You either have a part that's hard to make, or a supplier who only has one answer for it. This page is the difference: a technical review before tooling is cut, a process chosen around your part, and a scope that keeps shrinking your team's vendor list.
Not a sales funnel with engineering bolted on at the end — engineering at the front, where it can still change the outcome. Eight steps, in the order they happen.
It starts engineering-to-engineering, not with a sales call. Your engineers and ours, on the print, the application, and the constraints — a deep dive into the project before anyone talks price.
Whether the part as drawn can be manufactured well — and what to change if it can't. Specific recommendations, each with the reason attached. Detailed in its own section below.
Most programs arrive with a material already selected. We pressure-test that selection against the process, the application, and the device's life, and support qualification of the final choice. The work here is selection and validation support — matching a material to the part and proving the choice — with custom compound development when the right material doesn't exist off the shelf.
The tool is designed for the program's life, not its first purchase order: requirements, cavitation strategy, mold design, mold-vendor selection and management, validation, and transfer. You get the right tool without ever managing a toolmaker.
The process is chosen around the part — not the other way around. Liquid injection molding, gum silicone molding, compression rubber molding, transfer molding, overmolding / insert molding — with silicone extrusion and silicone tubing when the part calls for a continuous profile. Because they run side by side under one roof, the part is never forced into whichever process a supplier happens to own.
IQ/OQ/PQ process validation and first-article inspection — evidence your quality team can defend for years, not just at launch.
Cleanroom environment molding on a press-based floor, automated where volume demands it, running 24/7 when programs do — from first articles through full commercial volume, under one ISO 13485:2016 quality system.
Precision secondary operations, sub-assembly, and packaging in-house; sterilization coordinated through a qualified partner. Detailed under Scope Reduction below.
A customer comes to us and says: make this. It's rarely that simple — and pretending it is, then quoting anyway, is how programs end up paying for the same tool twice. So we deep-dive into the project and the design first, and come back with solutions: manufacturability.
The print as a manufacturing problem: geometry, tolerances, material callout, and how the part will be molded, demolded, inspected, and handled at production volume — not just whether it can be quoted.
Specific changes, each with the reason attached — what it does to tooling, cost, and quality over the program's life. The recommendations are ours; every decision stays yours.
The issues that are cheap to fix on a print and expensive to fix in steel. Found in a technical review, they cost you a conversation. Found after tooling is cut, they cost you a tool — and a timeline.
You own the component design — we make it manufacturable. What IRP brings is design for manufacturability and mold design: manufacturability review, recommendations, and the tooling and process engineering to produce the part you designed. The device, the component design, and the regulatory submission are yours.
Every step IRP absorbs is a step your team doesn't have to source, qualify, manage, and audit. The more we take on, the shorter your vendor list gets — and the less of your program lives in handoffs between suppliers.
| Scope IRP absorbs | How it's delivered | What comes off your team's plate |
|---|---|---|
| Tooling program | Mold design and engineering by IRP; fabrication through IRP-managed mold vendors | Sourcing, qualifying, and managing a toolmaker |
| Secondary operations | In-house | A converting vendor, another PO, another quality handoff |
| Sub-assembly | In-house, cleanroom | One more supplier inside your audit scope |
| Packaging | In-house | Sourcing and qualifying a packaging supplier |
| Sterilization | Qualified third party, selected and coordinated by IRP | Sourcing, qualifying, and scheduling a sterilization provider |
| Outside resources & specialty processes | Qualified partners, coordinated by IRP | Finding and auditing the vendors each extra step would otherwise add |
Where a step is partner-delivered, we say so. The sterilizer is a qualified third party and stays visible as one on the paperwork — what changes is who has to find, qualify, and manage them.
We can't do everything ourselves — no honest supplier can. But we can help you get to everything, and every step we take on is one less for your team to carry.
One press-based floor in San Clemente, California — different processes, materials, and programs running side by side, under one ISO 13485:2016 quality system.
Liquid injection molding, gum silicone molding, compression rubber molding, transfer molding, and overmolding / insert molding run side by side, with inspection and functional testing inside the cleanroom rather than down the hall. Automated work cells where volume demands them; 24/7 operations when programs do.
The point of the floor isn't an equipment list. It's that the process gets chosen around your part — because every option is in the building.
No — and we're direct about it. You own the component design; we make it manufacturable.
What IRP provides is design for manufacturability and mold design: a technical review of your print, specific recommendations on what to change and why, and the mold design and process engineering to produce the part you designed. The device, the component design, and the regulatory submission stay yours.
Design for manufacturability is a structured review of whether the part as drawn can be manufactured well — geometry, tolerances, material callout, and how the part will be molded, demolded, and inspected at volume.
It happens at the front of the engagement, engineering-to-engineering, before tooling is cut. An issue found on the print costs a conversation; the same issue found in steel costs a tool.
Yes. Sterilization is delivered through a qualified partner and coordinated by IRP, alongside packaging and any outside resources the program needs.
Your team doesn't have to source, qualify, and schedule a sterilization provider, and the partner remains visible on the paperwork.
No. A contract manufacturer builds your finished device. IRP is a component supplier: we manufacture the custom silicone and rubber components inside the device — molded, finished, sub-assembled, and packaged as required — while you own the device, the design, and the regulatory submission.
The roles are complementary: contract manufacturers are often the ones installing our components.
The print is the starting point — geometry and tolerances, the material callout if one has been selected, expected annual volumes, and any sterilization, packaging, or secondary-operation requirements.
If some of that isn't settled yet, send the print anyway: the first step is a technical review, not a form, and unresolved questions are exactly what it's for.
New program or supplier transfer — the first step is a technical review of your print, engineering-to-engineering. Bring the part that's hard to make.