In a decade, Cook Medical has gone from a company with a uncoordinated tracking plan to one of the first medical device companies with a truly global unified barcode system that simplifies supply chain operations. As of January 1, 2013, all products coming out of the North America from Cook will carry a GS1 global trade item number (GTIN). The move was part of an industry agreed-on sunrise date, promising the ability to accept, provide, and manage products bar coded with GTINs. That accomplishment is a testament to many years of hard work and dedication of multiple teams in the company, explains Reed.

But it wasn’t easy, Reed says. “When we first started talking about it, everyone had their own needs and their own ideas of what they wanted our product codes to be.”

The GS1 sunrise objective consisted of 6 goals for companies, as follows:

Choosing a Standard Tracking System

More than 10 years ago, Cook’s CIO started working with FDA and other subsidiaries to develop a system to track products. Gavin Seyler, global brand marketing manager for healthcare business solutions at Cook, says that major industry health systems, such as Kaiser, the Mayo Clinic, and Intermountain Healthcare had chosen GS1 standards, and asked  industry to follow the same plan. FDA, however, has not made following any particular standard a requirement. The most common standards used in industry today are GS1 and the Health Industry Business Communications Council Supplier Labeling Standard (HIBCC SLS). 

For companies who are just beginning to adopt a tracking plan and who might be having trouble deciding which bar code system to use, choosing one and just going with it seems to be the secret.  Both Seyler and Reed agree that companies should make the decision for themselves. They say to choose one that will best represent the broadest number of stakeholders, which can include players up and down the supply chain.

Most importantly, however, they say is “just start.” Because making the decision on which system to go with is not the hardest part.

Moving to Implementation

Reed says there were hundreds of people who were involved in the planning and execution of the project. Cook formed a multidisciplinary team that took just shy of 5 years to complete the heavy lifting for the project.

Cook is a private company, and so doesn’t disclose the costs of implementing such a system. However, Reed admits the cost was significant, “not just in raw dollars, but in time, energy, effort, and sleepless nights.”

“If you had asked me before we started how long it would take, I wouldn’t have predicted 5 years. I would have said 8-10 months,” he says candidly. “Organizations who think they can accomplish the task in a year or two have unrealistic expectations.”

Reed lists some of the project challenges that had to be overcome. “We had to figure out documentation and regulatory details, design acceptable and readable bar codes, and ensure the standardization, among many other tasks that we never would have anticipated.”

Cook’s multidisciplinary team met about once per month, and when necessary, every 2 weeks, and sometimes once a week, “and of course, there were millions of informal meetings,” he says. At different times, the team involved representatives from nearly every aspect of the company, such as IT, regulatory, quality, marketing, operations, customer service, warehouse, and manufacturing. Reed says that most of the team members would say the process went well. “It was clearly an amazing effort, and it was far more daunting than we expected.”

Worth the Pain

Despite the trouble, Seyler and Reed say the project was unequivocally worth it. “Using GTIN helps customers get their arms around their own supply chains; it provides a common language for products,” Seyler says.

GTINs and other similar programs provide the best way for companies to understand what products are on the market and where they are. “We heard our customers saying, we are going here—and you better come with us,” says Reed. In addition to responding to customer needs, FDA has been pushing industry to adopt a standardized system as soon as possible.

Unique device identification will be mandatory for medical devices. Reed explains that the GTIN provides UDI data as well as other types of tracking data that are good for business. “The unique identifier takes the GTIN and adds specific data elements required by FDA. It is a greater extension of a data repository,” says Reed.

“We had to continually remind ourselves and the organization why we doing what we were doing,” says Reed. Reed describes a meeting in which someone compared medical devices to peanut butter. “I can’t remember who said it, but we often talked about the fact that a patient is better off if there is a recall on peanut butter, than if there is a recall on the device,” he says. “If that doesn’t drive you to do the right thing, I don’t know what will.”

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