Pilot Production

Pilot Production: Process

Pilot manufacturing is the process for devices that will be tested in clinical trials or pilot markets before transitioning to full-scale production. By performing early-stage pilot manufacturing builds, Inzign investigates the customer’s design and processes to improve before the changes and improvements may become too cumbersome and costly. Inzign’s fully stocked dedicated pilot manufacturing line allows them to try several different strategies, ensuring Inzign deploys the best possible process before customers commit to major capital equipment expenditures.

This pilot manufacturing process includes: product design, process FMEA, plastic part design, material selection, design transfer to manufacturing, prototyping, validation and verification (assembly, testing, tooling and fixtures, equipment validations so that industrial fans and other equipment can fully operate, experiments, packaging, sterilization, accelerated age studies and transit testing). Additionally, Inzign’s focus on both operational excellence and lean manufacturing drives their engineers to continuously optimize the pilot manufacturing process design within FDA GMP parameters.

During this pilot manufacturing phase, Inzign’s experience in unearthing potential difficulties can save customers significant headaches, and costs, down the road.

Pilot Production : Finding the Right Fit

Pilot manufacturing is a crucial step in full-scale medical device manufacturing. If the customer’s medical device is successful in a pilot market or clinical trial, it will likely transition to full- scale production. But if the medical device has flaws that are revealed during the Pilot Manufacturing phase, the medical device may need to be reworked. Reworking a medical device takes more time and more money. This is why customers need to find a medical device manufacturing company that takes seriously the integrity of this process.

Inzign works with customers to find the most appropriate and efficient balance for time and budget needs. Inzign personalizes our approach based on customer’s unique products, requirements and budgets, all while going strictly “by the book” to provide customers with a documented, verified, and validated manufacturing process to streamline the medical device’s approval with the Regulatory Authorities.