The Trial phase ensures solutions realized in the development phase of the medical catheter extrusion can be reproduced over the long term. The introduction of document controls is a key element of the Trial phase, during which the focus shifts to control and repeatability of production of the medical extrusion. Purchasing controls ensure the long term availability and quality of raw materials while identification and traceability controls ensure the proper handling of materials throughout the extrusion process. While much of this work goes on “behind the scenes”, the technical sales representative may provide the client with some newly created documents for their review and approval.
Putnam Plastics maintains production and process controls appropriate for precision medical device components. These global controls are reviewed jointly by the engineering and production teams to ensure that they meet the specific requirements of the client’s product. Environmental and contamination controls along with inspection metrology are examples of controls that frequently need to be customized for a particular product.
Design and process validation typically take place simultaneously with the fabrication of one or more Trial lots. The technical sales representative and the client work together to determine the number of lots and quantity of prototypes required depending on the complexity of the medical device and level of validation required. During the fabrication of these lots the production and process controls are tested and the processes are validated. Along with the prototypes, a quality report is provided to the client that contains inspection data and statistical analysis to demonstrate the process validity. The client then utilizes the prototypes in their own builds and reports back to validate the design.
Upon completion of the trial phase, the technical sales representative provides the client a production quote, including unit volume pricing and lead times to be referenced on future production orders.