The Upcoming UDI Requirement: Will Your Teams Be Ready?

19 Jul, 2018

In the United States medical device market, a UDI or “unique device identification” must be attached to all medical devices that fit within certain criteria. The set of regulations that cover the usage and requirements for UDI, also known as GS1, are administered by the US Food and Drug Administration (FDA). Like all FDA regulations, the GS1 is subject to periodic updates, and the latest change will go into effect in September 2018.

As most device manufacturers and their sales teams are aware, the UDI is often called a “label,” but this is not a perfectly accurate description; it’s an identifier that accompanies the device throughout its production, distribution, sale and use, and often remains with the device even after implantation. A permanent knee replacement, for example, will still bear an identifier that can be read by both human and machine and will not be subject to loss or degradation even after years of use, or in some cases, repeated use.

What are the impacts of the FDA’s new UDI regulations?

As one can imagine, a new UDI regulation will have an impact on the medical device manufacturing industry, from product development to marketing and sales. Even though your sales teams will not likely be involved in the path to regulatory compliance, they should be able to answer customer questions and address the concerns of hospital decision makers and healthcare providers.

Five years ago, a rule went into effect (the final rule) requiring device manufacturers to identify devices by class (I, II, or III) and apply properly formatted labeling to items in required classes. The data for all relevant devices was to be submitted to the GUDID database (the Global UDI database maintained by the FDA). During each subsequent year since that time, compliance milestones have become more specific and stringent – specifically for implantable, life-supporting, and life-sustaining devices.

Prepare your sales team with the requisite information.

While sales teams will have limited control over device manufacturer’s adherence to these milestones, they should be prepared for potential challenges and questions that may play a role in contract negotiations. Make sure your teams are adequately versed and appropriately updated on the company’s progress toward compliance. In the meantime, provide support resources so your sales reps know where to turn when they need additional information. Most important, allow and encourage your reps to connect their prospects directly to medical experts and upper-level managers who can address concerns that fall outside the rep’s range of information.

Support your teams and give them the tools they need to field as many questions as possible on their own. Start by sharing the details of the new regulation, and turn to the medical sales recruiters at Buckman Enochs Coss and Associates for additional information.