From concept to validated production with one manufacturing partner
For device companies with a concept or early design: DFM, steel prototype tooling, molding, machining, assembly and validation under one roof, with no minimum order.
UTP Solutions takes medical devices from concept or early design to validated production in one U.S. facility. Engineers start with DFM reviews and in-house mold-fill simulation, build prototype tools in steel with water lines so early parts produce usable process data, then mold, machine, assemble and package parts under one ISO 13485 certified Integrated Management System. Validation runs as IQ, OQ and PQ, and there is no minimum order, so emerging medtech companies can start small and scale without changing partners.
The path from concept to launch
DFM and design review
Engineers pressure-test manufacturability, run mold-fill simulation and flag risks before steel is cut. Need CAD or part design? We can create it.
Prototype tooling in steel
Steel tools with water lines run like production, so the process data from early parts carries forward. The same tool can serve as a bridge tool and absorb many engineering changes. Aluminum is available if you prefer it.
Molding and machining
Scientific injection molding, ISO Class 8 cleanroom molding and Swiss and 5-axis machining under one roof.
Assembly and packaging
Joining, finishing, UDI marking, cleanroom packaging and sterilization coordinated through qualified providers.
Validation, testing and design transfer
IQ / OQ / PQ, DFMEA and PFMEA, support for your risk file and design history file, and coordination of biocompatibility, transit, sterile barrier and sterilization validation testing.
Production and supply chain
Ramp on validated processes, with inventory programs and component sourcing to protect continuity.
Built for emerging medtech
- No minimum order. Start with prototypes and first articles without committing to volume.
- Engineers who have been on the OEM side. We understand design controls, human factors and launch dates that can't slip.
- One partner from first tool to volume. No re-sourcing between prototype and production.
- A reply within two business days. From an engineer, not a quote queue.
New product introduction questions
Does UTP work with startups and emerging medtech companies?
Yes. UTP supports early-stage device companies with DFM, prototype tooling and first articles, with no minimum order.
Can UTP take a design from concept to production?
Yes. UTP covers DFM, tooling, molding, machining, assembly, packaging, validation and supply chain in one U.S. facility.
Why does UTP build prototype tools in steel?
Steel tools with water lines run like production tools, so early parts produce usable process data and fewer surprises at validation. Aluminum tools are available on request.
Does UTP help with validation?
Yes. UTP runs IQ, OQ and PQ and supports customers' risk files and design history files during design transfer.
Talk to an engineer, not a call center.
Bring your concept, drawings or current pain point. A UTP engineer replies within two business days with real guidance.