MLVx 2026: The Year in Preview with Sean Smith

So on who wants to say hello anyone Leo start with you. How's it going good? It's good start to a new year. I've made my coal with 7,000 Recall Connections on LinkedIn finally just a day late a day late dollar short No, not Never never Stephanie, what's the word? What's the word? Well, I say a happy new year and Merry Christmas and season greetings all belated

Yeah, it's it's kind of weird right now. We have no snow here at all. So Just went up high today 2300 meters and there's still no snow Really? Are you 300 meters and there was no yeah, but not the day Where are you Stephanie? I'm in Switzerland and like yourself bad, but where is Switzerland and Beiberstein? Okay, because out of my window here at 2,000 meters. I was skiing last weekend or the last couple of days Oh, okay. Where was there? Where was that? Pizzol

It's the mountain out here and I was already skiing four or five times with my kids this year. Okay. Well, that's hopeful That's hopeful No, not out here. It's all green Verbia has no So let's go ahead and get started I'm gonna try to monitor the panelists. I don't know something's going on. I can't promote francesco And try one last time To make him co-host. It's just not letting me Something is wrong. Probably user error lord only knows What linkedin has done today?

They're not linkedin. Um, what should we call it? Um, zoom. Yeah, so, um wanted to look back at 2026 you know The good the bad the ugly And take a look going forward where you all think We should focus what would be most useful How we can support you all these things are fair topics. Um, and what we're looking at is So we We grew a lot. Um, I took over these Friday calls After the 10x conference in May from Joe

Hey, just many of you may know Who he has retired Um, and the transition to the new platform has been A little hit or miss. Um More miss than hit. Um Well, one thing that has been consistent is the Friday calls have continued to grow Um, both in popularity and attendance and and I hope Um in in content. Um And it's This is a this is a blended platform. It's you know, people are allowed to participate Please feel free to jump in at any time during this discussion. Um, it's it's it's not your straightforward

Oh, here's a lecture on this. We're going to go through a slide deck like a webinar Uh, um, and at the same time, it's not a free for all So we try to structure the thing and I try to work with each speaker On what's going to work with their particular presentation style. Some people are heavier into presentations Some people are heavier into discussion. Some people are all discussions. Some people are all presentation You know, and so finding that balance has been difficult From an operational perspective and then of course the platform Being, you know, the bane of my existence. Um in the email announcements one thing that we did get

Um, completed is a new single registration form Which I'll share with you Um that you can sign up to get the reminder every week There's no need to sign up every week If you sign up for the join every friday doesn't mean you need to join every friday It means you'll get the reminder automatically. You don't need to sign up. So that is you know Yes, remind me every friday Um, and I think that'll be convenient for a lot of you who are here today um But you know um going back to the

Sorry The year the year of growth. So we had all these sessions. We had all these webinars um, and that was exciting. We did lots of um LinkedIn posts. I want to share with you sort of the The weekly post process Um just so that you can see it but it's a manual process that we go through every week of um finding what content is um Out there on on LinkedIn. Um, and we follow a certain number of people Um regularly. We're always on the lookout for new content um

I'm always open to hey, this is a really great LinkedIn post. Sean, you should consider featuring this. Just send it to me Um, and and we'll take a look at it But what we look for when we look for LinkedIn posts is really Are you telling me something that I don't already know? Are you adding value? Um, are you sharing a recent update or are you creating an educational post that's actually helpful? um, you sing a lot more um chat gpt generated content. I have nothing against chat gpt generally um, however, I think we're going to reach a point of saturation with that kind of

educational content that just sort of Ask chat gpt to break down, you know a certain topic and um and slice it up what I have noticed is Videos don't perform very well um Putting a lot of pictures up Doesn't really perform every very well a single picture performs better. Um slide carousels seem to perform extremely well I don't see many text only posts anymore. Um It's I I think it's difficult for Um people to notice them. I think that people scroll rate past them um

looking at Some people that have been extremely Successful on on LinkedIn. I suggest you take a look at your deagle. Um, he has uh Done remarkable work in the kappa area and the thing that I think is really interesting Is that he's taken an area like kappa and he's basically said this is the hill i'm gonna die on it's gonna be kappa And I am going to do two or three posts a week That are going to explain this from different angles. He's got different ways of doing it And what has happened is he's developed a following and the following has grown and grown and grown And so now his posts Automatically get a hundred or more or even more

Likes and comments the thing that seems to be driving the algorithm more than anything And martin you can chime in on this is Has less to do with the number of likes Uh that you got uh, but rather the um the number of interactive substantive comments and the more Um discussion that gets sparked on LinkedIn the more they continue to show your post um that said you can Create a value list discussion um Which you know, for example, I Um did a post about being sick at christmas, which got me something like 24,000

You know views and I didn't find that to be a really high value Um In fact, I was you know On on the verge of not posting it at all Sometimes the things that Have the most viral effect don't really have any value to the audience in terms of education in terms of understanding in terms of deepening so I would I would caution that what we're looking for when we're looking when we're evaluating posts is Are you sharing a document? Are you sharing special insight? Are you sharing? something that only you are qualified to talk about or You know, no, I mean no one has that special privilege, but they you know, are are you sharing?

insight at a level that is That that is valuable to the community. So What we're looking for when we're looking for content is is it interesting? Are people are are people responding to it? um and You know sometimes I've posted things that only two people have liked You know, um, it's not necessarily a numbers game at all if there's value in the post um, and um Then then it then it's something that's worth exploring so I don't know. I'm gonna ask you, you know, if

What you're seeing on linkedin the content that resonates with you and any anything else about linkedin in terms of you know getting more followers or um Developing your linkedin presence or why should I even be on linkedin in the first place? um Is there any value in it and I would and I would and I would say that You know a lot of clients come to me and they're like, oh if I develop this this linkedin content schedule You know with this posting rhythm and all this stuff. Am I going to get more clients from this and linkedin really isn't a quid pro quo It's not any guarantee of getting clients

The value in posting on linkedin is creating consistent presence in the marketplace So that people are familiar with your name They've seen your comments on the thing and that you've defined an area that That you're going to tackle rather than saying. Oh, I'm doing all of mdr You know, I'm I'm you know, I'm qualified to talk about any part of mdr. Well. Yeah, you may be But that's really not honing in on a specific Area that you're going to say this is what this is what I specialize in think of a restaurant That has a signature dish. What is your signature dish? You know, what do you want to be known for?

um When people say, oh, yeah go to martins. He does You know really good regulatory roundup. You know something like that. Um, the So I'm going to open it up to comments here, but you know really looking at linkedin in how we can Leverage that platform the linkedin groups just don't They don't work for me. I mean, I'm actually the administrator of a group of the medical devices group with 350 000 members and I can't get four likes to save my life in that group And I'm the administrator of the thing so I don't see any value in groups. Um

You know what what we're talking about here is moving How we how we leverage linkedin to move people off of linkedin and into groups like this into a network where we can have discussions um and um And and and so forth So Is that helpful not helpful? I don't know Can can I just make a comment or get some feedback from you guys on this? um, I go on to linkedin quite a bit I'm not constantly on there because I get pinged a lot

um, but What I've also noticed is sometimes I even get important posts that are like two weeks late later or even a month And I'm wondering why the heck am I getting some of these things so so many weeks later if I'm You know always checking some of the people important people Do you guys know how the algorithm works or you know, sometimes I have webinars That are posted online and it's already two weeks ago, right? It's sort of annoying sometimes So the linkedin algorithm is a private thing that is constantly evolving And they keep that lockdown

Very tightly. What I can tell you is that what you're shown in your feed Is based on who you're connected to who those people are connected to And what's trending on linkedin? So they may decide two weeks after the fact that people are still talking about a certain webinar And decide to show it to you the order in which that Shows up is is highly uncontrollable. That was the essential reason why we started Medtech leading voice in the first place was because there was no predictable way to get linkedin to show you content of value It for for the medtech community

So what we did was we said well, who should we follow and linkedin said follow who everyone you know and And so then we went to a bunch of people in the industry and we said Well, who do you follow and they said oh, I follow these people And so we started to follow them and that's when the mlv 25 was born and it was 25 people worth following on linkedin from that medtech leading voice was developed Which we said let's find the top 10 or 15 posts every week Um that have the most value so that you don't rely on the algorithm to show you Um, you know what what's happening because if you rely on the algorithm

You know, there are things that you can do with who you follow in terms of ringing their bell And making sure that you always see their posts. There are things that you can do To sort of up your chances of seeing the best content But again, they're going to show you what they want to show you in the order that they want to show it to you in And a lot of it is increasingly based on who's giving them money Because you'll notice that they're like, do you want to boost this post? Do you want to boost this post? Do you want to boost this post? And In my answer is categorically no um so That leads to the idea of okay, how do we move people off the linkedin platform and onto another platform and that's

Not easy to do. We've done it successfully with the webinars. We've done it successfully with the friday calls What i'd like to see happen is a sub stack publication for medtech leading voice come into being Which allows us to publish longer forum content on more Thoughtful dissertations more thoughtful ideas more thoughtful discussions Rather than what's going to capture somebody's attention for 30 seconds in the feed Because I don't think that there's a lot of value there. I also don't think that there's a lot of value in terms of the llms there You know, I don't think the llms are looking to linkedin to say who's the authority on

um pmcs Or 6a 601 So if you think about The way that people are searching for information the way that people are searching for experts in 2026 They're going to be increasingly turning to the to the large language models to chat gpt and claude In gemini and they're going to be looking for who can I trust? Who can I turn to? for medtech expertise on subject xyz and I think that the people who are going to come out ahead are the people who are consistently producing high value content on these topics Accordingly what we've done is we've taken every webinar that we've done

And every friday call we've transcribed them We've chunked them and we're producing a searchable version of the mov 100 And all of the webinars and all of the friday calls so that the llms will be surfacing the full text Conversations and the actual voice of the experts Our our place in In the medtech ecosystem is the voice of the experts The very center of what we do is medtech expertise. And so what we're trying to do is to become a hub that the llms will turn to to look for who are the most credentialed

expert speakers on this topic From that perspective We're looking at 2026 and we're saying what are the topics that are worth deeper exploration In the more specific they become Whether or not we're talking about document control kappa 6 to 601 a specific standard A specific aspect of clinical a specific aspect of risk Specific aspect of product engineering cyber security You know the more specific and the more detailed that we get the greater value We're going to be providing to the community at large and the more that the llms will turn

to This this content resource so From there We get into the idea of okay digital summits What is the digital summit a digital summit is 10 to 20 speakers on a given topic each one taking about a half an hour So first one that we're thinking of doing is femtech and You know designing For women in the special needs of women in in medical devices You know There's a lot of room for a variety of topics So now you crowd source this topic and you bring 10 20 different experts together to discuss this thing

Now Is somebody going to go and sit through six hours of this or are they going to watch the thing in bits and pieces? You know people are going to come to it At at different levels and participate in different ways But the thing that an expert can do is they can say i'm going to discuss this aspect of it And i'm going to create A take home document That people can take with them that they can remember me by So they get a checklist they get a guide they get You know a summary version of what they discussed in in their section or an expansion of that They get something that they take with them that

Provides them a reason to reach out and contact you after the fact It's not oh, I went to this thing and now i'm going to hire Stephanie. You know it's It's the beginning of a connection. It's the beginning of a conversation And so what i'm i'm hoping is that We explore new types of content private workshops um large summits um mini summits I'm planning a mini summit for the end of february on the italian medtech market I already have i don't know seven or eight speakers at this point. My goal is 10 um from

uh The competent authority from notified bodies um in people talking about things like distribution um Contract manufacturing clinical studies, etc Trying to give a 360 degree view of the italian medtech market Sean Yes I was in milan. So I have a couple contacts. I can connect you with Fantastic many manufacturers Good manufacturers are always hard to get to speak um, but uh You know, they they tend to not want to share all that information Um mass mo is

An interesting guy. Maybe he'll want to share I always welcome new conversations. Um, so I've talked a lot. There's a lot of opportunities here in front of us What do you all think? Martin I think that so the post you spoke about earlier about you being sick and getting lots of uh attention so Yes emotional posts get good responses My best post that I've ever had from a response point of view have been emotionally driven posts

Whether if you do that consistently whether it really works. I don't know. I don't want to take that risk um So that's one thing that continuous presence is a key So you need to have a continuous presence. Whatever that means whether it's in comments Or posts so I sort of have a high continuous presence, but that's also to do with the group And so my experience with the group is good it's It is work, but it's very focused and I have a very high performance group so I don't know if it grows whether we will see performance going down It's only like 14 000 users

members and climbing and whether that activity will decrease I don't know, but it has a very high The numbers of activity are are nuts. You know, it's like very high. So And there are things from the algorithm point of view that you can do as groups if you can't do On the general in the general forum and that is you can like post low to post one after the other and the algorithm Doesn't chop you down because they're all going into the group whereas if you are posting in the general LinkedIn space And you post too often too close together then it's going to see it as spam

And also, I mean the common thing think mistake people are making is when they repost their own post or repost in general So repost with a comment or with some input And then it becomes a post in its own right But if you just repost blank Then it then LinkedIn sees it as a duplicate post and it's going to put it down in the algorithm So if you're going to create multiple posts and you're seeing that I do this a lot I usually do a post in the group and a post in the general LinkedIn and the post in the general LinkedIn usually goes out later than the post in the group So the group gets some preferential treatment if you like

But I cut and paste physically the two posts. They're identical But they are two separate posts So I I completely agree the content of value is key And that content of value can be in a post or it can be in a comment Or it can be in the in a repost And a content of value in a comment is pretty Good because it expands the audience for that post Like always I tried to do with the newsletter. I always try to put a comment in there with some

Some added input Because that's expanding I you know I've been doing this series on the performance, right? If you look at a post or an article or a newsletter as a performance The comments are expanding that performance. They're expanding the audience It's very fluid Right. It's a very fluid situation people making comments are actually performers. They're mini performers on the outside of the core post so So we have that's the way I look at it and I don't think That we're just looking at electronic media and we're looking at At a different forum and yes, we have to look at how the search machines and models

Are leveraging this so if we get a peer outside how How it's going to be leveraged but I like I have the I have the index tool Which basically points back to linked it. So I'm continually fueling the two I've get them to work in symbiotic symbiotic Relationship and I think there's a key to that if you want to take people off of linked it into your own forum Let linked in benefit from that as well because it's a cross-fertilization. It makes the two work together But that's that's what you have to think out. That's the trick. How do you make it work? You know and and I think the method you use is very good where you send out these clips

This was the this was last Friday and you In in two minutes you have a summary of all the key points or some key points raised on the previous friday, and I think that's a really That is what's going to attract someone. It's like, oh, I missed something Maybe I register for the following week Mm-hmm, or maybe I register what I discovered to my to my payroll was that I thought this is great. The newsletter thing is great because you can offer everybody a sub subscription So on this mini series I've been doing I sent it out as a newsletter so I wanted to do The regulatory roundup

That's a newsletter Turn it into a newsletter so people can subscribe the format and everything will be the same It's just a way of pushing it out to people Because I'm now doing like a daily roundup essentially what ends up being a daily roundup and so That was great until and linked in said you can have up to like five newsletters. So I thought this is good So I create this newsletter for the mini series and then I go back like a week later and so on to do this newsletter for The for the roundup and it's like no you can't You can have up to five newsletters, but you're only allowed to create one one one every two weeks

So I have to wait Yeah, I I always thought you're only allowed one newsletter period No, you're allowed five Oh, it says you're allowed five, but it says it will only let you create a newsletter, which is not Every two you can create those five, but you have to do one every two weeks to create the five and get them running But I'm able to publish one every week Yes, once you once you publish I have got one at the moment the the mini series is going out every day, right? Ah, so once One other thing I've noticed um You guys probably know this but uh

Is that if I go on to your profile Sean? I I don't see all the posts that you've done So sometimes I'm on linked in and I have to do something else quickly and I want to register for you know Some session that's not on a friday Um, and then it disappears on me because I come back a half an hour later and I go on your profile I don't see it and I then I checked other profiles as well And not everything not all the posts that are on linked in Um show up and it's you know, I think they're doing this on purpose that the You're looking linked in more than once a day Because you don't have a full you don't have all the posts to associate with a person

I noticed It's it's it's it's really really difficult to find a historical post I did some brief guides like two or three years ago It's really difficult to find them if I don't have a tag for them in adoption I mean it becomes data mining exercise on linked in Because it's a linked in is a thing for the moment It's not interested in something that happened a year ago or two years ago And there may be information in something one or two years ago And that's why I created the index so that everything that goes on the Qa ra group that has any content of what I would say content of value ends up in the index

So you can at least do a a key word search or something in the index to find stuff Yeah, but even even if someone did, you know seven posts in two weeks You don't find the seven posts that they did in two weeks That's what I've noticed, you know, I've gone on different people's profile And you just can't find the things anymore Even if you're given like for example, Sean's name Sean Smith's name I don't find the post that I was looking at maybe yesterday I Yeah, I mean there's LinkedIn can make it difficult for me to find my own posts LinkedIn make it find it difficult for me to find my own events

LinkedIn can make you know anything difficult the expression, you know screw up a two car funeral Um comes to mind Um, but the Is there a work around I I'm raising this because I'm just asking the community here There's a work around to finding these things Because it's sort of sad. It's some of this the stuff is valuable content for your everyday You know and you have to sometimes drop something and get something else done and then you come back and you can't find it anymore I just said it just said the link via email to myself So when I see something on my cell phone, which I say, okay, I need to read that

I I send it via email to myself because I I know what you mean I know this problem Good point. I I used to do a snapshot and then I realized I can't find it anymore Yeah, that's the reason why I used I I sent the link to my to my email So I at least if we take that when I'm back on the computer so I can find it You also can save the Link If you go in the three dots or whatever it is. Yeah, the three dots You can pull down and save the link Yeah, okay So what I guess I'm trying to say not the most efficient though Because then you have to look at all the safe posts yeah So I guess what I'm saying as well is that, you know, we have our group has really valuable content Sean

And it's going to disappear now and again on linkedin, right? So even though if we do a lot of effort and you do a lot of effort um I mean, is there any bargaining chip with linkedin to sort of raise the profile the med tech leading voices that this stuff doesn't disappear um No, the biggest way to keep the stuff from disappearing is to keep the conversations alive, you know For you know people not to write comments like, uh, you know, thanks for including me you know, it Yes, it's a comment 11 words is apparently So I hear You know what triggers the algorithm 11 comments that are 11 words or longer

um are Given more weight Then thanks for sharing You know, um, it's not The not all comments are created equal um, and so, you know but I mean when When I talk to clients when I when I talk to people, you know, I talk about visibility I talk about credibility and I talk about connections And I think that the reframe if if I were To think about it Is most of the stuff that you were told about your value proposition about your unique selling proposition about your target market about your ideal customer profile

Is more or less marketing garbage um that has been popularized over a long period of time by people who are um Not very good at what they do and What I find is that in our business where you're talking about I'm looking to hire an expert on topic x That people are turning to their network. They're turning to people that they know they're they're they're Increasingly turning to the llms for advice How who should I hire? How should I hire them? You know, what what how much should I expect to pay that sort of thing?

and that what We're faced with is The people that Band together Are going to do better than the people that try to do this alone that um, you know, this is this is this is this is not a solo activity um You know it it takes it takes a village and I think that So the idea behind the visibility and credibility and the connection somebody needs to mute um and is That it's around this consistency. It's around the consistency of of

You know, um presence and providing value Throughout the year. It's not a matter of showing up once a month and saying hey, does anybody want to hire me? You know, here's my value proposition. Here's what I can do for you. Here's what I'm an expert at You know, here are the top 10 lists that I'm on You know, here are the here, you know, it's the The things that It's like all the information that goes on a website is irrelevant here What you're trying to do is you're trying to convince An audience that hasn't asked the question You know, why should I hire you? and that so, you know I mean, we're all in the same position

which is Trying to adjust to a reality which the the sand is shifting very very quickly under our feet and I think that you know if if If I were, you know to summarize what people come to me for and people ask for is You know, how do I get known for? this how do I in and um The answer is, you know, be present be relevant be consistent provide value you know and Theoretically theoretically the business should take care of itself

You know, um, it's not a matter of writing to more people and saying hey, do you want to hire me? That's not generally a A viable option. I mean, we all get those emails probably in dms Where somebody just shoves their resume into the thing and is like This is what I can do for you. Do you want to talk? I mean, how many of you even have ever responded to that? You know And yet it's very tempting when we talk about ourselves to turn around and say this is me. This is what I can do um and uh So, yeah, it's

It's you know a strange double edged sword um Martin and I were talking briefly before the call. Um, and we were talking about um 2025 being a year of proposals and 2026 being a year of of actual implementation uh qmsr mdsap um the proposed mdr uh In and how that's going to shake out. What do you all see? Is is topics shaping 2026? In areas where you would

like to see a mini summit or You know more I can I can start. Um I I just wrote an article on I didn't write an article, but I wrote some something on LinkedIn or um I think that people skills availability to actually take over The challenges that the industry will be facing in 2026 and beyond and how I mean for the next five to 10 years um That class of professionals that we're expecting especially because of the complexity that is

shaping up pretty much As we move on with new products new technologies and and even now with AI um And I mean that not only for the industry, but I actually mean it for the regulators Because the regulators have gone through a major overhaul of their institutional knowledge So now when you reach out to the FDA and other Uh regulatory organizations, you find that there's a lot of new people. So The way decisions will be made The way policies will be implemented to even the way compliance and quality Will be achieved Um, I think that this is going to be a challenge and I don't actually it's not just only in quality, but

Even in manufacturing and validation Pretty much across all functions with it so so I think that we need to figure out a way to sort of understand and maybe Even even for us in consulting, how do we support? organizations that are evolving in in organizations that That in a certain way do show a gap. I mean as a consultant a lot of the Assaulting work that I do sometimes is really helping clients on the basics not on the complex because Even the basics are still a challenge. So so to me people and organizations It's going to be a challenge even the way organizations will be shaped and how organizations are developed

It's going to be a challenge which will have an impact on How products are brought to the market? How products in commercial distribution actually dispose of? um, I'm I'm concerned that there there could be even a situation where you know for the sake of being comfortable and safe Products will be rejected And maybe they didn't need to be rejected products will be recalled And maybe they didn't need to be recalled which is going to be an expensive proposition to the industry So that's my concern. So And to me people are the key to any Uh gxp activity you could have great procedures. You can have great processes. You could have great facilities

You name it But if you don't have to write people managing directing executing It doesn't really matter if you have a third state of the art facility. It really doesn't matter if I have great procedures People will think processes will fail because people run processes processes don't run people Procedures don't run people People actually run procedure. So that's that's my perspective. I think that way this this could be a theme on how do we Think outside the box Yeah um

I mean, I I think what you're what you're pointing at is that, you know So much change all happening at the same time It has a destabilizing effect on on these companies and um So it's it's an effect change management um You know to At least maintain the consistency of the people Uh throughout the process, you know, I don't know something like that Uh to a to a certain extent. Yes, sorry I think you have a situation occurring if we look at If we look at the qa ra space We have seen a migration

happening or an evolution where People who are pure regulatory Have difficulty surviving if they don't have the quality piece And quality people need a bit of the regulatory piece And now we're seeing the technical bar being rosed where I think risk management is a really good example, right? We have the risk management specialist Right, so they could put together a risk management A group put together great risk management and be all 14971 compliant Oh, but now they have AI And now they have software as a medical device, which I've all got different

levels of risk management and now we have CVSS And basically for someone like me, you just put all of that Mapping into your risk management plan and bring everything out on the 14971 Top level risk evaluation assessment But if you don't have that knowledge and if you don't understand what software it's if you don't understand what AI is And you don't understand what cyber vulnerability really is Then It's extremely challenging. You're going to be completely lost You know and this whole cyber vulnerability is just one tiny piece of information security

You know, what is the point of making your Your device super secure against cyber attacks If your company isn't super secure and all the development documents And all the development information is sitting on the cloud unencrypted I mean It's like There is so much going on. It's very very difficult For management and the experts themselves to have the oversight That's a great point. Um, and I think We're going to see more and more

cybersecurity issues both at the level of the the device and the whole connected environment which the The device exists within And all of the vulnerabilities that exposes Companies to is an excellent point Two other people have posted one said harmonization of standards and another person posted about uta med Darin, do you want to say anything about uta med? I don't know if you're still on Or the person who posted about harmonization, which I have to check

That was me I think it's all it's an ongoing discussion. We still have A huge gap for resources So it will probably stay on the agenda for quite a while Also in 2026 Well, the FDA just published their updated list of recognized standards Yeah, because it for the FDA it's The FDA can do it alone And in europe with the harmonized standards you need Not only the you commission who publishes it You also need san senilek who writes the The the set and access the forward

You need the has consultants which are third parties Hired by the you commission to review it give it back to the standardization What is before it can be published? There are a lot more people involved in that And it's a very slow process It's a very slow example A great example So 20417 back in march second edition Was drafted for fdiss and in tokyo and I was part of that and we sent it off to be reviewed for an xz

And it sat and sat and sat and sat and we finally Are you And a couple months ago because it just sat We finally I think it was through I think it's the vnna agreement I always get these agreements mixed up We went to iso and said it's not getting processed We need to split with the agreement And just get it published. So it's hopefully going to publish without the annexed in Approximately march because it's been sitting so long not getting processed So we're not going to have an annexed for 20417

Second edition which has significant changes. I mean we had Several hundred comments. I believe in tokyo last march that we went through We spent two and a half days going through all the comments This is Yeah, so there's some really good changes coming through um Couple comments about yuda mid and this other thing in the chat Bota mid I guess is how you would say that beautiful yuda mid better yuda mid

and There's a there's a link in there has anyone tried it. I'm not sure what it is. I'm not And shan, I think I found my mic. I can speak a little bit to why I put yuda med in We got a minute here. Yeah, go ahead. Um, so yeah, again yuda med has been such a slow slow roll Over the years and I think with the the four modules becoming mandatory in 2026 It's gonna probably catch a lot of people by surprise If I try and get a little bit from fda data The udi good id uh 483 findings just over the past couple years have skyrocketed

There's two that are now in the top 15. They just released a 20 25 43 data I've been working with a clients who did not register in good id. So I think You know, it's triangulating a little bit But I I think a lot of people are going to be surprised by the yuda med Requirements and it's going to sneak up on them. So That's why I think it's a good one to cover this year excellent Anybody have any thoughts about yuda med good bad otherwise We need the same time. We are now Switzerland out of yuda med. So we have our own system which also gets mandatory 2026 The word is small country

It's an own database So if you cover the yuda med Probably you also need to Do the same again for Switzerland if you're selling to Switzerland I think Italy and Spain are also keeping there um registration databases At least for a while I imagine that a number of other countries are as well Yeah, but Switzerland is not part anymore of yuda med. So at all. So Right, it will stay there at least As long as we are not again part of the single market for medical devices Well, I think that we could do a whole session just on switzerland

um, I mean Really the The decision to opt out of mdr was um something and uh um It was not an opt out. It was a kicking out So it was never my voluntary with switzerland to to get out there No But you have you have quite some people here on the on the list from switzerland. So I think It took the post as feasible to do some once a call on a friday about switzerland Stephanie and martin Yeah, I agree I'm in Me too. So we already have two at least

Sean, I would also like to talk about i am dr. F um as well Any importance of are you speaking on them? Yeah, I would like to yeah, is that still a go I hope Yeah, yeah, I just you know getting sick. I was just cutting up fell behind but yeah, um, uh, Stephanie is going to be talking next week on i am dr. F um, and uh Tell us give us a give us a preview Well, I what I'll do be just as first of all introducing i am dr. F as it is um an organization that's really pushing Harmonization and some of the benefits and then some of the things that have been brought from that organization

um And uh spread and you in use internationally and we know some of these things But we're probably not aware where the origins are um, for example the md sap program Um, the vigilance coding that has been adopted by the eu and some of the other benefits like for example um, if you have an md sap um certificate and report Um brazil the regulatory authorities from brazil will not come within the year To audit your quality management system of your legal manufacturer. They're going to take four years till they come And I mean if you can think about the financial benefit of that, I mean, that's you know, worth thinking about for your organization

Right, so that's just a little bit of a pre cap of what i'll be talking about I appreciate it So we're about out of time Um Yeah, can I just say about two seconds? Sure um I think I've been with this group since joe h days for a while and then I truly enjoyed this whole 2025 And I think amongst the group of people I public are the least of any knowledge Because I was in it for 28 years and switched to a medical device in the last 10 years But I want to say thank you to all the experts on the panel and some of them are not I have learned so much from all of you like leo every time I have six six zero one

Questions I always go to your link in and look at your post or go to Uh you too or whatever and then for some other experts like um michelle lot and I just really enjoy learning from everybody and then I start to follow Most of you and trying to learn so I hope 2026 will be another wonderful learning year for me and I just want to take this opportunity to say Happy new year and thank you all the experts Very well said. I appreciate it um, thank you for For saying that um, you know, if anybody else would like to add any comments feel free otherwise um, we'll resume next week

Um, those of you who are interested in speaking this year, please reach out to me Um, you know, we'll develop the topics together. I'm not gonna You know Shove you in front of everybody and be like go you need to be the expert, you know I think that Is important to think of this as a collaborative environment is important to think of the The benefit of having a number of people in the room You don't need to be the smartest one. Nobody likes the smartest person in the room. Just think of martha steward and what happened to her you know, um Everyone was happy when she went to prison. Well, not everyone but you know what I mean

so I mean that you know, don't be martha steward and uh, um Yes, absolutely. Canadian requirements. That sounds good. Um, yes So I want to wish everybody a happy and prosperous 2026 um You know, if you have questions for me, please feel free to reach out. I'm always available to talk and um Yeah, thank you. Thank you everyone for being part of this Thank you, Sean For collaborating and bringing us all out To our best Thank you, michelle as well Thank you all the experts and I couldn't thank you enough for helping me learning to do my job

Excellent. Thanks everyone. I'll see you next week Bye Thank you Thank you