In September 2016, the U.S. Food and Drug Administration’s Unique Device Identification (UDI) regulation deadline arrived for most U.S. medical device manufacturers. In response, industry invested billions of dollars into UDI implementation and compliance. Now, the EnCompass system leverages UDI, combined with patented processes and mobile scanning technology, to deliver cost savings and increased revenue to device makers worldwide.
“Originally, UDI was developed to cut through the complexity of the U.S. device distribution system and facilitate critical recalls. However, as implementation has progressed, it’s become increasingly clear that UDI can and should serve a much larger role," said Jay Crowley, former FDA senior advisor for UDI, and now vice president of UDI at USMD. "The EnCompass system—including the 121nexus platform—is the first commercial product to deliver on this promise. It’s no exaggeration to say that systems like this are why UDI was created.”
Major device makers are leveraging UDI and utilizing the modular EnCompass system to meet vital business requirements:
- Inventory Compliance: UDI scanning app (free download from the iTunes store here) ensures the product is correctly labeled and registered in FDA’s GUDID.
- Direct, Mobile Ordering: UDI scanning app—customized for home or hospital users—integrates with manufacturers’ online ordering system for seamless online sales.
- E-Labeling and E-Marketing: Mobile app delivers point-of-use labeling and easy access to training, testimonial videos, and all other assets that make up product’s “digital dossier.”
- Automate Content Processes: Cut content cost, risk, and turnaround by 50 percent with XML content management for automated publishing, together with automated translation processing.
“The ability to leverage UDI and drive revenue is completely unique to the 121nexus platform,” added Charlie Kim, president of 121nexus. “By combining our patented digital distribution technology with the content management and translation automation capabilities of the EnCompass system, we can deliver value to our customers.”
Headquartered in Cambridge, Mass., 121nexus delivers digital content while driving revenue with end-to-end mobile technology by leveraging manufacturers’ existing UDI labeling technology. 121nexus’ patented technology gives medical device manufacturers the ability to share required information, issue recall updates, and push marketing information in any language with a simple scan of the existing packaging bar code. The 121nexus enterprise-grade platform goes beyond regulatory requirements to instantly deliver safety, training, and marketing information and enable direct-to-user mobile sales.
TransPerfect Medical Device Solutions is the specialized medical device division of TransPerfect. With annual revenues of more than $500 million, TransPerfect is the world's largest provider of language services and content management technology to the medical device industry. From offices in more than 90 cities on six continents, TransPerfect offers a full range of services in over 170 languages to clients worldwide. TransPerfect is fully ISO 9001- and ISO 17100-certified across all offices. The Medical Device Solutions group is also certified to ISO 13485 and ISO 14971.