Novel device development - the UPC approach (3)

Clinical supplies - for expediency these are usually made off single impression-tooling over a number of batches with controlled assembly. To ensure this can happen quickly to support product launch critical paths, we recommend working with final suppliers at the FEP product stage. UPC expects to support the project hands-on at this stage to ensure time-line success at the supplier. The earlier hard-work providing design integrity begins to pay back here.

To market launch - at UPC we review tool and assembly machine detail to maintain device performance, reliability and safety. Product QC strategy should reflect the FMECA outcomes and so UPC as the engineering design authority can provide this bridge into manufacture. Dimensional classification across the product again should tie to the product and process FMECA's. Tool validation programmes need a product champion to ensure performance and safety are maintained in the web of tolerance growth and nominal shifts of the typical manufacturing path. UPC are there always to keep you out of any lurking crevasses before market launch.