Manufacturing Transfers: How Flexan Helped an OEM Deliver 140+ Precision Medical Device Platforms Without Missing a Deadline

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

Flexan’s comprehensive contract review and manufacturing transfer processes ensured all project and product requirements were documented, tested, corrected, and transferred properly. We structured efficient parallel documentation, review, and approval processes to streamline the validation process in keeping with the very strict timeline needs.

Throughout the course of the project, Flexan:

• Transferred and validated more than 20 unique pieces of equipment and over 200 molds
• Duplicated all fixtures and inspection equipment
• Successfully transferred all components to Flexan’s production team, which allowed them to supply two OEM plants simultaneously
• Transferred assembly operations with zero interruptions

Projects this large can have unexpected challenges which could upset and delay the entire project and bring financial and operational issues. However, at Flexan, our detailed project management system can spot potential issues early, allowing the team to create rapid responses. This allows us to take action quickly and minimize disruption to timelines.

By the end of the project, Flexan had validated:

• 31 subassemblies
• 26 extrusion part numbers
• 65 molded part numbers
• 15 special process part numbers
• 70+ backup molds and fixtures

With more than 75 years of experience, Flexan brings a wealth of capabilities to manufacturing transfers:

• Integrated Quality Assurance throughout a 7-step phase-gate project plan, with metrics and gates to identify issues early on, which minimize additional cost and delay.

• Ability to work with multiple customer sites and functional/leadership structures to ensure that project goals are met.
• Dedicated personnel and processes to effectively resource a project and achieve the commitments of the project timeline.
• Extensive experience in proactively designing a clear, methodical, and robust design control process to prevent last-minute challenges prior to production.
• History of effectively managing the logistics for raw material, supplies, and equipment to manage timelines.

If you have a project requiring experience, innovation, and a commitment to excellence, contact Flexan’s manufacturing transfer experts today.