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New program or supplier transfer — it starts with the print.
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Send your print — an engineer responds.
Every supplier you're evaluating will show you an equipment list. Ours comes with a structural difference: one engineering team, one ISO 13485 quality system, and one press-based cleanroom floor that runs everything from a first article to full commercial volume. Molded in the USA, in San Clemente, California.
When a part fails in the field, the failure always traces back to one of the four. So that's how our capabilities are organized. We take ownership of all four — so you own none of them. The depth lives on each capability page; this page is the map.
Late-model LIM presses, fully automated work cells, robot demolding, cleanroom environment molding, 24/7 operations.
→ Molding & MaterialsClass 101 and Class 102 tooling stewardship end to end: mold design, DFM, cavitation strategy, vendor management, validation, transfer.
→ Engineering & ManufacturingLSR from every major supplier, HCR gum silicone, EPDM, fluorosilicone, conductive grades, organic and synthetic rubber, custom elastomer formulation to spec.
→ Molding & MaterialsValidated (IQ/OQ/PQ) using scientific molding methods, lean, flashless where it matters.
→ Engineering & ManufacturingLiquid injection molding, gum molding, compression rubber molding, transfer molding, and flashless molding all run under one ISO 13485:2016 quality system — certificate scope: "Custom Critical-To-Function Engineered Components."
Your part arrives as a print. Between that print and a validated production cell sits the work that decides whether a program holds for years: technical sessions where our engineers deep-dive the design, manufacturability review that surfaces problems before steel is cut, and program management that carries the part from first article through full production. It's what separates IRP from the commodity shops below us — and from the contract manufacturers above us.
You own the component design. Our engineers make it moldable, measurable, and repeatable — recommending changes so the part can actually be made at your tolerances and volumes.
Technical sessions that deep-dive the design before tooling: geometry, material selection, cavitation strategy, and how every Critical-To-Function dimension will be measured.
Every step IRP absorbs — tooling management, validation, sterilization coordination, packaging — is a step your team doesn't have to source, qualify, and manage.
Customers tend to define IRP by the one component they buy. The range is wider — each capability below carries its own page, and its own depth.
Liquid injection molding (LSR), compression rubber molding, transfer molding, overmolding / insert molding, and gum molding — with a materials portfolio spanning LSR from every major supplier, HCR gum silicone, EPDM, fluorosilicone, conductive grades, and organic and synthetic rubber, compounded to spec.
Explore Molding & Materials →The operations that finish a molded part: slitting, die cutting, deflashing, sub-assembly, complex inspection, sterilization through a qualified partner, and packaging. Each one a vendor your team doesn't have to source, qualify, and manage.
Explore Secondary Operations →Continuous silicone profiles and silicone tubing, extending the molded portfolio.
Silicone Extrusion →3D-printed reference parts and quick-turn prototype tooling — functional elastomer parts in hand before production steel is cut.
Prototyping →Custom elastomer formulation to spec — LSR, HCR gum silicone, EPDM, fluorosilicone, and conductive grades — when the right compound doesn't exist off the shelf.
Material depth lives under Molding & Materials →IRP manages the life of your tool — mold design, DFM, cavitation strategy, mold-vendor selection and management, validation, and transfer. You get the right tool for the program's life without ever managing a toolmaker.
Tooling lives under Engineering & Manufacturing →ISO 13485:2016 certified and FDA registered — the two marks that matter — with ISO Class 8 cleanroom environment molding, validated processes, and functional testing.
Explore Quality →These run side by side on one floor, under one quality system. No geometry gets forced into the wrong process, and no material gets chosen for our convenience.
Two-part liquid silicone rubber, metered, mixed, and injected into heated precision tooling — automated end to end for Critical-To-Function silicone components.
Where rubber is molded — rubber isn't injected, it's compression molded. Organic and synthetic rubber compounds, and larger silicone geometries, formed under heat and pressure.
Tighter dimensional control for multi-cavity work and molding around inserts, including flashless transfer tooling.
Silicone or rubber bonded to metal, plastic, or another silicone — one bonded, validated sub-assembly from one supplier.
High-consistency gum silicone for parts that need physical or chemical properties liquid silicone can't deliver, with compounds formulated to your spec.
Flash controlled at the source — tooling that molds the part clean instead of paying to deflash it downstream. In a medical device, flash is a contamination risk, not a cosmetic one.
A molded part often isn't a finished component. Cutting, converting, joining, and packaging usually mean another vendor, another PO, another quality handoff — and one more supplier inside your audit scope.
Precision slitting that turns molded stock into finished valves and components.
Components converted to final shape from molded sheet and stock.
Flash removed where the process can't eliminate it at the source.
Molded components joined and delivered as one validated sub-assembly.
Custom inspection solutions engineered per program — including vision processes for parts standard inspection can't see.
Coordinated through a qualified partner.
Device packaging, done where the part is molded.
Every operation on this list is one your team doesn't have to source, qualify, and manage. The more steps we absorb, the fewer suppliers you carry — and the smaller your audit scope gets.
Most customers first buy a single part — a valve, a seal, a septum — and assume that's all we make. Custom silicone and rubber components from this floor run across every application area medical devices touch.
IRP sits in a specific place: above the commodity shops that take a print and ship parts, below the contract manufacturers that build entire devices. Here is exactly where the lines sit.
What we bring is design for manufacturability and mold design: technical sessions, manufacturability review, recommended changes so the part can actually be made, and the tooling engineered to make it. The component design is yours; making it manufacturable is ours.
We mold thermoplastic substrates in service of an elastomer component — the plastic half of an overmolded part, produced so both halves of the bond carry one accountable name. If your program pairs extruded thermoplastic with the elastomer, bring it into the same conversation and we'll scope it with you.
If you're outsourcing the entire device, you need a contract manufacturer. We make the custom components the device can't function without, delivered as parts or sub-assemblies — we don't do final device assembly.
If the part is commodity rubber bought on price, we're not your molder — and we won't pretend to be. But if the part is small on the BOM and total on the function — send the print.
Both. Silicone is an elastomer, not a rubber — and IRP molds across the elastomer family. Liquid silicone rubber (LSR) runs by liquid injection molding, high-consistency gum silicone runs by gum molding, and organic and synthetic rubber compounds run by compression rubber molding and transfer molding. Rubber isn't injection molded — it's compression molded.
If the application calls for a non-silicone elastomer, we compound and mold to spec.
In practice they're the same engineering conversation, which is why we always pair them. Insert molding loads a component — typically metal, like a cannula — into the mold and forms silicone or rubber around it. Overmolding bonds silicone or rubber over an existing substrate: a plastic housing, another silicone.
Either way, you get one bonded, validated sub-assembly from one supplier instead of two suppliers and an adhesive step.
Yes. Sterilization is coordinated through a qualified partner, and packaging is handled in-house. Along with slitting, die cutting, deflashing, sub-assembly, and complex inspection, these are secondary operations we absorb so your team doesn't have to source, qualify, and manage a separate vendor for each step.
No — and we're direct about that. The customer owns the component design. What IRP brings is design for manufacturability: technical sessions where our engineers deep-dive your design, flag what won't mold, measure, or scale, and recommend changes so the part can actually be made at your tolerances and volumes. We also design the molds.
The component design is yours; making it manufacturable is ours.
No. Contract manufacturers build finished devices. IRP makes the custom silicone and rubber components that go into your device — molded, finished through secondary operations, and delivered as parts or sub-assemblies. Building the finished device isn't our scope, which is exactly why device OEMs and contract manufacturers alike use us as the component supplier.
New program or supplier transfer — it starts with the print.