Is Your Global Labeling Strategy Within Reach?

by Craig Hodgson, on August 16, 2016

A hot, muggy Minneapolis didn’t slow down an energized group of industry IMG_0560-square_300x300.jpgprofessionals who gathered for last week’s 4th Annual Medical Device Global Labeling Strategies conference. The two-day event brought together a healthy cross section of Regulatory, Quality Assurance, and Labeling experts to discuss current packaging and labeling processes—particularly as they relate to emerging global standards. Judging by the topics covered and candid testimonials from speakers and attendees alike, there is still work to be done, but most people left feeling better about their situation than when they arrived. A few takeaways from the event…

Difficulty still within the US – While a good portion of the event focused on international labeling requirements, we heard about the ongoing struggles with UDI compliance here in the States. Several attendees were willing to air their frustrations with the regulation—as well as with the FDA. That said, there were constructive use cases shared to help companies adapt their current UDI strategies to meet impending global labeling requirements. Still, with another deadline looming next month for Class II device manufacturers, you can be sure many manufacturers are scrambling to comply and overlooking a single, sustainable approach to UDI barcode labels.

Mega-label or mega-headache? – In attempting to streamline global labeling initiatives and accommodate localization, we learned that some companies create what they call a master “mega-label” for their products. As it implies, this one label contains every relevant language and symbol required for global compliance, often supporting a dozen different translations of the same text or country-specified language. The concept makes sense, but it must get a bit unwieldy, especially if you’re dealing with limited real estate on a device label. Rather, we would recommend a standardized approach for designing and managing label templates in software that pulls the translated text, requisite symbologies, and data automatically—from existing, trusted sources of truth—for that particular region and partner. The information is always accurate and you create a much cleaner, space-saving label to support all of your devices.

Not just labelers, but agents of change – On day two, after hearing several presentations on the trials and tribulations of medical device labeling, Kent Allen, senior manager of lifecycle labeling for Johnson & Johnson—and fill-in chairman for the event—raised a very good point. He noted that because of all the hard work presenters and attendees had done for their companies in overcoming inefficiencies and finding new ways to adapt to global labeling requirements, “we’re not just labelers, but business leaders.” Hard to argue with that sentiment when you consider that new innovations in enterprise labeling are helping medical device companies of all sizes reduce costs, improve response times, and enter new markets faster than ever. Bottom line results that should get noticed all the way up to senior leadership.

Never venture alone – In speaking with attendees and also hearing some of the presentations, there was a recurring sense that this event was part educational, part support group. Not literally of course, but so many companies appear to be in the same camp in terms of complying with FDA UDI requirements and preparing for international standards. Certainly there’s a degree of comfort knowing that your peers are facing similar issues, but more than that, it’s the collaboration and sharing of experiences in this kind of forum that enables attendees to go back to their office with new ideas to help solve specific challenges. As one refreshingly frank presenter said, “you should never do this on your own” and invited everyone to take down his contact information. And no, he was not an exhibitor, but someone who went through UDI compliance the hard way—and was willing to share his lessons learned to anyone who needed it.

All in all, the conference echoed some of the discussions we’ve had with customers and partners regarding enterprise labeling for the Medical Device Industry. Much progress has been made with UDI readiness programs, but many companies are still slow to adopt a standardized, enterprise-wide approach to barcode labeling and compliance.

We look forward to seeing you at future conferences and events and discussing some of your own challenges. Our next stop will be at the Q1 Productions’ Medical Device Labeling and Packaging Conference, Sept. 28 – 29, in Phoenix. Hope to see you there.

In the meantime, check out our recent survey report “Taking the Pulse of UDI Compliance” conducted in partnership with USDM Life Sciences. See how you compare with your peers and their implementation of UDI barcode software to meet impending global regulations.

Read the Survey Report

Topics:Medical DevicesRegulatory

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