A prototype should answer the questions your production part will face. Ours are molded by the same engineers, in the same materials, on the same processes that will carry your part to full commercial scale, so what you learn in the first run still holds true at the millionth.
Early parts get made however is fastest: a one-off tool, a short-run shop, a material that was on hand. They look right. They fit right. The team moves on.
The prototype is judged on form and fit, because that is all a one-off tool and a convenient material can really tell you.
A production supplier, a production tool, a production process. Dimensions drift. Flash appears where it never did. A sealing surface that sealed in the lab weeps in the fixture.
Every change sends the part back through testing, and the launch date moves by quarters, not weeks. The prototype did its job. It just answered the wrong question.
Prototype suppliers and production suppliers are usually different companies. At each handoff the mold changes, the material lot changes, the process changes, and the people who learned the part's quirks leave the program. It is the first re-source on the program, and it happens before the device has shipped a single unit.
When it is time to scale, the path is already set: prototype tooling informs the production tool, the process parameters carry over, and the quality system never changes.
Qualify once. One partner from first sample to the life of the device. The part you learn in the first run is the part you keep receiving at full commercial scale, from the same floor, under the same quality system.
Each step is part of the production program, so nothing is thrown away and nothing has to be relearned.
Our engineers review your design for moldability, tolerances, parting lines, and gate locations, and flag risks while they are still easy to change.
We recommend the right established grade for the application, or develop a custom compound when no established grade will hold the requirement. Material Development →
We own the tooling process from requirements through design, DFM, vendor selection and management, and validation, with a cavitation strategy that looks past the first run to the volumes ahead. You never deal with a toolmaker.
Parts are molded in the press and the process is dialed in: temperature, pressure, cure, and cycle, all tuned to hold your critical-to-function dimensions.
Sample parts are measured and documented against your print before the program moves forward, with non-contact vision metrology where the geometry demands it.
Once the part and process are proven, the program moves into IQ, OQ, and PQ and into production with the same team, the same process, and the same quality system behind it.
Most molders are built for one end of the volume curve. The ones built for high volume will not take a clinical build seriously. The ones built for short runs cannot carry you to commercial scale.
We run both, on one floor, under one quality system: from first articles and clinical builds measured in pieces to high-volume programs measured in hundreds of millions of parts a year. As volumes grow, cavitation and automation scale on a planned, staged path, validated at each step, without restarting the program.
The people who learned your part in the first run are the people who produce it.
Parts are developed on a real mold and a real process, so early results predict production results.
The first supplier change most programs make happens before they ship. This one never has to.
The questions production will ask get answered first, which is what actually shortens the path to launch.
Proof that the prototype and the production part come from the same system.
On one floor, under one quality system.
Both ends of the volume curve, run side by side.
From the first sample forward.
Certificate scope: "Custom Critical-To-Function Engineered Components."
Molding elastomers.
When programs require it.
Early builds can be very small. Quantities are set by what your program needs at each stage. We prototype for parts headed to production, so we will ask about the volumes ahead as well as the first run.
We own the tooling process: requirements, design, DFM, cavitation strategy, mold vendor selection and management, validation, and transfer. You get the right tool for the part, the material, and your volume and cost targets, without ever managing a toolmaker.
The same materials we mold in production, including liquid silicone rubber, HCR gum silicone, fluorosilicones, conductive grades, and organic and synthetic rubber compounds. Prototyping in the production material is the point.
Without a handoff. Your part moves from sampling and first article into validation and production at IRP Medical, with the same team and process behind it.
Yes. New programs typically begin under a mutual nondisclosure agreement before drawings or files are shared.
Send us your design and tell us where you are in development. Our engineers will map the path from first sample to full scale.