At GS1 Connect in San Diego in June, Jay Crowley, VP, medical devices and UDI practice lead at USDM Life Sciences, presented insights on unique device identification (UDI) implementation for medical device manufacturers. We talked with Jay about implementation challenges, timelines, and how UDI is causing companies to evaluate their product portfolios.
HCP: What are a few of the main current hurdles or considerations for manufacturers who still need to implement UDI?
JC: A lot of it really depends on where an organization is today, what products they’re making, and where they're distributing.
Most of what we see—because it's the people who are active from my perspective—are manufacturers who are distributing products globally, and are trying to address the global UDI label requirements. We have requirements in play in the U.S. and in Europe. But there's a number of other countries that are active—China, Korea, Saudi Arabia, and others, as well those who are beginning or in various stages of the development of UDI requirements.
I think the big challenge for manufacturers distributing global products is trying to assure that (1) if their products are UDI compliant today, that that works for products globally, and (2) if they're still on the journey towards UDI compliance, that what they're doing with UDI labeling will be extendable to the global market as new requirements come into play.
The more interesting and almost more ambiguous problem is trying to figure out how the data portion—the UDI database portion—of this is going to work. In the U.S., we have FDA's Global UDI Database, GUDID. It's pretty static and well-understood in terms of what needs to be submitted. In Europe, EUDAMED is an evolving idea and structure.
Other countries have their own databases, some of which we understand how they're going to work, and some we don't. We're trying to figure out what that's going to look like for manufacturers, how are they going to collect and manage the data, submit the data to these global databases, and maintain it over time. There's lots of other nuanced challenges going on, but for manufacturers in that global space, that's the really big challenge and one that we're all still struggling to understand.
HCP: Are there any issues you’re encountering with the coding and marking technology/hardware itself at this point?
JC: I think that part is pretty well understood, though it may not be applied. Certainly, manufacturers are always making changes and improvements to production lines with the dynamic nature of the device industry. There's still improvements to how products are marked.
At the same time, there's a debate going on around the 2D data matrix in healthcare. We have some manufacturers who are either migrating or considering migrating from linear barcodes—sometimes multiple linear barcodes—to a data matrix.
It's the chicken-and-egg kind of debate about whether anyone is ready to scan 2D. Do they have imaging scanners? Where's the broader ecosystem from that perspective?
There's also a lot of manufacturers who continue to use proprietary barcodes for various purposes and they may not want to change that. These existed before UDI to support warehouse management or a distribution control system. So, they have proprietary barcodes along with a UDI barcode, and that confuses downstream users. There's a lot of hand wringing—is that the best thing to do? Can we migrate? When should we migrate?
HCP: At conferences, we see bigger players talking about robust pilot projects. But small and mid-size companies may only have one person working on UDI implementation while wearing other hats. What labor issues are you seeing lately?
JC: This goes back to the “migration to global” conversation. Many companies moved through U.S. implementation five or six years ago. They got their products for the U.S. market compliant and then, as happens (particularly in the medical device space), those people left. So now, Europe and other countries’ programs are coming along, and the people at a given company that handled this—and understood what they did and why—are gone.
Many companies are having to start over. Either what they did before isn't extendable to other markets or they don't really know why they did what they did. This can vary from DI [device identifier] (GTIN) assignment, to label changes, data collection and management, and – maybe more importantly – change control. There’s a lot of workforce movement. Between the mergers and acquisitions in the device space, hiring and layoff cycles, people promoting out of one group into another, or people picking a different job, there's a lot of loss of that history of what they did and rationale. So that's an interesting dimension to it.
|Read this story on MedAccred's focus area for Labeling, Printing, and Unique Device Identifier (UDI).|
HCP: Have you and the companies that you help already begun seeing benefits on this level of traceability? Has the focus mostly been on the success of becoming compliant?
JC: A lot of it is certainly compliance with regulations. Even here at the GS1 Connect Conference, there's a lot of discussion of healthcare provider uptake and use of UDI. There are pockets of people who are using it, and some who aren't.
Companies are seeing supply chain benefits in terms of order reconciliation. They can answer questions like, “What did I order? Did I order what I wanted? Did I get what I ordered? How many do I have?” There are certainly benefits to those organizations who have done that, both healthcare organizations as well as device manufacturers, who are leveraging UDI and the data associated for distribution control.
Both from a visibility and a recall perspective, organizations are better off if they’ve implemented. But not everyone's doing it and not everyone's engaged. Organizations are at different levels of maturity in terms of UDI.
For me, the interesting, unexpected benefit is not directly related to UDI (I have a whole talk track explaining that the problems with implementing UDI have nothing to do with UDI).
A lot of manufacturers have challenges in understanding their product portfolio. What do I sell where? What do I even sell? What's an active SKU and what's obsolete? At least in the companies that we work with, and have worked with for a long time, they have a better basic visibility and control of their products at a much more specific and granular level.
They typically have the ability—without going through three or four different systems or talking to however many departments—to know what they produce, where products go, and what products can go to what domains. I think, for a lot of companies, that level of visibility and control of hasn't existed, hasn't needed to exist.
As we look globally, you need to understand what products can go to what markets. With Europe, companies are really doing some rationalization of their product portfolios because moving to certify your products to the new regulations is a lot of work. They don't want to do that with everything.
There are very specific language requirements now from a label IFU (instructions for use) perspective that didn't really exist even under the directive. So now, there's this much better handle on, “I sell to these four European countries, and therefore, I need to be sure that my language requirements for those four European countries are met,” as opposed to saying, “Well I distribute to Europe.” So, there's a lot of those organizational benefits to companies that didn't exist.
There's some parallel ideas there as well. One of the challenges in the medical device space is understanding what is a device, an accessory, a spare/replacement part, or something else.
|Read this story on hurdles to implementing eIFUs (instructions for use).|
When we say ventilator or infusion pump, people understand what that is. But there’s a lot of other “stuff” that manufacturers sell and distribute. Back to the previous comments about visibility and control, this really highlights what I actually physically distribute, and knowing the regulatory status of those things, which is important.
HCP: How do compliance activities differ across markets? With differing requirements in the U.S., EU, and other markets, are companies following the most stringent guidelines or is it more granular?
JC: My idiom or analogy is sort of the middle of the road. Many companies stay in the middle of the road, so that what they're doing from an identification, marking, label and packaging perspective can work globally. There are certainly differences when you get into certain types of products and product classes, there are other exceptions and requirements that come into play.
To some extent, we do focus on the most stringent. For example, if we use a data matrix, that's accepted everywhere while some places don't want multiple linear barcodes. Today, it's largely a combination of the EU and U.S. requirements that produce that middle of the road or that most stringent case.
For the other country regulations, they aren’t so concerned with changing the UDI, or making more requirements on how products are identified, or the application to labels and packages. Where we see a difference in global requirements is the data—what data they want to see and how much.
Europe’s EUDAMED device registration and UDI database requirements are much more extensive than the U.S. requirements. The EU has concerns about substances in products so that gets labeled and put into the database, as well as how products are disposed of. Those differences then spill over into how the devices are labeled, which spill over into information that needs to get into the database.
HCP: Do you interact with a range of new and existing products on the UDI compliance journey? What deadlines are manufacturers working toward?
JC: We work with a combination. Sometimes it’s new companies with new products. Some companies don’t have global products, they have products for the U.S. market, products for the European market, products for the Asia Pacific market, etc., so all they did was U.S. implementation. Now we have to look at the rest of world and that's a combination of conversations because they have to ask if they want three different products, or can they have one. It's back to my comment before… it has nothing to do with UDI, but with how you want to manage your product portfolio.
This year, September 2022 is the Class I compliance date for UDI in the U.S. The date has undergone enforcement discretion twice now.
- First in 2018, because of some concerns about GUDID they postponed it to 2020.
- Then because of COVID-19, they postponed it to September 2022.
There’s a group of companies in the U.S. who make only Class 1 medical devices. They’ve been working on this and, if they’re not complete, then they’re on their way.
But there are a lot of manufacturers who only make low-risk medical devices—orthotics and other products. They may not have big clinical departments, or even a full-time regulatory affairs person. They tend to struggle more with what these regulations are. They're a hard group to understand or reach because they're not the people at conferences, engaged in the conversations, or in working groups, etc.
It’s an interesting group in and of itself and it exists globally—some may make things for multiple industries. For example, a plastics manufacturer makes tubing for the automotive industry and others, and they also happen to sell tubing for IV pumps. There's some unique challenges that lie ahead in getting them onboard, having them understand what they need to do, and making that a bit of more systemic than it might normally be for them.