Challenge:
A medical device manufacturer relied on an overseas supplier to produce a critical molded component used in a disposable diagnostic device. Long lead times, inconsistent communication, and growing concerns about supply chain disruptions created risk for the customer.
The company needed a domestic manufacturing partner capable of handling a mold transfer while maintaining regulatory compliance, product quality, and uninterrupted supply.
Solution:
AdvanTech Plastics conducted a comprehensive mold transfer review, including tooling inspection, process validation planning, and production readiness assessment.
Working closely with the customer’s engineering and quality teams, AdvanTech:
- Evaluated existing tooling and recommended preventive maintenance improvements
- Established documented process parameters
- Supported IQ/OQ/PQ validation activities
- Implemented lot traceability procedures
- Transitioned production into a controlled manufacturing environment
- Integrated secondary assembly and packaging operations
Results:
- Successful mold transfer completed without disruption to customer supply
- Reduced lead times through domestic manufacturing
- Improved communication and project visibility
- Enhanced quality documentation and traceability
- Established scalable production capacity for future demand growth
Key Capabilities Utilized:
- ISO 13485 quality systems
- Medical device injection molding
- Validation support
- Mold transfer expertise
- Secondary assembly and packaging
- Supply chain reshoring support
Related Capabilities
- Medical Device Injection Molding
- Micro Injection Molding
- Cleanroom Molding
- Mold Flow Analysis
- Engineering Services