For engineering, quality, and supply chain teams building insulin pumps, patch pumps, CGMs, pens, and infusion sets.
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.
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 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.
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.
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.
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.
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. 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.
Offered after the checklist downloadSend 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 reviewTell us the part, 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.
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