What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode, you’ll hear from two guests with UDI experience. You’ll learn a lot about UDI and learn where to find some fantastic resources that can increase your knowledge.
Laura Maher and Brittani Smith are both Medical Device Gurus and Greenlight Gurus. Their jobs involve guiding companies through regulations and quality requirements and challenges unique to MedTech companies and medical device professionals, and UDI is among those challenges. Both Brittani and Laura bring a wealth of experience and knowledge to the topic.
Listen to the episode to learn the difference between device identifiers and product identifiers, the process of getting a UDI and applying it, then going on with the registration process, and how to think about the UDI requirements that are coming into effect.
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Some of the highlights of this episode include:
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What UDI is and the difference between the device identifier and the product identifier
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Physical applications of UDI
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The leading zeros and what they mean for packaging
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The process flow of getting the UDI, applying the UDI, and registering the device
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Challenges with bar code verification
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Tips for manufacturers going through UDI implementation
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Uploading to GUDID
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Why the UDI requirement is in place
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The different acronyms involved in UDI
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The importance of finding and using the resources available to you
Links:
Greenlight Guru Ultimate Guide to UDI
Memorable quotes from this episode:
FDA doesn’t set a specification for what your bar code quality should be, but depending on who you’re using, your GS1 specifically, they have standards for what the quality of their bar code should be.” –Laura Maher
“Just like Laura, I became a little bit of a UDI expert at the company, just because I got to learn the ins and the outs of it.” –Brittani Smith
“You’ve got to be careful about contrast and the color that you’re using for your bar code.” –Laura Maher
“For your surgeons and your patients, the end users, the biggest thing is safety.” -Brittani Smith
Transcript:
Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. I'm excited to have two medical device gurus on the call today. Brittany Smith and Laura Mayer. We'll start with Brittany.
Since you're to my left, I guess. Brittany, do you want to give a little bit of your background? Well, I guess first, how are you doing today?
Brittani Smith: I'm doing well, thank you for asking.
Etienne Nichols: So, yeah, tell us a little bit about your background.
Brittani Smith: Yeah, so I spent almost three years in the industry. My degree is in biomedical engineering.
Um, so I worked for an orthopedic device company, spent some time in quality, regulatory, and a little bit of development engineering.
And I've been at Greenlight for a few months now, so I'm excited to be here today.
Etienne Nichols: And Brittany's years of experience, it feels like, I don't know, you've lived many years within a year, so it's pretty crazy the amount of experience they've packed into you. That's pretty cool.
Brittani Smith: Yes. I jam packed those three years.
Etienne Nichols: Yeah. And Laura, how are you doing? And why don't you tell us a little bit about yourself as well?
Laura Maher: I'm doing pretty well. It's a good day.
So, I have about 10 years of experience in industry.
My degree and background are chemistry, and I started in analytical chemistry for pharma and medical device and then kind of jumped into product development and process improvement and quality management.
And I've done a little bit of pretty much everything, but I love it and I'm excited to be here.
Etienne Nichols: Awesome. Well, I'm excited to have you as well. I've had medical device gurus on the podcast before, but I've never had two, so this is almost overwhelming. We'll handle. We'll see if we can figure this out.
So, the UDI is the. Well, the UDI. The subject I wanted to talk about with you guys was unique device identification.
So maybe we can talk a little bit about your experience with UDI and start from there before we get into like, what is UDI? But, uh. And maybe we'll start with you again, Brittany. What's your experience with UDI and. And your relationship with UDI?
Brittani Smith: Yeah, so UDI was actually one of my very first activities when I got into the industry. So, I worked with UDI my entire.
Laura Maher: Time in the industry.
Brittani Smith: A lot of it was managing the assignment of UDIs to our new products and then getting those submitted into the good ID database. Um, I also spent a lot of time in labeling, so making sure that the. The right UDI was with the right product label and then working through, you know, getting everything into our new database correctly on the labeling side.
And then I started to work with some EUDAMED activities.
Don't know if we want to get into that today, but I do have a little bit of experience with EUDAMED. So, yeah, I spent, I think UDI touched every aspect of my industry experience because even when I started transitioning development engineering,
I was starting to help with some of the print updates to get the direct marking specifications onto our drawing. So, I spent a lot of time with UDI.
Etienne Nichols: Yeah. Okay. Laura, what about you? What's your experience with UDI?
Laura Maher: So, somewhat similar. UDI and I are very dear friends, so we, my company was like, hey, we've got this thin line for UDI coming up and we not really anywhere ready for this. So, they reached out to the figure it out person on the team, which was me, and they're like, hey, you know, UDI, this is your project.
Figure it out. Thank you. And then walked away.
So, I spent a lot of time learning about it, and the more I learned, the less I felt like I knew about it.
And it was just somewhat of a stressful process. But, you know, I had to figure out, we were already getting UPCs for our label, so we were like a little bit there, but had to figure out, you know, how do you label additional layers of packaging and what PIs do we need and how do you get a Gudib account and who needs to be on there and what needs to be in there and how do you verify barcodes and how do you fix the issues that come up during manufacturing?
Etienne Nichols: So, yeah, okay, so that's really cool. So, and I love that you were the figure it out person. How did you get to be that person? Any. Any history there?
Laura Maher: I think it's just googling skills. So, you know, you're. You're on a small team and you know, you're trying to figure stuff out and you figure a couple things out and then they're like, oh, we don't know about this.
You know, you want to figure this out? Like, sure, let's do it. You take courses, you Google a lot, you read a lot. And then eventually they're like, oh, you know, you know, enough.
You're the person now.
Etienne Nichols: I heard a word this morning. I think it's a Japanese word. I. I'm gonna mess it up now that it's just popping in my head. But Shoshin or Soshin, I can't remember which, but it was the idea of having a beginner's mindset and.
And that ever learning. So that's maybe the. Maybe the English version is the figure it out person.
Maybe I like that better.
Laura Maher: I. I love that it fits into the. I like being a jack of all trades, master of none, but adding onto the back of that, you know, a master, or it's like you're the master of many is better than a master of none or something like that. But I like knowing a little bit about a lot of things.
It's good.
Etienne Nichols: Yeah. Okay. So, we. We threw out a lot of Acronyms, and the FDA loves acronyms. I guess we should too. But we. Why don't we talk about what a UDI even is?
And.
Yeah, let's just start there. What. What is a UDI? When you think of UDI, what is that?
Brittani Smith: I can take that first. So, it's. It stands for Unique Device Identifier.
And something that took me probably a little bit longer than it should have is the UDI is comprised of two parts. So, there's the DI and the PI.
The DI is your device identifier, which comes from an issuing agency. It's a combination of a company code. Depending I. My experiences with GS1, I know it's what Laura's is too. But there's other agencies out there.
But there's a company code and some other digits and a check digit and then your PI, your product identifier. So, my experience, that was our lot number, but it can be lot number, serial number, expiration date.
I know some people will use their manufacturing date.
So, what, you know, what you need to include is dependent on what your device is.
So, we. Our UDI was comprised of our DI and then our lot number as our PI.
Etienne Nichols: Okay.
And there's a little bit more to how you apply it. And I guess. Well, there's a couple different things. I guess you go upstream of where you get the UDI, and you apply it to your device.
But then there's the physical aspect of it. Laura, I don't know if you want to speak to the. Maybe the physical application side of it.
Laura Maher: Sure. Yeah. So, you know, we have this requirement that we have UDIs on all of our devices, with your base UDI being on the, you know, the packaging. That's going to be what the clinician encounters. And then you go from there, moving up your levels of boxes. And then you know, if you have an instrument or implant, you've got to do that direct part marking.
But figuring out that process of you have to have a unique identifier for every level of packaging. And there's different ways to approach that. Whether you have your issuing agency issue several DIs for those which can use up your number of DIs, or you can do the process that I like, that's super easy of using those leading digits at the front.
So, you've got 00 for your base, then 01 for your next level of packaging, 02 for your next level of packaging, and then calculating your new check digits based on the leading numbers.
Etienne Nichols: So, let's talk a little bit about the check digit because that was something that I'm not super familiar with and I, I know you, you kind of dove right into it to where you can actually calculate that, which is super cool. Maybe, maybe just walk us through what a check digit is and how you.
Laura Maher: Calculate it so you know the tech digits, making sure that your numbers make sense and that you're creating good code for this barcode. And DS1 has a really great barcode calculator which I definitely suggest you use instead of trying to do it by hand.
But I curious when I was starting to do all these check digits as I was creating these different dis and I was like; there's a pattern here. I'm like, wonder why there's this pattern.
So, I looked into it and it's because you multiply the di. You start with multiplying the first number by three then by one by three by one by three and then you take the sum of those numbers and subtract it from the nearest whole number.
So, you might get like 68 is the sum and then you subtract it from 70 and that'll be your check digit. So. So fun fact for the day.
Etienne Nichols: So, you mentioned the. Let's say you get 10 dis from an issuing agency.
Tell me a little bit more about the leading zeros as far as. Are you using it for different levels of packaging?
Laura Maher: Yes, yeah, sorry. So, your primary or your device or your primary packaging, whichever is more relevant to your device, your code is going to have you store it in like a 14-digit format, but the actual number is 12 digits. So, your UPCA is 12 digits, but it has to be for your GS1 barcodes, it has to be 14 digits.
So, there's two zeros in the front of your primary packaging, UDI and then your secondary packaging, you can do 10.
Etienne Nichols: Sorry.
Laura Maher: I have something.
And then for your next level, so your, you've got your pouch, it's gonna be 00.
Your shelf box is going to be 10.
Your shipper is going to be 2 0. So, you kind of go up using that leading digit system because it's not relevant to like the meat of your di, but it specifies, you know, what level of packaging it is and then it's made unique by that new check digit.
But also how, at least for me, when I'm trying to keep track of, you know, hundreds and hundreds of UDIs of, you know, you start to get to know your product portion of that UDI and so you recognize what's part of a family.
Etienne Nichols: Sorry, that was so. No, that's good. That's really good. And that's a great tip too. I. That's a new one for me, so that's really cool. So, the. So, when we think about, like, I don't know if supply chain's the right word, but the process flow of getting a UDI, applying a UDI or maybe applying it to your device and then physically applying it to your device and then registering that with the good ID.
Can we talk a little bit about that? I don't know which area you're more comfortable with but starting from.
Starting from.
Well, we already talked about getting it from the issuing agency, but now. And now you've talked a little bit about generating that number for the different levels. What about the actual application on the actual device?
Do one of you want to speak to that?
Brittani Smith: Yeah, I can. I actually got to experience it from start to finish.
So, I'm, you know, I'm sure people handle it a different way at every company, what makes sense and depending on what your device is. But the way we manage is the regulatory team. We owned the UDI process and the way it worked is we would maintain the UDI list and when the engineers were doing new product development, they would reach out.
We had. It was me for a while and then we had a couple other individuals. They would ask, I need a UDI for this device. And we would, you know, take the part number, take the part description and, and give it to one of our open UDIS we had from GS1 that hadn't been assigned yet.
We would give them that number back and they would use that to put it on the drawing.
And as they're doing the development work, you know, we keep that in our, our list of products, kept track of it. And then when they were getting ready to release that device to the field that's when we would make sure that the UDI that we assigned is still what they used for the device.
And then we would go through the actual upload process into good ID. And we utilized read tech.
So, we would send them the spreadsheet, they would take care of the upload within their system.
And then that that upload process gets put into the FDA's database, which is what? On the front end is the good ID database.
On the back end you can, you know, that's where if you have you own UDIs, you're able to go in and edit those records. But we did it where once we were ready to actually launch the product, that's when we were uploading it into the good id.
And I know that class ones just became mandatory, I think just September 24th. We were talking earlier today, but we met, we just handled it like everything was mandatory because of the volume of products we had. It was an easier lift to just do everything now and just get into that routine versus having to go back and when the, when the mandatory date was coming in, having to upload thousands of records.
Etienne Nichols: Yeah, that's really cool. And it's cool that you saw it from all different aspects. I guess usually it seems like it gets handed off and then someone, the next person doesn't have a clue where it came from and so forth.
So that's really cool that you saw the full life cycle.
What about the actual application? Are there any issues that you saw, either one of you really, with either the printing on the labels or the direct part marking? What were some of the issues and challenges that you experienced?
Laura Maher: I would love to speak to this because barcode verification is something that I dug deep into in my UDI journey. So, it's something that I think a lot of people don't think about when they're going through the process of applying UDIs, is that, you know, FDA doesn't set a specification for what your barcode quality should be, but depending on who you're using, you know, GSI or GS1, sorry.
And specifically, they have standards for what the quality of their barcode should be. And you'll probably, you'll experience or you'll encounter some standards, like IEC15434 is the 2D standard.
And it'll have, you know, what you need to meet. So veridic people, when they get into verification are very surprised at how expensive barcode verifiers are. There can be thousands of dollars. And that's because it's not just reading the Barcode like a scanner is, it's looking at the print quality if it's in square, if you, the, if there's some sort of, you know, misprint or corruption of the data.
So, it's looking at every aspect of your barcode and making sure that it's correct. And usually it there, there's like a number score and a letter score, but it has to be at least like a C or better.
So yeah, we had a lot of issues with getting, you know, meeting verification. So, our, our main issues were like printing. So, the printer head getting dirty or not having enough ink creates what's called modulation issues in your barcode and then also having incorrect strings of data.
So not having good hygiene when it comes to storing and inputting your code into a barcode generator.
Brittani Smith: And we had a lot of challenges when it came to actually the label size and the product size worked in the pediatric industry. So very small devices and you know, it has to be easily readable, plain text. That's part of the. So, like actually having the numbers on your label, you know, in a global label, those can get very crammed.
So, we had a lot of challenges making sure that you could even like it was readable to the naked eye so that it wasn't too small.
And then also figuring out, you know, how do we get this 14-digit code on these devices. And so, whenever there were some devices, we just couldn't get the UDI on.
And it was just one of those things of making sure we documented the justification of we can't meet the minimum size requirement because of the size of the device. So, you'll only find it on the packaging.
So, making sure that you document that justification.
And then I also had the joys of remediating some UDIs that had gotten misaligned in our list.
So, figuring out what's on the device, what, what did we submit, what needs changed? That was one of my very first activities. So that was kind of a trial by fire for UDI for me, which just like Laura, I became a little bit of a UDI expert at the company just because I got to learn the ins and the outs of it.
Etienne Nichols: Brittany's one of those people, I think that if you threw to the wolves, she would come back leading the pack.
Brittani Smith: I appreciate that.
Etienne Nichols: One of the things I experienced when we were using DPM was I, I realized that the inspectors were having to take the part over to a specific scanner and then they'd type down whatever the number was so that they could put it on the inspection report.
And so, I bought a few just handheld scanners that could plug into their computer.
And we figured out a way to populate the number on the inspection report, like right underneath it. So, it was easy to tell if anything was off on that 2D barcode.
And I kind of doled them out to people that I really liked and they were like, yeah, they show off with their 2D barcode scanner. But what other things do.
Do you have any tips for manufacturers who are going through this UDI implementation?
Laura Maher: I have one just based on.
Not everybody has extravagant packaging, so to speak, but some people do take a lot of pride in their packaging design and all that. You've got to be careful about contrast and the colors that you're using for your barcode.
So, if you think about the color of the light that's reading a barcode is red. So, you really want to kind of steer clear of any colors that are in that wavelength as well as you need good contrast.
You don't want to put a barcode on a dark background or, you know, have weird patterns intersecting your barcode.
Speaking from experience. So.
Etienne Nichols: And here's what you probably from your chemist background, I remember we were looking at 303, 304 stainless steel.
When you would mark it, you'd basically be, I guess it's etching the.
You're. Yeah, you're, you're, you're not engraving, you're just etching the, the top. And it would rust if you, you didn't passivate it. And then you have nitric versus citric passivation. So, it's just a whole rabbit hole you can go down. And to make sure that, let's say you're marking a surgical stainless tool, you don't want that to rust during an operation just because it has a UDI barcode on it. So that's, that's interesting thing to think about.
You weren't going to say something, Brittany?
Brittani Smith: Yeah, I've seen the, the rust in grooves before.
And so sometimes you gotta be a little innovative on how you're going to mark because etching may work on one material and then introduce new risks on another material. So, there's a lot of considerations to take in there.
Etienne Nichols: Yeah.
Okay. So, when it comes to the documentation, the upload to good ID you mentioned using ReedTech, which I can maybe put a link to them in our show notes so that people can have an idea of how to get, to get ahold of them if they need to.
But what about that, that uploading to the good ID I know Maybe we don't want to talk about EUDAMED. We actually mentioned this morning there's so many attributes that go into the good id and for the EUDAMED it seems like it's triple.
I don't think the requirement is till the end of 2024 for like true requirements for EUDAMED. Is that correct?
Laura Maher: Maybe, we'll see.
Brittani Smith: Yeah, it's been extended like five times now. So, I, I hold my breath on saying any definitive date on EUDAMED because I'm pretty sure too when they say the date, that's the go live.
It's a voluntary period first. So, there's the beginning of the voluntary and then there's the mandatory like a year later.
Laura Maher: So, and then if it's like, if it's anything like how the FDA rolled it out, they prioritize your high-risk devices. So, anybody with a Class 1 device is going to be, you know, not heavily.
Etienne Nichols: Yeah, so. So, what are some of the reasons? Because sometimes when I think about, you know, what I have to do, tell me the rules and I'll just, just let me just give me, tell me exactly what to do and I'll just go do it.
That's nice when we can have that. But also, sometimes we talked about, well, maybe not put it on this device and, and justify why.
Maybe it would be nice to know why do we even need a UDI? Is that, I mean, to me it's helpful to know why a requirement is in place. Do you have any thoughts on the benefits and the pros and cons of UDI placement?
Laura Maher: We can tag team this, Brittany, if you want to go.
Brittani Smith: Yeah. So, for your, your surgeons and your patients, so those end users, the biggest thing is safety.
You know, the good ID database, anyone can go in and search for devices. So, if I have a hip implant and I have, you know, I know what my UDI is because they gave me an implant card or my surgeon wants to look up, you know, some of the additional attributes like you mentioned.
I can go to good ID, and I can look that up. So, and it's making that, that information about the device forward facing for those patients and the end users.
So, you know, some additional details about your device.
So that's one the biggest thing that I always like to highlight. You know, patient safety is always thankfully at a lot of the crux of a lot of decisions that the FDA makes and other, you know, governing regulatory bodies.
Laura Maher: Another important part of that is I don't know if you've ever been in an OR, but they're they scan those UDIs and they get associated with the patient and the surgery that's going on.
So, it's really helpful to have that information because if something goes wrong, if the patient has an issue, they have that information available to give back to the manufacturer. If you ever look through the MOD database or had customer complaints for a device, you don't always get lot number or, you know, very specific information about the device because it's been thrown away, it wasn't noted anywhere.
And then you're just kind of in the dark about, you know, what do I need to look at, what products could have an issue, what do I need to recall?
So, it really helps companies manage those processes and target that issue if they know what product is a part of that.
Etienne Nichols: Yeah, having been.
Sorry, don't mean to catch off. Yeah.
Having been a manufacturing engineer, it is so helpful if you have to run a CAPA to know, you know, just narrow my scope just a little bit. I don't want to look through every single DHR that in this entire cabinet.
So yeah, that's, that's definitely beneficial. I can see that.
Yeah, that's really cool. What other advice, piece of advice can you give to.
Well, you know what, actually I had one other thing I want to say about that.
It's interesting. When you're in a company, even if it's a big company or full of companies who. Or professionals, med tech professionals who've been in the industry for a while,
it seems like a lot of times UDI is just the redheaded stepchild that nobody really wants to own.
And so, if you understand it and own it, you're kind of a valuable person in the organization. It seems like, like you're a figure it out person or you know, it's just, it's just really valuable information to know.
So, if you can present that and also the why behind it, I think that's really helpful. So that's one of the reasons I asked about the why.
Brittani Smith: But yeah, definitely it's one of those.
Laura Maher: It's one of those have to haves.
Brittani Smith: Not a nice to have. Like you have to have this, this UDI.
And so, if you can position yourself to, you know, if there's an opportunity to take some ownership of it or at least help improve the process, I'd say jump all over because, you know, there's a lot to know.
But it's one of those things that there's a lot of good resources about UDI. There’re some things in the industry there's not A lot of resources.
You're really relying on other. I mean, the MDR in a whole. We talked about a whole AMA yesterday about this. Of course, the MDR is learning a lot from people's successes where UDI, even though it's a. It just became mandatory for those class ones. There's a lot of really good information.
And again, you know, I had a really favorable experience with ReedTech. I recommend them just because they made our life so much easier. We accidentally downgraded our subscription one year.
So, we had the premium where we just sent them the spreadsheet, they took care of the upload. And then there was a year where we still used them, like for their database for the portal, but we were doing the upload, and it wasn't super challenging. But it was so nice when we got back to that premium subscription to where they were doing that for us.
Cause it just took a lot of weight off of our shoulders. So definitely felt a little bit of the pains that year and was able to teach some other people, you know, how we learned a lot from that year, learning, you know, the back end of it.
But it's very nice having somebody that can help you with those, those backend activities.
Laura Maher: And your issuing agency will usually have a lot of great resources as well. I know I did a training course through GS1 that was really helpful. And honestly, I went in a little bit pigheaded about it because I was like, there's only one section on the FDA for this UDI course.
Like, there's all these, you know, hours of time on other parts. And I was like; I just want to know the FDA part. But one thing that you really need to know as you approach this is you have to know that you have to know the science of barcoding and the quality around it, how they're calculated, like, what the importance of is, of how you put this information and store the information is absolutely critical to understanding the FDA side of things. And I know I mentioned earlier, it's like the more I learned, the less I felt like I knew.
What changed that is spending time learning about barcoding and the data and how to make sure that it's right. Like that's what made. That was like the aha moment for me for understanding how to comply on the FDA side with knowing that science behind it.
So go ahead. I was gonna say, I think a lot of times we get kind of pigeonholed and stuck into like we're medical device. We need to just focus on the medical device side.
But when you're bringing in these other standards. There's so much more to the story, I guess than, you know, just regulations.
Brittani Smith: Oh, and UDI is one of those things. It's not going away. More and more markets are starting to adopt like this good ID database type thinking.
And so, we're just going to see more and more countries requiring the UDI. And you know, taking EUDAMED out of it, I think a lot of countries are just going to leverage the same requirements as UDI.
You just may have to submit to an additional database.
But I mean it's, it's here to stay. So, embrace it, learn it and just set yourself up for success so that your life's easier down the road.
Etienne Nichols: Yeah. And I'll include in the show notes links to GS1 to ReedTech. We also did a RET. An episode on UDI with Gary Saner from ReedTech. So, if you want to know even more, he goes into some, some depth of, on some of this stuff as well.
So, I can link to that in the show notes. So definitely look at that.
Just, I'll just kind of recap just a little bit. And if you guys have additional things you want to say, definitely pipe up. But the thing that I was going to bring up was just a UDI is a DI plus a PI.
DI is the device identifier. That's a static number that applies to your company and your specific device.
And then the PI is the production information. It could be lot number, could be expiration number, manufacturing date, expiration date, and that's really what it is. And then how you present it could be UPC, could be 2D, could be HR. Is it HRI, human readable interpreter Interpretation. I think it's, I think that's right.
HRI, whatever that is. Human Readable. I forget about the I. It's lowercase too. But and then and then submitting that to the issuing agency or to good ID or EUDAMED and so forth.
I probably missed something that's very high level. But if you have any other war stories or any other thoughts, love to hear them.
Laura Maher: I have a question for you. What's the acronym for the barcode? If you got the Human Readable HRI, the UPC or the AIDC, the Automatic ID and Capture.
Etienne Nichols: Oh yes, the AIDC. I forget about that.
Brittani Smith: There's no short of acronyms in this industry.
Laura Maher: This topic alone I presented on this one time. I just had a whole page. I'm like, these are all of the acronyms that you're going to encounter when you're learning about UDI because they're so.
Brittani Smith: I always think of the UDI as a formula. It's your UDI equals your DI plus your PI.
Yeah, the math person. So that always helped me remember. Okay, what do I need for this?
Etienne Nichols: We didn't talk about G10s.
Maybe we should do that the DI.
And correct me if I'm wrong, the DI is essentially the G10, the global trade Identification Number. Is that right?
Laura Maher: Yes.
Etienne Nichols: Okay.
I knew you were going to check me, Laura, so I didn't get it right.
So, another acronym to have in your toolbox of acronyms. But I, you know, but Maybe I'll find GS1 has a really good explanation of all this as well. So, I can put that in the show notes as well.
Laura Maher: They have a really great guide that is like 50-pages long that has tons and tons of information.
I highly recommend downloading it. It's free.
It even has like. I thought this was really helpful. But it tells you what you need based on the class of your device and where you sell it. So, you have different requirements for retail versus non-retail and then class one versus class two or class three and the types of barcodes that you can utilize for each of those things.
So highly recommend.
Etienne Nichols: Fantastic. I'll put that in the show notes as well. And also, I feel like I should mention Greenlight Guru actually did a ultimate guide to UDI. So, in conjunction with ReedTech, RE Tech partnered with Greenlight Guru to build that.
So, check that out too.
Laura Maher: I thought the author was, was, was a cool, was a cool guy.
Etienne Nichols: I don't know about that. Gary Saner was cool. I also co-authored that. So yeah, it was fun.
Very cool. Thanks for getting on the show today and talking about this. Very, you know, it's not always a popular subject, but you're right, it's a popular in the sense that everybody's going to have to do it.
Any last pieces of advice?
Did we already do last piece of advice?
Laura Maher: Maybe my only last piece is asking for help. Get training, use ReedTech or someone else. You know, just work with, work with people who know it because the people who do know it probably like it a little bit. I mean I love; I love UDI.
So, you know, don't be afraid to ask for help.
Brittani Smith: Yeah, that was my big thing. Just using, always using your resources in this for UDI and just in this industry as a whole.
I think sometimes people forget Google. Like just look it up and you'll find, I mean, you know, use a credit like a credible resource but I mean, the FDA itself has a ton of great resources and at Greenlight we have a ton of great resources and to just, you know, finding those resources and using them.
Etienne Nichols: Yeah, fantastic. Awesome.
Well, I will let you guys get back to the rest of your day. I thought this was really good. And we'll see you all next time.
Laura Maher: Yes.
Brittani Smith: Thank you.
Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you.
Email us at podcast@greenlight.guru.
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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.
