From Zero to Six Million – Using a Component Management Process to Scale Up Manufacturing of Drug Delivery Devices

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. The right process ensures that all parts meet specifications and are inter-assembled efficiently. This paper presents a case history wherein a successful component management process helped provide consistent, cost-effective, extremely scalable, and high-yield drug delivery device production.

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