The seals, valves, septa, and overmolded components inside your device get molded on one floor, by one engineering team, under one quality system, from a ten-piece first article through sustained high-volume production. No mid-life re-source. No second validation because your supplier ran out of room.
A diabetes device is worn on the body, filled with fluid, and expected to run without intervention for days at a time. The parts that make that possible are a seal, a valve, a septum, an overmolded gasket a few millimeters across. They are also the parts most likely to fail an audit, hold up a validation, or trigger a line-down call at two in the morning.
By the time the program reaches this point, the tolerance stack is locked and the enclosure is tooled. The elastomer has to fit exactly what is already there. There is no room left to design around a supplier who cannot hold the dimension, cannot hold it lot after lot, or cannot hold it at the volume you are heading toward.
Pick for the launch volume and you will be doing this again in three years.
Yields drift. Lots get argued over. The tool was built for a volume you passed two years ago, and every capacity conversation ends with a quote for a new mold. Somebody has already used the phrase "we may need to dual source."
This is the expensive problem, because the cost is not the parts. It is the requalification you are trying not to do.
That is the habit, and it is the reason the same program gets re-sourced in year three. The fix is not a better vendor scorecard. It is qualifying against the volume curve instead of the launch number.
Low-volume, high-mix work and high-volume automated work run side by side here, under the same quality system. That is rarer than it sounds, and it is the whole reason the second qualification never has to happen.
Every part that comes off our floor is controlled by four things: a machine, a mold, a material, and a process. We take ownership of all four, so you own none of them. Here is what that looks like from your print forward.
Geometry, parting lines, gate location, and tolerance stack reviewed before a mold is cut. Most of the cost and most of the risk in an elastomeric component is decided here.
Full tooling stewardship: requirements, design authority, DFM, cavitation strategy, vendor selection and management, validation, and transfer. Sized to the volume you are actually going to run. You never deal with a toolmaker.
FAI, MSA, DOE, IQ, OQ, PQ, with full material and product traceability from raw lot to shipped carton. Built as the work happens, so it is audit-ready any day.
Cleanroom environment molding, automated work cells, and 24/7 operations running the same validated process at ten thousand parts and at ten million.
Anyone can mold a good first article. Diabetes programs are won and lost on part number four hundred thousand and part number forty million.
Quality management system integrated directly into our ERP.
Not down the hall.
Plus 3D stereo microscope inspection.
Molding elastomers.
Leak, inflation, rebound, and response testing matched to what the part must do.
Material and product traceability on every lot, round the clock for large-scale and time-sensitive programs.
We are not a catalog. Every component below is custom, tooled to your print, and validated to your requirements. This is a representative list, not a limit.
Do not see your component? Tell us your application. We mold far more than fits on this page, and if we cannot mold it, you will hear that fast too.
Send us the printMost diabetes programs arrive with the material already specified. We work across every major liquid silicone supplier, so you are not forced into a compromise grade because of who we happen to buy from. Where no catalog grade holds the requirement, we compound to it.
Most engineers land here in the middle of an evaluation, not at the end of one. So there is something useful at every stage, and none of it requires a decision you have not made yet.
Twenty questions to ask any molder before you qualify them, including the four most teams skip and regret. Use it on us, and use it on whoever else is on your list.
Get the checklistA checklist tells you what to ask. It cannot tell you whether a specific tool, at a specific cavitation, will still be the right tool at forty million parts. That is a print-level conversation, and it takes about thirty minutes.
Momentum step, thank-you pageSend one print. An engineer walks the geometry, the likely process, the cavitation path to your projected volume, and the two or three things most likely to bite you later. You leave with the answer whether or not you ever quote it.
Book the reviewQualifying a new supplier on a launched diabetes program is one of the least appealing projects in a medical device engineer's year. Tooling has to move or be rebuilt. Validation has to be repeated. Someone has to own the risk.
It is also the moment that decides the next several years of the program, which is why it is worth doing once, with a supplier built to carry the volume you are heading toward rather than the volume you are shipping today.
We do this regularly. Bring us the print, the history, and the failure mode you are trying to design out, and we will tell you honestly whether we can improve it, match it, or whether you are better off where you are.
Yes. We mold seals, valves, septa, gaskets, and overmolded components for insulin pumps, patch pumps, continuous glucose monitors, insulin pens, and infusion sets, from first article through high-volume production.
Cavitation strategy is planned against your projected volume curve rather than your launch forecast, so added capacity is a planned step in the tooling roadmap instead of a new supplier qualification. The process, the quality system, and the engineering team stay the same.
Liquid silicone rubber, gum silicone, fluorosilicone, conductive grades, and organic and synthetic rubber compounds. We work across all major liquid silicone suppliers and compound to custom physical property requirements where no catalog grade holds.
Yes. Molding, inspection, secondary operations, and packaging are performed in controlled cleanroom environments inside our ISO 13485:2016 certified facility.
Programs run from first article through sustained high-volume production. High-cavitation cold runner tooling, automated work cells, and 24/7 operations support the upper end.
Yes. We overmold onto plastics, metals, polyimide, film, fabric, and other silicones, and we mold thermoplastic components for silicone overmolding applications.
We handle slitting, die cutting, sub-assembly, inspection, and device packaging in house, so components arrive ready to install. Sterilization is coordinated.
Yes. We regularly transfer launched programs, including tooling transfer, revalidation, and requalification.
ISO 13485:2016 certified and FDA registered. The certificate is available on our Quality page.
Send the print, the volume, and the requirement. You will get an answer from an engineer, not a form letter, and an honest one even when the answer is no.