Clinical to Industrialisation

Development

When partnering on device development projects Neucin Design understands the need for continuity in the development process and have the capability to continue to lead the development activity once a project reaches the pilot-scale clinical production stage all the way to commercial product launch.

During the clinical device stage the Neucin Design team have been responsible for the design, build, set-up and installation, qualification (IQ/OQ) of low volume manual assembly lines to enable clinical device builds in conjunction with assembly process mapping, providing operator training, procedure development, troubleshooting assistance, build oversight, control documentation and confirmation and release testing.

From the clinical stage the Neucin Design team become a conduit for the transfer of the device design to a contract manufacturing organisation. Our intrinsic knowledge of the device help to establish a robust platform for which the device can be further developed to suit the requirements of high volume manufacture, inputting and collaborating cross-functionally across various technical disciplines to ensure device robustness and deliver a commercial device platform.

“Device design management and governance creating a clear development pathway from pilot scale clinical volumes through to industrialisation and product launch”

Technical leadership, device design governance and device manufacturing and assembly implementation from the clinical stage through to fully industrialised commercial scale volumes.

Experience working in partnership with contract manufacturing organisations through complex and demanding qualification and validation processes to ensure product quality and function.

Full integration and collaboration with technical teams across sites taking a hands-on and pro-active approach throughout the entire development process up to product launch.