A US-based orthopedic OEM needed a more reliable way to support growing European demand without compromising domestic cleanroom capacity. Ensera enabled the transfer of end-of-line processing for titanium trauma and extremity screws to our facility in Poland, improving regional responsiveness, supply flexibility, and cost optimization.
Growing European demand was placing greater pressure on our customer’s US cleanroom capacity, where a broad sterile product portfolio competed for scheduling priority. This made lead times for European products less predictable and reduced the flexibility to respond to regional demand.
With delays risking product availability, surgeon preference and market share, the customer needed a more reliable European route to sterile product without disrupting domestic operations.
With Ensera able to offer facilities in both the US and Europe, a number of different solutions presented themselves. In discussion with our team, the customer adopted a regional end-of-line strategy that retained screw machining in-house in the US while moving final sterile barrier packaging and cleanroom processing closer to European demand.
Ensera established a dedicated European route for converting non-sterile titanium screws into sterilized, market-ready products. This gave the European portfolio a more reliable path through cleanroom processing, without competing for scheduling priority within the customer’s US operations.
The model increased flexibility to support European growth while releasing US cleanroom capacity for domestic priorities and reducing the freight volume and costs associated with shipping finished blister-packed products.
Thanks to rigorous project management planning and cross-functional collaboration, Ensera managed the technical transfer to our FDA-registered, ISO 13485-certified facility in Poland without disruption to existing supply.
The transferred process included:
We also completed the validation program required to establish the European process. This included rinsing validation with a log-reduction study, microbiological validation and testing, seal-integrity validation, and sterilization validation.
Once machined in the US, the non-sterile titanium trauma and extremity screws could be shipped compactly to Europe for final cleanroom processing and sterilization at speed.
The most successful international supply models don’t just support growth in one region. They create flexibility across the wider business. Localizing end-of-line activities can help manufacturers balance regional demand while maintaining focus on their domestic market.
- Marta Karwan, VP Orthopedics EMEA
