Executive Summary

In this case study, Glemser Technologies worked with a client to smooth the integration of a new acquisition. The client purchased a competitor in order to create a more well-rounded medical device group. Once purchased, the new group had to be integrated through a potentially complicated, laborious process of rebranding and relabeling the products to comply with the new parent companies’ requirements and new European Union requirements. Glemser worked with the client to create a new, smoother process to be deployed in the coming years.

Case Study

Challenges

A life sciences client purchased a competitor’s surgical vision organization to combine with its own consumer vision group in order to broaden its range of optical solutions and create synergy in an integrated vision medical device group. A complicated process for changing labels evolved from a series of observations in quality audits that resulted in Corrective and Preventive Actions (CAPAs) in the acquired company. Programs to rebrand medical device labels and ensure compliance with the emerging European Medical Device Regulation (EU MDR) highlighted the need for a streamlining of the cumbersome quality process to change product labels.

Solutions

Glemser analyzed the labeling change procedure and developed the following recommendations to improve the process:

• A comparative labeling change benchmark with a similar medical device group
• An optimized set of process steps built through workshops with the labeling team
• An intake form to improve initial planning of labeling changes
• A workflow diagram to establish an accurate initial scope of a labeling change
• Proposed regulatory guidance documentation, including examples, for the labeling change team to correctly interpret North American and European labeling requirements

Results

Glemser presented its recommendations to Supply Chain, Regulatory, and Quality leaders in a program that included approaches to challenges in process, organization, information, and technology. This allowed the labeling team to take steps to improve the change process. Glemser also collaborated with leaders in Supply Chain and Finance to develop a rough-cut business case to seek funding for full deployment of labeling change optimization over the next couple of years.