Although September marked the first unique device identification (UDI) compliance deadline—for Class III devices—many manufacturers are still in preparation mode. And, unsurprisingly, as industry has soldiered forth with implementation, a number of complex issues have come to light, according to Jay Crowley, a former senior advisor for patient safety and UDI architect at FDA who now serves as vice president of UDI services and solutions at USDM Life Sciences.
In the early days of UDI development, Crowley recalls, stakeholders assumed that the primary challenges with implementation would be centered on enumeration of devices and similar issues. But the more significant stumbling blocks—so far, at least—have actually centered on process, organizational, and business challenges, he says.
The rollout of UDI in the United States has caused some confusion—and perhaps a bit of tension—between medical device manufacturers and contract manufacturers, for example. Determining which party is responsible for performing which UDI-related tasks, assigning the UDI to the product, applying it, verifying the bar code, collecting the data, and submitting the data is a massive undertaking, Crowley notes.
"It often requires a lot of individual conversations," he says. "Any one company probably doesn't want to do it 52 different ways because they have twenty some-odd private label activities and twenty some-odd contract manufacturing activities. But they may end up having to do it 52 different ways." Although there are efforts to develop systemic solutions to this sizable obstacle on the path to implementation, there's simply not a one-size-fits-all solution.
Nor is there an easy pathway for large manufacturers that have actively acquired an array of companies and product lines over time. Wildly disparate data systems and SOPs, in addition to a lack of visibility into such basic information as how to identify products, the number of levels of packaging a device has, or a device's product code, present a daunting organizational challenge, according to Crowley.
"One of the first things we do with a new client is to ask them a question that, on paper, appears to be a relatively straightforward question: 'How many medical devices do you make that you think will be subject to UDI.' And they have no idea," Crowley comments. "They've got systems that were never designed to provide information in this way. Just wrapping their heads around how many finished medical devices they actually make subject to UDI that are distributed in the United States is an enormous task."
Once companies have a handle on their basic product portfolio, iron out UDI responsibilities with contractors, and have implementation underway, they must contend with the GUDID submission. This critical component of UDI prompts a plethora of questions related to location of data, who actually owns the data, and change controls.
"Getting that data together in one place, figuring out how you're going to store that data, managing that data, submiting that data, and managing this [process] going forward is an enormous challenge, and one that most organizations aren't ready for," Crowley states.
To steadily navigate these unfamiliar waters, it's imperative that companies—particularly large organizations—have a multidisciplinary team leading the UDI charge. "Make sure you've got everyone this might touch, at least that's tangentially involved," Crowley advises. "There's a huge void in terms of people just knowing what [UDI] is and what's going on. If you get the right team on board, then you can understand your product portfolio and what that looks like. It's a lot easier then to move this along."
Critical team members include a strong senior champion and project manager in addition to stakeholders from regulatory affairs, quality, IT, and labeling. Product managers or other experts on the company's product portfolio are also essential.
"[UDI implementation] isn't a very sexy thing; it's a brute-force effort," Crowley says. "I think, ultimately, it's going to be very useful and a very positive experience. But its going to take us a while to get there…and it's going to be a little painful in the process."
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—Shana Leonard, group editorial director, medical content
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