Bulletin, Member News

Beyond Compliance: Device Firm Reaps Benefits from Project Leadership

When a global medical device manufacturer faced a tight turnaround for new FDA labeling compliance, it turned to professional project management to get them through. The thoughtful planning and communication not only helped the company beat the compliance deadline, but also broke down divisional barriers, created processes to meet upcoming compliance requirements, and evolved technology for future growth.

It began in 2012, when the FDA required all medical devices distributed in the U.S. to have a unique device identifier (UDI) code. This meant the company had to relabel four Class II pumps and 500 different accessories, such as tubing and IV sets, manufactured at three different global plants. The company also had to submit product information for each device to the FDA’s Global Unique Device Identification Database (GUDID).

Realizing the complexity of the project, the company hired Integrated Project Management Co. (IPM) to oversee the project and provide recommendations for future growth.

IPM developed a plan for how to approach the UDI transition, which required all products to comply simultaneously. Because this meant defining and coordinating efforts across multiple workstreams, a multi-site, team-based approach was required.

IPM visited three manufacturing plants and met with stakeholders at each location to help prepare the team for the work ahead. The plants also needed to replace a 20-year-old production line and packaging systems at 21 work stations with systems that could interface with the new SAP systems and databases required to drive label printing—a $20 million capital expense.

One plant had already developed a solution based on manufacturing products individually by serial number and barcodes. Borrowing and enhancing this concept would enable the two device manufacturing plants to meet UDI packaging and labeling requirements and eventually transition to a serial number-based method to meet future FDA requirements for product traceability. IPM and the company team decided to use this solution for pharma, pumps and accessories—an approach that reduced equipment costs in some cases by as much as 20 percent.

IPM also helped implement an adaptable system with the capability to print labels in real time via on-demand printing, which will help the company streamline its manufacturing processes.

The medical device manufacturer began printing the new labels in July 2016, and by July 31 was fully compliant with FDA requirements—two months ahead of deadline.

IPM had worked closely with the company’s management team on the transition and provided them with a guidebook for staying on track with future FDA and global requirements. After being embedded in the company’s team for more than three years, the lead IPM consultant was honored by his coworkers with a commemorative plaque recognizing his dedication to the team.

The project sponsor stated that the real benefit delivered by IPM was the ability to keep the company’s best interests front and center. Before the UDI project, few of the company’s projects came in on time. By project completion, techniques for project scoping, planning, communication, and execution were being used across the organization.

To read more about UDI compliance, visit