Once a device concept has been realized, it enters process design and development. PMP works closely with your team throughout this phase, adhering to design for manufacturing principles to ensure that the device can be produced at anticipated volumes. Are the right processes in place? The right materials? The right workflow? All of these factors must be considered — and verified — to ensure that production is streamlined and efficient and that all FDA regulatory requirements are met.
This may involve procuring and installing equipment and then qualifying all equipment to ensure it produces devices that meet the required specifications. This also involves documenting and optimizing process flow to maximize production efficiency.
Because PMP is a single-source provider, with many manufacturing technologies housed under one roof, we offer some advantages when it comes to process design and development. We can coordinate and manage all of the interconnected activities required for a complex medical device manufacturing program, ensuring the most optimized sequence. We also enjoy complete control over the supply chain and can track the impact of late shipments and other materials-based changes on production.
The ultimate goal of process design and development is to create a viable manufacturing process that is scalable, repeatable, and completely documented for regulatory reviews.