Category
Drug DeliveryAbout This Project
Confidential Client
Nanoliter-Accuracy Delivery System
A worldwide healthcare company focusing on innovative devices and pharmaceuticals needed a delivery system to inject precise volumes of a new therapeutic, and they turned to Key Tech for a full-scope engagement. The cart-based delivery system secures a disposable syringe and tubing set and dispenses microliter fluid volumes with nanoliter accuracy. Key Tech developed the durable device, performing system architecture and user interface definition before designing and verifying all electromechanical and firmware elements. The client developed the disposable with a 3rd party manufacturer while in parallel, Key Tech met critical durable development milestones to ensure functional prototypes were available for demonstrations with key opinion leaders. A diverse team of Key Tech designers, engineers and a partner CM collaborated to create and V&V a product compliant with IEC 60601-1 3rd Edition. Key Tech also supported the client in preparing the regulatory documentation required for submission to the FDA.
- Ep 33 Design as a Platform for Future Assay Tests - March 27, 2024
- Benefits of Consumable and Instrument Development by One Partner - March 5, 2024
- Ep 32 Where to Focus De-Risking - February 5, 2024