Drug Delivery
About This Project

Confidential Client

Pharmaceutical Mixing System

A worldwide healthcare company focusing on innovative devices and pharmaceuticals developed a therapeutic requiring removal of a transfer buffer prior to infusion. Key Tech was engaged to design and verify a syringe-driver-based system that would remove the transfer buffer without damaging the therapeutic. Starting with a system requirements set, Key Tech developed all aspects of the design: the user interface, hardware and embedded firmware for ease of use and compliance with IEC 60601-1 3rd Edition. The complex durable/disposable interface was managed as well, accommodating disposable design revisions by the client during parallel development. Functional prototypes were delivered for client demonstrations to key opinion leaders to foster commercial interest and solicit design feedback. Separate durable and disposable contract manufacturers delivered V&V units, and Key Tech verified the device, while the client performed user validations.

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