Medical Device Manufacturing Transfers: The Process of Transferring Medical Device Custom Plastic Manufacturing to BMP Medical

Reshoring medical device and component manufacturing is gaining traction as companies recognize the benefits of relocating production closer to home. For organizations relying on injection molding and injection blow molding, transferring operations to a trusted U.S.-based manufacturer like BMP Medical offers significant advantages, including enhanced quality control, Intellectual Property (IP) protection, compliance, cost and supply chain stability.

If you are considering transferring your medical device manufacturing from overseas, BMP Medical has the expertise and structured approach to ensure a smooth transition. Below, we outline the comprehensive process involved in transferring, alongside the benefits and key considerations.

The BMP Medical Transfer Process

At BMP Medical, we’ve developed a step-by-step process to simplify the complexities of transferring medical device manufacturing, ensuring efficiency and regulatory compliance at every stage.

1. Initial Assessment and Feasibility Study

1. 1.  Evaluating tooling, materials, and designs: We assess the compatibility of your tools and materials with our systems.
   2.  Understanding production needs: We analyze your volume and quality expectations to align with our capabilities.
   3.  Ensuring regulatory compliance: Our team identifies any gaps in meeting U.S. standards, such as FDA regulations and ISO certifications.

This assessment provides a clear picture of your requirements and confirms the feasibility of the transfer.

2. Tooling Inspection and Validation

For existing molds, our expert engineers conduct a thorough inspection to determine their compatibility with BMP Medical’s equipment and processes. We:

1. 1.  Inspect and evaluate molds to ensure they meet quality and performance expectations.
   2.  Modify or retrofit tools as necessary for optimal integration.
   3.  Conduct sample runs to validate tools under our stringent standards.

If new tooling is needed, BMP Medical works closely with you to design and fabricate molds tailored for high-efficiency, quality production.

3. Production Setup and Process Optimization

Once tooling is approved, our team establishes a robust production process customized to your product’s specific needs. This stage includes:

1. 1. Selecting and testing materials to meet regulatory standards.
   2.  Setting precise parameters for injection molding or blow molding processes.
   3.  Establishing comprehensive quality control protocols to ensure consistent output.

4. Regulatory Compliance and Documentation

Compliance with U.S. regulations is at the core of BMP Medical’s process. We ensure:

1. 1. All documentation is prepared for FDA audits and submissions.
   2.  Processes align with ISO 13485 standards for medical device manufacturing.
   3.  Full traceability is maintained for all materials and production activities.

5. Pilot Production and Full-Scale Manufacturing

Before scaling to full production, we run a pilot production phase to verify:

1. 1. Tool performance under actual manufacturing conditions.
   2.  Consistent product quality and functionality.
   3.  Adherence to delivery timelines.

Once the pilot production is validated, we seamlessly transition to full-scale manufacturing, minimizing downtime and ensuring a steady supply.

The Benefits of Transferring to BMP Medical

By reshoring your manufacturing operations to BMP Medical, you gain:

1. 1. Enhanced Quality Control: With in-house processes and U.S. oversight, quality is consistently monitored.
   2.  Regulatory Expertise: Our deep understanding of FDA and ISO standards ensures your products meet all requirements.
   3.  Reduced Lead Times: Domestic production means faster turnaround and more reliable delivery schedules.
   4.  Supply Chain Resilience: U.S.-based manufacturing reduces risks associated with overseas logistics and geopolitical issues.

Why BMP Medical?

BMP Medical has over four decades of experience in medical device manufacturing using advanced custom injection molding and blow molding techniques. Our focus on innovation, quality, and customer collaboration makes us a trusted partner for transferring production from overseas.

Contact BMP Medical today to discuss how our streamlined transfer process can enhance your manufacturing operations. With our expertise, you can achieve better control, superior quality, and a more resilient supply chain.