Flexan has been offering a wide variety of rubber, silicone, and thermoplastic molding and extrusion services for more than 75 years.
Recently, Flexan worked with a Top-30 medical device manufacturer to transfer their manufacturing components to Flexan’s facilities. The benefits to the OEM were numerous, and the transfer involved more than 140 implantable Class-III custom silicone components. The project required a tightly controlled production environment while ensuring continuity of supply and quality standards.
This manufacturing transfer initiative, commonly called a “Lift and Shift” project, involved an aggressive timeline with the ultimate goal of replicating the OEM’s original manufacturing floor at Flexan’s manufacturing facilities, as well painstakingly replicating the OEM’s original operations and quality processes.
Working closely with the OEM, Flexan was responsible for installing and validating the OEM’s complex, state-of-the-art proprietary manufacturing system. Our experts leveraged significant technical expertise in equipment and software validation to do the following for more than 140 custom medical devices, all without a timeline slowdown or supply chain disruption:
- Conducted an in-depth risk assessment
- Developed software validation solutions
- Transferred and validated customer-owned tooling, equipment, and supporting software
