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“From Zero to Six Million: Using a Component Management Process to Scale Up Manufacturing of Drug Delivery Devices” White Paper from NN, Inc. Precision Engineered Products Group (PEP)


  • August 1, 2016

  • Drug delivery devices constitute one of the most rapidly growing segments of the medical device manufacturing market. Makers focus substantial R&D efforts on designing delivery mechanisms for new and existing drug formulations. However, even good initial designs can’t guarantee that all the parts for these devices can be manufactured correctly and assembled consistently, with few rejects. Success demands that parts suppliers adopt a systematic component management process for delivery of interrelated components.

    When multiple parts must fit into a single assembly at tight tolerances, sourcing parts to multiple suppliers may lead to off-spec pieces or lot-to-lot misalignments. OEMs would be well advised to choose a single source with a sufficiently wide array of core competencies in the advanced manufacturing methodologies often required. And perhaps most important, the chosen supplier should approach a challenging multipart project by utilizing a well-designed component management process.

    Screen Shot 2016-08-09 at 9.43.57 AMThe right process ensures that all parts meet specifications and are inter-assembled efficiently. More than that, it helps furnish the following advantages:

    • Consolidated supply chain management
    • Automated lot-to-lot consistency
    • Efficient assembly process troubleshooting
    • Shorter time to market
    • Improved drug delivery device performance
    • Systematic component traceability
    • Ongoing manufacturing cost management
    • Efficient scalability for high-volume production

    Such a process should include close attention to elements such as initial design, process variables, scalability, tooling development, supply chain coordination, certification and traceability, and quality best practices to ensure on-spec, exact-tolerance results. With proper planning and performance, these can provide affordable, highly scalable drug delivery device production.

    The “From Zero to Six Million: Using a Component Management Process to Scale Up Manufacturing of Drug Delivery Devices” white paper from NN, Inc. Precision Engineered Products Group (PEP) presents a case history wherein a successful component management process helped provide consistent, cost-effective, extremely scalable, and high-yield drug delivery device production.

    Visit NN, Inc. Precision Engineered Products Group (PEP) at Partnerships in Drug Delivery October 26-28, 2016 at Fairmont Copley Plaza in Boston, MA.

    Read the white paper here.