Deadline Could Drive Lean Processes for Medical Device Sector

As a September deadline looms for companies across the medical device sector to meet federal standards first promulgated in 2013, concerns are rising that some firms may have waited too long to fully comply.

The rules are the latest phase of a multi-step mandate by the U.S. Food and Drug Administration (FDA) that establish a unique device identification (UDI) system to label and track medical devices through distribution and use.

In sum, the FDA rule requires device labelers to include a UDI on device labels and packages. Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI also must be directly marked on a device that is intended for more than one use.

“We see companies scrambling to catch up to meet the deadline for Class 3 devices,” says Brian Clark, Global Business Development Manager, Packaging at Microscan (Renton, Washington). “We don’t think this deadline will be pushed back as has happened with other deadlines.”

Equally challenging may be the paradigm shift that many medical device supply companies face as they move their organizations to embrace automating what had been largely manual processes.

“We have seen a lack of expertise in selecting solutions,” says Dan Hare, vice president of sales at Matrix Systems & Solutions (Sanborn, New York). In particular, many medical device suppliers have not taken a broad enough approach to comply with the regulations. Knowledge silos may keep a company from fully realizing the potential benefits that UDI may offer. For example, an IT staffer may understand her company’s network issues but may know little about the label validation process. The upshot, Hare explains, is that “piecemeal solutions” are being implemented and may result in errors and even product recalls.

“Data entry is manual and processes often rely on tribal knowledge,” he says. What’s more, the opportunity that UDI offers to “lean-up inefficient processes” may not be fully realized.

Matrix has teamed up with Datalogic Automation (Bloomington, Minnesota) to develop and deploy software that ultimately can tie together the enterprise and better enable process efficiencies.

“What I see in the market are people starting to conform,” says Mark Kremer, vice president, Machine Vision & Laser Marking at Datalogic. Even so, “there’s a big gap in understanding how to take that data and sort the database and work vertically upward to conform.”

Datalogic has “come a long way” toward integrating the “locate, read, mark and validate” process for the medical device sector, Kremer says. “That’s the basis for our solution and we can have all different kinds of modules from that. Four years ago we added laser marking and we’re realizing the fruits of that.”

The ability of any manufacturer to go away from dot ink is something that’s important to UDI, he says. That includes marking and tracking the use and reuse of devices from the manufacturer “all the way out to the patient all the way out to the asset management of a hospital.”

For Microscan, the September UDI deadline is a major business driver that has “impacted our business in a positive way,” says Clark. The company is going to market with products acquired in August 2015 through the acquisition of Label Vision Systems. The company has three basic offerings for the sector: inline high-speed vision systems, inline thermal printed label inspection and verification, and offline with manual verification..

“Our order rate has gone up significantly for these types of products,” Clark says. Even so, a primary concern is that some medical device companies won’t meet the September deadline. “It’s broader than having verification in-house,” Clark explains. “It’s really about implementing a solution within the organization. Some companies won’t get there because they started too late.”

Clark says that an important component of his sales process is to educate organizations on compliance requirements. “Depending on their size they may not have a system in place” to ensure full compliance with the federal regulations. “We feel that [education] is an obligation to our customer base” and specifically point customers to GS1 to help them learn about regulatory compliance.

GS1 is one of the three accredited issuing agencies for the FDA. The others are HIBCC and ISBT128. Labelers will need to register with one of these issuing agencies in order to get FDA accreditation. Additionally, labelers must submit data to the FDA Global Unique Device Identification Database (GUIDID). This data must be scrubbed for accuracy and compliance to GUIDI requirements prior to submission.

Exception Handling
Another critical, but often overlooked, area for medical device companies to consider is exception handling. “What happens if this part isn’t validated?” asks Kremer. That means when a labeling, tracking and verification system is designed, “we need to bring all of this to bear: we need to understand how it affects them operationally, how to collect the data, how to handle false positives or exception handling.”

Manual verification is a common practice today, but that process typically uses two people looking at a single tag to double verify its accuracy. “The Datalogic systems are there to not only guide and execute the information that is needed per part, but also to validate it and add that data to the validation process in an automated fashion,” Kremer says. “We’re looking at it from end-to-end and what do we have to design up front to meet the end result.”

This process involves “tying together technologies, looking not only at the validation but also the execution, and getting the data together with some sort of middleware that can link back up to their supervisory systems, and it’s going to be a global interface,” says Kremer. “The key to it all is we’re providing the images, we’re laser marking the OCR 2D code. When we bring that together with integrators or OEMs or directing users at an operational level, that data has to be figured out. How does it conform to the UDI database? In the market, people are starting to react to conform, and they don’t know how to get into full compliance.”

Kremer adds that Datalogic is bolting on more OCR tools and pattern-sorting tools. “These are advancements that I think are going to take us to the moon,” he says.

UDI is coming, like it or not. Companies should use it as an opportunity to improve their processes, advises Matrix’s Hare. “Implementation could allow reengineering some processes that weren’t lean in the first place.”