In this example, we partner with our customer, a medical device OEM who has been manufacturing a single-use steerable catheter that we recently helped them design, develop, and launch. We help them transfer their technology to set up manufacturing at our Biomerics facility in Costa Rica.
Our customer is ready to scale up
The steerable catheter has been very successful in a hospital setting for a large hospital network. Physicians are raving about the ease of use and successful patient outcomes for heart valve replacements. Our customer has reached the stage where they are successful in the interventional device market and they need to scale up their production quantities.
We meet to scope out the requirements
Our Design Services team meets with engineers and senior-level decision-makers at our partner’s company to discuss their requirements for large-scale production. We create a design transfer plan with comprehensive requirements documents and a project schedule, leveraging our experience from hundreds of manufacturing line transfers we have successfully completed for our customers. We align with our partner’s expectations, and anticipate and mitigate risks. We are familiar with the customer’s product and with our comprehensive production facilities in Costa Rica, and the planning stage goes very quickly through an on-site cross-functional kick-off meeting.
We transfer our customer’s manufacturing line and validate the process
Harnessing our team of engineers with extensive knowledge and expertise in every aspect of the steerable catheter’s design, we transfer, develop, and install equipment and work areas to prepare the receiving site. We collaborate with our partner to transfer knowledge from their production line to the new production team in Costa Rica through reciprocal visits, capturing tacit knowledge not always captured in process documentation. We help set up the supply chain and obtain inventory. We complete process validations to validate the production process and ensure production readiness.
We work with our customer to start up the line
With everything in place and processes validated, we start up the line and begin producing the steerable catheters. We monitor quality, ramp up production levels, and perform regular reviews, adjusting and continuously improving the process. The tech transfer is complete.
Our focus is customer-centric
“Our customers appreciate the engineering expertise in our Centers of Excellence, which provides a depth and breadth of support as we transfer production lines, including transfers to Costa Rica, where we have an extremely talented and dedicated team who manufactures best-in-class medical devices. They also value our robust transfer process and talented team members who help them execute successful line transfers in a thoughtful and efficient way.”
- Brian Curtis
Executive VP of R&D at Biomerics
