The State of UDI Across the World

In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and regulatory compliance.

They embark on a comprehensive exploration of the ever-evolving landscape of UDI requirements, shedding light on crucial deadlines, common pitfalls, and strategic insights for achieving global compliance.

From the intricacies of European UDI requirements to the specifics of implementing UDI systems in markets like Australia and beyond, this episode is a treasure trove of actionable insider knowledge for medical device professionals navigating the complexities of UDI compliance.

Interested in sponsoring an episode? Click here to learn more!

Listen now:

Love this episode? Leave a review on iTunes!

Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Key Takeaways

1. Increasing global adoption of UDI requirements signifies a move towards standardized device identification for enhanced patient safety.
2. The push towards digital transformation in regulatory compliance highlights the industry's shift towards efficiency and data accuracy.
3. The growing complexity of global UDI regulations challenges manufacturers to adopt flexible and scalable solutions for compliance.

1. Start early with your UDI compliance strategy to accommodate the evolving nature of global regulations.
2. Engage with experts and consider leveraging technology solutions like ReTech for streamlined compliance processes.
3. Stay informed about regulatory changes in key markets to ensure continuous compliance and market access.

1. Will AI and machine learning play a more significant role in automating UDI compliance processes?
2. How will the expansion of UDI requirements into emerging markets affect global medical device distribution?
3. Can we expect a universal standard for UDI compliance to emerge, simplifying global regulatory landscapes?

Links:

• Gary Saner on LinkedIn
• Etienne Nichols on LinkedIn
• The Ultimate Guide for UDI
• ReedTech's UDI Compliance Solution 

Memorable quote:

Feedback:

Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Sponsor:

This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

Transcript

Gary Saner: Sometimes you come across these global medical device nomenclature terms that become deprecated and they're obsolete. They're replaced by maybe two or three other better, more granular identifiers for that particular item in the past.

So, health authorities check to the current list, and you might have picked this five years ago, and lo and behold, you didn't know about it, but now you try to use it and it's rejected. In the world of medical devices, time is usually of the essence. But here's the problem. Traditional product development processes are usually as slow as molasses. They cause delays and they're headaches.

For companies like yours, Greenlight Guru is the ultimate solution for MedTech's biggest challenge. You may be facing lengthy development cycles that drain your resources and hinder progress, but we streamline the entire product development journey.

We make it faster, we make it more efficient and less prone to hiccups by centralizing your data management, automating your workflows, and allowing real time collaboration. It's all here. It's designed to propel your projects forward.

And guess what? Regulatory compliance is built right in. It reduces the risk of costly revisions and ensuring you stay on track. With Greenlight Guru, you're not just developing products, you're accelerating progress, making a difference when it matters most.

Don't let inefficiency hold you back. Embrace innovation with Greenlight Guru. Go to www.Greenlight.Guru to learn more.

Etienne Nichols: Hey everyone, welcome back to the global medical Device podcast. My name is Etienne Nichols. I'm the host for today's episode. With me today to talk about UDI unique device identification is Gary Saner, who is a subject matter expert on medical device unique device identification, UDI, and other structured content reporting to regulatory agencies and commercial organizations.

UDI is one of those mysterious subjects. If you've not actually worked with UDI, it's very much a black box in a lot of people's minds. So, I'm always thankful to have people like Gary on the show. He has over 30 years of experience in software development, process management and data administration. In the last 15 years, he's been focused on the life sciences and MedTech industry. So, he also serves as the co-chair of the industry's structured product labeling technical team and is on the advisory board of the medical devices group.

And maybe not as prominent in some people's minds. But he's also helped write the ultimate guide for UDI that we have published on our blog at Greenlight Gruen. So, I'll put a link to that in the show notes as well if you want to follow up on that.

But Gary, enough about that. How are you doing?

Gary Saner: I'm doing good. Really well. Glad to reconnect. We've done a couple of these little podcasts in the past and always enjoyable to share some information and work with you folks over at Greenlight Guru.

Etienne Nichols: Yeah. Well, thank you for coming on the show. It's always good to have you on the show. It's good to bump in you at shows as well. I know we bumped into each other at raps, and I can't remember if you're at MDM West. You know, it doesn't matter. I know you're all over the place, but it's good to pin you down. We can have this conversation.

Gary Saner: Yes, absolutely.

Unfortunately, it's not a one-time thing where you learn it and then you're done. UDI has this ongoing life connected to it, so we do have an opportunity to continue the conversation and keep things fresh. So, it just doesn't seem to know. Once you do it, you're done and you close the books and you call it a project and you write it off, but boom, that's not the case. You keep after opening up those books and making changes, and lo and behold, there's another compliance date that comes around, or there's a new health authority that comes on board.

So, we continue the conversation.

Etienne Nichols: Yeah, no, it's a good point, too, because especially if you're a company that plans to go global, I think our last conversation was focused on the US. Maybe this conversation, we can go whichever direction makes most sense. But one thing that I know a lot of people are wondering about are the European deadlines and the UDI requirements.

Maybe we could start there. What are some of the upcoming European UDI requirements that manufacturers need to comply with, and what is some of the impact of that rollout?

Gary Saner: Yeah, so there's a couple of things to remember. One is you need to assign a basic UDI very early, and then there's placing UDI on the labels and there's registering the UDI into EUDAMED. So, let's go back and talk a little bit more about the assignment.

The European Commission had greatly encouraged. We'll put it that way. To keep your legacy products on the market. They had a milestone where you need to engage a notified body to examine your product and get ready for conformity assessment.

And coupled with that is some phrases in the medical device regulation that say you have to have your basic UDI in place and assigned before you talk to your notified body. Many companies that have walked down this and are already engaged notified body have passed that particular milestone. But for the rest of those that still have products that they would like to keep on the European market and continue to place those products on the market, they have a milestone and it's only three months away.

So, if you had not started, you're probably in bad shape and you need to scramble. So, the May 26 of this year, just roughly three months, you'll need to engage a notified body. And the reason I bring that up is the basic UDI would need to be assigned to your portfolio. Now you get a couple extra years, we can talk a little bit more about a proposed legislation from the European Union that will establish similar milestones for in vitro diagnostics. And they start at 2025, 2026 and 2027.

And let's assume that those particular dates will eventually come into force and the law will be passed. The proposed regulation would be passed, and that was just proposed recently in January here.

So that will establish similar milestones for the in vitro diagnostic. So, all that's about the first point, assigning the basic UDI early. The second point is related to placing UDI on labels. So, there's a schedule that the MDR has in place and firm dates in the particular regulation itself, and the class threes and two, A and B, those dates have already passed, going back to 2021 and 2023. So, your class ones, if you put class one products on the market, this would be a future date in May of 2025 to make sure that the product has UDI actually on the label.

And then again, in vitro diagnostic, that conversation is a little bit later, starting in 2023. And then depending on your class, it can go out to 2027. One thing I do want to make clear, though, Etman, we get this question a lot. Well, what about my legacy products? Do I have to put UDI on them? And the quick answer to that is no, there's no requirement to place UDI on your legacy product labels.

This is only applicable to the MDR compliant. And the last thing I want to talk about, and this has created a lot of confusion, what is the registration date? When do you have to report this UDI information into EUDAMED? There's a module, the UDI device module, one of the six modules. It's actually been open since 2021. So, you can voluntarily submit since then for years now, but everybody wants to know the mandatory transition time. When do I really need to do this right? So that as of today is going to start the fourth quarter of 2027 and then last 18 months now on the books.

And this is really significant. People are a little panicky about this. There is this proposed EUDAMED rollout that you kind of referred to in that question. The rollout provision allows the commission to take any one or multiple modules, any one of the six, and the actor module and the UDI module would definitely be good candidates.

And to do the audit trail, do the audit on that and declare them as fully functional and then make them required early without waiting for all six modules to be completed. There's one module that is taking a huge amount of time, and it would delay all six being in place all the way out to 2027.

But if this particular regulation is passed, there's wording that says that mandatory period could be two years earlier, not 2027, but as early as the fourth quarter of 2025. And the other kicker is that it's not an 18-month long window, it's only a six-month window.

So. Oh, my goodness. This was, as you would expect, this is quite an alarm, right? It's like, oh, my goodness, I thought I had this well taken care of. I put it on the shelf; I'm not worried about it. And now, boom, it's right around the corner. So that is very significant. One thing that is going to be an impact from that is that with this early and very short reporting period,

I expect that many companies will not have completed their conformity assessment with their notified body, and therefore they will be required to register their legacy product and then eventually have a second record submitted to EUDAMED for their regulatory compliant, like the MDR and IVDR compliant device.

So, I think it's going to force a lot of duplicate or not duplicate, but two records in EUDAMED without a doubt. So, it's pretty significant. We're keeping a close eye on this particular proposed regulation.

Etienne Nichols: So right now, what is already out there, though, you said 2027. I hate to speculate that if the regulation doesn’t but maybe let's just talk about waiting. Whether you wait till 2027 or let's say this goes ahead and is finalized and the rule passes where they have to upload it by 2025, fourth quarter, like you said, what's the impact of waiting? How long does it take to get this information uploaded and what's the general thought on that process?

Gary Saner: Yeah, and it's very dependent on a couple variables. Some companies are very well positioned, meaning that they have their attributes pretty well controlled. They might have submitted data to the US already because those compliant states have passed. So, they have that under their belt.

They know about UDI. Now, unfortunately, it's not a cookie cutter. You can't just say, oh, I'm just going to duplicate what I have with the US and submit that information to EU. So, it's like twice as many attributes. Instead of 57, you now have 111 attributes to deal with. And you have a basic UDI hierarchy and so on. So, it's much more complex in the European front.

But if your data is pretty well established and some companies have been using part numbers and they have not converted over to a UDI product identification system, that increases your effort and timing if you don't already have acceptable identifiers for your product.

And then again, how many products do you have? How many people do you have assigned to the team and how long are they work? Are they half timers or. I don't know. I have a rough rule of thumb that we have 2000 products. It's going to be a couple of months to work everything out, learn what your gap analysis is and clean everything up.

Some companies we deal with, some companies that over have like 100,000 records or more. Wow. And they literally are at that task for years to bring everything together. This collecting and cleansing is quite a significant effort. So, it's a good point. And I can understand a little bit of panic if you had a huge amount of products and not started and now all of a sudden you see something fourth quarter next year.

That certainly calls for alarm.

Etienne Nichols: Yeah, well, I guess a lot of light being shined on European and then a little bit more in the past, but like you mentioned, it's already passed. But the US requirements, what if we go outside those two big players?

What about someone like Australia, which I don't know a lot about, but can you talk to us a little bit about Australia's approach to UDI compliance, how it differs maybe from European EUDAMED?

Gary Saner: Yeah, well, good report there. They're actually making very good progress.

We find TGA is very open to industry interaction. They've had over 19 webinars with industry. So, by the way, that's completely opposite of what you find with the European Commission. There is very low engagement, as you know. So, it's very encouraging and they have pretty good focus on building their product.

Now, there's a couple of differences and maybe we just kind of try to remember some of these things where we do a side-by-side comparison, let's talk about just the database itself. European Union is putting this EUDAMED, and it has six modules and it's huge. A lot of interactions between the actor module, the vigilance module, the certificate module and all these six modules. And at the same time, it cleared the table with all the regulatory requirements and creates a brand-new framework.

The Australian UDI implementation is very much like the US. It's simply a layer on top of the existing medical device registration. So, they have RTGG, the registration of devices and that doesn't go away, it doesn't get replaced. It actually links to their new UDI database. So, the concept is much simpler, the scope is much more reduced and focused just on known, just like the US where they built a good id database and it was really just Udi. And all your other medical device registration listing platform was untouched. The other thing I'll mention. Oh go.

Etienne Nichols: No, no, that's really exciting to hear. No, keep going. This is good.

Gary Saner: The other bit of information is dramatically different is both in the US and in Europe, the manufacturer was responsible, quote, legally to actually make the submissions. And it's a slightly different mix in Australia there the regulation, and we expect it to come out second quarter of this year. But most likely, and it has in the past, the draft version says that the local sponsor is legally responsible to make the submission. So that is organization, an entity that has an address in Australia, maybe they're in Sydney or Melbourne or whatever, but 90% of the products in Australia are imported into Australia. So, there's a huge amount of dependency on these local sponsors to do the work. Now they can delegate to the manufacturer, or they delegate to a third party to make some submissions on their behalf.

But the business arrangement and one of the takeaways here is that if you sell into Australia, you obviously have one of these local sponsors that's a known prerequisite to do business there, but you need to talk to them and say, hey, what's this UDI are you up on know?

Do you want me to contribute?

The manufacturer still has to create the identifiers for Australia and then share that with the sponsors so they could submit the report know. Anyway, it just has to be worked out.

A couple other things I'll say about the data. We mentioned that European Union has a pretty complex set. They have this hierarchy of a basic UDI as a grouping level, and then a lot of attributes, like 111 grand total.

You go to Australia and it's much less there's about 67 attributes and the alignment is very close to the US. They don't make use of the basic UDI, they don't make use of the European medical device nomenclature, EMDN. They specify the GMDN, the global medical device nomenclature, which the US uses.

And the Australia's used a standard from hl seven. So, health level seven has an SPL standard for structured product labeling, and they're making use of that as a machine-to-machine connection. So, in my point of view, I think Australia turns out to be much more aligned to the US implementation than the EU.

Although when they originally wrote their letter of intent, they talked a lot about the European Union as being a precedent and it just has not been implemented that way. We see a lot more alignment to the US than the EU. So, some of your data that you might have collected for the US is probably good candidate to reuse for the Australia and not so much with the European Union data set. It's interesting, isn't it?

Etienne Nichols: Yeah, that is interesting.

Maybe they're trying to scare people so that when it finally rolled out, you're like, okay, we can handle there any other. Well, before we leave Australia, are there any dates we need to be thinking about when it comes to that region?

Gary Saner: Yeah.

Going back to some of the early letter of intent, Australia, TGA was making the comment, well, we're going to follow and not be earlier than implementation of the EUDAMED.

Etienne Nichols: Okay.

Gary Saner: And now I'm not sure that's going to happen. So, if we were to use the 2025 fourth quarter date for the EU, which would be this early date, and that six-month date where all devices, all classes need to be reported in that six-month period. So that right around the corner, if you go to Australia, their target is also 2025, the second quarter. So, it's actually a little bit earlier. Okay. And that's dependent on their approval of a legislation, and then they have one year thereafter, which they say will actually open up the doors and make it required.

So, I'm actually putting my money on that. Australia would actually be a little bit earlier.

I'm willing to take some bets, but anyway, it looks like it's now on paper, it's time to be earlier. Now, one thing I will mention, when TGA opens their door and makes it required in the second quarter of 2025, assuming everything goes to plan, they have a schedule just like the US had a timing schedule based on risk class, and the first class would need to come out just as of the second quarter of 2025. But then there's three years schedule for the lower class, the class ones to eventually be required.

So, it's kind of like the US where there's a long window over a couple of years. And again, we're doing side by side comparisons here and the difference in the EU is not that way. All the classes need to be inside that six-month window. So, I think we need to get back maybe 2025 and see what happens.

Etienne Nichols: Yeah, absolutely. We'll pencil that in for 2025. But I know there's a lot of different things that go into your regulatory strategy, but maybe on this particular piece of criteria then it sounds like if you have a product in the US, maybe shooting for Canada, if that's on your horizon, maybe that would be something sooner than Europe. I don't know. What are your thoughts there?

Not to get too far out of our lane but giving some of that just for that regulatory piece. If someone's thinking, okay, I'm in the US now, I'm going to target these other regions. Sounds like Australia might have a little bit lower bar and perhaps on this particular area for shooting for rather than going straight to Europe.

Gary Saner: So, I would think Australia would be a little bit more able to be reusing the information and your techniques. I don't know, it's a little bit closer in the model than what you have with the EU. And I expect, by the way, Canada, there are no plans. I don't want to get anyone scared here. There's no plans right now for. They're doing a little bit of pilots in the back-office sort of thing.

But I would imagine Canada to follow to the US as then, you know, there's Saudi Arabia out there. They're kind of close to the US. They don't have basic, you know, there's Brazil and anyway there's Switzerland. Switzerland, by the way, we do expect that to be pretty much a mirror image of the European Union…EUDAMED. So, there you will be able to do heavy cross use of what you have in place for the…so, you know, pair those together. But all the others seem to follow the US model.

Etienne Nichols: Okay, this almost seems like something I'd like to see a list or a table. Is that something you guys are working on or have anything like that? I'm a visual learner, but it feels like countries are just popping up and coming up with new legislation all the time.

Gary Saner: Yeah, that's a good point. We can supply kind of like a world roadmap, and we can make that as kind of a piece of collateral. They could download connected to this podcast, but we do chart that out. So, it's kind of interesting. We started with the US way back in 2013, 2014. Time frame and list about, I don't know, it's up to now about a dozen different health authorities and when they implement it. So, it's a pretty detailed chart. But unfortunately, there's a lot of data that needs to be conveyed because again, many of these are rolled out by the class of the particular device.

They're just not a single date. There's maybe three or sometimes four different dates for each health authority. So, we'll keep that in mind. I think that's a great idea.

Etienne Nichols: Yeah. Well, if we're able to get it before this show goes live, we'll put in the show notes.

Gary Saner: Okay.

Etienne Nichols: So, kind of talking about the other, you mentioned a few different countries there. Are there any we're missing where something's coming up soon, or any dates that you'd like to share with any additional countries before we kind of talk a little bit more about implementation?

Gary Saner: Well, I still have Saudi Arabia on the corner of my desk. They have a compliance date a year ago where they rolled out three of their high-risk devices,

D, C and B. And Class A will be due this year in September. And you are able to make manual entry into their website. And there is a series of six different spreadsheets that they had piloted, and there's this possibility of using those spreadsheets. What we're waiting for is a firm data dictionary, and it seems odd that they haven't put that in place yet because they passed the compliance states.

We talked to some companies, and they say as long as they're still not able to provide a good data dictionary, we might submit a couple manual records or none. And we're going to wait until we have to submit the 30,000 when something becomes a little bit more conducive to bulk submissions.

So, I think the health authority there in Saudi Arabia is probably reviewing some overlap that they had with some other databases, and we keep waiting for some kind of guidance as to what the game plan is. If I was a company, I at a minimum submit a few records just to show that I made some.

Yeah, and if I only had a few, I don't know, maybe go ahead and make those manual. It doesn't look like they're ever going to put a machine-to-machine connection together like an API like China and South Korea did, or other types of gateways that the US and EUDAMED has in place. By the way, Australia does have a machine-to-machine connection. We were actually one of the first vendors to make a submission into their pre-production environment with a machine-to-machine connection.

So, we know that's going to be in place. But Saudi Arabia just seems to be a little bit out of the mix here as far as automated bulk submissions.

Etienne Nichols: Yeah, well, that's really interesting. A list of all the different machine to machine by country. And maybe as a side note, having Saudi Arabia on the corner of your desk someday I'd like to see a picture of your desk.

I'm sure I picture just, you know, a world map with little pins. I don't know, but it's amazing to me that you're able to keep up with all the different dates across the. It's really, really fantastic.

Any other countries or things that stand out that you feel like would be helpful for the listeners?

Gary Saner: Well, we're closely watching the progress with Switzerland. They had made some good progress with their actor module. So, remember, this is an equivalent of the European Union's EUDAMED with those six different modules, and they did some testing with the actor module.

Looks like it's functional now. This year they're going to be working on the device module. So, we're keeping a close track on that, see how the progress goes, and participate in testing as the opportunity arises. One other, and I'll mention it, causes some alarm in that Brazil has a regulation in place that says you have to have UDI in place this year.

And it's like, what the heck? We're not getting any updates on the UDI database. And if you read the fine print, there's another line, says that submission to the database will be dependent on the ANA visa, the regulatory health authority there putting an announcement out and say that we're ready to collect data.

So, we're kind of hearing from back office that they are way behind in building their UDI database. They might even be trying to secure a vendor to build it. So maybe they have some specs and some high-level policies, but it looks like it's way behind the actual development.

That said, the other part of the regulation says, I want to be clear, UDI for reporting purposes appears to be, in my opinion, at least two years off in Brazil, and yet the regulation has this requirement for UDI to be placed on the product labels.

I haven't heard a good clarification as to whether or not that would be delayed or that portion of the regulation would still be in place. So that's one thing. If you do sell into Brazil, I alert you to get in contact with them to see what the actual requirements are.

Etienne Nichols: Okay. And that is interesting how there are kind of two things that work hand in hand, the UDI on the label and the attributes that you have to update. So, one of the difficulties in the reporting module then is whatever you put on the label, you'd have to make sure you have all of the attributes covered or really what you're publishing.

I mean, some of those aren't going to be on the label, but there is some overlap. That's the real big concern. Is that accurate?

Gary Saner: Yeah. And there are, let's say for conversation, maybe six to maybe even a dozen fields and attributes that you will see on the label. So certainly, the device identifier. So, there might be some information about whether it's a single use or if it's multiple use, the number of times that it's able to be reprocessed.

There might be information in there about temperature limits. There might be some other information that would be identifying the actual manufacturer. So, some of that information is coded directly.

Other information is captured using different methods. So, you don't see the actual labeler name being submitted. You might see the Duns number, or in the European environment you might see something called the SRN, the single registration number for that actor being part of the data that you have to submit.

But you're right, when you put something on the label and report it to the database, those values definitely have to be in sync and should not deviate one from the other.

Etienne Nichols: Yeah. Well, let's go ahead and talk a little bit about the more implementation side because you work with so many different companies all over the world. I'd love to know what are some of the common pitfalls that you see in achieving UDI compliance in these countries.

And I don't know if you want to pick one from this country, that country, just if they're differing difficulties or if it's kind of the same across the board. Everybody makes the same mistakes.

I don't know what are your, the.

Gary Saner: I think in this particular case, we have experience with the US, South Korea, China, some submissions into the Europe, but not full blown yet. And Australia is just trying to get started. And we see some common pitfalls. I won't focus on anyone in particular but let me try to think about some of these off the top of my head.

One of the first things that we come across is the lack of education and training. What is your experience? How well do you know the regulation? And many times, they're quite broad in scope. So, you kind of have to read it a second time and say, okay, now, which part of this refers to my business?

Does my portfolio fall into this particular clause or not? There's initial reading, obviously, but you really do have to go back and make it customized for your particular scenario.

Another pitfall I see is a lot of people will start late. So, these companies that have large portfolios, don't underestimate the time that it takes to collect the data and cleanse it. And by cleansing, I'm referring to checking it against the business rules. So, you might collect the data.

And I'll try to use a real simple example here, like a date format. So, you might have January 1, 2024 spelled out like that in your data, and yet you have to submit it as 2024-0124 totally different format.

Etienne Nichols: Yeah.

Gary Saner: So now cleansing the data and making sure it meets the actual accepted grammar and syntax. In some cases, there's actually something called list of values, where it's controlled terminology.

Particular area might be MRI status, and you have to match what's in the regulatory list, word for word, down to the letter. Otherwise, if you don't match it, it gets rejected. So that becomes pretty tough. Cleansing the data, let's see, another area is many times device straight based products are pretty straightforward for product identification.

But when it comes to packaging levels, when you get to systems, when you get to kits or accessories and spare parts and other type of things, it just raises a lot of questions like, well, wait a minute, I have part numbers on these things, but now I have to assign it with an official UDI and what is the rule?

And is this an actual particular component that I need to report that's going to cause some evaluation in time, and people usually stumble on that a little bit. The other thing I'll mention is just simply straight out poor quality of the data. Let's talk about a GS, one, g, ten. This is one of the product identifier formats. So, the last particular digit, I should say, is something called a check digit, and it's based on the preceding 13.

So, you build your 14 number based on the others. And sometimes, for whatever reason, the transcription or whatever is wrong and quality sacrifices, sometimes you come across these global medical device nomenclature terms that become deprecated and they're obsolete. They're replaced by maybe two or three other better, more granular identifiers for that particular item in the past.

So, the health authorities check to the current list, and you might have picked this five years ago, and lo and behold, you didn't know about it, but now you try to use it and it's rejected. So, the quality of the data is another area of keeping a common pitfall. You just don't have good control over these particular values.

Another point I make is that sometimes there's no data owners. It's uncommon for a company to have all this information collected. It's the first time it had to be assembled one spot. So, you'll find this information different sources. And some companies have challenge establishing who's the data owner of this and establish some governorship around keeping it updated and maintained.

And one last thing I'll just throw out there at the top of my head is some companies have a pitfall in thinking that this is a point solution. So, they might have put something in place, like a system in place for the US, and that's totally fine if they only market to the US. But if you're a global company, there are multiple health authorities that are coming on board. And we have seen some companies suddenly realize that what they did for the US is now totally inadequate or it's very costly to try to duplicate for the EU.

So, they didn't build a solution that would be flexible and to be expanded. And that can be a real expensive mistake.

Etienne Nichols: Maybe we can talk a little bit more deeper in that because I'm curious. We talk about pitfalls sometimes and I really learn from the mess ups and the mistakes. But maybe a successful implementation would be interesting.

However, in the weeds you want to get on this, but if a company, or do you have an example, not names or anything, but of a company that put together a multinational strategy that was relatively successful and what areas they could overlap and reuse, do you have any thoughts or suggestions when it comes to putting together a strategy that could meet multiple markets?

Gary Saner: Right. So, there is one come to mind. It's actually on our website, so you can go there and read it a little bit more. But the short conversation about that they were a small company, manufactured neurodiagnostic and neuromonitoring and sleep diagnostic products. They had a small team, a couple of new members, and limited time that they could assign to the UDI process and get it up and running. And they were just overwhelmed with changing UDI rules. The data specs kept changing and it was just a little tough. So, we were able to actually help them.

And initially the first wave of help came as part of education. And we talked about UDI, some requirements, what the policies were. We also trained them on our system for onboarding. And then through the second phase where we actually created an account for them in our database, they were able to do the data collection, the cleansing and make the submissions automatically.

And I don't know, I think the quick takeaway on all of this particular scenario is that there was three parts that they were very glad to have taken care of. One was the education and getting some subject matter experts to help them guide through this particular topic. And then secondly, the support level. So, as they had technical questions, we were able to help them and answer questions. And the third was the actual technology platform.

So, in this particular case, technology made a huge difference for them. They were able to bulk process the data, they able to get real live visibility, they could generate reports. And bottom line is they were to improve the accuracy and reduce those manual errors. So, it was a good case study to talk about because they kind of walked through the steps of moving into a support from read tech in this particular case. But initially they were overburdened. They had quite a bit of challenges.

Etienne Nichols: Interesting. Well, we'll definitely try to get a link to that and share that in the show notes if anybody's interested in learning more about that case study. Yeah, that's good for companies looking maybe to make immediate improvements to their UDI compliance. Do you have any recommended actions?

It sounds like maybe we need to talk about how ReedTech supports UDI compliance processes. But if a company's not ready to use a vendor, and then maybe we can go into what ReedTech does too, if somebody's ready to take that plunge.

Gary Saner: Yeah. So, there is some activities the European Union is definitely going to be rolling out, hopefully this regulation that is being proposed. We talked about the dates for Australia, in the US, potentially contact lenses, they're back on the shelf, but there's a lot of things that would be coming down the pike. And a couple recommendations are that you plan for these new health authorities and expansions of scope.

So, EU obviously is on everyone's mind, but keep a close watch on Australia, Switzerland, UK, Brazil, Saudi Arabia and so on, and plan and allocate resources. So, I would definitely recommend that particular action. The second one is if you have a point solution for the US, for example, or maybe you don't market the US and your stark and put a point solution together for the EU.

I would ask you to step back and think about a more holistic global solution and avoid the single point silo that you're going to get into. And then you're bound by its technology wise and just unable to add other type of health authorities.

And the third scenario is where many companies realize the benefits of connecting their internal repository to an external, what I refer to as a data hub. And you're able to keep all your content in a master system internally, but when it comes time to actually submitting to the health authority, there's so many nuanced gateways, there's different connection, there's different protocols, there's actually different data sets, and we have yet to see any of those be repeated as we go from us to South Korea, China, EU and Australia, they all create their own little scenario.

So by implementing a model that has your master data, which you control internally and you use for many other systems, so you want to feed that master value to other internal systems, but you might realize the importance and benefits of feeding an external data hub and letting that data hub take care of the different protocols for the health authority.

So, you just kind of use that as a spoke and you go out to all the different health authorities. So those types of recommendations are what I'd ask a company to take a look at as they start to implement this system.

Etienne Nichols: I think that's good advice. I think that's really good advice because I can see how if someone says one off, okay, I'm going to go to the US. Okay, the deadlines, now I'm going to repeat my work.

There's a lot of duplicative work that you could potentially be doing. So, yeah, always begin with the end in mind.

Gary Saner: Right.

And have that particular goal. Now, you mentioned read tech. I'll just put a word out there about some of the things that we do. As we mentioned in that case study, one of the things that we share is a lot of education and training, expert consulting.

So, it's kind of like the soft matter. It's hard to put a particular dollar value around it or just put a metric on it, but Doug, on it, people want to pick up the phone and get an answer right away from someone that they can trust.

And that's what it comes down to, being able to access very quickly education and get that support that you need, and we provide that. We pair that with our technology base. So, we have this regulatory compliance system. It does operate as that data hub module that we talked about where it's software as a solution.

You connect your internal system if you want to make automatic connections to us. And yet we're very flexible. So, a number of our clients have less than ten records, and there's some that have a single record, and they just simply put that in an attachment to an email and send the data to us.

So being very flexible with a lot of different types of interfaces for the very high complex automated scenario, down to the very simplistic, simple manual file attachment sort of thing.

That is, I think, one of the unique things that we're able to put in place, the people and the platform are noteworthy, where we're able to share that expertise and support, and the platform being this scalable. So, it's good for company that has a few records, good to those that have over 100,000.

It's the same platform, same level of support, and yet it's just how much you pump through it. And it's built for this electronic data record and handling. So, we've been able to supply that provide very robust data validation for that cleansing activity. And it was purpose built for UDI, so it's not some other system that has been tweaked and cobbled to handle UDI.

The last thing I'll mention is the experience. So, in this particular arena, we've been very fortunate. We have over 33% of all the good ID SPL records, the electronic records that have been sent to the FDA. We've supplied one third of all those and work with a lot of different clients, over 450 clients, and I don't know, grand total of around over 800,000 records.

So, we have seen a lot of different scenarios. And when you come to us with your scenario, most likely we have seen something just like that, or close to it in the past, and we'd be glad to help you along this particular path.

Etienne Nichols: Fantastic. I really appreciate you coming on the show and talking about all these dates. We have quite a few things to go in the show notes. So those of you listening, we have the world map for all the different regions and some of the different things that are going on there.

That case study, I'll put a link as well to ReedTech so people can learn more about what you are doing over there with them. Gary, any last pieces of advice for companies or thoughts?

Gary Saner: No, just start early and keep at it. Don't stop, don't stop.

I'll tell you, one of those other concerns is there's an attitude that, oh, I just have to do this and I'll create this as a project and I'll assign a project manager to it and four months will be done and we'll just kind of retire the UDI activity.

That is serious shortcoming. And what could happen is you might actually propagate and publish erroneous data out to the health authority, and then once that gets out, it could be life threatening and it's extremely difficult to try to correct any bad values once it's been published and now in the downstream industry use.

So, we take that very seriously of trying to make this data as accurate as possible, certainly timely, meet all of the deadlines. But we want to work with you to ease that pain.

Where you take that data related to the medical device, whether it be registration and UDI content, make sure that's submitted accurately and on time to the health authority. And eventually we'll start to see what's happening in the US where there's propagation of this data into downstream users.

The healthcare supply chain, the hospitals, clinics, doctor's office and patients are now able to all pull data and work with this content that's supplied back and sourced from UDI. So, we'll leave it at that. Thank you for the opportunity at the end. It's been a great period of time to talk with you and we're glad to reconnect.

Etienne Nichols: Yeah, no, thank you so much. You got my mind thinking about all the positive benefits of this because a lot of times people look at this as a necessary regulatory evil.

But if you think about when all of these are online and the access to this kind of data and to see trends and different, it's going to be pretty amazing, provided we have clean data, like you said.

Gary Saner: Right?

Etienne Nichols: Got to have that goal. So anyway, maybe we'll talk about that again sometime. Sounds like we have something on the books, or at least we should for 2025. So, thank you so much, Gary.

Gary Saner: All right, talk to you later. Thanks.

Etienne Nichols: All right, take care everybody. We'll see you later.

Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy say same thing with computer, just look for that. Leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening and we'll see you next time.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.