Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.

Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.

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Some highlights of this episode include:

• What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.
• Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.
• Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.
• Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.
• UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.
• Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.
• Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.

Links:

FDA UDI Homepage: Unique Device Identification System

CDRH Guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) (July, 2021)

FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)

Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers

Code of Federal Regulations (CFR)

FDA - 510(k) Submission Process

FDA - Software as a Medical Device (SaMD)

FDA - Premarket Approval (PMA)

ABILIFY

Mike Drues on LinkedIn

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable quotes from this episode: 

“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” Mike Drues

“It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” Mike Drues

“The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” Jon Speer

“This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” Mike Drues

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: On this episode of the Global Medical Device Podcast, I catch up with Mike Drues from Vascular Sciences. The topic. UDI, Unique Device Identification. What's the big idea. Is there something new here? I mean, technically speaking? No, not really. I mean, FDA did finalize a guidance on this. And this is not a how to do UDI per se, but Mike and I do talk about some of the nuances, but also some of the benefits of UDI, and some of the potential that UDI can bring to your products and technologies in the medical device world. So I hope you enjoy this episode of the Global Medical Device Podcast. Hello and welcome to the Global Medical Device Podcast, this is your host and founder at Greenlight Guru, Jon Speer. The topic today should be well, I think it's interesting and we'll get into the details, but to set the stage a little bit. I remember a few years ago when the UDI regulation came out in the United States, Unique Device Identification, I was doing some work for a few companies and we were just trying to scramble, and just trying to figure out what this is? What we needed to do? What the process was? We reviewed guidance documents, and the information that was available at that time. And it was confusing. But anyway, fast forward quite a few years later, is it any clearer? Well, joining me is Mike Drues, from Vascular Sciences. So Mike, welcome to the Global Medical Device podcast.

Mike Drues: Thank you, Jon. Always a pleasure to speak with you and your audience. And yeah, this is an interesting topic Jon, but let's be flat out honest here, this is a flat out boring topic, or at least it can be. And like many topics of regulatory, it can be as about as exciting as watching paint dry, but that's not my intent. So I'm going to try as much as I can with your help Jon, to lighten things up a little bit here.

Jon Speer: All right. So as we usually do, probably a good place to start is what is it? What is UDI?

Mike Drues: Good question. UDI the acronym, the Unique Device Identifier. I sometimes refer to it as a Universal Device Identifier. It's an important topic, but as we just said, it can be a boring topic. The impetus for today's conversation, Jon was the guidance that FDA just finalized last month on this particular topic. But I'll be honest with you, this is a topic that I've thought about maybe talking about in one of our podcasts for many years. And I've pushed it off and pushed off largely because, how can we take a topic like this and make it interesting? Dare I say it even exciting or maybe even fun. And then the other reason why I thought this would be a good topic for us to discuss is because yeah, it is a pretty boring or can be a pretty boring topic, but it's a very important topic and it's amazing to me, how many companies, including some of my customers are getting in trouble with FDA. And whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they're getting observations on because of some aspect of UDI's. And I think not to jump the gun here, Jon but I think the root cause of a lot of this is something that you and I have talked about many times. And that is many people are focusing on following the regulation without really understanding its intent. And so one of the things I'm hoping to drill into a little bit with your help, Jon is the intent of all of this UDI regulation, including the guidance that FDA just finalized. And by the way Jon, just one other quick historical note, and then I'd love to hear your thoughts as we get going here. The guidance as I just said, was finalized last month, whatever the word final means in the context of guidance, there is no such thing as final. The draft guidance came out five years ago on UDI's and the original published in the CFR, in the Code of Federal Regulations actually goes back eight years Jon. So it's taking us quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. So why the heck is it taking us so long? Well, we'll get into that, Jon. But anyway, your turn.

Jon Speer: Yeah, and I guess we don't often do this, but probably good to give listeners a disclaimer, the intent of this conversation that Mike and I are having about UDI is not intended to be a, how to work instruction type of conversation. We're more talking about what it is? Why it's important? Maybe, some tips and pointers and some advice, but as far as the nuts and bolts the dirty details of how to do it, when to do it, where to do it? That's not necessarily the intent of this conversation.

Mike Drues: And I may add justification for that, I'm sorry for interrupting, is twofold. First of all, at least in my experience, Jon the problems that companies are running into are not because of the detail of implementing it. In one case, a company came to me because their 510K submission was rejected because they didn't have the UDI's as part of their labeling in their 510K. And in another case, another just got dinged on a manufacturing inspection because they weren't following... They didn't even know they had to put on UDI's on their particular device. So we're talking about some fundamental problems here, Jon that go above and beyond just the details of, what information do you put in that code?

Jon Speer: Yeah. So I want to unpack both two things that you just said. I want to talk a little bit about, how does one not realize eight years after this was put into the CFR, that UDI information needs to be part of the submission. And how does one not realize that this is important for manufacturing? But before we do, so you said something a moment ago that Walmart has been doing this for decades. So maybe let's start there. What is a UDI? What is a Unique Device Identifier? I mean, is it a barcode? Is it a catalog number? Is it a skew? What is it, I guess just generically speaking?

Mike Drues: Yes. A great question, Jon. And I looked into this a little bit myself. There's actually a number of different formats or technologies or options that companies have, not just with medical devices, but with products across the board. So what is talked about in the guidance that we just referred to is Automatic Identification and Data Capture or an AIDC system, but FDA also from the Universal Product Code or the UPC system. You're probably familiar with UPCs when you go to the grocery store, Jon it's the little barcode on a variety of different products. I know you're going to hold something up. I've got some props to share with our audience that we'll get to, but there you go. But also QR code, Quick Response codes that we all are now scanning when you go to, for example, a restaurant and they don't want to give menus because of COVID, so you scan this and it pulls it up on your phone. That's another form of identification, and a third form of identification is RFID chips. For example, you probably have, when you go through the electronic toll booth and you have a transponder in your car, that's a passive way of providing ID. In other words, there's no battery required. It's like a tuning fork. So you would hit it with a particular frequency of energy, wavelength of energy. And it responds, it resonates exactly like an electronic tuning fork. And I think that's important when we talk about for example, implantable devices that are going to go inside your body because you can't... Think about this, Jon if you have a coronary stent or a breast implant or a hip implant, that's inside your body and you need to know what it is? What lot number and so on. You're probably not going to cut yourself open and look to see what the barcode says. So there's a lot of different ways that this can be done, not just with the traditional barcode, although that's probably the most common connotation. Does that make sense, Jon?

Jon Speer: Yeah, it does. And let me recall some memories from when I was working on some UDI projects many years ago, there are a couple of components to it, but the gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product, if I remember correctly, right?

Mike Drues: That's correct. And putting it into regulatory terms or better for you, Jon as the quality guru in the room, putting it in quality terms, this should not be a foreign concept to anybody. This is the concept of traceability, that's all an UDI is, is traceability. And I'm going to use a few props of my own, if you don't mind, Jon.

Jon Speer: Yeah, sure.

Mike Drues: You may remember-

Jon Speer: You're on video so why not, yeah.

Mike Drues: You may remember your infamous mustard podcast where you used ketchup and mustard extremely effectively to illustrate the concept of substantial equivalence in the 510K. And to your credit, Jon, I don't know, I won't embarrass either one of us by looking up, if you recorded that podcast. It was a long time ago.

Jon Speer: It's been a bit, yeah.

Mike Drues: But I still to this day, use that podcast in many of my regulatory training, so hats off to you. Well, I'm going to follow in your footsteps, if you don't mind-

Jon Speer: Yeah, please do.

Mike Drues: I'm going to use some substantially equivalent metaphor. Here we have a bottle of Coke and a can of Coke. So a UDI will be able to allow us to distinguish between this bottle versus this can. But that's not good enough. That's where our technology is right now, Jon. That's not good enough. What I want to be able to do is I want to be able to distinguish this can of diet Coke from this can of diet Coke. In other words, these are exactly the same cans or are they? Well, they're really not. And so this is the level of traceability that ultimately we want to get to. I don't want to be able to distinguish or identify an entire batch or lot or whatever you want to call it, which is what these UPC codes do right now. I want to be able to distinguish this can from this can. I want to be able to distinguish this medical device from that medical device, and by the way, Jon, it's exactly the same with drugs, with pills. I want to be able to distinguish one pill inside of a bottle from another pill in the same bottle. That to me is the traceability that we ultimately need in this industry for a variety of reasons. As I suspect we'll just get into, and by the way, Jon I just dripped water, condensation all over my-

Jon Speer: At least there was water in that soda.

Mike Drues: That's true.

Jon Speer: Yeah. I mean, not to insult certainly you or me or the listening audience, but maybe some of these things are obvious, but why would I need to know down to the pill or down to the individual unit level? Why would I need that sort of traceability to know that?

Mike Drues: Yeah, great question. Well, it's all about traceability. Why is traceability important? Well, one of the reasons why it's important is if there's a problem, if we... I just coincidentally taught a two day course on post- market surveillance and complaint handling. If you have a complaint that's sent to your company about one of your medical devices, one of the things you're supposed to do.... It's amazing Jon, how often this doesn't happen, but one of the things you're supposed to do is investigate that complaint and try to determine what in the engineering vernacular we would call the root cause. In other words, is it a design issue, a manufacturing issue, a user issue, a material issue, and so on? And depending on the type of problem, then you want to be able to take corrective actions in the form of maybe issuing a dear doctor letter or possibly even a recall. And you want to know what devices were affected. Well, what you could do I suppose, is you could recall all the devices that were made of this type. But if the problem let's say for example Jon, it's a manufacturing problem and we can narrow it down to one particular batch, one particular lot for example, why do we need to recall everything if it only affects one small slice of the pot? So one example of why these things are important is problems, but there are other examples as well. Can you think of other situations where traceability would be important?

Jon Speer: Well, I mean, I was going to share an experience that I had years ago, way before UDI, I was working for a catheter company. And the way we identify catheter is there was a part number that size and the number of lumens and links and a lot different attributes about that. That wasn't internally defined set of nomenclature that we used. But whenever we package them and terminally sterilize them, then they would get a lot number assigned. But every, each of those catheters was individually manufactured as part of common work order or traveler or whatever the case may be. So they're all bundled together, but they were all individual pieces, parts, components, materials that were constructed. That were all, manipulated, manufactured and what have you. And they got a common lot designation post sterilization so that we could tie it... For lots of reasons but primarily, one of the reasons was traceability to that particular sterilization lot. Which is okay, great. We had pretty good traceability and one could argue it was a class two device, certainly we're at and maybe even exceeded the level of expectation from a traceability perspective, except when there was a problem. I remember one scenario, there was an issue in the field with a particular catheter and I think a tip separated. And we went through the whole complaint investigation and tried to identify as much information about that as we possibly could. And it was identified as probably a bigger issue, well a big enough issue that we wanted to contain it from becoming yet even a bigger issue still. But we couldn't isolate or narrow it down to the specific lot. And that lot might've comprised of hundreds, maybe even thousands of individual units, we couldn't even narrow it down to a specific date. So we had broadened our scope of product that was potentially impact to tens of thousands of units, and I don't think we ended up going down the recall path with that particular scenario, but had we had to have gone down that recall path, that would have cost easily hundreds of thousands if not millions of dollars to pull all of that product and that inventory back in so that we can do a more thorough investigation to truly identify it. So I know that wasn't exactly the answer to your question, but-

Mike Drues: I love linking traceability, in your case to the sterilization process, that's a terrific example. Let me throw on a couple of other examples that don't necessarily have to deal with problems or complaints or recalls. Because to be honest with you, Jon, as we talked about the medical device industry has been struggling, trying to implement this for a long time. Well, I think that the applications that we're using today in terms of UDI's are laughable doing. And again, Walmart has been doing this for a long time. How about inventory control? So when you go to Walmart and you buy a product and it's, they scan it at the cash register, not only does it ring up the price, but it automatically takes one of those things out of the inventory and further, it automatically puts in an order to replace it, to order more. Hospitals and doctor's offices can be doing exactly the same thing. And you mentioned, I think the word compatibility, Jon it's one of my favorite regulatory topics, because it's so broad. But how about when you scan a device with your code, whatever it is, barcode, a UPC code, a AIDC code, I don't care what it is. How about it comes up with a list of compatible devices that it can be used with, right? So you mentioned the catheter for example, so what guidewires can we put it? The balloon catheter what stents can we deploy using it and so on and so on. So this is not rocket science, Jon these are all things that are very, very easy to implement, but I just don't see it happening right now.

Jon Speer: As I said, that last point is really intriguing to me because, in the catheter world, one company may have the preferred catheter, but a different manufacturer may have preferred guidewire and another one still may have a different needle. Is anyone going to that level of identifying that level of compatibility with different devices that you're aware of?

Mike Drues: As part of the regulatory process, Jon we do have to in the traditional labeling, identify what's compatible. At least that's, not to go off on a tangent here, but that's the traditional approach, as opposed to defining what I call a technological envelope. Where instead of things specific devices that our device is compatible with, we define a technological envelope. A list of technological parameters, such that as long as your device is diameter between X and Y and length between A and B and durometer of so on and so on, it will be compatible. But I haven't seen it happen very much where people are incorporating that into the UDI or a similar kind of labeling like that. It certainly could be and I think it would make a lot of sense. And an interesting wrinkle, Jon if we wanted to kick the regulatory portion of our discussion up many, many notches. When we indicate in the high- level labeling, what devices are compatible with, that would be considered on label. But what if our device is compatible with other things that are not on our high- level labeling and what if we include information when you scan our UDI, that would be then indicating for an off- label use. I'll leave that as a rhetorical one Jon, but that presents some dilemmas, certainly when it comes to the FDA.

Jon Speer: I mean, I understand a lot of the business advantages of doing so, and I get from a regulatory body perspective why this information is useful, but I mean, to your knowledge is FDA... I mean, how are they leveraging or tracking or managing UDI information? Do you have any insights there?

Mike Drues: Well regrettably, Jon and I have to be honest here. I blame both industry as well as FDA for not having any creativity or imagination in how these technologies can be used. Maybe an alternative way to address the question that you just asked is what are the challenges that we face in implementing UDI? Because I went through the guidance like any good regulatory professional, but unlike a lot of the other regulatory folks, I don't just read what's in the guidance. What speaks louder to me is what is not in the guidance and why is it not in the guidance? So in no particular order, Jon here's a list of a half, a dozen or so different challenges that I thought are around UDI's. Some of them are addressed a little bit. Many of them are not addressed at all. So for example, what if you have... And these are all problems that I've run into in my own regulatory consulting practice. What if you have a teeny tiny device? A device that's physically so small, that it would be difficult, maybe even impossible to put a label, barcode or otherwise on? What about if you have a piece of software, as we've talked about before Jon an SAMD, a Software as A Medical Device hardware, and as a result, there is no package per se. Well, the labeling requirements are the same. This is one thing that amazes me, people think that software is so different compared to all other medical devices. Well, in reality, it's really not that different. If you understand the principles, the philosophies of the regulation. No, there is no sticky label that goes onto your software because there's no box that you put it in usually but, and this is something that on a tiny bit, you can put the UDI on a menu command, so it pops up on the screen. So you're essentially creating a virtual label, so there is traceability that way.

Jon Speer: Well, and let me chime in on that one too. I mean that, software routinely, I mean, there's any software that's developed has burgeoning or any modern software should have burgeoning. So this isn't a foreign concept from a software perspective. It's just about a matter of making it available.

Mike Drues: Correct. Absolutely correct. And here's an interesting question, do we need to... Remember a moment ago, I said, ultimately I want to be able to distinguish between two of the same Coke cans. I want to be able to distinguish this one from this one, because it could be there's a problem with this one, but not that one, right? Well, what about when it comes to software? If I have two copies of allegedly the same software, to be able to distinguish between them. I remember one time, and this is a true story Jon, somebody was submitting a PMA to the FDA, and they were looking at the submission requirements before electronic submissions. And it said you had to submit multiple copies, I think it was either six copies. And they said," Well, do I have to submit six PDF files? Six PDFs of the same PDF files?" I said," You're smoking something." But it begs the question in software, do we need to have that level of differentiation? But that's a solvable problem, if you understand the principles of deregulation, not the literal interpretation. And one of my customers asked me this just last week, how about if you have a single use device, a disposable device that originally was packaged by itself and now make it a thousand of them and put them into one big box. Do they have to label each and every one of those thousand of them in the big box or on the package? The guidance doesn't go that far. And the guidance can't possibly specify every scenario, every contingency that every device and everybody a company's going to run into. I can't tell you Jon, maybe it's just me, how many of my customers complain because they say the guidance is not specific enough. Well, dah, it's not supposed to be specific.

Jon Speer: Go ahead, keep going. You're rolling.

Mike Drues: It's supposed to be a starting point. It's supposed to be guidance. This is what we think to think about. You're supposed to take this like a quality management system. You're supposed to take this and apply it to your own situation. I don't mean to, you said I was going to, maybe I don't know if you've meant that in a good way, apparently I'm not sure.

Jon Speer: No, it's a good way. Well, let's go back to the example that you just mentioned, where they sold the product in single units, and now they've decided to box a bunch of them. A hundred or whatever it was. This is where you get to think for yourself, right. This is a business decision. I mean, is it worth the cost and the resources or whatever the case may be to individually label those with Unique Device Identifiers, in that box of a hundred? Or do you just treat it as a box of a hundred? You have to think about the upstream and downstream implications of that and-

Mike Drues: Exactly correct.

Jon Speer: And you and I have talked about plenty of times before, and this is yet another great example, people should be careful what they wish for, because if you want super prescriptive, do this, don't do that and do it this way. You're going to get it.

Mike Drues: I don't often do this Jon, but let me give you the exact advice to my customer in that situation and feel free to either agree with it or critique it. But basically what I said to them is I said, look, if you truly understand the principle, what we're trying to accomplish here of traceability, then ideally each and every one of those thousand widgets in that box should be labeled individually because it's possible that you might have a problem with widget number 89 that does not have the same problem in widget number ninety. So theoretically, if we can, it would be best to have that individual label on each of those thousand devices. But I also said pragmatically, we could probably get away with or justify not labeling them individually, just simply putting a label on the outside of the box. Like when you go to the grocery store, Jon and I'm dating myself, but if you buy a box of Twinkies for example, and you take one out of the box, it specifically says not labeled for individual sale, because the label on the outside of the box will cover what's in the box. I have no problem with doing that Jon with one caveat, and I think this is what you mentioned, and we have to take a risk- based approach. In other words, what is the risk and possible harms that could result from that risk, of a problem with each of those devices? In other words, if the risk is minimal, I have no problem taking that for the lack of a better phrase. And that is labeling the outside of the box and not the inside of the box. On the other hand, if the risk is potentially significant, I don't think the Twinkie approach is justified. And I would go a little bit further and look at ways that we can identify each and every one inside that box. And it's that regulatory logic Jon, that I'm trying to emphasize here, that I would stand behind. Because quite frankly, I don't care what the guidance says, if somebody comes in, that I just referenced a moment ago, and they got pinged on a manufacturing inspection, I will present my logic to the inspector or to the FDA. As long as the logic is sound that in my opinion, Jon is what matters most. Am I naive, Jon? Did I just fall off the turnip truck yesterday? Or do you think that gee, maybe this Drues guy is a wackadoodle, but maybe there is a method to his madness.

Jon Speer: I think there's a method for sure. When we first started talking about this and started describing UDI and you used an interesting word that I hadn't thought of really until we started talking about it. But instead of unique, you said Universal Device Identification. So I'd read an article the other day about some work that Brazil is doing with UDI. I know there's been a lot of movement in the EU and I assume a lot of other regulatory bodies across the world. So is it possible in your opinion for the EU to actually be universal auth? In other words, does UDI as defined by FDA mean the same thing as UDI, as defined by ANVISA in Brazil and EU competent authorities?

Mike Drues: Yeah. Great question, Jon. Or putting the question a slightly different way, can we have, will we ever have a universal or global identification system? I certainly hope so, but to be honest, I don't see it happening anytime soon.

Jon Speer: Yeah, I don't either. We seem to be quibbling a lot about the format and the information, between FDA and industry. I don't know. I hate to be cynical, but do these people, are they just simply trying to justify their own job descriptions? This to me makes no sense. Back in the day, obviously you don't remember this Jon, but in the early days of railroad, there was no standard gauge distance between the rails. So here in the United States, if you wanted to take a train, for example, from New York to LA, you might have to change trains a couple of times along the way. Why? Because literally the gauge of the track would vary from place to place and you would have to get off one train and get onto another. Eventually somebody came up with the idea of "Gee, maybe it might be a good idea to standardize this." Electricity is the same way. We don't have a standard electrical system. When I used to travel a lot before COVID especially internationally, I would have to carry around all of these different adapters. Global currency, we still don't have a global currency. So are we going to have a truly universal standard for medical devices? I hope so, but like I said, I don't see it happening anytime soon. It'd certainly would save us a lot of time and money if we did. Oh, for sure. I mean, I can remember numerous products where the item was exactly identical, but we had to have two different part numbers and multiple inventories, depending on where in the world it was going to go. So there was an element of the part number that had some uniqueness to it if you will, but it was based on where it was going to be sold. And it's just, to your point earlier, I mean, Walmart figured this out right for their inventory, as I'm sure other industries have as well. They sell products globally. This isn't something that hasn't been solved before.

Mike Drues: And to use a regulatory metaphor Jon, do we have a global risk or classification system?

Jon Speer: No, we do not.

Mike Drues: Why not?

Jon Speer: I know.

Mike Drues: So how about before we wrap up just a couple of other additional challenges as I see them to UDI's. Because I say this with all due respect to my many friends in the industry who spend a lot of time struggling with these problems. I see what we're doing with this technology, truly the lowest of the low hanging fruit and there's so much more that we can be doing with it. So for example, I hinted out a moment ago, what if you have an implantable device, a device that goes inside your body? Putting a barcode on it, maybe it might be useful up to the point of putting it into the patient. But once it gets into that patient, that barcode is probably not going to do you much good. And if you're going in there to look at the device anyway, the patient probably has bigger problems to begin with. So I love the idea and I've been involved with several of these technologies already, Jon using some sort of RFID or RFID like chip, like you've probably seen ads on the TV, Jon for identification chips that you can put into dogs. You can even program them with the health records of the dog and they scan it and they get all that information. We have that technology, there's no reason why we can't be using it. Another challenge, and we ran into this in the past, what about with reusable or re processable devices? The classic example that comes in mind, something that Jon, I had a lot of involvement with several years ago, is the duodenoscope fiasco. That led to the deaths of a number of people here in California, as well as elsewhere because of problems with reprocessing. Well, if you have some sort of a UDI label on your device and your device is intended to be reprocessed, your UDI label needs to be designed and tested to make sure that it can withstand whatever reprocessing procedure that you're going to be using. And how many reprocessing? Is it going to be a hundred times, a thousand times? In other words, and I've seen this happen before jet, what happens if you reprocess your device X number of times, and your UDI label falls off, or becomes unreadable? You've now defeated the entire purpose of having a unique or universal, whatever you want to call it, device identifier, right? This was not spelled out in the guidance but to me, this is common sense. This is something that if you truly understand how a product is supposed to be used, all of these things should be common sense. And then the last example that I would just share real quick, Jon is in the area of combination products and specifically digital pills, right? I'd mentioned earlier, not to overuse this metaphor, but I want to be able to distinguish this diet Coke can from that one. Well, imagine I didn't pull out any pills from my medicine cabinet, Jon to illustrate, but if I have two pills under the same bottle, I want to be able to distinguish the other, even though they're both labeled the same and they're both in the same bottle, one way that I can do that is by putting a little RFID chip inside of the pill. Now, some people might think, oh my gosh, that's going to be overkill for an application like that. Well, it is overkill for an application like that, but here, let me give you a legitimate example. This is a product that I was involved with a few years ago. You may remember, or be familiar with a particular drug called Abilify, which is a psychotic medication it's given to people that have schizophrenia and other kinds of mental disorders. Well, you can imagine patients that have these kind of mental disorders compliance, swallowing a pill every day or multiple times a day is not an easy thing to assure. So what we did, and this was the first time it was done back in 2014, we took a little RFID chip that, oh, by the way, we got a 510K on first. We put that, now it turns into a combination product. We come up with a little sensor originally like a Holter monitor that you can wear on your belt that would then transmit a signal to a cell phone, such that when the patient swallowed the pill and it dissolved inside of them, that sent a signal and we could assure compliance and so on. And now that technology is starting to be used in other places. It's just a riff on the whole concept of different application, but the concept is itself is exactly that.

Jon Speer: Well, that last example that you shared is really interesting because compliance, and I'm not talking from a regulatory perspective, I'm talking about patients-

Mike Drues: Patience compliance.

Jon Speer: ...taking their medications is one of the bigger challenges, certainly in the pharmaceutical industry, it's patients don't take their medications and they don't get better and that sort of thing. But you don't have any way to know whether or not they did take that. So it seems like in the grand scheme of things, a relatively simple yet creative approach to do that and the costs of RFID and maybe you don't do it on aspirin, every single bottle or pill and a bottle of aspirin. Maybe you do, I don't know, but the cost is not ridiculous in the grand scheme of things either so.

Mike Drues: Cost benefit just like risk benefit, those are things that we have to take into account. So bottom line Jon, and these are just a few examples, I mean, I could... With more examples of challenges and technologies that are either addressed in the guidance very, very little, or in most cases, not in the guidance at all. But I can't emphasize this point enough Jon, and this is not something just relative to our conversation today, but a lot of our conversations in the past. All regulation, including the guidance that we're talking about today, it's just the beginning. It's the starting point it's recommendation. We're supposed to take that like the preamble and the FDA's website, and we're supposed to apply it, tailor it, personalize it, whatever you want to call it to our particular situation. And so it should not be frustrating to people when they read guidance and they say, it's not specific enough, it's supposed to be more general. Otherwise, as you said before Jon," Be careful what you wish for you just might get it."

Jon Speer: True. Any other final thoughts or takeaways or is that a good place to park this?

Mike Drues: Yeah, just to wrap this up just to, speaking of packaging and labeling and UDI's are just under the general umbrella of labeling in my book. So just to put a big wrapper and a big bowl on top to send our audience off on their way. Obviously be aware of the UDI requirements. To get a question from the FDA," Where's your UDI?" And you look at them like a deer in the headlights. I mean, to me I had this happen before Jon that's like somebody came to me with a device they were working on that was going to go inside somebody's body for the rest of their life, a permanent implant. And when I asked them about biocompatibility, they said," What's that?" If you don't know... You're laughing Jon, this is exactly why we have so much regulation. But people need to know that this is something their supposed to do and not just to be familiar with the UDI requirements in general, but be able to apply them to their particular device, to their particular technology. Like that not so hypothetical example that we talked about, where you have one widget that's labeled individually, and now you want to put it in a box with 999 of it's closest friends. How do you handle that situation? That's up to us. That's not up to FDA to tell us. That's up to us to figure out.

Jon Speer: And hopefully everyone listening today is at least familiar enough with UDI to know that it's something that they need to address. But at the risk there somebody who is like," What is that? This is a new topic." UDI, I think this is a general statement. I don't think it's an overgeneralization, but UDI is applicable to a 100% of medical devices today, definitely in the United States and pretty good chance outside of the United States you're going to have to address UDI for all medical devices, regardless of class.

Mike Drues: Like usability, up until about seven or eight years ago, when the infusion pump fiasco occurred, usability was the exception rather than the rule. As a result of that now it's the rule rather than the exception. I think Jon, to your point, UDI's seems very similar, UDI is the rule rather than the exception. So just be aware of those requirements, figure out how to apply them to your particular situation. Keep in mind that guidance is only guidance, it's not specific, it's written for a very broad audience. You as an individual, an your company, you all need to figure out what you need to do? What makes sense for your particular device? Certainly take a look at what other people have done, if you're working on a 510K device, the natural thing to do is to take a look at the predicate or other similar devices and see how they handle some of these UDI challenges. But on the other hand, if you're working on a new device, like a De Novo device or something like that, there might not be a direct predicate to look at. So you still have to take a look at the guidance, you'll have to understand the principles, you'll have to take a look at similar devices. But at the end of the day Jon, you have to come up with a plan that makes sense for you. And then you have to be able to defend that plan when FDA comes knocking on your door and says," Hey, you're not doing this. Why not? Or why are you doing this?" And so on, and so on. That's the way I see this game played Jon, how about you?

Jon Speer: I'll be honest, when we first started talking today about EDI, I thought there was something there. But this has been thought provoking for me because on the surface it does just feel like labeling, and there is an element of that. And I certainly understand the pros and cons or certainly the ramifications of the traceability, but this is where the regulations are what they are. And this is not something that's optional at this day and age, nor do I think we want it to be optional. But I think this is a great example of there's a lot of ambiguity when you read the regulations and the guidance's that are there. So use your noggin, think for yourself. Apply what makes the most sense for your business and for that product when it comes to UDI, so that's my final thought.

Mike Drues: And a synonym for ambiguity, in my opinion, Jon is opportunity.

Jon Speer: Exactly.

Mike Drues: It is an opportunity to interpret that in a number of different ways. And my very last thought to end this today Jon, and then we can wrap this up. There's an expression, if you're going to steal, steal from the best. Jon's Speer, one of the best in this business, if I'm going to steal, I'm going to steal from my friend, Jon speer. So here is my humble attempt at illustrating exactly the same thing.

Jon Speer: Well it's pretty good. Yeah, I know that's a blast from the past, so I appreciate you sharing. And thanks for the insights on the topic of UDI. Ladies and gentlemen, Mike Drues, Vascular Sciences. Of course, we got into the weeds a little bit about the topic of UDI, there's lots of resources that are out there. Mike's got a lot of experience, speaking of and helping you figure out how to navigate and manage all those nuances of UDI. And frankly, all other regulatory matters that you might be faced with or exploring with your products and technology. So look him up Mike Drues, Vascular Sciences. And on the quality side, Greenlight Guru we're here to help you as well. Greenlight Guru is the only medical device success platform on the market today, designed specifically and only for the medical device industry by actual medical device professionals. We have workflows to help you manage your design and development, your risk management activities, design or document records, quality events, and so on all in a single platform, a single source of truth. So if you'd like to learn more, go to www.greenlight.guru, and we'll be happy to have a conversation with your needs and requirements and see if we have products and solutions that can suit you. As always thank you for continuing to keep the Global Medical Device Podcast as the number one podcast in the medical device industry. That's because you continue to tune in week after week, after week to listen to the new episodes that we have in topics that we get to discuss with Mike Drues, and other industry experts. So keep spreading the word to your friends and your colleagues, to keep us in that number one spot, so thank you so much. As always 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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