Optimizing your production line for FDA approval and scaling.
- Dedicated 400 ft^2 class 10,000 (ISO class 7) pilot line manufacturing and assembly area
- Extensive equipment available for use without capital expenditure
- Process FMEA / FMECA
- Validation/verification pre-clinical builds
- Design for assembly (DFA) and Design for manufacturability (DFM) assistance
In order to receive PMA or 510k approval through the FDA, you must first have a validated manufacturing process. With JunoPacific's considerable experience and expert engineers and technicians working with you, JunoPacific can guide you through this process. Our New Product Introduction team looks at your whole product lifecycle, from the first sub-component to end-of-life considerations, to see where JunoPacific's advanced manufacturing technology can simplify the production and assembly of your medical device while making it a more robust and reliable process. DFM (design-for-manufacturability) experts evaluate where small design changes can lower CpK values while reducing capital expenditure on tooling, while DFA experts analyze simplifying your assembly by combining components and/or using multi-shot and Spin-Stack® technology.
JunoPacific’s portfolio is full of medical devices that have successfully used this approach, transitioning from pilot manufacturing builds, through FDA approval, and on to successful roll-out to the market.
Pilot Manufacturing: 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, JunoPacific investigates your design and processes to iteratively improve before the changes and improvements may become too cumbersome and costly. Our fully stocked dedicated pilot manufacturing line allows us to try several different strategies, ensuring JunoPacific deploys the best possible process before you 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, DHF, DMR, DHR, validation and verification (assembly, testing, tooling and fixtures, equipment validations, experiments, packaging, sterilization, accelerated age studies and transit testing). Additionally, JunoPacific’s focus on both operational excellence and lean manufacturing drives our engineers to continuously optimize the pilot manufacturing process design within FDA GMP parameters.
During this pilot manufacturing phase, our experience in unearthing potential difficulties can save you significant headaches, and costs, down the road.
Pilot Manufacturing: Finding the Right Fit
Pilot manufacturing is a crucial step in full-scale medical device manufacturing. If your medical device is successful in a pilot market or clinical trial, it will likely transition to full- scale production. But if your medical device has flaws that are revealed during our Pilot Manufacturing phase, your medical device may need to be reworked. Reworking a medical device takes more time and more money. This is why you need to find a medical device manufacturing company that takes seriously the integrity of this process.
At JunoPacific, we work with you to find the most appropriate and efficient balance for your time and budget needs. JunoPacific personalizes our approach based on your unique products, requirements and budgets, all while going strictly “by the book” to provide you with a documented, verified, and validated manufacturing process to streamline your medical device's approval with the FDA.