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New program or supplier transfer, it starts the same way.
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Nobody makes "medical devices." You make an infusion set, a surgical instrument, a diagnostic cartridge — and each application imposes genuinely different demands on the components inside it: biocompatibility, tolerance, sterilization method, volume, regulatory pathway. A component supplier has to understand which of those apply to your part — then mold against them, and prove them at release, lot after lot.
Every application below is served from the same operation — custom silicone and rubber molding, secondary operations, and functional lot release. What changes is which constraints lead: each card names the component types we mold for that application and the demands that decide how they're made.
Our largest market. Infusion set and pump components — septa, seals, valves, and tubing — molded at sustained, automated volume for programs where supply can't hiccup.
Diabetes →Skin-contact silicone and bonded sub-assemblies for on-body devices — soft durometers that flex with the wearer, materials selected to the biocompatibility spec, and volumes that scale when the product wins.
Wearables →Check valves, duckbill valves, septa, seals, and silicone tubing — the components the drug or fluid travels through, molded flashless where flash is a contamination risk and released on function, not just dimension.
Fluid Path →Seals, valves, and skin- and tissue-adjacent silicone components for compact devices with long wear and dwell durations — tight tolerances, materials selected to the biocompatibility spec, and parts a patient actually feels.
Women's Health →Seals, diaphragms, and precision-molded silicone components for programs where qualification is measured in years — validation-first tooling, a locked process, and functional release on every lot.
Cardiology →Gaskets, seals, valves, and fluid-handling components for instruments and consumables — parts where dimensional repeatability and particulate control decide whether the assay runs.
Diagnostics →Seals, diaphragms, and overmolded / insert molded sub-assemblies for surgical instruments and equipment — components that must hold their elastic response through repeated sterilization cycles.
Surgery →Skin-contact silicone components in soft durometers — material selection to the biocompatibility spec, and molding repeatable enough to trust for wear measured in days.
Wound Care →Custom elastomer components for dental instruments and delivery systems — small, tight-tolerance parts where material compliance and repeatability drive the spec.
Dental →Septa, seals, and closure components for pharmaceutical packaging and delivery — drug-contact parts where compound selection and contamination control carry the regulatory weight.
Pharma →Seals, gaskets, and overmolded / insert molded components for orthopedic instruments and delivery systems — parts that hold their mechanics through repeated sterilization cycles.
Orthopedics →These are the applications we're in most often — not the limit. If the part is a custom, critical-to-function elastomer component for a medical device, we can almost certainly mold it. Send the print and we'll tell you fast.
Tell Us Your Application →If the part is a custom, critical-to-function elastomer component, the application list is open — we engage at the print, answer feasibility fast, and if we can't mold the part, we say so fast too.
Across every application we serve, critical-to-function elastomeric components fail in four ways. The entire operation — component families, molding processes, lot-release testing — is organized around preventing exactly these.
| Failure class | What it looks like in the field | The component | How it's proven | The process behind it |
|---|---|---|---|---|
| Sealing & reseal | A seal that weeps in storage; a septum that cores or won't reseal after repeated puncture | Septa & seals | Leak-tested lot release | Flashless and transfer molding — no flash, no deflash handling, no contamination path |
| Flow control | A check valve that cracks at the wrong pressure, passes backflow, or occludes | Valves & duckbills | Functional release on flow behavior; inflation testing | Liquid injection molding plus precision slitting and finishing |
| Elastic response | A diaphragm that loses rebound or drifts under repeated actuation | Diaphragms | Rebound & response testing before shipment | LSR or HCR compounded to your property spec, under a locked process |
| Bonded interfaces | An overmold that delaminates from its metal, plastic, or silicone substrate | Overmolded sub-assemblies & custom CTF components | Validated under IQ/OQ/PQ; inspected with non-contact vision metrology | Overmolding / insert molding — every overmold a bonded, validated sub-assembly from one supplier |
Whatever you searched to get here, the part you need lives in one of these four rows — and every row is proven on function, not just measured on dimension.
Every quality part needs four things — a machine, a mold, a material, and a process — and we take ownership of all four. The same process range serves every application on this page: liquid injection molding, compression rubber molding, transfer molding, overmolding / insert molding, silicone extrusion, and the secondary operations that finish the part. What changes is the selection — the application's demands decide the process, the material, and the release tests.
Behind every selection sits the same validation stack: FAI, MSA, DOE, IQ/OQ/PQ, and complete lot traceability. Which is why the proof reads the same wherever the part ends up: a validated process, and function demonstrated physically.
Across every application, the material decision is where biocompatibility, sterilization, and drug contact get resolved — before the first part is molded.
Materials selected to the biocompatibility spec for the contact type and duration your application dictates — skin contact, tissue-adjacent, drug contact.
Medical-grade silicone and elastomer compounds available in USP Class VI grades where the application demands it.
Compound selection accounts for the sterilization method your device will see.
Diabetes, wearables, fluid path, women's health, cardiology, diagnostics, surgery, wound care, orthopedics, dental, pharma — and many more. The list is open at the edges — if the part is a custom, critical-to-function elastomer component for a medical device, we review the print and answer feasibility fast. If we can't mold the part, we say so fast too.
Yes — as a component supplier. IRP molds custom silicone and rubber components that go into Class II and Class III devices; the device classification and registration stay with the OEM. IRP's ISO 13485:2016 quality system, IQ/OQ/PQ validation, and complete lot traceability are built to support component qualification at that level.
No. IRP is a component supplier, not a contract manufacturer. IRP molds custom medical components and bonded sub-assemblies that go into other companies' devices — the finished device and its registration remain with the OEM.
Yes. The engagement starts the same way at any size: send the print and an engineer reviews it for manufacturability. Tooling and process strategy are planned so the same supplier carries the program from feasibility runs and clinical builds through full commercial volume — no mid-program supplier change standing between your device and its volumes.
New program or supplier transfer, it starts the same way.