Fast, Low-Risk Manufacturing Transfer for a Medical Device OEM

The Challenge: Rising Costs and Delivery Instability

Like many manufacturers today, this OEM was feeling pressure from multiple directions. Tariffs were driving up costs on key components, while logistics constraints were making lead times less reliable. The result? A supply chain that was becoming more expensive, harder to predict, and increasingly difficult to manage.

For a medical device manufacturer, those issues are more than just operational headaches. They can become compliance risks. The company needed to transfer manufacturing quickly, but they couldn’t afford to introduce new variables that could compromise product quality, documentation standards, or delivery performance.

What the OEM Needed in a New Supplier

This wasn’t a situation where any fabricator could step in.

The OEM required a supplier with:

• An established quality system
• Strong regulatory discipline
• The ability to support medical PPAP expectations
• Clear documentation practices
• A proven approach to risk reduction during transfer

They needed a partner who could move fast, but still operate with the structure and rigor expected in regulated manufacturing.

The DeWys Solution: A Structured Transfer Plan & Dedicated Work Cells

DeWys responded with a structured manufacturing transfer plan supported by both engineering and quality teams. From the start, the focus was on maintaining control, minimizing risk, and creating a repeatable foundation for long-term success.

To support the OEM’s requirements, DeWys implemented dedicated, validated work cells designed specifically for medical device manufacturing needs. This allowed for tighter process control, improved traceability, and better overall consistency throughout production.

DeWys also brought a robust quality framework supported by our ISO 9001 quality management system. This ensured that documentation, process discipline, and quality planning were built into the transfer—not added later as an afterthought.

Implementation: Ownership From Quoting Through Launch

To keep the project moving efficiently, DeWys assigned a dedicated project team spanning quoting through production launch and full implementation.

This team established priorities, timelines, and clear ownership across all transfer activities, including:

• Process setup
• Documentation development
• Quality planning and control strategy
• Validation execution aligned to customer requirements

Work was completed within the dedicated medical work cells, and required validation activities were executed by the DeWys team based on the OEM’s specifications and regulatory expectations.

Results: Stability, Confidence, and Scalable Production

By transferring manufacturing to DeWys, the OEM achieved meaningful improvements quickly.

The results included:

• Improved price stability
• More reliable lead times
• Stronger quality confidence through controlled processes and documentation
• Validation support that aligned with project and regulatory requirements

Just as importantly, the OEM gained a scalable production approach supported by continuous improvement. This positioned them to meet future demand growth without reworking their supply chain again.