Medical injection molding, from first shot to multi-million-part programs
Scientific injection molding for medical device components in medical-grade and high-temperature resins, with ISO Class 8 cleanroom molding and in-house tooling, made in the U.S.
UTP Solutions is an injection molder with an ISO 13485 certified quality system at an FDA-registered U.S. facility for medical device companies. We mold on 16 presses from 22T to 950T using scientific (decoupled) molding, so each part is made inside a documented, validated process window. We handle insert molding, overmolding, two-shot (2K), vertical and high-temperature molding in resins including PEEK, PEKK, PPSU, Ultem (PEI) and polycarbonate. Programs run from about 100 parts a year to multi-million EAU, with no minimum order. We cross-validate programs on matched presses from 22T to 950T, so a program can move between presses during maintenance without downtime.
Molding capabilities
| Presses | 16 presses, 22T–950T |
|---|---|
| Micro and vertical molding | 28T Arburg vertical for micro overmolding, needle hubs and cannulas · 102T Arburg vertical for stylets, driver assemblies, introducers, guides and electrical component housings |
| Two-shot (2K) | 600T two-shot press for high-cavitation soft-touch handles, integrated seals and housings |
| Large tonnage | Up to 950T for structural components, OR accessories, product dispensers and OR console housings |
| Cross-press validation | Matched presses in the 22T, 110T, 390T, 720T and 950T ranges, with matching barrel and screw combinations and dryer setups, validated with capability studies so a program can run on more than one press |
| Processes | Scientific (decoupled) molding · insert molding · overmolding · two-shot (2K) · vertical molding · high-temperature molding · mold-in-color |
| Materials | PEEK, PEKK, PPSU, Ultem (PEI), polycarbonate and other engineering and medical-grade resins. Qualified grades confirmed per program. |
| Cleanroom | ISO 14644-1 Class 8 cleanroom molding and assembly |
| Annual volume | About 100 parts a year to multi-million EAU programs · higher volumes through added cavitation and multiple tools · no minimum order quantity |
| Prototypes | Rapid prototype tooling in about 3 weeks, depending on part complexity |
| Automation | Automated where volume justifies it, with end-of-arm tooling designed and built in-house, including a collaborative robot cell for stainless steel tube bending on suction devices |
| Process control | DOE, documented process windows, SPC, IQ / OQ / PQ support |
| Metrology | Onsite QC laboratory with equipment including two CMMs measuring features to 0.0001" and a Keyence vision measurement system · tolerances confirmed per part during DFM |
| Quality system | ISO 13485 certified · ISO 9001 · IATF 16949 · FDA-registered facility |
Where we help
Micro and insert molding
Micro overmolding, needle hubs and cannulas on a 28T vertical, and stylets, driver assemblies, introducers and guides on a 102T vertical.
Insert- and overmolded assemblies
Metal inserts, stylets, cannulas and PPSU or thermoplastic instrument handles overmolded onto shafts machined in our own shop.
High-temperature resin parts
PEEK, PEKK, PPSU and Ultem parts that need heat resistance, chemical resistance or repeated sterilization.
Two-shot handles and seals
High-cavitation soft-touch handles, integrated seals and housings on a 600T two-shot press.
Cleanroom-molded parts
Components molded and assembled in our ISO Class 8 cleanroom for programs with contamination limits.
Large structural parts
Structural components, OR accessories, product dispensers and OR console housings on presses up to 950T.
How we control the process
Scientific injection molding treats the process as the product. Our engineers separate fill, pack and hold (decoupled molding), run DOE to find a robust process window, and document it before validation. In production, SPC watches the critical dimensions so drift gets caught before it becomes a reject.
That discipline pays off twice. Validation goes faster because the process was characterized first. And when you scale, the same process window carries from the first production lot to full volume.
Cross-press validation keeps your program running. Wherever possible, we run matched presses in the 22T, 110T, 390T, 720T and 950T ranges with the same barrel and screw combinations and dryer setups. We validate your process and run capability studies across them, so if one press is down for maintenance, your mold moves to another without requalification delays or lost production.
From prototype tool to production mold
- DFM and MoldFlow first. We review gate location, wall thickness, draft and material choice before steel is cut.
- Rapid prototype tooling in about 3 weeks to prove the part in the real resin.
- Bridge tooling when you need launch quantities before the production mold is ready.
- Production molds built for the volume you're heading toward, with in-house repair and maintenance.
- Existing molds welcome. We take tool transfers and typically shoot first parts within 3 business days of arrival when no repairs are needed.
Injection molding questions
What is the minimum order quantity for injection molding at UTP?
There is no minimum. Programs run from about 100 parts a year to multi-million EAU, and higher volumes are handled with added cavitation and multiple tools.
What happens if my mold's press is down for maintenance?
Wherever possible, we cross-validate programs on matched presses in the 22T, 110T, 390T, 720T and 950T ranges, with the same barrel and screw combinations and dryer setups, and run capability studies across them. If one press is down for maintenance, your program runs on its matched press without downtime.
Can UTP mold PEEK and other high-temperature resins?
Yes. We mold PEEK, PEKK, PPSU, Ultem (PEI) and other high-temperature and medical-grade resins. The qualified grade is confirmed for each program during DFM.
Does my part need cleanroom molding?
It depends on the device's contamination limits, the downstream cleaning and sterilization steps, and your risk assessment. Many components don't need a cleanroom. When yours does, we mold and assemble in our ISO Class 8 cleanroom. An engineer can help you decide during DFM.
How long does a prototype mold take?
Rapid prototype tooling takes close to 3 weeks, depending on part complexity.
What tolerances can you hold on molded parts?
Achievable tolerances depend on the resin, geometry and feature size, so we confirm them per part during DFM. Our QC lab measures features down to 0.0001" on CMM.
Do you support process validation?
Yes. We support IQ, OQ and PQ to your protocol, with first article inspection and documented process windows from scientific molding.
Is UTP a medical injection molder in Michigan?
Yes. UTP Solutions molds medical device components at its facility in Evart, Michigan, and supports device companies across the United States, from Michigan and the Midwest to both coasts. Customers are welcome to visit for process reviews, audits and tool transfers.
Talk to an engineer, not a call center.
Send the drawing, the resin and the volume. A UTP engineer replies within two business days with what's feasible before you commit to tooling.