Critical-To-Function Components for Medical Devices

The industry is the same.
The physics of failure aren't.

Nobody makes “medical devices.” You make an infusion set, a surgical instrument, a diagnostic cartridge, and each one imposes genuinely different demands on the components inside it: biocompatibility, tolerance, sterilization method, volume, regulatory pathway. A component supplier has to know which apply to your part, mold against them, and prove them at release, lot after lot.

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ISO 13485:2016 · BSI FM 590598/ FDA-Registered/ ISO Class 8 Cleanroom Environment Molding/ Made in the USA/ 24/7 Operations
Applications

Every application.
One component discipline.

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.

Largest market

Diabetes

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.

Explore Diabetes

Wearables

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.

Explore Wearables

Fluid Path

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.

Explore Fluid Path

Women's Health

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.

Explore Women's Health

Cardiology

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.

Explore Cardiology

Diagnostics

Gaskets, seals, valves, and fluid-handling components for instruments and consumables: parts where dimensional repeatability and particulate control decide whether the assay runs.

Explore Diagnostics

Surgery

Seals, diaphragms, and overmolded / insert molded sub-assemblies for surgical instruments and equipment: components that must hold their elastic response through repeated sterilization cycles.

Explore Surgery

Wound Care

Skin-contact silicone components in soft durometers: material selection to the biocompatibility spec, and molding repeatable enough to trust for wear measured in days.

Explore Wound Care

Orthopedics

Seals, gaskets, and overmolded / insert molded components for orthopedic instruments and delivery systems: parts that hold their mechanics through repeated sterilization cycles.

Explore Orthopedics

Dental

Custom elastomer components for dental instruments and delivery systems: small, tight-tolerance parts where material compliance and repeatability drive the spec.

Explore Dental

Pharma

Septa, seals, and closure components for pharmaceutical packaging and delivery: drug-contact parts where compound selection and contamination control carry the regulatory weight.

Explore Pharma

Many other applications.

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

The application list is open at the edges. We engage at the print, answer feasibility fast, and if we can't mold the part, we say so fast too.

One Risk Model

Different devices.
The same four ways to fail.

Across every application we serve, critical-to-function elastomer components fail in four ways. The whole operation, from component families to molding processes to lot-release testing, is organized around preventing exactly these.

Failure classWhat it looks like in the fieldThe componentHow it's provenThe 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 and 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 critical-to-function 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

Swipe to see every column

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.

Capabilities

The application changes.
The discipline doesn't.

Every quality part takes a machine, a mold, a material, a process, and the team behind them, and we take ownership of every one. 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.

Explore Capabilities
Materials & Compliance

The material carries
the compliance burden.

Across every application, the material decision is where biocompatibility, sterilization, and drug contact get resolved before the first part is molded.

Biocompatibility

Materials selected to the biocompatibility spec for the contact type and duration your application dictates: skin contact, tissue-adjacent, drug contact.

USP Class VI

Medical-grade silicone and elastomer compounds available in USP Class VI grades where the application demands it.

Sterilization Compatibility

Compound selection accounts for the sterilization method your device will see.

Molding & Materials
FAQ

What sourcing engineers ask.

What medical applications does IRP serve?
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.
Can IRP work on Class II and Class III device components?
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.
Does IRP make finished devices?
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.
Does IRP work with early-stage device companies as well as large OEMs?
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, with no mid-program supplier change standing between your device and its volumes.
Next Step

If your component is on this page,
or should be, send the print.

New program or supplier transfer,
it starts the same way.

Starting a new program?

From clinical builds to commercial scale, engage our engineers at the print.

Start Your Program

Transferring a program or mold?

Revalidation is a given. We plan it around your inventory bank, so your line keeps running while we qualify.

Transfer Your Program
Typography preview
Preview only. Your pick follows you across the design pages.