We mold the critical-to-function silicone components inside insulin pumps, patch pumps, continuous glucose monitors, pens, and infusion sets. Same engineering team, same quality system, same floor, from a first article through sustained high-volume production.
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 small, soft, and almost invisible on the drawing. 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 a program reaches launch, the tolerance stack is locked, the enclosure is tooled, and 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 scale.
That is the problem we were built for.
Insulin delivery depends on seals and valves that do not leak, do not weep, and do not migrate over a multi-day wear period. Function is verified, not assumed.
Components sit against skin and against fluid for the full life of the device. Compression set, rebound, and material stability over time matter as much as the dimension on day one.
Diabetes components are among the smallest we mold. Flash, gate vestige, and parting-line witness that would be cosmetic in another market become functional defects here.
Silicone rarely arrives alone. It is overmolded onto plastic housings, molded around metal, and bonded to polyimide and film. The bond is as critical as the part.
Diabetes programs do not ramp to thousands. They ramp to millions, and every one of them has to look like the first article.
Four of those five are the failure classes every critical-to-function elastomer faces: sealing and reseal, flow control, elastic response, and bonded interfaces. Diabetes is where all four show up on the same device, at the same time, at volume.
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.
If the component is elastomeric and it is critical to function, bring us the print.
Do not see your component? Tell us your application. We mold far more than fits on this page.
Send us the printEvery part that comes off our floor is controlled by four things, and we take ownership of all four so you own none of them.
Late-model liquid injection molding presses, cold runner and hot runner tooling, fully automated work cells, and robot demolding for high-cavitation programs.
Full tooling stewardship: requirements, design authority, DFM, cavitation strategy, mold vendor selection and management, validation, and transfer. Cavitation is driven by your volume and your target price, not by what happens to be on a shelf. You never deal with a toolmaker.
The right elastomer for the wear profile, the fluid, and the bond, sourced across every major LSR supplier and compounded to spec where no catalog grade holds the requirement.
Validated, documented, and inspected on the dimensions that actually matter to function.
We review geometry, parting lines, gate location, and tolerance stack before a mold is cut. Most of the cost and most of the risk in an elastomeric component is decided here.
Multi-step tool development managed end to end and sized to the volume you are actually going to run, not the volume you launch at.
FAI, MSA, DOE, IQ, OQ, PQ. Full material and product traceability from raw lot to shipped carton.
Cleanroom environment molding, 24/7 operations, and the same validated process at ten thousand parts and at ten million.
Most 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.
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.
A molded part that still needs three vendors before it can go into your device is not finished. We take that work off your plate.
One supplier. One quality system. One set of documents to audit.
Qualifying 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 and doing it with a supplier built to carry the volume you are heading toward, not just 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.
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.
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 us the print, the volume, and the requirement. You will get an answer from an engineer, not a form letter.