Case Study: High-Mix, Low-Volume Medical Assemblies
Reliable and Scalable Manufacturing Solutions for High-Mix Medical Device Assemblies.
1. The Challenge: Reliable Manufacturing for High-Mix, Low-Volume Medical Devices
A medical device startup required an ISO 13485 compliant manufacturing partner for custom small-batch, high-mix medical cable assemblies. The supplier needed capabilities including rapid prototyping, full material traceability, and scalable production to meet growing demand, all within strict medical industry quality standards.
2. Tailored High-Mix, Low-Volume Medical Assembly Solutions
Understanding the critical importance of flexibility and communication for medical startups, we developed a customized, process-oriented medical assembly solution including:
- Dedicated Project Management: Single-point contact ensuring streamlined communication.
- Flexible Production Lines: Ideal for efficient, quality-assured low-volume, high-mix medical assemblies.
- Robust Documentation:Comprehensive batch records, ensuring complete material traceability and regulatory compliance (ISO 13485).
3. Streamlined Implementation Process for Medical Device Assembly Production
Our engineering experts collaborated closely with the startup’s team, providing Design for Manufacturability (DFM) input to enhance medical device assembly efficiency. Rapid prototypes enabled timely verification and validation testing. During production, our adaptable scheduling supported fluctuating demands, optimizing inventory management without overcommitment.
4. Successful Results: Reliable Medical Assemblies and On-Time Product Launch
Our tailored medical assembly solutions ensured successful results and a timely product launch:
- Met Critical Launch Deadline: High-quality, fully-documented medical assemblies delivered promptly.
- Enabled Scalability: Flexible manufacturing smoothly supported growth from prototype to full production.
- Became a Trusted Partner: Now a go-to supplier for all future medical device development projects.
Project Snapshot
- Client: Medical Device Startup
- Industry: Medical
- Challenge: Low-Volume, High-Mix, Traceability
- Solution: Dedicated PM, Flexible Production
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