Technology Transfer of Medical Device Production Processes
Progress recently participated in a Technology Transfer (TT) project for several Medical Device production processes. This involved transferring production processes from a Dutch facility to one of the client’s production facilities in the USA. The project was divided into several workstreams covering different aspects, such as Product Assembly (transfer of the actual production process), Factory Design (preparing the receiving site for the new processes), and Supply Chain (buying and installing new equipment, and creating a plan for the raw material supply chain to both sites). Our senior consultant Michelle Langeslag stepped in as Project Manager to lead the project for all different workstreams.
The project was not a typical TT project in which processes are transferred from one production location to the other. In this case, some production processes in scope were also kept active at the original location. Basically, the processes were copied. To ensure the product output is the same from both production locations a more thorough alignment of supporting systems on both sites was needed. With this project being a first, this meant that key stakeholders had to be brought together to discuss and set up the desired, but also still achievable future state in terms of e.g. quality documentation, production documentation (work instructions, batch records), production planning, and (legal) responsibilities. Despite differences in systems used the team managed to come up with satisfying solutions that ensure the same products are manufactured at both locations.
With the alignment between the production locations achieved during the project, the client could not only start manufacturing the products in scope at the US site, expanding the production capacity to meet an increased market demand, but they will also be able to leverage the achieved alignment for future transfer projects. Successive milestone celebrations showed how the project was supported by resources across the entire company: from production, engineering and purchase to QA, RA and finance, both in the US and the Netherlands. A true multidisciplinary success story!
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