Considerations when Transferring Medical Device Manufacturing

by | Jun 10, 2024 | Blog, Uncategorized

Manufacturing transfers are essential for ensuring the continued success and growth of medical device businesses by enabling efficient, scalable, and compliant production operations that meet market demand and deliver high-quality products to customers. This could involve transferring the manufacturing process from a development or pilot production facility to a larger-scale manufacturing facility for commercial production. Or, transferring production to a different supplier or contract manufacturer.

Global Interconnect, Inc (Gii) has played a key role in many manufacturing transfers over the years, helping our customers drive positive business results by creating efficiencies and mitigating risk throughout the production process. These outcomes can be crucial from both business and product standpoints for several reasons:

Scalability:

As a medical device gains regulatory approval and market acceptance, there is often a need to scale up production to meet increasing demand. Manufacturing transfers enable the transition from small-scale production in pilot or development facilities to larger-scale manufacturing operations capable of meeting market demand.

Cost Efficiency:

Transferring manufacturing to facilities with greater production capacity or lower production costs can lead to economies of scale and cost savings. This can improve the overall profitability of the product and the business.

Regulatory Compliance

Medical devices are subject to strict regulatory requirements, and manufacturing facilities must adhere to Good Manufacturing Practices (GMP) and other regulatory standards. Manufacturing transfers may be necessary to ensure that production facilities comply with relevant regulations and standards, particularly if the device is being manufactured in different regions or countries.

Supply Chain Optimization:

Transferring manufacturing to different suppliers or contract manufacturers can help optimize the supply chain by reducing risks related to single-source suppliers, improving logistics, and ensuring continuity of supply.

Testing and Validation:

Testing simulated typical usage in real medical settings, such as cable coil and connector mating cycles, along with auto wash and autoclave sterilization cycles exceeding 300. This thorough process would ensure key functions and quality were maintained. Parallel validation with verification testing accelerated project completion, bringing the product to market months ahead of schedule.

Quality Assurance:

Manufacturing transfers provide an opportunity to implement process improvements and quality control measures to enhance product quality and consistency. This includes refining manufacturing processes, implementing new technologies, and optimizing production workflows to minimize defects and deviations.

Market Expansion:

Transferring manufacturing to facilities in different geographic regions can facilitate market expansion by enabling better access to local markets, reducing shipping costs, and addressing regulatory requirements specific to those regions.

Whatever the reason, transferring manufacturing involves detailed planning, validation, and coordination between multiple parties to minimize disruptions and maintain product quality throughout the transition.

That’s the “Why.” Here’s the “How.”

Lift and Shift:

This is simply the process of transferring manufacturing from one production facility to another, with minimal changes and requalification. This method enables quick transfers when needed; for example, if the current manufacturer is underperforming.

Engineered Solution:

This allows Gii to take a hands-on, deep-dive approach to production with the goal of creating efficiencies, optimizing the overall design of the product, and improving the manufacturing process – all while meeting existing requirements. Our proven, effective transfer process includes teardowns, reviews and approvals for all new designs and enhancements.

Transferring the manufacturing of your medical device can be a real game-changer when it comes to risk mitigation, scalability, cost efficiency, quality and compliance.

Global Interconnect, Inc (Gii) stands at the ready to help you through the transfer process with the ultimate goal of supporting your company’s strategic growth initiatives and helping you gain a competitive edge.