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.
ISO 13485:2016 · BSI FM 590598/
FDA-Registered/
ISO Class 8 Cleanroom Environment Molding/
Made in the USA/
24/7 Operations
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.
For reservoirs, cartridges, housings, and fluid path interfaces.
For controlled one-way flow.
For cannula insertion, needle penetration, and resealing.
For pressure, venting, and environmental sealing.
Bonded to plastics, metals, polyimide, film, fabric, and other silicones.
For sensor bodies and wearable enclosures.
Delivered ready to install, not ready to finish.
For contact, grounding, and shielding applications.
If the component is elastomeric and it is critical to function, bring us the print.
Tell us your application. We mold far more than fits on this page.
Every 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.
Molding & MaterialsFull 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. You never deal with a toolmaker.
Engineering & ManufacturingThe 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.
Molding & MaterialsValidated, documented, and inspected on the dimensions that actually matter to function.
Engineering & ManufacturingThe same four stages whether the run is ten thousand parts or ten million.
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.
Across the full durometer range.
Including custom compounds built to your physical property requirements.
For aggressive fluid and chemical exposure.
Selected to the application requirement.
For electrically functional components.
Where an off-the-shelf grade will not hold the requirement.
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.
Molded stock converted to finished valves and components.
Delivered as one validated sub-assembly.
Custom inspection solutions engineered per program.
Device packaging, done where the part is molded.
Through a qualified partner.
Tubing and rod, cut to size, extending the molded portfolio.
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.
Tell us the part, the volume, and the requirement.
You will get an answer from an engineer, not a form letter.
From clinical builds to commercial scale, engage our engineers at the print.
Start Your ProgramRevalidation is a given. We plan it around your inventory bank, so your line keeps running while we qualify.
Transfer Your Program