High-Mix Low-Volume Manufacturing
JunoPacific provides premier low volume medical device manufacturing services in the Midwest and Silicon Valley.
- MUD (R) mold bases for cost savings
- Family tooling for reduced unit price
- Interchangeable cavities and cores
- Prototype and bridge tooling
- Design for Manufacturability assistance to simplify and reduce number of components
- Two-shot and spin-stack (r) to eliminate assembly and 2nd operations
- Standardizing parts
Capital equipment expenditure is often an issue for medical start-up companies looking to move into a scalable validated manufacturing process for FDA approval. Machine parts and one-off prototypes are useful for the evolution of the device design, but when it comes to 510k or pre- market approval, the process used to manufacture the submitted parts needs to be the same as the one used for production down the road. For plastics this means tooling and mold investments, and for assembly it can mean welding horns and a host of other fixtures. JunoPacific can help keep these affordable even for a start up budget while reducing changeover times to efficiently produce low volumes of a high number of parts.
Keeping Up-Front Production Costs Low
Plastic injection molds can be expensive. Depending on the complexity of the part, desired throughput of the mold, and the life expectancy of the mold, they can be upward of $500,000 each. For a startup on a shoestring budget this can be an impossible hurdle. But when you’re going for your PMA, 510k, or even market introduction you don’t need a high cavitation hot runner fully hardened mold that can last millions and millions of shots. Especially in the early stages while the product design is still subject to modifications you need tooling that can be easily adaptable and readily changed for minimal costs.
That is why JunoPacific offers prototype, bridge, single cavity, and family tools to reduce your upfront tooling expenditure. By putting 4 separate parts in the same mold base with a directional runner system, you can save the cost of the 3 additional mold bases and also the costs of 3 additional tool setup charges for getting the mold in the press. By using softer tool steels such as P-20 and sometimes even Al, we can reduce the amount of machining time to create the mold and therefore the price. Granted, these tools won’t last the millions of cycles the full- hard production tools will, but at the start up stage most of the time you don’t need them to. Additionally we can reduce the number of mechanisms in the tool such as by using hand loaded inserts instead of unwinding cores. Although part cycle time will increase, the corresponding decrease in mold cost will justify the increased part price for low volumes.
Streamlining, Standardizing, and Reducing the Number of Components
A major advantage to involving JunoPacific early on in your design cycle is our design for manufacturability assistance. Due to our years of experience in the manufacturing world, our engineering and new product introduction team can identify possible design changes that won’t affect the functionally of the device, while reducing tooling costs and making the manufacturing process more robust. Additional technologies such as over-molding and two shot can identify areas where we can combine two or more parts into a single component, streamlining the assembly process, all while maintaining the ability to easily scale up for larger production runs once your device reaches the marketplace.
Another area for potential cost reductions is the standardization of certain components. Say for example instead of having a left and right housing, create a single housing half that can function as both. Or instead of molding a custom clip, use a standard one already on the market being produced by the millions and incorporate it into your device.
JunoPacific's team is here to help. With our ability to quickly change over our assembly lines and molding presses due to our commitment to lean manufacturing, 5S, and operational excellence we can scale with you as you grow and enter the marketplace.