Embracing UDI Labeling and a Validated Solution

by Craig Hodgson, on June 22, 2017

In contrast to last year’s UDI event, attendees at the recent UDI Conference in Baltimore seemed more positive and accepting of the regulation. Not that anyone has ever questioned the intent or goal of UDI—that is, of course, the precise marking, labeling and tracking of medical devices across the extended supply chain, from manufacturer to patient. But the 2016 event saw many frustrated faces seeking answers and quick-fixes on how to achieve UDIcompliance, especially as they were confronted with the exhaustive collection and management of the data that goes into UDI. More than a few of these same faces were spotted in long lines in front of the FDA’s booth. Not this year.

This year was different, perhaps because more manufacturers, contract manufacturers and distributors are further along with their UDI programs. For a lot of the people we talked with, compliance has been met; now it’s a matter of fine tuning and improving efficiencies within their organizations—and with their global partners. And the event organizers, including representatives from the FDA, put together a full agenda that captured where a good number of Class II and Class III device companies are with UDI compliance. Indeed, many of the sessions focused on the progress made in the industry, expectations for international UDI compliance, and improvements in data management within the GUDID.

More specifically, the sessions covered these key topics:

  • The role of FDA in UDI adoption and the growing commitment by industry groups
  • How UDI impacts customer relationships, market positioning, and operational efficiencies
  • The influence of UDI across the healthcare eco-system; from point of manufacture, to point of consumption, and downstream to the clinical registries
  • UDI-related standards development in multiple industries and global UDI harmonization efforts

In our conversations with attendees, a recurring topic was the validation process associated with deploying a medical device labeling solution. Depending on the workflow and products used, labeling validation can be draining on organizations as every department from Quality and Marketing to Logistics needs to get involved and on the same page. Fortunately, both Loftware and USDM Life Sciences were at the UDI Conference to answer questions and point med device professionals to a faster, more cost-efficient way to achieve that critical validation.

Just last year, Loftware and USDM launched the Spectrum Validation Accelerator Pack (VAP) to dramatically reduce the time and cost of implementing a validated, compliant labeling solution - by up to 50%. It’s the only VAP for Enterprise Labeling and provides a set of content-rich templates that can be configured to help you meet critical phases of testing and qualifying UDI barcode labeling. It also enables you to validate and experience, more quickly, the industry’s most powerful, scalable labeling platform. We were able to speak at length with attendees about their labeling challenges and how the VAP can help streamline validation, even when working with suppliers, distributors and providers.

If you missed this year’s UDI Conference, we would welcome the opportunity to share how customers like you are aligning labeling to their existing business processes—faster than ever imagined—to not just comply with UDI, but drive measurable gains in supply chain efficiency. Take a quick peek at the Spectrum VAP data sheet to learn more. And then contact an expert from Loftware or USDM Life Science to get started with your labeling validation project. There really is a faster, more cost-effective way.

Also, we invite you to watch a webinar from earlier this year featuring GS1 US's VP of Healthcare Greg Bylo as he talks about steps you can take to "Make UDI Labeling a Program, not a Project". Check it out!

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Topics:Medical DevicesRegulatoryLabeling

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