Miami for.

Okay.

Several years. And no, I'm not going back to Florida. Sorry.

Well, I I could understand why.

He probably misses the heat in summer.

Yeah.

Yeah. Mugginess. Yeah, no. I was in Southern California. Very well, Temecula, which is sort of desert area. It's about an hour north of San Diego. If the traffic isn't bad. And this is actually a nice change, because we rarely saw rain, and it was always hot.

Yeah.

And dry, so I sort of enjoy the rain, even though this time it was pretty long.

Do you get a lot of snow?

No, not really we've had some snow, but it never lasts more than a week or 2, and.

Because it's rain. And that's yeah. Yeah.

Yeah, it turns into rain. We've had a little bit of ice black ice. The first.st

Correct.

Year we were here, which you have to be careful of. But since I work from home I don't have to drive anywhere. It's not really too bad.

There was someone stepping out, you know, on those stairs, and you need to be careful.

No, it was we saw one car that had gone around a corner a little too fast, and was on its side in the ditch, so.

That wasn't fun to see. Been there. I'm French Canadian, so I know what it is.

We did have 18 inches one year. That was pretty neat, but it was gone in a week, so it's mainly because we're up a little high about a thousand feet. Joe, you're back. You're on mute.

Thanks. I originally showed up as Shawn, just in case Shawn was still somewhere in Europe. access to anything. So now that I see, he's back and restored in a good form I shape shifted back to my own total suck. He's gonna make me a co-host.

In one second. I'm just trying to print this.

So I missed the story of when did you get home from the looks of you? 10 min ago?

Thanks. Joe.

I love you too.

I'm just trying to print this document that won't print. For some reason.

Well, at least introduce me to your friend.

Our speaker today. Stefan. Oh, Tupin! Is that correct? To pronounce to palm.

Stefan. Yeah, I've I've I've here in the Us. Most people will say Steven. and I don't turn around because I don't know they're talking to me. But oh! Then, when they repeat 5 times and say, you must be talking to me. Stefan. Yeah, I know it's a there's different version with the E at the end, with the e instead of the a so.

Now you said here in the Us. But you're not here in the Us. Today, are you?

Yeah. I'm in Miami.

Oh, is that where you live?

Yeah, since 10 years now.

Oh, okay. Well, then, you have to change your name to Steven Tupin.

Well, even the last time is not easy also, so I will have to change the whole thing. I always have to spell it, you know.

I'm thinking that your accent hails you from France.

Oh, I was just saying that I'm French. Canadian. Yeah.

Oh, okay. And how did you find one another?

I forgot.

It's a small private network.

Yeah, it is. I probably will reach out to you.

Let's let's call it Medtech, leading voice.

If you co host me, I can help you with the.

Working on it.

I know you are, but you're working on and letting everyone in.

Well, I'm trying to find you. List. Oh, there you are! You're here. I'm sorry I'm still.

Little.

Make co-host your co-host.

Thank you.

Okay, I'm going to grab coffee and you start.

Oh, well, I'm going to start by saying, here's Stefan.

He's French Canadian. He lives in Miami.

And he is the what of Dawa Medical, Llc. The founder.

Founder, President bathroom, cleaner. Whatever.

My father.

Double trades.

She cook and bottle washer. I think that's a military reference.

Yep.

What are you gonna teach us today, Stefan?

Teaching. I don't know well. what we do at that. One medical is mostly to help, you know. Foreign Manufacturing company of medical devices to enter the Us. Market. That's our specialty. We're trying to be a 1-stop shop meaning that we serve mostly small to medium sized company startup and When people come to us they have a 5, 10 K. They're all excited. and they think that you know it's gonna be easy. That's where we step in helping them with everything they need for the Us. So everything. Post 5, 10 k. Or, you know, clearance or listing or approval of their device. That's where we come in and and help them

with importation, distribution, warehousing, reimbursement, whatever you need under the sky.

Who was your last employer, that gave you the skill set you needed to go out on your own.

Well, I spent 17 years in the pharma industry. That's how I started in the healthcare system in Canada. Like I said, you know I'm French Canadian. So I I started there working with different big corporation sales rep management position touching into marketing in different, you know, field in Pharma until I got fed up of big corporation. If I can say I guess I don't feel I don't. I don't fit very well in a corporate mold.

Know.

And so I decided in 2,011 ish. to go into the dark side of medical devices. It's pretty. It's rare that people move from med tech to Pharma. But it's pretty common that people, I think, do Pharma, to med tech, anyway, that was my experience.

Why do you think that is.

It's a good question at that time. The reason I left Pharma is because he was getting so much regulated regarding what we can. You can do at that time. With physician. You know I'm I'm part of the generation where in Pharma you you had the luxury to travel with physician in nice destination. And blah blah, you know. And now, you know, you cannot even bring a muffin, you know, to a clinic. So I was. I was a little bit tired of this, of that, too restricted. And I found that in Med Tech was different. It was. It's still related. Obviously, but

it's it's less, and you have more latitude, you know, to interact with customer. But and I think a lot of informal revenue very by the book. What you can do And going in med tech was easier for me. That's how I made I made the jump. I had at that time, you know. a friend who had a distribution company in medical devices, and he was bugging me, you know, to join. But I was in Pharma with a management position with gold cage, you know. You know you were stuck with nice salary and nice car and a stock option. It's like, you know what? So?

But I was so so tired of that corporate world and and I had enough. I needed a change at that time and and then, and is when he came back to me another time. I said, yes, I will, I will do it, I will! I will, I will make the switch. It was intense, because I knew nothing really in my device. Not well, not that much. It's 2 different world, obviously but so I was just I just, and who go ahead.

You had no medical device background when you made the switch.

No, no, my background, my, my academic background is medical, you know I have a bachelor degree in medical biology, and then I have a master in experimental medicine. But I had no background in Med device itself.

Are you a father?

Hmm.

Are you a a parent.

Yeah.

How old are your children?

Oh! And now are you asking for my age? How old I am?

Well, no, I'm not.

I have 2 kids. My son is 30, and my daughter is 28. So yes, I'm old enough.

Fair enough, but so what I'm hearing you say is that as head of household, responsible for 4 mouths. with relatively little experience in Med Device as an independent consultant, you left the relative security of Pharma to go to Med Device. That sounds hugely risky to me.

It was

Scary like. How did you do that 1st year?

I got divorced from.

It's a good start.

It makes things worse, obviously. No, I think sometime in your life you're at that point where it doesn't matter. You know I had enough. Need the change? It was not an impulsion, because I I was thinking about it in a year. So you put money aside while you, thinking to do it, and and I made a great deal with that distributor in Canada where you know I'm I told them what I was expecting in your revenue? Even at being a consultant for them. You know I was not an employee. And it was tough at the beginning. You know you eat Mac, and cheese, you know a lot, but it was worth it, because the freedom is worth a lot. You know, more than money.

and I know a lot of people in Med Tech, especially in Ortho, for example. You know, they look for that salary they can get, you know, and it's what drive them. That was not. I'm a very passionate guy, you can tell, maybe, but you know it's not about the money. It's about being happy doing something that I like And obviously you look at. You know the revenue because you want you need to survive. But that's not the 1st driver. No, it was not for me. And it's still today, with my own business here in the Us.

What's about your clientele.

Say that again. I'm sorry I have a hard time to hear you.

Tell us about your clientele. Who are you serving today?

Yeah. So today, just to make a quick story. In 2014, I was still working for that distribution company in Canada, and they were manufacturing a medical device, simple stuff for international cardiology. And they had a nice market share in Canada. Obviously, it's Canadian product. They were looking for the Us. Market. And because of my background academic background, I was doing a lot of teaching training, clinical study, you know, for them in Canada, in Europe. And I said, You know what I will do my market research and and we're gonna start, you know, a process to to launch this product in the Ui. So I moved down to

to Miami, because at that time, you know, Cath Lab were more permanent here in the east coast, especially in Florida and I I started to look for distribution doing clinical trial in hospital. But a we we fail. I will take the blame. I fail because what happened is. we thought we knew what the Us. Market looked like, what's what was needed. but we were far from, you know, having all the check, you know checklist done. And that's how I learned that you know what we I'm sure we're not the only one. There's probably tons of people in the same situation and

because I was here, and because the work I was doing in Canada, some manufacturing company that we were helping for Canada, reached out to me and says, Hey, I heard you're in the Us. Can you help out? That's a little bit how it started here. I say, you know what. There's something here. And now you know. our target customer are small to medium size. We have. We have some customer that they have like. There are 2 or 3 people in the company startup, you know. They put their own money into this and I realized that a lot of time. People make mistake. It's not normal, either. Make mistake, but it it could be very costly.

And the main reason is because people don't know everything they need. All the red tapes I could be talking about reimbursement value analysis Committee. I could be talking about custom. It could be, you know, initial importer, a lot of things that people don't realize that they need for the Us. That could be different. Compared to other country. And, as you know, we saw a shift since the last 10 years between before Medical Device Manufacturing Company were looking to launch their product 1st in Europe, but with the new Mdr. That switch that change. People are looking for the Us. First, st because it seems to be easier to get into. You get a 5, 10 K. You're good to go in their mind.

So to answer your question, you know that's that's our customer, the one that you know they don't have a Us. Entity. They're looking for help sometime they come to us for one specific service. But when we sit down with them they realize that we need more. And that's that's how we can help.

Nice. Well, I don't imagine you have slides for us today. Do you want to take us through an example of someone who's recently reached you, and how you're helping them make that move to the Us.

Yeah, so there's a lot of mistake that people make. And and and I will say, when when we been asking on what the 1st mistake people make is not doing their due diligence. Meaning that, taking the time to research. they have a 5. Again, they have a 510 K. And they think that they're good to go. We work with a lot of consultant, you know, in the Us. Outside the Us. That are more specialized in regulatory, so they will help the customer to get, you know. A 510 k. Or de novo, or whatever. You know, a Pma submission with the FDA. But after that the consultants say, Okay, you're good. We help you out.

And those manufacturing company. They feel alone because it's okay, what's next? You know, how should that? And usually their 1st reaction is, we need distributor. We need to find distributor for our product. because again, they don't have a Us entity, so they need somebody And then the they start talking with some domestic distributor here, and they realize that well, I cannot sell and ship to those product that those manufacture those distributor because they're not registered with the FDA as an importer. And that's the 1st thing the 1st mistake that they make is that they don't realize that here in the Us.

A domestic distributor, if they only buy product that's already in the Us. That doesn't mean it's Us. Product, but product that's already in the Us. They don't need to tell anything to the FDA. They just buy the product and resell them, or just be a 1099, you know, for that company. But as soon as you import medical devices the FDA is very clear. If you are the importer of those medical devices you need to be registered with the FDA. They call it initial importer, and this is in place by the FDA. For one reason mainly is traceability of product. So they want to make sure that everybody is involved from manufacturing design civilization, and the distribution here in the Us. Are registered. So they

the FDA knows that there's somebody somewhere that's responsible of the traceability of their product. So if you ship to a distributor and the distributor is not registered with the FDA as an importer. You're in trouble. If you ship to a 3 pl. Or to Amazon because you have you shipping toothbrush, for example? Well, Amazon doesn't take that responsibility. Day one. Because. as an initial importer, first, st you have to be registered this year, as you know, establishment registration. It was $9,280. Who's gonna do that as a domestic distributor, you know.

There you go!

$9,280, almost.

What?

To be listed with the FDA as an importer of medical devices, just to be listed just to be listed. It's the same price as a manufacturing company when they register with the and they list their their product and their company. That's the that's the they call it establishment listing.

The listing entitles you to distribute anything you want, not per company.

Exactly.

Right? Okay? So that doesn't seem like a that doesn't seem like an amount that would dissuade someone from getting into the distribution business.

Well, it's depend, because if it's gonna be the only product you're going to be importing for that company. It's a it's, it's it's it's a $10,000 that you have to pay every year. So plus one of the other reason why people don't do it is because you can be audited by the FDA. Nobody wants. Have the FDA in their office auditing them. And you need a real office, as you know, a lot of 1099, for example. They don't have a real office, you know, with it could be virtual, could be their home. And you you need staff also to to do that. So for those reason domestic distributor, they don't want to do that. They don't want to pay that. Because they can buy similar product. Maybe

that's already here in the Us. So why go through all this and plus you have to deal with the importation process with custom. You have to register with custom pay to get a custom bond. So you know again, they don't want to do that. So the initial importer is really one of the service that we offer. That we currently represent over 135, you know foreign manufacturing company or domestic distributor who hire us, you know, to be their initial importer product doesn't have to come to us. But on paper on the Commercial Invoice. We are responsible of that importation of medical devices.

So are you personally a distributor.

We do also distribution. But what we started to offer in at the last quarter of 2024, and now in 2025 is mostly to do matchmaking between manufacturing company and potential distributor in the Us. Either a distributor or 1099. But that's that's a topic that's interesting, because when we talk with foreign company they have a hard time to understand the sales structure in the Us. How it's set up. Obviously they can do oem find, you know, a a distributor, and and you know, do oem

But most of the time that's not what they're looking for. They're looking for a stocking distributor. Somebody's gonna buy the product and resell it. And in their mind it's done Well, first, st you know, as you know, it. It doesn't work like that depending of the field of expertise. It will be a cell structure that could be totally different. It's easier in interventional or radiology or cardiology to find a stocking distributor that will cover a couple of states. It's not the same thing in spine orthopaedic where you have way more, 1099, you know. and when we talk about 1099, most of the time foreign company, they don't understand what it is exactly. It's very blurry for them. We have to explain what it is, and they like they push back because say, No, no, I don't want to deal with those people.

because it's a lot of work for them, because themselves as a manufacturing company, they will have to do all the shipping, all the invoicing go to a value analysis committee, you know. That's that's painful. Again, thinking about those small, medium sized company where they don't have the staff to do that. Again, we can step in and work with them. either by taking that role with the hospital, being a vendor and using the 1099 network that we have and and and and do the rest. Obviously, we there's a fee for that, you know. We charge, but we try to help them to smooth thing out, you know, when they try to find distribution, because again.

depending on the the type of product is not. It's not as easy as they think, especially if they're coming with a Me too. Product. You know, they got a 5, 10 k. The product is there's other products similar on the market.

I just shared a link with everyone on the on the call. It's an article I wrote goodness knows how many years ago. It's 1 of the 1st things I point people to about how distributors are not looking for something else to distribute. They have plenty and to think like. But my product is great. Okay, how how incremental is it for me? And importantly, how robust is your training and product support for me? Because if you think that I'm gonna have now 101 items, and you are all of a sudden the most important one, you're very wrong, and you're gonna be disappointed.

That's okay.

So how many? How many distributors have you made that matchmaking with? I'm asking for a raw number. Is it more or less, more, fewer than 10.

It's more than 10 but we just starting we so couple of years ago, we we started to be more in the spine business as a distributor working with sub distributor mostly in like vertebroplasty and kyphasty. I was. I won't say easy market, but it's not as difficult, I think, as you know the implants or screw, and you know, plate stuff where there's 1 million of them. But since we're starting and the challenge that we had is that we built that network since almost 10 years. And I I wait literally waited, you know, 2024 to open that up

to our current customer, because we have customers selling from Bandaid and toothbrush to eye and robot and Crm, and everything in between could be, and different field of expertise, obgyn wound care radiology, cardiology, spine, orthopedic women health. So we build those that network since almost 10 years now, we're kind of ready to offer that to our manufacturing company. So it's kind of new. We kind of learning in the process. But what's difficult is like you said. You know, people come and they have a product. And they obviously think a lot.

Yeah, it's their baby. So they they want to have success. But but the I think that one of the biggest mistake, like I said at the beginning, is, people don't do their due diligence. Thinking does. The Us. Markets is good for us. Is it a good fit? Because, especially when you have a 5, 10 KA class 2, and you, you try to get your product to a vac, you know, value analysis committee. And and you're not bringing anything new. Oh, you could be cheaper by 10%. 15%. That won't cut it, you know, at the end of the day. Obviously.

Thanks, I remember, and this is a different industry, and many, many years ago. But I I joined a company once back in the heady Internet days. And I said. if I join you and I prove to you that you shouldn't be doing what you're asking me to do for you. You give me 4 months of severance? And they did, and it took 4 months for them to give me 4 months of severance. It was very lucrative for me. But the point is, they wanted to compete directly with E. Trade, and I said, I don't think so, and they said, No, no, we want you to. And I said, I'll do the analysis. But I think you're gonna find out. No. And then I'm going to be out of a job. So cover me. The reason I bring this up is.

people are, you know, not doing the thinking, and they're like me, too, and value Analysis Committee. Do you talk yourself out of a gig and say, Look, you're wrong, or are you able to do something like I didn't say, Hey, I'll be your consultant, but I'm telling you now. I need to be compensated when I show you why. This is a terrible, terrible idea.

Yeah. that's a good question. And we did have those discussions sometime. The thing is that if people come to us, you know, because they're just looking for us agent. That's an easy peasy, you know. We have a fixed price, and there's not much to do as usual, agent, because they want to list their product, or they want to submit a 5, 10 K. And they need a Us. Agent. Then, you know, they come back to us many months after. And they're ready to start in the Us. And we go through everything that we'll need. And I do. We do challenge people, are you sure? Because if you want us to be the initial importer? Fine, you know, we have a straight fee and we can do it. You want to store your product here in our 2 warehouses that we have in Miami and do the domestic shipping. No problem. We can do that

however, when it's time to discuss distribution. That's where you know, we not push back. But we ask those difficult questions. And sometimes they say, Whoa, okay, you know, I will have this discussion. We'll say your product is nice. Beautiful is cute, you know. But it's gonna be a tough run, you know, to find distributor. I'm telling you it's gonna be very difficult. And sometimes people still want us to to do it. And when we do that matchmaking we don't charge anything until we're successful. So we have to choose with who we're going to work. Because I don't want my marketing and sales, Guy, you know, to spend too much time on on the dead horse, you know.

How many folks do you have?

So here in the office with 5 people

These are 1090 nines or w twos.

No, the it's employee. They are employee here.

You.

So because, like the initial importer with so many customers which we do, that other initial importer, they they usually don't do. Is we help them with the shipping process, because that that's an entire other process discussion. But one of the mistake that people do. They don't think about that custom, thing, and product gets stuck at custom all the time because they have nobody to help them to build a commercial invoice. For example, that's on par with custom and FDA. When product enter here, it's kind of a two-step process. It goes to custom. First, st they review the information and they clear the shipment. But FDA has to do it because it's a medical device, and they have their own set of, you know, a checklist. What they're looking for.

and I cannot tell you how many times a customer call us. because they didn't consult us before, and they have a product stuck there for weeks, and and and custom can decide, you know, quickly, just to return the shipment. So it's very expensive for them when they don't plan in advance. and we we're not involved in advance. Also.

You know I haven't. In the years I've been doing this I can't recall a time when I've read a piece or consume some content that had to do specifically with hangups at importation. Have you done anything like that? Do you have something to share with us, or somewhere? You can point us.

And I think I don't have anything on writing but from our own experience since 10 years. Yeah, actually, what we did.

Publish something.

Maybe I should. Maybe I should. But what we did, you know? we have standard procedure, obviously, for everything that we do. That's another question. We get sometime from foreign company, you know. Do you have iso certification? No, there's not. Iso certification for what we do that doesn't exist. We do have central procedure. Obviously we have a consultant that we work with to establish those. And one of the thing that we put in there is is a checklist regarding custom and because it's I'm telling you every week. just shipping stock at custom. And it's gonna increase because I don't want to get into in detail. But what's going on right now with the new government imposing these new tariff

and eliminating. Yeah, it's gonna be chaos. We must make that connection. It's going to be chaos. So yeah.

No, I mean, I'm intrigued by that. But the tariff just means it's going to cost you more. But should that also change the dynamic of what has to happen. Yes, you have to pay more. Get it. Your fees went up. but the process itself isn't changing, is it? As far as you know.

The process won't change. It's gonna take longer. Also.

Is there a few.

Let's see, let's say, takes an example. Before every shipment that was under $800 was going under the radar, you know. Custom, they were not looking in it. You didn't need a formal entry, you know. With custom. So everything that's was under $800 from China, or whatever country, you know e-commerce thing.

800 won't change, but more people will be over the 800 mark.

Yeah. So now, custom will have to look at everything that's coming in the Us.

800 or 9.

Yeah.

From from $1 somewhere.

Yeah, yeah, it's it's published. It's a.

In the last month they published this.

Yeah.

Where did you read this? Where? Where do you.

I actually, it's on my link, and I post something on this. I can send it to you. So.

What's your source? What? Who? Oh, 1st our custom broker, but that that's coming from directly from the Government. They published that they said, that's they want to. Do, you know, they wanna because.

I I'm sorry I missed the point that you just made like that. Joe was like, oh, I didn't know that I didn't. I didn't catch the.

I was we were talking about the impact of tariffs.

And then.

I said, I get it, it's more expensive. But should that change the import process and being stuck at customs? And 1st Stefan said, well back in the day. $800 was the mark, and I said, Oh, I guess things that were 700 are now, you know, 810, and they're going to get caught. And he said, No, no, now it's forget about the 800. Now it's down to 0. Everything has to be? And I said, What's your source for that?

Captured it. Stefan.

Yeah, so I am trying to see on my link. And when I publish that, but essentially, yeah, everything that 800 rule, dollar rule is not supposedly, but we need to be careful here, because the government right now is flopping every day with those tariff things. So we're still not sure how it's gonna go. And the implementation will take a long time. Even that 25% from Canada and Mexico and the adding 10% in China that's increased the job at custom. The custom broker, 3rd party custom broker, or the custom broker at Fedex, Dhl or ups or usps. They're gonna have more work to do. More work means longer time for product to be processed at the border.

And it's not about visual inspection, because that's not what they do. It's all paperwork. It's very rare that the FDA, for example, we do a physical visual inspection of product. It happens but that those new rules would just increase the land. That's what we think. We increase the land at at the border. It's gonna take more time to process those shipment.

Wanna make sure. I understand if we import something that costs or would sell here for a dollar from China, from Japan and from Mexico. The new prices are a dollar 25, a dollar, 25, and a dollar 10 like it. It's cheaper now to to sell sell from China than it would be from Canada and Mexico for the same dollar lock product is that, am I understanding it properly?

Well, obviously, I'm not sure if custom and custom brokers we'll look at those value. I don't know. You know we're not.

My question is, is our government, if you want to use the word penalizing. putting a higher tariff on our neighbors products than from China that just seems counterintuitive to me.

Well.

Interrupt me.

I don't want to get into.

Not trying to get in the weeds of politics. I'm just in my understanding the numbers correctly.

Yes, yes, yes, so the danger there is that obviously right now. The Us. Cannot manufacture everything by themselves. and even, you know the big striker on Medtronic of this world. Even if they manufacture in the Us. It's not 100% of everything.

Right. They still.

Device that's from the Us.

Right.

So at 1 point it will influence the hand price, you know, because they they have to add that you know they're not gonna all absorb that tariff. How it's gonna go I don't know. but it will have an impact for sure.

Is anyone on the call up on this.

I'm I'm somewhat up on it. As you probably know, we're a distributor. We import product mostly from Europe. Been in business, going on 20 years. and we do similar to what Stefan saying that he sets up other companies to do. We've been doing that. We don't do medical devices. We do manufacturing processing equipment. And so we're we have our customs bond, and we use a variety of different logistics companies to bring product in and stuff like that. but it's large capital equipment. To the, to the question or the point of

your your question, Joe, where you said. is it mean a dollar 25 now from China, or from Mexico, from Canada, and a dollar 10 from China, not exactly because China already had a surplus charge previously added, and I believe it was 25%, and that 25% still there. But now there's an additional 10%.

Okay, that I was thinking it had to be. So. It's like 25 versus 35. It's an additional 10 versus the 25 we already had, because I don't. I hadn't heard about that.

Yeah, yeah, that's that's basically correct. From China. Mexico and Canada have been a favored trade partner for decades. And there was, I don't believe there was any markup. For duties, as far as I know, but we don't import from Canada and Mexico from not 100 sure about that. So I think this is the whole idea is it's new because he's trump has got a policy now saying we want to do this, but I agree with Stefan that none of these things happen overnight. The government doesn't move that fast, as we all know. and so they're the reality of it is, they'll vacillate back and forth many times before they finally settle down and have a have a hard number.

but it will impact the cost of goods that are imported, and for us on a on a different note, our newest invention, the dog feeding system. We talked about it a little bit. All of our parts actually, for that. All the components come from China. So that's our only real exposure into the china market in that respect. basically what Stefan's saying is all dead on the target. It's just a matter of, you know, some fine tuning there.

Like March 4th fluency, and you have to. Also. I'm glad you you joined. Now you're based in Chicago, and all of your work is based in Mexico. Mexico. Can you tell us your understanding? Your your firm must be all over this.

Yeah. Well, 90% of medical devices that are manufactured in Mexico end up in the Us. So, and most of these devices are done by multinationals like Medtronic, Baxter, etcetera. So it'll be. It's definitely a topic that we're seeing in Mexico how one of the biggest associations for medical devices that has post. 40 manufacturers are talking about how the possible impact is going to be with their with their business right? But also these are companies that are in Mexico for the long term. So, as we saw in last term of trump, I think this term, they're also trying to wait it out because they've done a lot of investments in the country.

And also right now there's Mexican officials in Washington trying to negotiate a better tariffs, right? So we'll still, there's still hope in in terms of that 25%. But at the end everything's gonna go and pass by to consumers. No, unfortunately, we also what we saw during the pandemic, and after the pandemic was a near shoring effect in Mexico that there were Asian companies coming to Mexico trying to settle in Mexico and then have that gateway to the Us. So that's also what the Us. Is trying to stop with this 25% tariff. It's also a barrier, for not Mexican companies or Us companies more for Chinese companies. I believe.

Oh, okay, that's interesting. You're saying that part of the government's rationale is we're on to you other countries who are near shoring to Mexico as a way to get around things.

Yeah, yeah, that's what was happening. And I think Asian Company saw that as an opportunity to set shop in Mexico. And then

It's only 25 versus 35.

Next work. Well, also the logistics expenses raised a lot during Covid during the pandemic. So they're anticipating some of those logistical costs as well, being closer to one of the biggest markets in the world or the biggest market in the world. Yeah, so it's pretty interesting. I do have a question for Stefan. That's aside from logistics, Stefan, I think we met once before. Good to see you again regarding the initial importer. Are you responsible for post-market surveillance? As well.

So what we are responsible? And that's by, if the definition is traceability of product and reportability of events. So you know, customer complaint, adverse event recall. That's mainly our responsibility regarding that role.

And do you as as the product gets distributed by sub distributors. how do you manage that traceability.

So we require that every quarter the manufacturing company, through the distributor, send us the information where the product are most of the time. If they ship, for example, to us in our warehouse, it's easy for us to do the trustability, because then we ship out to the final buyer or if they ship to directly to an hospital, for example, then it's easy to do the the traceability, because what we require also from the manufacturing company is doesn't matter to. They ship the product. We need to review the commercial invoice first, st there's 2 reason for that. First, st we log everything, so we know everything.

at least and also we can help them, you know, regarding the commercial invoices. Say, no, you're missing the listing number. No, you're missing the 5, 10 K. Number. There's this. So this we do, that for every shipment that's entering the Us.

Okay. Thank you.

But, Joe, just to go back to your question earlier. Regarding the tariff is that since many years there's no tariff on medical devices except China, for example. But there's no taxes on medical devices doesn't matter from where it's coming from. so that 25% is, it will be totally new. That was not there before. So for many years people were used not to pay taxes. There's still duty to be to get paid, but that's something else, you know. That's not high, you know amount. But the taxes. That's what you have a huge impact. And it's totally new for everybody.

This must be something that is like among your customers. The question that you've been talking about since January like this is the conversation.

And we have our time to get a straight answer, because they flip flopping every day. Our customer broker, you know, she sent us, you know, almost a weekly basis information about what has been published by the Government. What's being said? But the week after it changed, you know, it was to be supposed to be as soon as the the new. The new government was there then it was, you know, February, then it's March, then it's April. We don't know.

I haven't.

Down. Let's good about the corporate transparency act. How does that affect everything to the new reporting things that everyone has to do with under 20 people in their companies for the Us.

That's a good question. I'm I have. I have no knowledge that we have to sign those documents, you know, but I don't know how it did impact. Really, I don't know. It's a good question.

Well cause you have to do it as well as all of your importers. and then you have to have your information on all their import information, too.

Well, I don't know if they don't have a Us. Entity. Do they still have to do this? I don't know. Yeah.

Part of what I was asking, because they're trying to watch for flush through money.

Yeah, but I don't think if you don't have a Us. Entity, if you don't have a Irs number, I don't think that you you have to submit anything again, because, you know, 95% of our customer. You know, they don't have a Us entity. So they I don't think they.

You have to do it for them. Everything coming in from what I understood of that law.

I will have to ask our accountant, because I'm not sure I know what I know, but I know what I don't know.

Yeah, it's it's a $500 a day fine. So.

I need that we did, submitted something, but I don't know. I didn't do it personally.

Okay, thank you. So I just wondered.

That.

Anyone on the call wanna take us in a different direction. A question directly for Stefan. I have. Yeah, Luke.

Within the the companies you serve. How is marketing organized? Is that up to the distributors or the original manufacturers, or whatever. Because there's a catch. If we we have seen things that things are marketed in a way that doesn't fit to the product.

Yeah.

And the other way around is, we have a distributor in the United States, and they actually make better instructional videos than we do ourselves.

Yeah, that's a good question. And especially when we talk when people come to us and they want us to help them with with the distribution. That's 1 of the questions we explore with them about the marketing. First.st we need to be careful because people mix terms with the FDA. They will say that they have FDA approved product. Approved product is for class 3, product, for example, not for class 2, class 2, product are clear. They're not approved by the FDA. So people make that mistake when they use the FDA logo or the claim that they do so. We will review the marketing document that they have. We're not expert, but we know what looking for.

The second thing is that, as you know, what the marketing material that you use in Europe and and different country in Asia will not be the same for the Us. Because here in the Us. We like stories, you know. And and so a lot of time we look at that material. We say, you know what? I don't think it will fit the Us. Market. It's it's better than for them to use a consultant here in the Us. That would help them, you know, to sometimes just it's a quick fix, but But it's different, obviously. And and one of the big mistake also that people will make is they think that because they find stocking distributor, that they have nothing else to do. This is not true. You still need to be there, you know, fueling the distributor with marketing material, helping them. I don't think you should rely on the distributor to do it for you. That doesn't work.

You need to pay money to be here in the Us. To train people to go to convention. It won't just happen like this. You cannot let that in the hands of the distributor. You still need to have an overview anyway, because that could be dangerous. If you let the distributor do it the way they think it should be done.

I totally agree with you.

Yeah, we saw a big mistake. Happen in the past regarding this. But there's a lot of pitfall. That's why, you know, when they come to us. We talk about reimbursement. People don't understand a Cpt code. They don't know what it is they don't know about, you know. Something is just market research to do a good market research, a good market analysis to talk about value analysis committee. What's the difference between a distributor stocking distributor and 1099, the insurance. You will be surprised how many manufacturing companies try to enter the Us. Without an insurance, a product, liability insurance specific for the us market

when I say specific is mean that you could have a worldwide, you know, insurance for product ability. But a lot of hospital they don't like that they want. They want to see that it's include the Us. To make sure that they're covered. do we need $12510000000? It depends. But a lot of time. People forget that part. And they say, Well, we're going to get a product insurance liability when we're going to start selling. Well, that doesn't work that way, because an hospital will require to see your policy before buying your product. So it's a reverse. You need to get that that insurance before starting to sell in the Us. So there's a lot of pitfall that people forget to look at, and then we can help them asking those questions with them.

This is among the more international calls we've had in a while. I'm gonna count you as French Canadian, but we have Toronto, and we have the Netherlands, and we have Finland, and we have the Uk. And oh, sway! Come on. You're kind of like Mexico. So you really attract a worldwide audience today. I think that's quite a statement, young man.

Thank you. Well, that's like, I said, that's 95% of our customer, our foreign company name a country inside of Russia. And yeah, we have customer in U- Ukraine. Actually, no.

Wanna come online. You want to show your face and talk to him about your business in Ukraine. Is my Buddy York.

Oh, how are you? Sorry I'm I still haven't gotten up. Yeah, so but thanks very much, Stefan, for your your talk. It's very interesting. Because I do get involved in a lot of people that want to, you know, come over from Europe or other parts of the world. and they're kind of afraid of the Us. Market. And they really need help. With someone like yourself. I have a company that does product development. So my and all of my engineering teams are actually in the Ukraine also. So Ukraine is quite active, you know, unless you're in the particular war zone which we're not and businesses still go going on there.

as as it. And it kind of makes sense. These people need to work, they want to make, they have their livelihoods, and so on. So. so, yeah, that's my Ukraine connection.

So your your development work doesn't won't be affected by tariffs, because you're not importing anything except ideas which are not.

Yeah, I mean, we ship prototypes back and forth. But I don't. But they're not tariffed typically there. So. but that's yeah, no, we're not doing the manufacturing. So we don't really have any tariff issues.

For customers for your product development services are, do they tend to be American companies or.

Yeah, they're mostly they're. In fact, I guess they're all American companies or.

Because you are in America, and you're attracting the business.

Yeah, I mean, this is again, one of the the business is located here. This is Southern California. This is a medical hub for for med device. So there tends to be a lot of business here. That's that's why. And as you have seen, and we've had an offline chat here about. You know, there in Southern California there's been some pretty big change in terms of other companies that have been bought. you know, fusion biotech was bought by Veranex, which is a private equity firm. They're almost dead, they don't, they.

How did that happen?

Well, when did that happen?

Yeah.

Probably a year and a half ago, maybe.

I don't know that I knew that.

They, and they are now. But it went from 50 people to 5 people.

Oh!

Cause. They mismanaged it.

That means our Mutual Friend is probably not with them.

Steve.

Yeah.

No, he's well, he fortunately he sold, and so he cashed out. So he he's in good shape and is semi-retired so. But yeah, they they really have destroyed that.

And there are several other examples.

You know, bit planet Hollywood Planet, Hollywood Planet. Innovation. Bought them. They're they're not doing well. Other. There's several other small companies where people are retiring. and so the whole market is is kind of I don't know. so I guess it's a good time in some ways, because the some of that talent is available now which wasn't available before. So.

What do you attribute the purchases of these Southern California companies that have now withered.

Well. the withering is a common thing happens all the time. Anytime a big company buys a a product development firm. You wait 5 years, and they're no longer in existence. I mean.

Why?

It's it's cultural. I mean, product development is a very service oriented you have to be very flexible with your terms. You have. You know you're dealing with startups. You're dealing with people that are not necessarily the greatest customers and a lot of the these bigger companies that come in and buy these companies, or if they're a manufacturing company, and they try to operate in the same way as they do from their their their known business, it just doesn't apply. So if you don't have that experience, if you don't. you know it. And so they just basically piss off all the customers, and then there's nobody left.

That's very typical. So when you buy something like a product development firm. you really need to leave it alone and and put it in, you know, as have it operate as a separate entity, probably. but nobody ever takes that advice. So it's always I have the money. I have the power. I'm buying it. I'm gonna manage it. And then they spread out. manage it the way they know how to manage something completely different, and and then it. you know. Pretty soon everybody leaves, and it just withers.

The employees were at Omnica when they were recently purchased.

We're about 30.

And how many remain.

There they're. They're still in the like. 25. They they it takes time, I mean. and starfish medical being is a who bought them is also a product development firm. So you know, hopefully, that's more of an alignment. but they're also a big company. There are 300 people now.

I didn't realize.

Yeah. And So there's a lot of process overhead. And things like that that, you know. Run of the mill. Engineers don't necessarily like over time, and they they go and and migrate to things that they that they're more comfortable with. especially the good ones. Right? The good ones are the 1st ones to go.

Yeah, I suppose that's right.

Yeah.

Begin to wind down our call.

Sorry to. Sorry to divert.

I'm the one who gave you. I'm the one who took you there that was helpful and incremental. So thank you for that. And and I'm so happy to see you again. It's been a while.

Oh, we'll see you soon, I hope.

Stefan. What would you say as as we wrap up some top line like if you remember nothing else from this call, remember that? What? What are some real.

To to plan in advance. Do your due diligence like, I said. Do your research reach out to people who know how to do it in the Us. And and that that's why we developed that one stop shop. It sounds cheesy, but you know, if we, if the service that we don't offer ourselves. We have tons of consultant that we work with who can help out and give you the right direction, because it's easy to make mistake. It's very costly. We see that all the time, so plan plan in advance for sure.

Good point. So this ties.

Coming out to see us in California in 2 months. So fine.

I received the invitation thinking about it, and as Shawn said, we talk about this. So

Please do. I think it'd be incremental for for everyone if you're there. And Shawn, you have booked Dr. Borgel for next week, and the title is Women's Health Day. What do you expect? We'll talk about and learn.

So I have a I have a call with our Qm. Plus. She's that's where she's from later this afternoon, and it's Women's Health month, and she is their women's health expert. And so I don't really know until I have the call with them today at 2 o'clock to just over what we're gonna be talking about. But you know, I think it would be it should be good and looking forward to it. Also, I really wanna.

A wild story about women's health with a recent engagement with FDA. So, yeah, I look forward to that one.

Well, can you? That was just too much of a teaser. Can you give us a little.

It has to do with vibrators. Well, everybody show up next week.

Entertainment.

Be wild, conversation.

Entertainment is planned.

I also wanted to.

Watching the recording makes it all the way to the end of to get that one.

So I'm planning 2 webinars in the month of March. With Ed Doherty and Tatiana whose last name I can't remember offhand, and she advises companies on so the the broad topic is market access. But more specifically, she advises companies on nailing their value. Prop, so the startups have a tendency to not get their value prop. And then Ed is going to be talking about codes and market access and getting on schedules, and and show that the main theme of this is essentially just because you got a 510 K doesn't mean anybody's going to buy your product.

And so this is like, how do you position your product in such a way that you know it's disruptive, but not too disruptive, is going to get bought, is going to get coded properly is going to get on. The schedules is going to. And this is actually a 2 part series, because there's so much in this, but it ties in directly to what Stefan was talking about today. Which is, yeah, just because you have a 5, 10 K doesn't mean anybody in the Us. Is going to buy your product, and that there are a lot of steps around distribution and importation.

Yeah, I tell customers all the time. It's like, look at I I do product development, right? So I'm on the front end of the process. So it's always. And and I hate to tell them. But like this is actually the easy part. The hard part is the commercialization. I mean, if you're really gonna try to commercialize it yourself is, it's it's more expensive and more difficult than doing the development and getting the 5 10 k. In the 1st place.

So true. Yeah, yeah. And it's tough discussion to have with customer. Because, you know, obviously, they have this great id, and you know that it's it could be a very great product. But there's a huge different between the 5 team, you know, when your product is so innovative they don't realize that there's no reimbursement in the Us. For that. And that's gonna be a long process. And Shauna, I guess she's gonna cover that because you know that people are like what I have to wait 3, 5 years, maybe, you know, and spend money to do clinical study in a ribbon. What? So yeah great talk. It's gonna be a great talk for sure.

Don't join us, I hope.

Yeah. there's a there's, I mean, there's so much interesting stuff, I think, of the 5 10 k. As the 1st hurdle. Well, not even the 1st hurdle, but one of the one of the hurdles in the.

Well.

You know in.

You are, you are more. You. By the time you get to 5, 10 k. You should be close. You should be 70% like already have planned all those 1st things like there's so much stuff before the 5 10 k. So much most of it.

Or at least understanding what you're gonna go through. Because obviously, you know, when a customer come to us and they have FDA pending. it's not worth it to talk with distributor. They they won't say, Well, come to me when when you they get their 5, 10 K. Because what the hell, you know. So, but actually, if you're right. knowing what you're gonna have to go through and prepare for it for sure.

Rama, you you are very good at at sitting there and smiling. It makes me just intrigued to know what's going on in your head. Bye, Michelle, thank you. What what do you do? Tell us about you? Introduce yourself a bit.

I mean, I'm relatively new to the Med Tech space compared to everyone else that's on the call. I've only been in medtech for the past 8 years. But I'm working as a consultant. Yeah, I'm working with several companies, doing a little bit of everything, actually helping out, setting up Qms. Systems going from paper based to Eqms. Migrating Eqms. Systems. Iso. 1345 certifications. Mdsap. Preparing for ce marking. So I do a little bit of everything, a little bit of quality, a little bit of regulatory.

And as I asked us to find who? Where did you get your training before you went on your own.

So I'm still actually consulting for the company. It's called it's a Canadian company here and working in Ivf products assisted reproductive technologies, so help them get their Iso, 1345. And then I'm still working with them. I like long term clients.

To know what, if anything, because I've I've heard the Us. Government talk about Ivf and its stance on it, and I haven't kept close track on one of those. Have you heard anything to concern your company about.

The shifting political landscape on that topic. I mean, there's always a shift. Every administration. There's new things that are being implemented but largely, you know, for lower classification medical devices. It's pretty consistent. It's an established industry expectation, especially now, you know. I expect from then, with the next topic that we'll be hearing next week about women's health will be interesting to see about the trends in fertility, reproductive health. So it's a it's a growing field, especially because there's a rise in endocrine disrupting hormones and microplastics affecting reproductive health. So yeah.

Yeah, then the Administration wants to make it less expensive and more available in general.

There's a lot of big words. It sounds as though maybe we should have you as a featured guest coming up soon, too.

Maybe yeah, maybe.

Sean, you want to take this home.

Well, I just like to thank everybody for your attention today and for also, especially to Stefan, because we had another speaker lined up for this week who canceled on Tuesday, while I was in Europe and his so he I had been talking to him, and I was like, hey, do you want to do this thing on Friday? And he agreed to do it. And I think it was a really really interesting topic. And I learned a lot today. And so thank you.

Yeah, thank you for being flexible, and thanks in advance for arranging your travel and joining us in 2 months. They call that the assumptive close in sales and marketing.

And I'll get you a link to the to the Hyatt so that you can get the the group rate. Thank you.

In fact, I'll put it here.

Thanks. You guys.

Everyone got it.

One.

Yeah, for anyone who needs it. Here is the link to get the group rate at the high end. Bye, Bruce, okay, like, Sean said, Thank you, everybody, and it sounds as though we have an interesting talk for next week, so we will see you. Then make it a great week.

Take care!

Thanks, everybody. Bye, thank you.