Relocating device manufacturing: how to ensure a smooth product transfer and balanced global supply chain

The challenges of transferring manufacturing are not inconsiderable: regulatory hurdles, the risk of potential disruptions, and the need to maintain stringent quality standards. Add in the element of high price sensitivity, and the risks can feel insurmountable. 

So how can companies successfully navigate a product transfer without compromising compliance or performance? 

Achieving a well-executed relocation requires a methodical approach, expertly project–managed, that prioritizes regulatory compliance, effective supply chain management, and consistent quality. Here are four factors that can make the difference between failure and success:  

1. Prioritize regulatory compliance and project management from day one 

One of the most significant challenges in transferring medical device manufacturing is regulatory change notification, subsequent clearance or approvals. Non-compliance can result in costly delays, so putting structured, well-documented change-driven validation and risk management in place is critical if you want to ensure regulatory processes proceed without obstacles. 

2. Secure a resilient, cost-optimized supply chain

Supply chain disruptions can undermine the benefits of any manufacturing relocation. The COVID-19 pandemic highlighted the fragility of global supply chains, with recent geopolitical tensions, and labor and materials price inflation further reinforcing the need for a more strategic approach to vendor selection and logistics planning. 

The best way to mitigate supply chain risks is to ensure your new manufacturing location has: 

• Approved vendor networks to avoid sourcing delays 
• Diversified supply chain options to provide cost flexibility and mitigate risks 
• Logistics hubs in trade-friendly regions to optimize distribution and regulatory clearance or approvals

3. Maintain consistent quality standards across global facilities

Maintaining product consistency is one of the most challenging elements to get right when you are transitioning to a new manufacturing site. Any deviations in quality can lead to regulatory scrutiny and run the risk of damaging your brand reputation.  

This is particularly true if you are considering a dual or even triple supply chain strategy, for example with sub-assemblies, manufactured and inspected in one location with final assembly, packing and sterilization taking place in another.  

To achieve uniformity: 

• Align with both EU and U.S. regulatory standards and all applicable requirements
• Standardize process controls, validation protocols, and manufacturing best practices across locations for seamless integration
• Implement rigorous quality control measures to prevent variations in product performance

By ensuring these quality safeguards, you will be in a much stronger position to be able to minimize risks and maintain trust with your customers and regulatory bodies. All of which helps to speed up the process of any transition. 

4. Choose a manufacturing partner with proven transfer expertise

Selecting the right Contract Development and Manufacturing Organization (CDMO) is critical for a seamless transition. When you are exploring potential partners, make sure to verify: 

• End-to-end expertise in complex critical care surgical set transfers
• Digitized manufacturing systems to minimize any potential for human errors, enhance efficiency and traceability
• Specialized teams with a track record for on-time delivery and project management, deep regulatory knowledge and technical expertise
• A robust Quality Management System (QMS) to maintain regulatory compliance and quality assurance 

The bottom line

Relocating or transferring product lines and production lines for complex critical care medical device manufacturing can bring savings, optimize production efficiencies and free up resources—but only if done strategically. The key lies in proactive planning, a robust supply chain, and a strong partnership with an experienced CDMO. 

If you’re considering a product transfer, get in touch to discuss how we can help you achieve a seamless transition.