One engineering team, one quality system, one floor, from a ten-piece first article to 260 million parts a year.
The shop that carried your clinical builds caps out at commercial volume. The global house never took those builds seriously. Or the incumbent fails an audit, gets acquired, or exits the niche. Suddenly a validated, shipping device needs a new supplier, a new qualification, and a story for regulatory.
There's a name for it: the mid-life re-source. Its costs are invisible the day the supplier is chosen, and they all arrive mid-life:
One engineering team, one quality system, one floor, carrying the program from a ten-piece first article through full commercial volume. The volume threshold that forces a re-source somewhere else is just a capacity conversation here.
Too small for the global silicone houses to notice. Too critical to hand to a job shop. That's where most medical device programs actually live, and it's exactly what IRP Medical is built for.
Since 1980 we've molded the custom medical components devices can't function without, and not just the one part you buy from us today. Long enough to have carried programs from a first article to their two-hundred-millionth part, and to know what breaks in between.
Every serious molder shows you the same certificate. Ours reads it in the scope. A third-party auditor certified the words we live by.
You shouldn't have to guess how a molding program will go. Here's the path in four stages, the same four whether the run is ten pieces or a hundred-million-part year.
Talk to an EngineerYour design, our manufacturability review. Technical sessions, DFM recommendations, feasibility on the parts others no-quote, and material selection support across every major LSR supplier.
Full tooling stewardship: requirements, mold design authority, cavitation strategy driven by volume and target price, mold-vendor selection and management, validation, and transfer.
Sampling and process development, FAI, MSA and DOE, IQ/OQ/PQ. Functional lot release defined.
Planned, staged scaling on one floor and one quality system: added cavitation and cells on a roadmap, 24/7 when the program demands it, and hundreds of millions of parts a year if the device earns it.
We take ownership of all four, so you own none of them. Silicone or rubber, if your device needs a custom elastomer component, it comes off this floor.
Late-model LIM presses, fully automated work cells, robot demolding, in-mold vision systems, cleanroom environment molding, 24/7 operations.
Full tooling stewardship: mold design, DFM, cavitation strategy, vendor management, validation, transfer.
LSR from every major supplier, HCR gum silicone, EPDM, fluorosilicone, conductive grades, organic and synthetic rubber compounds, custom formulation to spec.
Scientific molding techniques. Validated (IQ/OQ/PQ), lean, flashless where it matters.
Liquid injection molding (LSR/LIM), HCR gum silicone injection, compression rubber molding, transfer, and flashless molding. Overmolding / insert molding onto metals, and silicone overmolding onto polyimide, silicone, and thermoplastic substrates including PA, PC, and ABS. Silicone extrusion: tubing and rod, cut to size.
DFM and product realization, tooling stewardship, FAI/MSA/DOE and IQ/OQ/PQ validation, cleanroom environment molding, non-contact vision metrology, lean NPI.
Precision slitting, die cutting, laser marking, cryogenic deflashing, alcohol washing, duckbill and valve finishing, sub-assembly, and packaging.
Every step we absorb, from sub-assembly through packaging, is one your team doesn't have to source, qualify, or manage.
One component discipline: custom silicone and rubber molding, secondary operations, and functional lot release, matched to whichever constraints lead in your application.
Our largest market: infusion set and pump components at sustained, automated volume.
Skin-contact silicone and bonded sub-assemblies that flex with the wearer and scale when the product wins.
Check valves, duckbill valves, septa, seals, and silicone tubing, all released on function.
Soft-durometer, skin-contact silicone with materials selected to the biocompatibility spec.
Critical components for programs where qualification is measured in years.
Gaskets, seals, valves, and fluid-handling parts where repeatability decides whether the assay runs.
Seals, diaphragms, and bonded sub-assemblies that hold their response through repeated sterilization cycles.
Gentle, biocompatible silicone repeatable enough to trust for wear measured in days.
Septa, seals, and closures where compound selection and contamination control carry the regulatory weight.
These are the applications we're in most often, not the limit. If the part is a custom, critical-to-function elastomer component, we can almost certainly mold it. Send the print and we'll tell you fast.
Tell Us Your ApplicationQualify your molding partner once. Keep it for
the life of your device.
From feasibility and clinical builds to commercial scale, engage our engineers at the print.
Start Your ProgramMoving a validated component means revalidation. That's a given. We plan it around your inventory bank, so your line keeps running while we qualify.
Transfer Your Program