Ramping up for remediation


Kelly Engineering helps an international medical device company create an effective and cost-saving delivery model for a complex product remediation project mandated by the FDA.


A U.S.-based global pharmaceutical and medical device company, with approximately 15k employees.

In light of a massive regulated recall issued by the U.S. Food and Drug Administration, an international medical device company was forced to repair approximately 300,000 devices at over 4,000 sites across the U.S. and Puerto Rico. Facing the impending mandatory project, the company initially sought to outsource the entire remediation to third-party repair companies. However, because it was important to the client that they own and certify the work product outcome themselves, the consultants at Kelly Engineering recommended a staff augmentation approach to be more effective.

Initially, the client chose to partner with multiple talent vendors, including Kelly Engineering. At the end of the first project phase, however, it was clear that we were outperforming the other suppliers, and soon the company engaged us to manage the entire remediation effort.

From the beginning, we took a collaborative, innovative approach, providing every level of program management and streamlining the work of the technicians, across all field locations.

Tapping into the expertise of the Kelly Engineering Field Services group, we managed the credentialing process, making it easier for employees in the field to gain access to the necessary hospitals. Our centralized team worked diligently to lift peripheral tasks away from the field technicians, allowing them to focus on delivering the highest quality work effort. We were also dedicated to robust client communication and reporting, ensuring the company would always know the status of the project.

Our ability to quickly source quality talent and our expertise in engineering field services empowered us to implement industry-leading processes. Lean thinking techniques, and performance-focused project management methods. By offering coverage geographically wherever the client needed it, and building collaborative traveling teams, we effectively optimized quality, efficiency, and timeliness. And because of our strong focus on process improvements and superior project management, we were able to deliver increased retention of intellectual capital.

Specifically, we achieved:
  • 98% on-time delivery
  • 2% turnover rate
  • 97% client satisfaction

Over the course of the engagement, our partnership has expanded into additional projects and skill sets serving the client. At first, Kelly Engineering provided only LPNs and technicians—which then evolved to also include program managers, project managers, and field service engineers. Today, Kelly Engineering continues to deliver more than promised, based on its unique delivery model and a commitment to meeting the customer’s needs and requirements.

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