Technology Transfer Case Study

Synopsis:

A world-renowned medical device company specializing in the development and manufacturing of a diverse range of cutting-edge cardiovascular device products was facing a complex technology transfer challenge. A series of acquisitions triggered the company to consolidate manufacturing from three different sites, transfer production for multiple products to a new site and upgrade the existing manufacturing processes for another location.

Challenges:

The complexity of the project was amplified by the multiple product lines involved and the locations of the facilities as two of the sites were outside of the U.S and multiple facilities in the U.S. The project was further challenged by limited internal resources and aggressive timelines. The project would require close collaboration with multiple stakeholders, careful planning, skillful project management and the flexibility to adapt to the ever-evolving needs of the project.

Actions:

Black Diamond Networks (BDN) reacted quickly to collaborate with the project stakeholders to understand the goals and timelines, and then presented a comprehensive project plan which outlined the deliverables, time estimates, resource requirements, project management and reporting framework, and identified the risks and roadblocks with corresponding mitigation plans. Once receiving management approval, BDN assembled the project team and quickly began to execute the plan. The team, consisting of the Account Executive, Project Manager and multiple engineers including manufacturing, process and quality experts, efficiently worked to execute a broad range of tasks, including process engineering and development; manufacturing changes; validation; component and material qualification and testing; assembly; test fixture and tooling design; SPC; DOE; supplier quality engineering; root cause analysis and non-conformance resolution; and numerous other technology transfer and process development activities. Throughout the course of the project, the BDN Team effectively negotiated the way through numerous unforeseen events to ensure the successful completion of the project.

Results:

Most importantly, Black Diamond Network’s solution enabled the company to manage project risks, instill lasting improvements and execute the project deliverables within the schedule. BDN’s team also created numerous GMP compliant templates, documentation and processes that could be utilized for future technology transfer activities. BDN demonstrated the ability to navigate challenges and built a lasting trust with the client empowering them to confidently take on future expansions, transfers and process development and improvement initiatives.