UDI Regulatory Changes and Your Digital Journey

Patrick Sullivan:

Welcome to another episode of ArcherGrey’s PLM Quick 30, where we dive into all things PLM, digital thread, and digital transformation. I’m your host, Patrick Sullivan. Thank you for joining us today. I’m sorry, I have to do it, “calling all companies affected by regulatory and compliance, calling all companies affected by regulatory and quality compliance.”  So, I had to sound the alarms to help raise awareness for today’s podcast because we have a special episode today, because we not only have one guest, but we’ve got two experts today that have tremendous experience in the life sciences industry. They’ve helped various medical device clients throughout their career to enhance their digital thread strategy, to ensure compliance in the ever-changing world of regulations.

Patrick Sullivan:

We want to help share their expertise with you, and the topic we’re going to dive into today is what do recent UDI regulatory changes mean to your digital journey?  We’re going to learn about the challenges today and discuss how to not only overcome them, but how do we do it in a way that will help you scale? Let’s meet our experts today, Caroline Byrd from Nextern and Sajesh Murali from ArcherGrey. Welcome to the both of you. Would you please introduce yourself, provide us a little bit about your background and experiences so we all know where you are coming from and the expertise that you’re going to share?

Caroline Byrd:

Sure.

Patrick Sullivan:

So Caroline, you want to go first?

Caroline Byrd:

Sure, I’ll have at it. I’m Caroline Byrd. I am the vice-president of regulatory quality and clinical for Nextern. Nextern is a company that helps device innovators realize commercialization, basically. We’ll meet you where you are and help you bring your product through to full commercialization through design and development and all the stages in between. Prior to joining Nextern very early this year, I spent the last, I don’t know, five years of my career or so ever since the beautiful EU MDR came into existence and the Clinical Evaluation MED DEV 2.7.1 Rev 4 came into existence. That’s where I was working at Abbott, like a biosystems and acquisitions along the way during that journey to understand these changing requirements, not just in the EU, but also globally, and how do we, as manufacturers of medical devices, keep up with all these changing regulatory requirements and most efficiently implement these new rules and new data that has to be managed around the world in all of these various global markets? So that’s a little bit about me and at least my recent happenings. 

Patrick Sullivan:

Yes.

Caroline Byrd:

… Sajesh?

Patrick Sullivan:

Excellent. Thanks, Caroline. Yeah, Sajesh?

Sajesh Murali:

Yep. Thank you, Caroline. Thanks, Patrick for doing this. This is good. Initially, when you spoke about a podcast, I was like, “What podcast?” So then when I heard about sharing the stage with Caroline, I’m like, “Yeah, sure. Let’s have at it.” So it’s a great opportunity to be here. So a little bit about myself, I’ve been in the consulting world pretty much for 18 years, been in the product life cycle, product development space, and about last decade or so, it’s been very close to life sciences. I’ve done work at most of the life sciences, the top 10 companies, clients, helping them more in the regulatory quality space and how to integrate their processes and bring the new product introduction, the change management, and the regulatory side altogether, and then it has an impact to your distribution, essentially. So my life has been around the regulatory information management most of the time and in product life cycle. So that’s pretty much what I’ve been doing for the last decade or so. So it’s a brief introduction of me and [crosstalk] give it back to you, Patrick.

Patrick Sullivan:

Yeah, great. Thanks, Sajesh. So let’s rewind a little bit, because I introduced this around UDI regulatory management. I suspect our listeners who know what it is and are listening to it because they want to find out more know what it is, but for the greater audience that may be interested in the topic just around regulation in general and how to deal with it from a digital thread, because I assume we’re going to uncover some things that are going to be of value to them as well, so UDI submission, what is it, and why does it matter now?

Caroline Byrd:

Yeah. Well, so UDI, the words behind UDI is unique device identifier, but you have to be careful because even anywhere you operate in the world, that means something slightly different as we’ve all been learning, as all these global regulations are coming through and defining things a little bit differently, deploying their own databases and software tools to store the related data. So you have to dig in a little bit deeper to understand what is the UDI and what are you placing it on, and where in the world are you placing your product? So that’s the regulatory angle is to understand what the unique device identifier definition is and then figure out what data to apply to that and can you use the same UDI now globally, or do you need to make some adjustments or changes? Therefore, you have a different number, a different barcode, things like that that get deployed on your product.

Caroline Byrd:

So this all started with the FDA. They invented the UDI concept and the GUDID database because they felt like they needed to know exactly what got produced where, by whom, and where was it going to the end user so it would help with recalls, in particular. It would help with post-market surveillance complaints and trending and being able to take action on your product if you knew within just one barcode, everything that was critical to identify that product. Then Europe took that concept and said, “We like that, but we’re going to do more. We’re going to separate out the unique device identifier into a basic UDI, a UDI-DI, and a UDI-PI.” So they made up levels of data that has to string together now to create your UDI.

Caroline Byrd:

Then, other countries who have their own regulation, like Japan and South Korea and different geographies, they’ve also said, “We like this idea of UDI, because we want to know exactly who sent what where in our countries so we can quickly respond to recalls or complaints, we want that too,” but they need it in local language. They care about different things associated with your device, so they want a little more data or a little less data than where it originated in the United States. So that’s all added a lot of complexity to the legal manufacturers’ obligations to ensure all of this traceability gets registered with the governments correctly, but then also deployed with each and every device that’s leaving your factory. So that’s just a little bit of the history and why this topic has been hanging around and is so complex for a long time.

Patrick Sullivan:

Yeah. So around what time? Well, Sajesh, do you have anything to add on that?

Sajesh Murali:

Yeah. Just I think Caroline, you covered at a high level, really great. All I heard at that time was data.

Caroline Byrd:

Mm-hmm (affirmative).

Sajesh Murali:

It’s the complexity of the data from the origination to how it gets formulated and to the way it gets submitted.

Caroline Byrd:

Right.

Sajesh Murali:

So essentially, it’s a combination of a data-driven approach, I would say, to how do you do R&D, quality, regulatory all tied together, because ultimately, the company sells product. As a medical device company, what are you selling? You’re selling a product. The characteristics of that product is what is required by the regulatory body. One thing that I want to start off is that they’re not two, three different things. They’re all the same thing because it’s all coming from your product. That’s what you’re manufacturing, so the metadata that the FDA is requesting, EU is requesting, Japan and Korea, they’re all metadata from the product, right?

Caroline Byrd:

Mm-hmm (affirmative).

Sajesh Murali:

So the complex nature of that is essentially, I would say, the way the companies handle the data and the systems in their ecosystem. When you start building that out, based on these changing regulations, like MDR, GDPR, and all these ISOs, the new ISOs updates that’s coming up, all of that. It’s just adding more information or the information being requested by these regulatory boards, which companies already have. There are a lot of these companies, they already have a lot of this information, it’s just that process of getting it out. When you think about it and look at the complex landscape of systems and data, you’re like, “Oh my God. How do I do this?”

Caroline Byrd:

Mm-hmm (affirmative).

Sajesh Murali:

So medical device companies have been making products for a long, long time. I’m glad that you brought up the topic of data because you can’t make anything without data associated to it, right? What’s the design? How should it be built? How should it be shipped? Who is it being shipped to? So if the data has, in some way, form or fashion always existed, why is UDI submission such a big topic now? Why does it matter now? I understand why it’s important, but hasn’t it all always been important?

Caroline Byrd:

Well, yeah. I think the difference is all of the data was written down somewhere in your design history file, or it’s in documents somewhere. It’s not sitting ready to use as data. I work with a lot of startup companies now. They don’t have investment yet into big PLM systems like large strategic corporations do. So where is their intended use statement? Where is the definition of their legal manufacturer? It’s in documents. So it’s always been there, to some extent, you’re right. There are some additional metadata attributes, though, that force you to dig deeper than you may be used to, to identify what materials are in your products and be able to claim those for reach compliance and levels and things like that, that Europe, for example, care about specifically.

Caroline Byrd:

So that’s really been the important thing, I think, with the pandemic as well. There’s just been so much more emphasis put on digital data, digital tools, accessibility to information at your fingertips in a digital way in order to execute around the world, because you can’t physically go into the office and pull up your scanned, your hard copy paperwork anymore to figure out where your master source of your intended use statement is, because I got to file that into these 10, 20, 30, 50 databases around the world when it changes.

Patrick Sullivan:

Yeah.

Sajesh Murali:

Yeah. That’s a great point. Again, I’m thinking of a subject and you’re already talking about that, Caroline. That’s perfect, right? So you said digital technologies, I think the place when it started back in, I think, 2013 or ’16 was when FDA started this whole UDI-

Caroline Byrd:

Mm-hmm (affirmative). Yeah.

Sajesh Murali:

They started turning the wheels, 2013, I think it was. I don’t remember the date correctly, but essentially from there to now, there’s been a lot of advancement in the technology, in the thought processes. It’s by lot of learning by either external agencies or even the companies, the med dev companies themselves as to how to innovate around this process, how to make it better, although I don’t think at that time there was any insights that are the other countries are going to start implementing it.

Sajesh Murali:

I think that we’ve got a lot more stronger when EU MDR came into play. I think all the other countries started jumping into that, “Oh yeah, let’s do UDI.” So it’s the need to create that digital thread, to have that connectivity where, and with pandemic, it made it in a worse for the better, I guess, it’s like you said, there’s no, “I can’t go to office to print anything or look up my scanned copy. How do I search for information, because it’s now in a document somewhere?” So I shouldn’t say it’s the pandemic; it started before that. The larger companies I worked with, it’s a very similar scenario. You said startup, these bigger companies, as you know, you’ve worked with a lot of companies too,

Caroline Byrd:

Mm-hmm (affirmative).

Sajesh Murali:

They are small startups and they have these small, siloed information that they do their things and they want to join it to, ultimately, cater to the UDI. So working with them to bring it to a holistic process is really important.

Patrick Sullivan:

Yeah. I appreciate you guys diving into that because it helps. Well, one, thank you, because we understand it’s a complex issue and it’s not just so simple as, “Oh, well the data’s there, you can go grab it,” it’s how you grab it. The different regulations per government body associated to it, so that’s by country, you all of those things and then the specific details of how they want that information submitted. So there’s lots there, but in your guys’ opinion, what are some of the top issues that companies are facing with the changing regulations from a UD perspective, because I know there’s other [crosstalk] regulations that they had to comply with, but specifically from a UDI perspective?

Caroline Byrd:

I think one of the struggles is as the governments have come out around the world with the different UDI requirements, every single one of them has a different timeline. So if you’re dealing with, I want to sell a globally available intended use statement set of claims, this physical product and I want to take it just with translations all around the world with CE mark, with FDA clearance, with everyone’s symbols and everything all loaded up, up on this label, right? Well, that’s a lot of work. These labels take a lot of time to change and manage and control and now I’ve got to employ these different requirements in different geographies all at different times. I think that is definitely for the large strategic organizations. That’s been a big struggle.

Caroline Byrd:

The idea that you have to be very nimble and be able to readily change your labeling and adapt to all these regulations around the world quickly and have your data available to submit, submit, submit, submit, that’s a big challenge for companies who have large portfolios. Another challenge that has come up in the diagnostics part of life sciences, the IVDR when it got deployed in Europe, it is very explicit on how you must define your intended purpose and your intended use statement to define your product as an in vitro diagnostic. That definition of what an intended use statement is, is very, very different in Europe than it is in the U.S., for example. So when you go and you had this product being sold globally, but now I need to get it under IVDR certification, you’ve now had to edit your intended purpose statement, which may up classify it in the U.S..

Caroline Byrd:

You may or may not have the ability or the time to be able to do that, so now you’re stuck with this product that you may not be able to sell globally anymore under the same intended purpose statement and same claims and now it’s got to be split. Now you’ve got double UDIs to manage and which factory is putting which UDI to go to which geography and the symbols associated with that. Those are, again, all complexities that companies are going to have to find ways to adjust and really tightly control what content can go where in the world. I don’t know if you’ve encountered anything else that’s [crosstalk] difficult.

Sajesh Murali:

Yeah, I think you touched on the main two points. One of the things that I’ve seen working with the J&Js and the Medtronics and the Strykers of the world, essentially, and a lot of med dev companies, they grow by acquisitions, right?

Caroline Byrd:

Yeah.

Sajesh Murali:

There’s a lot of M&A, so there are these companies that come together, and at one of the clients they were like, “I don’t know.” There were six different systems that had to undergo from the start to the finish to do the submission. Four of them were just legacy systems because it was three different companies who were involved in that manufacturing process of that medical device, so they just used their systems. So it’s that I would say sometimes they themselves complicated it, or it was the need of the hour or probably the priority was a little bit different than, “Let’s do the submission first. We’ll figure out the ‘how’ to do a submission later,” kind of question. But in general, that’s the other problem about how you tackle the M&A that come into play and the system landscape and the data landscape that you have. It essentially comes to the business strategy, what you did to enable it.

Patrick Sullivan:

Yeah, that’s interesting. I’m jotting notes down and again, rewinding to the question which was, “What are the top issues that they’re facing?” So going backwards, Sajesh, you were talking from a system per. Although you may be buying company A product, whether it’s Johnson & Johnson or Stryker or whomever, they might have acquired that product through another company, which it’s not like a click of a button where everybody’s on one system, so that’s an important point. There’s multiple systems that house this data that’s distributed in different places, and then you go up the chain from just the system of record, if you will, for that particular piece of information and then how it evolves and matures as it goes. So, Caroline, to your point around intended use, and then once it’s out in the market, how are you regulating that in the market? Then to your point, each government has their timeline associated to it and their own requirements.

Caroline Byrd:

Mm-hmm (affirmative).

Patrick Sullivan:

So I tried to ask what I thought was a easy question to answer when I said, “Hey, what’s the top issue?” But really, it can’t be boiled down to one issue because in order for the product to sell, you have to address all of those things as you put the layers on top of one and the other, and then there’s top issues that each layer that you have to overcome. So I appreciate you guys walking through that. Let’s take a U.S. based company, if they’re able to sell the product here, and I understand that different geographies will have different requirements, but if you have a baseline, and I assume the FDA is probably more strict than most places, with the exception of EMDR, sounds like it’s getting a bit more detailed, so if you have a strong baseline, why can’t you replicate that and modify it as you go along?

Caroline Byrd:

Well, I guess I don’t see any reason why you can’t. If you’ve got that data locked and loaded and you’re controlling it at a data level, not just within your documents, but you’re able to control that as data, now every geography, when they come through with their requirements, whatever database or system you’re using to control that information, you have to build it out and continuously to keep adding whatever additional information is required by these new right regulations. I would say, so wherever you start in your journey, if it’s with MDR, then you’re going to the U.S., or you start in the U.S. and you’re going to the EU or other places, there is a backbone core of the data that is the same. Then, it’s a matter of where do you push the data? In what format do you push the data?

Caroline Byrd:

We’ve even gotten into situations where it’s like they want month, day, year; others want year, month, date. You have to sometimes translate the data into a physical different language and so you have to use local people to do that, or control your data in a way that it can be translated and you’re controlling the translations at the same time. So again, wherever you start in this journey, just be prepared to have to build on it and adjust it and manage large data sets. If you’re doing it just for the U.S. and you’re just starting there, then it’s much more contained. That’s where a lot of us started was just it was difficult enough in the U.S., but it was just the U.S. Now we’ve got to push that data all over the place, change control, the configuration management, all those things come into play and become much more important.

Sajesh Murali:

Right. That’s a very great point. I would go a little bit technical here, but it’s true. The companies, the recommendation would be to think more from a scalable architecture perspective. You need to have your product or the product record that’s integrated and you’re overlaying information as you go by, as the product matures across different phases, like design, and from a validation perspective, a manufacturing perspective. You need to make sure that that information, that the product is scalable enough to take all this information along as it gets matured. You might not have information when you’re actually at a point where you’re designing the product, for example, but as you go through your testing, you’re more information comes in that is required for your UDI submission for a country A, might not be required for the country B. For country C, it might be a different variation itself, a small problem like notified bodies, right?

Caroline Byrd:

Mm-hmm (affirmative).

Sajesh Murali:

There is no notified bodies in the U.S., for example. There’s notified body in the EU, but they are different for different regions. Different companies use different notified bodies, so in a small metadata like notified body already has so many variations, very simple. It’s a simple variation. Now, it’s my same product. I’m making product X and I’m selling in three different regions. Now, I need to have the same information, but three variations of it. How do I store it? How do I save it? Do I create new products? I cannot create new variations of the product or new versions of that because the same version, essentially, I’m going to sell. So a very simple thing like that ultimately leads to, I wouldn’t say a problem, but it needs some thought as you’re looking at it. There needs to be something where you have the information collected and sorted and approved at one place, and there needs to be something in between, like a gateway, that essentially takes that information and also knows the regulations better.

Sajesh Murali:

So this gateway, which we can talk about it later more, the gateway, we are talking about something which knows what the end is going to look like, or U.S. needs it such a way, EU needs it such a way, Japan needs it such a way. So the company, as me as a medical device manufacturer, I would give that information everything to this gateway and the gateway knows based on my input that I need to send it to U.S., South Korea and EU, then all the three, the gateway takes care of it. So to your point, Caroline, you said about validation of the data, for each of these countries, if we have something that this architecture can take care of it, I think that’s one thing to think about, to keep in mind of, and to your point, don’t think about just U.S, and think, how can you make it larger?

Patrick Sullivan:

Yeah. I like those points that you guys just made and thinking about people listening to this, and again, bridging the progression of what information is needed and Sajesh, I like the term ‘gateway.’ Maybe we can consider it a little bit of a game, if we think about the evolution of a product from concept all the way through, can we walk through the process and talk about what’s required at each stage of the evolution of the product, just to give people some additional insight into some of the priorities? There’s so many that we can’t dive into them, but if we go from left to right in sequence from R&D, clinical studies, from left to right, what does that look like? Then, from a UDI perspective, what are some of those larger pieces of information, or more significant pieces of information that are required at each stage gate, if we could spend a couple minutes with that?

Caroline Byrd:

Sure. Well, I think UDI and having to worry about a lot of this probably doesn’t really come into play until you’re getting close to design freeze, and you know what you’re going to do, right? Like maybe, I’m trying to iterate very early on in my design and development cycle and I don’t know if this thing is going to have separated accessories that I got to sell with it, or if it’s going to be all packaged together in one package. I don’t know that the second that I initiate a design project, so I’m going to iterate, iterate, iterate, but I get to a point where I know what the intended purpose is. I should know who’s legally responsible for it as a legal manufacturer. I should know where in the world, literally in the world, I’m going to submit and take this thing.

Caroline Byrd:

You have to know your business strategy along with your design and how many bits and pieces of this system. How are you going to sell it? How are you going to put it on the market? Once you get to that point, that’s where the UDI data can start to be populated, I think, because you’ll know if I’ve got disposables and I’ve got a hardwired plug-into-the-wall kind system that supports those disposables or I’m going international with this thing, so I actually need three different cables or five different cables that are individually sold just as a cable. Then I’ll know how many catalog numbers I have, how many UDIs and device definitions I’ve got to deal with.

Caroline Byrd:

So that it’s about when it starts, I would say, it depends on what kind of company you’re you’re with and how large you are and what your end game is but normally you’re just going to the United States or you’re going in with CE mark, depending on where your country of origin approval you want to get it from and then you just focus there and you collect that set of data. Then as you get maybe acquired, or you just simply start standing up distribution channels in different parts of the world, now you need to start complying with those local regulations. It’s going to start a change management cycle with your engineering and labeling teams and your regulatory team.

Caroline Byrd:

So every time the business wants to do a change, well, they want to go into a new geography you have to assess all the impacts and what additional data do you need to have recorded in your systems in order to display those or communicate those. Then, when you get even further into it and now you’re getting bought out by a Medtronic or a J&J or somebody like that, so somebody’s come in and acquired you, they always want to take your products generally global, right? So even though maybe you started with FDA approval and you got everything neat and tidy for the FDA, be prepared for those global corporations to come in and expect you to integrate into their systems or build out your system to accommodate the probably rapid launch strategy around the rest of the world, and to fit into their distribution channels as well.

Patrick Sullivan:

So Sajesh, you had touched on those on the gateway side of things, anything to add on that breakdown? So, Caroline, thanks for walking through that. The three that I had was design freeze, distribution and then the scenario where, let’s say it’s U.S. or EU and one of these larger companies-

Caroline Byrd:

Market expansion. Yeah.

Patrick Sullivan:

Right, market expansion.

Sajesh Murali:

Right, So if we talk about from a process standpoint, as the information, it’s already touched upon by Caroline. I’m not going to bring up those points again, but the point is when the information gets matured and in the design phase and then goes to testing, there are also other things that comes into play like external suppliers, vendors that are all these communication that’s going back and forth. Then, you have a synchronization that is needed across that process, so it’s not just internal at that point, there’s also external entities that comes into play. So when we talk about it from a regulatory information management standpoint, I have an internal process going on, which is true, but there are a lot of external forces that it also, very early in the process, you’re doing a review with FDA, for example, asking for, “Do a review on my documentation process,” even to understand what kind of submission is needed sometimes. There’s a whole correspondence that’s going on with FDA way early in the process itself, right?

Caroline Byrd:

Mm-hmm (affirmative).

Sajesh Murali:

So the thinking, which I know a lot of companies are changing these days, but the thinking of doing a UDI submission or any kind of registration information way down in the product development process should be changed. It needs to start very early, to Caroline’s point, it starts as early as designed, when you put a regulatory plan in place, it is accounting for all of this. So companies are already doing it. They have a spreadsheet and they’re putting out, “These are the countries I need to sell. This is the version of the product.”

Sajesh Murali:

All of these are noted down, but then it is not formally tracked as part of systems and data and in the end, it’s like, “All right. Today is the deadline for me to start inputting all the UDI data and let me do it,” and that’s way down in the product development process. You don’t have to wait that far. You can start everything way early in the process and it just start accumulating in the system and maybe towards the end, I can just give a high-level architecture of how we could do it, probably, but if you have time.

Patrick Sullivan:

Okay. Well, that’s a good transition. So we’ve talked about how complex the issue is, how it builds as you continue to grow. We were talking about market expansion, but how to know and anticipate what information you need so you can collect the information in an efficient manner as you go along. So let’s shift the conversation to the solution. So what is the solution? If we can break it into three different categories from a strategic perspective and then building a foundation and then scaling, so the three areas are strategically, and then again, building the foundation and then being able to scale.

Caroline Byrd:

How do you get it all together and done? Yeah, no. Sajesh brought up a great point about, at some point in time, you are going to have to start acquiring blocks of numbers. It gets really, really, really tangible exactly what you need to do. So I think from a strategic perspective, though, the important part is to really forecast out, look at that horizon of where your product is going to go and start scoping in those supplier controls like you said. Materials compliance really is a hot topic in a lot of the world that gets directly tied back to your UDI. What materials are physically making up your product?

Caroline Byrd:

They want those things known both in your labeling and now in the UDI requirements. So anyway, you’ve got to zoom out. I think I’ll just maybe leave it there to say, “Okay, I’m a regulatory professional. I know I’ve got to look out ahead for U.S. CE mark, Japanese, whatever regulations I can tell my I team internally, “These are the kinds of things you need to start controlling and gathering data on.” Now, who ha who takes that now and actually starts building that foundation? Sajesh, where have you seen success in regulatory saying, “Here’s the rules, please go put this on your label now?” Where does it go after that?

Sajesh Murali:

Right.

Caroline Byrd:

Who puts that stuff in place?

Sajesh Murali:

Yeah. So it’s a great point, right? It’s a common, it’s not common, but it’s a question that comes to mind, right? Where do I start? Do we only think regulatory perspective? The point is it’s collaborative-

Caroline Byrd:

Right.

Sajesh Murali:

Because of the advancement in technology, the new technology that’s come up and the process orchestration between different functions, I think, you started in the beginning and then everybody’s part of that same process, okay? So let me put that in perspective a little bit, just to give an example. So when I’m building a product and I’m starting and I’m putting my information in some form of system, either it’s a product life cycle management system or a MDM system. The different companies have different ways of managing it or a document management system.

Sajesh Murali:

So the information is coming into that play, into some kind of database in the very initial stages. When you think about it you say, “Yeah,” you would reserve that block of numbers that are details that you have to worry about way at the beginning in the process, right? You go and reserve them, so you have those G10 numbers come into play, which is required for UDI and for your registrations, essentially. You start planning for where am I going to sell this product, so that means do those country needs submissions or registrations, the document submissions, right? So how do you plan for that? So you start planning for all of this in parallel. You talk to your labeling team and say, if it’s a new UDI requirement, is there a labeling change that’s going to happen?

Caroline Byrd:

Mm-hmm (affirmative).

Sajesh Murali:

Right? Typically, we have different labeling systems that does a lot more information around that. So if you have the centralized enterprise system that essentially takes the input of information from you at the design stage or at the design freeze stage, and you have all these information that is there, you start overlaying information in it. So now as my design control process progresses, my DHF gets made, I have things like ISUs coming into play, my instructions for use or intended use, all those things are getting populated. Then I would say, “All right, all these IFUs, do I make it a EIFU? Are there requirements which says, ‘Now you need to make it available online for patients to download the IFU? So how do you make that IFU to EIFU?'”

Sajesh Murali:

Then there are additional requirements from a EMDR perspective for clinical reporting, the PMSR, the CER reports, all of that. Then, the rigor around the demand for those reports are increasingly high. I think EMDR, if I’m not wrong, they need it every six months or so to review the documentation around that. So it’s a lot of pressure for one team to be doing this, where the team says, “Every six months, I have to go run reports, but I need to manage documents to do these things.” So if you take my concept of having this in that one enterprise system, when I say one enterprise system that could be made up of one or two different systems, okay, so don’t get me wrong. I’m just saying one as a collective effort here.

Sajesh Murali:

So you have the DHF information coming in, you have the clinical reports, you have the product data tied to your clinical trials, so that means these reporting features, they become these building blocks so you can start generating them going forward, right? You could have a workflow process that essentially generates these reports and spit it out every six months, for example, taking the right data at the right point in time from that one system or a combination of systems. Then, once you have all that information, you’re ready, you’re testing phase, you’re done, you have all the UDI-related information collected, the PI DI information, you create a package for it. You also have the information for the product registration, because essentially all of that is coming, essentially, from a DHF. All of that documentation then goes into a country submission, right?

Sajesh Murali:

Then in parallel, you have a UDI submission that is going on, so you have these submissions going on. Once that is all completed, at that point, you would then say, “All right, now it is all done. I got my submissions. I’m ready to go. I got my 510 K approved. My UDI is done. What’s next? Oh, I need to send this information to my downstream legacy systems, and maybe even to my distribution system,” where you say, “Can I ship this product now? Now that I have the regulatory approval, can I ship this?” Yes. Don’t get me wrong. Distributions have like tons of other things and they cannot just ship it because they got approval, but one of the major thing is that these approvals are done. I’ve seen cases with different companies where the communication between that is fuzzy, where they’re like, “Oh, I’m ready to ship it. I’ve done all of my stuff. I put it in a FedEx box. I’m shipping it.” ‘Hold on. Hold on. Don’t ship it. We haven’t gotten approval yet.”

Sajesh Murali:

So tying those things together, G 10 is another important thing you start in the beginning, but you need to keep track of it. So you make sure in the end, that G 10 information that was picked in the beginning is the one that is ending up in the label, because if it changes, if it’s not tied together, there could be situations where you’re printing something on the label, which is not the actual one, or the other way around. There could be mismatches in the data, which you have to worry. So at a holistic level, at a high level, I hope I was able to bring it out, the whole connected information, how you’re able to achieve that digital thread that we really talk about in the regulatory space. This is what it is, so it’s not just one function doing it all, but it’s a collaborative effort where regulatory is plugged into from the beginning and also at the end. They’re the ones who are making it happen.

Caroline Byrd:

Mm-hmm (affirmative).

Patrick Sullivan:

Yeah. Thank you both for walking through that. So let me see if I can try to summarize and you guys correct me if I misstep here, all right? So from a strategic perspective, what I heard from both of you was forecasting, looking at the end, understanding what is required and then starting from there, right? That’s at the design freeze stage, essentially, and so once you’re able to forecast those requirements from a foundation perspective, Sajesh, you had mentioned, have a strategy related to a system of truth, essentially. From an enterprise perspective, what is going to be your system of truth?

Patrick Sullivan:

It may be a collective solution or a collective system, but you understand that this is the placeholder for particular parts of data and then you either integrate with other systems, but from a process or system perspective, you know what it is. Then from a scale perspective, as long as your solutions in place can scale, first of all, without breaking, it sounds like you have to have an iterative process to constantly see what’s changing and then iterating through. Did I capture that correctly from those three stages?

Sajesh Murali:

Yeah. I would also add the integration to that scale, right? So your system should be able to scale from an integration perspective, where you’re talking to these distribution system, EERP system, being able to collect information from the field, any feedback coming or we didn’t even touch about any recalls or CAPAs, so that’s a different whole world altogether, but essentially, you need to make sure that that side is there which is helping you to be scalable from a data perspective.

Patrick Sullivan:

Well, you just [crosstalk] Sorry, Caroline. He just committed you to another podcast as we go into CAPAs.

Caroline Byrd:

I was just going to say, actually, we talked about the struggles and the complexities of this whole thing, but we didn’t talk about the value statement, which is what I alluded to in the beginning. It is about how do you make your recalls and your post-market surveillance, activities tracking, trending reporting in the EU, which is going to be a lot? It comes before you know it, that’s really where the value of a digitized product definition and UDI attributes and things like that really come into play to help you organize all of this post-market surveillance data that’s going to be coming at you day in and day out through all your geographies all around the world.

Caroline Byrd:

So how do you organize that? How do you code it? How do you utilize that to do this annual, or every two years, every five years, whatever it is based on your classification of device, how do you do all the reporting, and not just in Europe, but to Japan and to Brazil and to everyone else who wants those reports, maybe on different time scales and stuff like that? Data has to be readily available to you and well organized if you’re ever going to be efficient on that back end side.

Sajesh Murali:

Right. Sorry, go ahead.

Caroline Byrd:

No, I was going to say, well, so that’s a whole other podcast in and of itself [crosstalk].

Sajesh Murali:

Right.

Caroline Byrd:

If you use this data in the post-market surveillance space and become efficient with that, I think that’s a huge challenge and something it’s so new to all of us. I think we’re all trying to figure out what is the best way to do that.

Patrick Sullivan:

Yeah. That’s [crosstalk].

Caroline Byrd:

Sajesh, if you had another thought on that before I [crosstalk]

Sajesh Murali:

I was just agreeing with you that it’s a three piece to your point, from what we spoke of the UDI, there is also a whole world about product registration itself, which we didn’t bring up. We said it’s all integrated in there, but that’s a whole thing together because that also is impacted by regulations again, and changing regulations too, from some countries don’t have UDI, but they do have registration rules where you still have to submit these documentations to them. A lot of countries, it’s just manual. So how do I keep track of that in my system? There’s a lot of suppliers who are doing product registrations in different countries, so there’s a whole level of complexity around that, so I think we can take up some time for that.

Patrick Sullivan:

I started this podcast recording saying that I have two experts on the call. So the biggest challenge was first to, “Could we do it? Could we say what we needed to say in 30 minutes?” If you’re a loyal listener that it’s a general term. It’s under an hour, and of course we cover additional topics that need to be covered because although it’s a few words or acronyms around UDI submission, it’s very complex, which I trust everybody listening understands that at this point. Then, the solutions can vary depending on the organization and the strategy that you’re trying to pursue. So I’ve got some notes jotted down for a follow-on podcast if everybody’s up for it.

Patrick Sullivan:

We can build on this story and would love to hear from our listeners as well. If there’s a topic that you guys would like to hear in a follow-on podcast, we’d love to address it. Depending on the particular topic, maybe you’d like to be a guest too. So feel free to reach out, tell us at ArcherGrey at info@archergrey.com.