Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists.

In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of quality at Innovize, founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system.

 

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Some highlights of this episode include:

  • The FDA requires the UDI to adequately identify medical devices that are manufactured, distributed, sold, and used by patients.
  • According to the FDA, labels on most medical devices will include a UDI in readable forms to improve patient safety, modernize postmarket surveillance, and facilitate innovation.
  • UDI eliminates mistakes. If a patient is prescribed something, you scan everything that they do. If somebody makes a mistake, they know right away.
  • The UDI is stored in a worldwide central database. Different countries have different requirements. In the United States, medical device manufacturers can use three different types of identifiers (GS1, HIBC, and blood banking). 
  • For Bills of Materials (BOMs), it’s important to understand the rules of interchangeability to set medical device products apart and determine whether to assign different codes.
  • A data matrix and quick resource (QR) code are intermixed and both are two-dimensional. Mark explains how to visually tell the difference between the two and the three components required.
  • Integrating UDIs and codes into databases represents levels of complexity that are added to medical devices.
  • The UDI is intended for the hospital user. So, a sellable product needs to have a UDI that can be scanned and validated. When parts are too tiny, the UDI will be placed elsewhere on the product packaging.

 

Links:

Mark Rutkiewicz on LinkedIn

Mark Rutkiewicz on Twitter

Innovize

Consiliso LLC

Medical Device Company In A Box: The Case For Consiliso

FDA - Unique Device Identification System (UDI System)

European Union Medical Device Regulation (EU MDR)

Medical Device Innovation Consortium (MDIC)

ISO 13485 - Medical Devices

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable quotes from mark rutkiewicz:

“Every part that you use in the hospital room has a barcode on it.”

“If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.” 

“Nobody's really standardized." 

“You can scan it to make sure that you are using the right product with the right other products and with the right patient.”

 

Transcription

Announcer: Welcome to The Global Medical Device Podcast, 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.

Jon Speer: Hello, and welcome to The Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. Things are a little bit different today. As we promised you, joining me as co- host is Etienne Nichols. Etienne is one of our Medical Device Gurus. Etienne, I guess I should ask you. I know you're kind of taking on a new role. Are you still a Guru? Is that still an appropriate title?

Etienne Nichols: Yeah, someone actually asked me that yesterday and they said, " You're kind of straddling two fences right now," so it's kind of a situation, but yeah, still Medical Device Guru.

Jon Speer: All right. Well, welcome back, and I'm looking forward to diving into the conversation and I'm excited because we have, I guess, joining us today, Mark Rutkiewicz. Hopefully I said that okay. I know I practiced that a little bit, but Mark is with Innovize and Consiliso. Mark, welcome to The Global Medical Device Podcast.

Mark Rutkiewicz: Thank you, Jon. Thank you, Etienne.

Jon Speer: Oh, great place to start before we dive into today's topic is, can you just take maybe a couple moments to give folks a little bit of a background about who you are and Innovize and Consiliso?

Mark Rutkiewicz: Sure. Yeah. Yeah. You said Mark Rutkiewicz. I've been in the medicalized industry about 35 years. I've worked at about six different companies doing everything implantable defibrillators, implantable heart occluders, MRI machines, AEDs, disposable software/ hardware, sterile/ nonsterile. Been in that industry. Part of it has been mainly designing quality systems, so that's part of been my focus for the years. Redesigning systems, truly trying to make things integrated, and so that's what Consiliso is. I wrote a couple books on the topic of how to design integrated business processes for medical device companies to really make it easier. I was an engineer and I hated the way, you know, finding information and it was like, " This can be a better way of doing this," and so over the years I've developed this methodology and that's what I wrote. Currently, I'm also a VP of quality at Innovize. We're a contract manufacturer in the Twin Cities. Most of the medicalized companies, all the big ones all we're a supplier to. We make all different kinds of parts, more converting using films and adhesives.

Jon Speer: Yeah, very cool, and Mark, I remember before I hand it to Etienne to introduce our topic for today, but I remember one of the first times that I met you. I think it was at MD& M West or something like that. It was one of those types of shows, and you mentioned this Consiliso and you were passionate about it. I'm like, " All right, so if there's another nerd out there that's as passionate about quality systems as I am and he's got a book that he's written about it, I'm going to check this out." I read the book and I was like... I found myself putting little highlights and markers all over the damn thing and I was like, "It is a really good book." You've condensed a somewhat boring and nebulous topic of quality systems into actually, you know, for a medical device nerd, into somewhat of a fascinating read, so thank you for doing that.

Mark Rutkiewicz: Thanks. I'm glad you like it.

Etienne Nichols: You know a guy's serious about his work when he wrote two books on the topic.

Mark Rutkiewicz: I know, right?

Jon Speer: Folks, will provide a link to that in the notes that accompany the show. It's a relatively quick read. It's not boring and it's not super expensive, either. I encourage you to get a copy. I mean, it's more of a philosophy- type book.

Mark Rutkiewicz: Right.

Jon Speer: That's the way I interpreted it, so-

Mark Rutkiewicz: Yeah. The second book is a textbook.

Jon Speer: Yeah.

Mark Rutkiewicz: It's 500 pages on how to do it.

Jon Speer: Right, yeah. All right, Etienne. Where are we going to go today? What are we going to dive into?

Etienne Nichols: When we first talked to Mark, there are lots of different topics we could cover, so one, though, that is a topic... It's always a question mark in a lot of people's mind. That is UDI, unique device identification. I was curious to know a little bit more about what Mark would have to say on this topic. Mark, what do you think? Do you have any thoughts on this right now?

Mark Rutkiewicz: Yeah. UDI, I mean, everyone thinks it's, " Oh my gosh, there's this new thing going on," and it's like, " Oh my God, the FDA's requiring, it means it's compliance. I got to set these systems." You know, going back and peeling back the onion, what it is it's like, okay, the grocery stores figured this out in the'70s and'80s-

Etienne Nichols: Yeah.

Mark Rutkiewicz: ...and now medical device, we're a lot more complex. It's like, " Oh my God, this is painful." It's like it's the same thing as scanning the parts at the grocery store. About 15 years ago, I sat in on one of the sessions that the UDI team that was developing the standards, this is way before the FDA even required this, and they were talking about the concept of this UDI. Now, every part that you use in the hospital room has a barcode on it. They actually did a study in Japan that mainly was on the drug side, but the device side is sort of the same thing. It's like, " If this patient was prescribed something, then you scan everything that they do, and if somebody made a mistake, they would catch it right away." What they found is they eliminated tons of mistakes because of that, so the same concept. Pharma's been doing it, and then now in the U.S. for medical device we're required to do it. The concept is basically U. S. said, " A unique ID. That ID is stored in a central database in the world so that anybody who wants to know what that... If they scan that, they know what it is." THat's the basic concept behind it. Now, there's a lot of other things around it, and some of it's, you know, why medical device does it and how it's been implemented is different because we sell products all over the world and different countries have different requirements. When the U. S. came out with their UDI requirement, they basically define that you can have three different types of identifiers are available for you as a manufacturer to use. You can use the GS1 codes, which is the worldwide one. You can use the health industry barcode HIBC codes, or you can use... There's also the blood bank, and so that was really nice for the blood banks. Really, there is two choices, and the reason there's two of them, HIBC was original. HIBC came in for health code beforehand and basically what it was, some companies started using it because it allowed you to have any length characters in your barcode. You can have like a 30- character barcode, and then it was sort of free, so you pay a little bit, but you didn't pay a lot of money for it. The difference is because it has a long barcode, it also... You have to have a check sum when you do barcodes. The check sum identifier for HIBC is really poorly defined because you can use any characters in it, alpha, numeric, you can use dashes, you can use ampersands. I had a problem one time. We had a product using HIBC code and the check sum was a space-

Etienne Nichols: Oh, wow.

Mark Rutkiewicz: ...character. You couldn't even tell it was there. It's like trying to find it. HIBC, it was there because it's historically the reason. That's why they kept it in there and some companies have to convert over. Europe is requiring that you go to GS1. It's a standardized code for those identifiers. It's a specific length always and it's all just numbers.

Etienne Nichols: Yeah.

Mark Rutkiewicz: It's really straightforward and easy to program in computers and stuff like that versus having a variable length field. Now, everybody's starting to do it, requiring it. I think the last ones... There were some Class 1 exempts that were... They could actually use UPC codes, universal... It's what's in grocery stores and everything. It's sort of some Class 1s could be UPC instead of having the other codes that we're using now. Then, nowadays, too, a lot of people are switching to the two- dimensional barcodes, the data matrix, because it takes up less space.

Etienne Nichols: Right.

Mark Rutkiewicz: You can do the data matrix one and you can put different information in it, and so if you read through the standards, there's like hundreds of different pieces of information you can encode in a barcode. Just stripping it all back, what's required is you need to have for your product a number that identifies that product so that when somebody looks it up, they can find it. Now, that number... One of the things that when I was in the standards committee listening to what these guys were saying, part of it is we really need to understand rules of interchangeability, and we'll talk about that at a later time on bombs, but if you want to be able to tell these ones apart, even though it's similar- type products, you might want to assign it a different number, and so that's really the key there. One of the interesting things about the GS1 barcode is it's like 13- character barcode, and when you get one you need to determine how many codes you want to assign by your company-

Etienne Nichols: Yeah.

Mark Rutkiewicz: ...and it's in order of magnitude. You can have 10 codes, a hundred codes, a thousand codes, 10,000 codes, a hundred thousand codes and that's you pay for what you're going to use and that's basically what it is and so trying to manage all of those numbers. If you're a big company, you're going to have... You want to put this all into your systems that you use for managing your billable materials and how you sell products and stuff like that. You want to manage it that way. That's sort of my thing on Consiliso is integrating it, so don't do this in a tool over here and manage this over here, and then you tell the FDA this over here. Then, it's like, how do you keep them all aligned? You want to try to integrate them all together. Don't try and develop a separate system trying to integrate this together. Now, the two aspects of FDA is you need to get it number, so you go to one of these organizations and you get a number-

Etienne Nichols: But it sounds like, just to interrupt real quick, so-

Mark Rutkiewicz: Yeah.

Etienne Nichols: ...you mentioned GS1 and HIBC, so I would say just to kind of sum that up, it sounds like you strongly recommend GS1, then.

Mark Rutkiewicz: Yeah. Well, Europe's going to require it.

Etienne Nichols: Right.

Mark Rutkiewicz: FDA allowed both, but everybody's using it now, so, I mean, some of the bigger companies I know, some orthopedics and stuff, we're developing this a long time who say it's so many different configurations it was easier. Going to that, probably you're going to have to... You're probably putting dual codes on it for a while to transition. So it's sort of... It'll be easier and you be able to get it all into a data matrix barcode versus having to maintain this.

Etienne Nichols: The difference between a data matrix and a QR code-

Mark Rutkiewicz: Right.

Etienne Nichols: ... what are your thoughts there? I hear people

Mark Rutkiewicz: Yeah

Mark Rutkiewicz: ... you get them

Mark Rutkiewicz: intermixed. They're both two- dimensional, so it's a little box with a bunch of dots in it, and actually, I've seen some horribly printed QR codes, you know, data matrix, and they can read. I mean, your phone can read them. 15 years ago it's like, " I need a special reader." Well, nowadays, anybody's phone can read these things.

Jon Speer: We all have yeah.

Mark Rutkiewicz: Yeah. The QR code basically has three targets in it. You look at a QR code, you'll see like three little circles with a dot in them. That's a QR code. Data matrix will have two solid lines on two of the edges, so that's a data matrix. That's really how you can tell them apart. The data matrix, the more information you have, the bigger the data matrix can be, so it'll encode more data. It'll scale in size. If you have... Typically, most companies I've seen is you have your identifier, you know, G10, Global Trade Identification number. Then, you typically add two more pieces of information. One's your lot or serial number and one's like an expiration date.

Jon Speer: Yeah.

Mark Rutkiewicz: That's sort of the key. Those basic three are really what you need, so-

Jon Speer: Mark, you mentioned when this first kind of became a requirement in our industry a few years back, to your point, this isn't new tech. It's been in food and other places for a long, long time. But I remember at the time I was working with a med device company as a consultant trying to help them navigate the whole UDI process. It was complicated, not because it was hard per se, but it was complicated because the process was poorly defined. Those that listen to The Global Medical Device Podcast know I'm very much a fan of FDA, but this particular rollout, it was not well done. I'm trying to find information because I'm interested in trying to ensure that we're meeting the compliance requirements for UDI. I understand the importance of it, but the information out there was terrible. It was really terrible. I hope things have gotten better.

Mark Rutkiewicz: Not really

Jon Speer: That was your reaction? Not so much?

Mark Rutkiewicz: No, I mean, because it's really a multifaceted- type thing. You're the company. You have to know your interchangeability of your parts yourself. You have to deal with this third party for assigning a number. Then, once you get that defined, than you have to tell the FDA.

Jon Speer: Yeah.

Mark Rutkiewicz: If you sell in the U.S., then you have to tell the FDA, " Here's my product, here's its ID," and then here's 40 other attributes they want on your product. So-

Jon Speer: Right.

Mark Rutkiewicz: ...they never asked those attributes when you make the submission. It's like, " It's in my submission." No, they don't ask you, " Is it sterile in that data field?" It's in text, so you submit this stuff. The FDA's submission process should integrate that into your UDI submission, but they built a whole separate database to track UDI information. Now, when you do this, you have to answer these 40 questions for your product, and so a lot of companies did. There's a lot of third- party companies got out there and said, " We'll do it for you," because they'll build your own database-

Jon Speer: Right.

Mark Rutkiewicz: ...work with you, assign numbers. Then, they'll auto- load this into the FDA database. That's what a lot of companies did. It's like it just, "I'm going to outsource it because I don't want to deal with this," because you have to. If you really want to do it right, your internal systems, you need to design your systems so that when you create a SKU object that describes what you're going to sell. The G10 numbers should be on there, and then these 40 other attributes that the FDA wants should be loaded on that so you can just extract it.

Jon Speer: Yeah.

Mark Rutkiewicz: Some companies, you have to totally redesign your computer systems to do that, so they don't want to do that. They'll build another tool. Now, you've got to get interfaces and other things happening, so that's why it became complicated because they want to collect information about the products. Now, Europe in the new-

Jon Speer: Yeah.

Mark Rutkiewicz: ...EduMed database, they're trying... I have no idea where they're at. I'm really having to dug into what they're doing, but the concept is everything is in one database. You register your company and your company has IDs. You register your products as part of submission and then that UDI information is linked there. Then, every complaint is tied to that product and the company, and then your recall is tied to the complaint and it's all tied in one gigantic database. Aah,

Jon Speer: Philosophically, the benefit of a UDI I think is huge-

Mark Rutkiewicz: Oh, absolutely.

Jon Speer: ...and, you know, that connectivity globally, I hope we get there as an industry because you know, the EUDAMED, the databases that have been long talked about for EU and DR, they sound amazing. I can't wait till that becomes a reality and kind of connect all this data and information because it can be complicated, I think, as a med device company. I know most med device professionals, they want to do the right thing, but they don't know where to go or what the process is or what this regulatory body requires and how to feed-

Mark Rutkiewicz: Right.

Jon Speer: ...information there. The process hasn't been architected or defined well enough to make that process a little bit easier.

Mark Rutkiewicz: Right. From the user point of view it is not architected, and this is why I try and do in Consiliso. I haven't really laid this one out in Consiliso, but as a user, this is what you have to do as a business process to manage this. Like I said, I said each geography... Now, if Europe is doing this, is Japan going to do something similar in the future? Australia's doing more integrated stuff right now with like recall and their registration, so each geography... As a manufacturer, if you're selling in all of these geographies, like, " How do I design a system that works for all of these systems?"

Jon Speer: The U is supposed to be universal, right?

Mark Rutkiewicz: The UDI is. That number-

Jon Speer: Yeah.

Mark Rutkiewicz: ...and your name-

Jon Speer: Are-

Mark Rutkiewicz: ...but then you have... If you're a multinational, okay, which center designed the product, that's it's ID number, versus this one manufacturers it, versus this one sells it? Then, as you become... If you're a startup company, are you one place? You're one location, you make one product. It's easy. As you start trying to get complicated, part of it's tax advantages and other reasons or closer to your customers and supply chain, but then that just adds levels of complexity to the UDI. Who puts on the UDI? Who's the labeler?

Jon Speer: Yeah.

Mark Rutkiewicz: Well, I'm a startup company in the U.S. I only sell in the U. S. It's actually easy. You just do it yourself-

Jon Speer: Yeah.

Mark Rutkiewicz: ... and you don't have areally complex product, but you start getting to complex products, it's like... I think one of the questions is... You guys were asking one question earlier before we started this is software. Software is a medical device. Does this have a UDI? It should. Now, as you rev the software, it's versions, should it have a different UDI for every revision? That questions the interchangeability and stuff and how you apply that, but now you got software going around the world, too, and it's different languages. You know, just dealing with complexity around the world.

Etienne Nichols: That makes sense, so is that handled practically with the serial number side of the-

Mark Rutkiewicz: Definitely there's not serial numbers. Software's a quantity of one always, so there's not really-

Etienne Nichols: Right.

Mark Rutkiewicz: ... it'sjust revision, so you assign a new G10 number every time you reconfigure it is what the concept would be.

Etienne Nichols: Yeah.

Mark Rutkiewicz: I really haven't looked into what they've been doing on that for software specifically, but just for typical devices like wound care dressings and stuff like that, it's pretty straightforward and configuration- wise it's pretty easy. You start getting devices with software and different electronics and modules and you change the scope. Now, I've had products in the past where, you know, an external defibrillator, one circuit board, but it spoke to you told and you whether or not how to shock. Well, there was 29 languages and then you put it into a plastic housing and then somebody wanted branded, so we had like one circuit board, it became a thousand SKUs. What G10 is it, then? Is it a thousand G10s? Or is it one G10 because it's the same circuit board? Yeah, you have to make decisions and that's part of this is every company makes decisions differently. That's why they let the flexibility in it and so that's why there's really no common process out there because medical devices are not the same as any other industry. If you're in the automotive industry, what do you make? You make cars. You can have an internal combustion engine, you can have an electric vehicle, but it's still a car. What's a medical device?

Jon Speer: Yeah. It's so broad. That's one of the things whenever... You know, Greenlight hires a lot of folks like Etienne and myself who have industry experience, but the majority of the people that come to Greenlight, they don't have any medical device experience, so they all go through a new hire orientation. We've got other training in- house to teach them, but that's one of the things. I have a session with every new hire that comes in and my first question to them is, " Name some medical devices." You get things from defibrillators and knees to hospital beds, to tongue depressors. I mean, it's so, so broad and so diverse. Folks, while we're taking a quick break, I want to remind you we're talking with Mark Rutkiewicz. Mark is with Innovize and Consiliso. Mark, while we're taking this break, tell us a little bit more about Innovize. I know you mentioned briefly at the intro that Innovize does some contract manufacturing. You're in Medical Alley, where thousands and thousands of medical device companies are. Also, I guess, while we're taking this break take a moment to talk a little bit about Consiliso and how that might be beneficial to people.

Mark Rutkiewicz: Sure, so Innovize, we're a contract manufacturer. We've been focusing on medical for the last 15 years. Got into it as a... We're a converter, which is when I got here, I didn't even know what that was. It's like so basically if it says bandages, they're a medical device. They're really exempt. I mean, but how do you make a bandage? Nobody touches it. It's all made by machines and it's basically you're taking films and you run them through a machine and you have like a rotary die cutter so you can automatically make these things by the millions. That's what we do. We print, laminate, we die cut, we laser cut, and can package devices that are more like disposable- type things. We do a lot of things with wound care, with diagnostic components, parts that go into pacemaker and defibrillators. We make a lot of parts for that. We're also getting to wearable sensors now, so sensors, anything that stick to skin. So-

Jon Speer: Right.

Mark Rutkiewicz: ... if you want to stick to skin, you gotto replace it every day. Where do you get that? You know, a lot of manufacturers make adhesive, but not in that shape, and so we buy from the adhesive manufacturers and then we cut everything to shape for our customers and then document and maintain traceability and all that stuff because it's a medical device, so intense quality system on that. Consiliso is a sister company to Innovize, so we started that after I wrote my books and just have.... We got a separate website for it. It's crosslinked with the Innovize website. I do consulting on designing quality systems and reintegrating quality systems, and so it's really more for if you're growing. Where's all your information, your quality system, and what's the best practice? There's not one software application that can run an entire medical device company. It's impossible. There's to many different requirements and each company's different, so there's quality system side, but then there's the financial side, and then there's-

Jon Speer: Absolutely.

Mark Rutkiewicz: ... clinical sideand regulatory side. You can merge a lot of it together if you architect it ahead of time, and that's what Consiliso supplies. How do you architect everything? Financial requirements if you're public or private can change some of the rules, even what you're using on that side. Quality system, are you making a disposable? Are you making software? Are you making... Do you have to do servicing on this capital system? Your requirements for your tools may change and that's how you manage all of that. That's what I do with Consiliso.

Jon Speer: Okay. Well, thanks for sharing that, and I know we're kind of getting toward the tail end of our topic today on UDI. I want to throw a question out there because I remember, again, going back when this first became and when you first started hearing from FDA this is going to be a requirement in the next year, whatever the timeframe it was, the industry was freaking out and because, I think, a lot of people heard, " Oh, I have to put the UDI on my actual product." I remember a very specific example, like a pedicle screw, like, " How in the world am I going to put a UDI on a pedicle screw?" So-

Mark Rutkiewicz: Right.

Jon Speer: ...maybe it's time to dispel or bust some myths here. Does UDI actually have to be on the actual product?

Mark Rutkiewicz: There are.... There used to be identifiers on the product. What you sell, the sellable object has to have a UDI. What is the intent of UDI? It's really intended for the hospital user so they can validate that. If I tell this patient's supposed to get this, this, and this, you can get that. If in the operating room they have a pedicle screw, they could scan it. Well, it's typically in a kit. If you're doing orthopedic with screws and stuff like that, it's in a kit. You can scan the kit and then the kit can be crosslinked with that. Now, you may want to look at things up ahead of time. Like when I was doing final pacemakers defibrillators, there was a serial number on the can, we serialized it, but once it was in the patient, did you see the serial number? No, because it was on the can, but we had X- ray IDs at the time. If you had an x- ray, you could see what kind of pacemaker it was, which manufacturer, and then you could do the telemetry and talk to it and see what device it is. The intent is trying to be able to find the information about the product, and then some longer term is then the patient, the patient we try and give... We were an implantable device manufacturer, give them an ID card. This is what you have implanted in you, lot... You know, here's the serial number, here's the model number, so the G10 can be included with that now.

Jon Speer: Yeah, that makes sense.

Mark Rutkiewicz: Basically they know what's inside them.

Jon Speer: Yeah, that makes sense. What do you think, Etienne? I know you've had to deal with this in some form or fashion in your career, too.

Etienne Nichols: Yeah, it was interesting. When I was working on it, I was struggling to figure out, how do we do this? Is it brand new? My wife had... I don't know if I can go into personal details. She actually had a pacemaker at the time and got it replaced. It was 10 years old and it had the UDI with the 2D barcode. That's like, " This is not new," you know, for my career, but I thought that was very interesting. We struggled with, " How do you validate the direct part marking on the product?", and things like that. It was an interesting world, so yeah, I love hearing what you have to say about it.

Mark Rutkiewicz: Yeah, I mean, the FDA has guidances on direct part marking and what size. We got a tiny part, and you can do some barcodes that are... You don't have to write it all out. You can do some smaller like barcodes that as long as you describe how to use them, if it's really tiny, but you could also do packaging. I mean, a wound care, a bandage isn't directly marked with a UDI. It's on the packaging that you throw away, so the part itself doesn't have a mark on it, but implantables, you want to track and stuff like that. You can scan things depending on how it's going to be used. Can you scan it so you can make sure that you are using the right product with the right other products and with the right patient? That’s actually the key.

Etienne Nichols: One quick thing, so I had interrupted you early on when you were talking about, " Okay, this is the process, You get the is barcode from GS1. You go, you put it on your product." I think I interrupted you at that point, so I just wanted to see if you could sum up that. I know it goes into almost a decision tree as you get into contract manufacturing, but any advice that you can give to medical manufacturers in that timeline?

Mark Rutkiewicz: I mean, what I've been seeing here is we have lots of different companies that we make products for and I've seen some other companies that do some contract manufacturing, too, and nobody's really standardized. The FDA, drug side, the FDA says, " Here's your drug facts and it has to look like this," so all of the drugs sort of look the same. Medical device, there's no guidance on it. It's like, " Fit it where you can and use these symbols." You can use the... At least you can use the ISO standard symbols. They don't require you to spell them out anymore on the labels like they used to. It's just trying to design labels, and so I think if the industry would just come up with... If you're going to just create a label from scratch and use something start with this, " If it doesn't work, that's fine, but at least start with that." That'd be a good thing to work with, and actually, I work with MDIC a lot. I've been involved with a case for quality. That would actually be... This is interesting that we're talking about is is like that would be a good project. We're working on a-

Jon Speer: It would.

Mark Rutkiewicz: ...a group called The Safe Space Project and this would be a good one to also look at standardized labeling, and it's just templates. If you're going to start with something, start with this at least versus people trying to come up with designs. I've seen manufacturers, they have no idea even what's supposed to go on the label, their brand, if they're a startup company. Even your experienced company, you know exactly what you want, but if you're a startup it's like, " What am I supposed to put on here?" Whoever you use as your regulatory person for submissions is typically going to bring some kind of template tool to bear for you. Yeah, UDI is typically... You try and use the symbols for reference for the model number, lot number, and expiration date, and then just put those exact same fields in there. Most labeling software today integrates that and autogenerates the barcodes within the software. I mean, 20 years ago? No, but today, almost every labeling software all generally, so it's not like everybody knew they needed to do it. There's half a dozen labeling softwares that... It's out of the box way, so-

Jon Speer: They're pretty affordable today, too. I remember like 10, 15 years ago, some of the labeling software and the labeling equipment was pretty expensive, but it's pretty affordable these days.

Mark Rutkiewicz: Yeah. It's a lot easier. They've designed and integrated it. That really helps. Even five, six years ago, how do I generate a data matrix barcode? That wasn't available. Now it is. I mean-

Jon Speer: Yeah.

Mark Rutkiewicz: ...it's all sort of autogenerated. A lot of places have it. A lot of places have the tools. If you're big enough, you can buy your own and if you generate a lot of them. One of the projects... When I was at AGA Medical doing implantable heart occluders, we ended up redesigning our whole labeling systems because we were having errors all of the time because we were using the standard methodology where you bought a label that was pre- printed with some information. Then, you ran it through a zebra printer and added more information onto it. It was just horrible, so we just totally changed it and designed an integrated system with a labeling software and basically bought blank label stock and printed it on a standard copy machine printer.

Jon Speer: Yeah.

Mark Rutkiewicz: It met the requirements for what we needed, so it was simpler.

Jon Speer: Pace.

Mark Rutkiewicz: Yeah.

Jon Speer: Like I tell... It's been a while since I told the story, but younger engineers about when I started and it sounds like one of those old man stories like where, "Oh, I walked uphill both ways to school in the snow barefooted," but there were times early in my career where I was literally cut and paste, like having a piece of paper, cutting something out and taping it. They're like, " Old man, you're crazy," but yeah, it's real. Well, Mark, I think this is probably a good place to put a pin in on the topic, at least for now on UDI. I mean, my take on it is, yeah, the process is a little convoluted, a little complicated, but from what a UDI is, it's not that deep. It's not that complicated. It's had a lot of benefit, but certainly if you need some help and guidance on UDI, there's a lot of resources that are out there. You can reach out to Etienne or Mark or even myself. We've been through there and these things a time or two, so if we can't help you, we'll point you in the right direction so let us know. While we're wrapping this episode up, of course, I want to thank our guest, Mark Rutkiewicz with Innovize and Consiliso, and of course, Etienne Nichols at Greenlight Guru. I want to remind you, too, that Greenlight Guru, we're here to help. We have the only medical device success platform on the market today. Well, what is a success platform? Well, it's designed specifically for the medical device industry by actual medical device professionals and it includes workflows to help you manage your design and development, your risk management activities. It helps you manage documents and records, including electronic routing and review and approval and revision control. We have workflows that help you manage all of your quality events postmarket, things like complaints and customer feedback and CAPAs and things of that nature and it's all tied together. Mark's right. You're not going to find one software solution that does everything that your medical device company needs, but when it comes to managing all of your quality- related information, Greenlight is a single source of truth for that information that's all tied together. I encourage you to check it out. Go to www.greenlight.guru and learn more about our software, and if you'd like to talk to someone from our team to share what your needs and requirements are and see we have products and services that can help you, we'd love to have that conversation, so check it out. As always, thank you for listening to The Global Medical Device Podcast. It's the number one podcast in the medical device industry, and that's because you're listening to it and because you continue to share The Global Medical Device Podcast with your friends and colleagues, so thank you for doing so. Till next time, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to The Global Medical Device Podcast.




 

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