Overview
Client: Phase 2 Medical Manufacturing
Consultant: Teresa Nelson, Full-Time New Product Development Engineer
Project: Medical Device Product Transfer to Manufacturing
As a New Product Development Engineer at Phase 2 Medical Manufacturing, Teresa Nelson led the successful transfer of multiple medical device products from customer design to full-scale manufacturing. This involved a wide range of technical and operational processes, from product validation to assembly and packaging. Teresa’s expertise ensured that each device met stringent quality requirements, facilitating a seamless transition into production.
Challenge
Transferring medical device products to manufacturing posed several key challenges:
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Validation and Testing: Ensuring that all manufacturing processes, such as ultrasonic welding tubing leak testing, and assembly processes were validated to meet rigorous product requirements.
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Sterile Barrier Packaging: Designing and testing sterile barrier packaging that adhered to industry standards while ensuring product integrity during sterilization and shipping.
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Cross-Functional Coordination: Managing multiple stakeholders, including customers, manufacturing teams, and clean room operators, to ensure the smooth implementation of new products into production.
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Training and Assembly: Developing assembly processes and training clean room operators to handle complex medical device assembly and packaging requirements.
Teresa's Role
As the lead engineer, Teresa took responsibility for multiple facets of product transfer to manufacturing:
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Ultrasonic Welding and Leak Testing Validation: Teresa spearheaded the validation of ultrasonic welding and tubing leak testing processes, ensuring that all welds and joints met strength and safety requirements. This included conducting weld strength testing and gauge R&R (repeatability and reproducibility) studies to ensure consistency in production.
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Sterile Barrier Packaging Design and Testing: Teresa played a key role in designing sterile barrier packaging, such as Tray/Tyvek lids and Tyvek/Mylar pouches, to meet industry standards for medical devices. She led packaging integrity testing to ensure the products maintained sterility through shipping and handling, contributing to successful sterilization validation.
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Assembly Process Development and Operator Training: Teresa developed the assembly processes required for manufacturing and ensured that clean room operators were trained on all procedures. She created detailed training programs that allowed operators to perform complex assembly and packaging tasks in a cleanroom environment.
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Prototype Lots and Sterilization Validation: Teresa led the development and manufacturing of prototype lots, ensuring that all components were tested for quality and reliability before scaling up to full production. Her oversight of sterilization validation guaranteed that all devices were compliant with sterility requirements and ready for market release.
Key Outcomes
Teresa Nelson’s leadership as a New Product Development Engineer led to several significant outcomes:
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Successful Product Transfer: Teresa’s work facilitated the seamless transfer of numerous medical devices from customer designs to manufacturing, ensuring products met industry standards for quality, safety, and sterility.
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Validated Processes: Her leadership in validating welding, leak testing, assembly and packaging processes ensured that the manufacturing of these devices adhered to the highest standards, minimizing the risk of defects and ensuring patient safety.
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Efficient Production: Teresa’s development of assembly processes and operator training ensured that clean room operators were fully prepared to manage the complexity of medical device assembly and packaging.
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Sterilization Validation: Her oversight of sterilization validation ensured that all devices were compliant with stringent sterilization standards, enabling them to be safely released to the market.
Conclusion
Teresa Nelson’s work at Phase 2 Medical Manufacturing exemplifies her deep expertise in new product development and medical device manufacturing. Her ability to lead complex, multi-faceted projects involving validation, packaging design, assembly, and training contributed to the successful production of numerous medical devices. Teresa’s leadership, attention to detail, and problem-solving skills were critical in ensuring that each product met stringent regulatory standards and was ready for market release.