One U.S. partner from concept to validated production.
UTP Solutions helps medical device companies get to market faster and with less risk. Design transfer, tooling, scientific injection molding, precision machining, cleanroom assembly and supply chain support, all under one roof and one Integrated Management System.
UTP Solutions is a Michigan-based, ISO 13485 certified and FDA-registered medical device contract manufacturer. Privately owned and veteran-led, with U.S. manufacturing roots dating to 1974, UTP combines Swiss and 5-axis precision machining, scientific injection molding on presses from 22T to 950T, an ISO Class 8 cleanroom, in-house tooling, assembly and packaging in one facility. Device companies from emerging medtech to established OEMs use UTP for design transfer, new programs, mold transfers and second sourcing, with more than 99% on-time, in-full delivery over a rolling 24 months.
Where are you in your journey?
Every path leads to the same place: a manufacturable design, validated production and a supply chain that scales with you.
I have a concept
Turn an idea or early design into a manufacturable, launch-ready product, with no minimum order.
New Product Introduction →I have a design to transfer
DFM, design transfer and validation support that carries your requirements into production.
Design & Regulatory →I need a new or second source
Move or duplicate a program without disruption. Without repairs, first shots usually come within 3 business days.
Transfer a Program →I'm scaling to production
Ramp on validated processes with supply chain continuity.
Scale to Production →Vertically integrated, from concept to commercialization
Six capabilities, one accountable team. No re-sourcing between prototype and production.
Design & Regulatory
DFM, design transfer, validation
Tooling
Prototype to production molds
Injection Molding
Scientific, cleanroom, insert
Precision Machining
Swiss and 5-axis
Assembly
Joining, finishing, packaging
Supply Chain
Sourcing, inventory, sterilization
Built by people who have been on the OEM side
Engineer-led
You talk to engineers who solve problems, not a call center or a quote queue.
Regulatory discipline
ISO 13485, 21 CFR Part 820 aligned with FDA's QMSR, design controls and IQ/OQ/PQ validation.
U.S. supply continuity
Machining, molding, tooling and assembly in one U.S. facility, so nothing waits in transit between suppliers.
Prototype to production
Scale from first tool to validated volume without changing partners.
Everything your device needs
Precision Machining
Swiss and 5-axis CNC machining of instruments, implant components and machined assemblies in titanium, stainless and PEEK.
Learn more →Scientific Injection Molding
Decoupled molding on 16 presses from 22T to 950T, including insert, overmolding and high-temperature resins.
Learn more →ISO Class 8 Cleanroom
Molding, assembly and packaging in a monitored ISO Class 8 cleanroom, with sterilization coordinated for you.
Learn more →Mold Transfer & Second Source
Bring a tool in from another molder or qualify a second source with a structured, documented transfer.
Learn more →Assembly & Value-Added
Electromechanical assembly, joining, passivation, UDI marking, cleanroom packaging and sterilization coordination.
Learn more →Quality & Certifications
One Integrated Management System covering ISO 13485, ISO 9001, IATF 16949 and CMMC, with AS9100D targeted for 2027.
Learn more →U.S. manufacturing roots
Injection press range
On time, in full (rolling 24 months)
Engineer response time
Where we work
Medical Devices
Instruments, implant components, disposables and capital equipment, from first prototype to commercial launch.
Explore →IndustryDefense & Aerospace
CMMC Level 1 and ITAR compliant machining and molding built to MIL-SPEC and MIL-STD requirements.
Explore →IndustryIndustrial / Select Automotive
IATF 16949 certified, high-volume molding for demanding industrial and select automotive programs.
Explore →Common questions
What does UTP Solutions do?
UTP Solutions is a medical device contract manufacturer offering design transfer support, tooling, scientific injection molding, Swiss and 5-axis precision machining, ISO Class 8 cleanroom molding, assembly, packaging and supply chain management in one U.S. facility.
Where is UTP Solutions located?
UTP Solutions is in Michigan and serves medical device, defense, aerospace and industrial customers across the United States.
Is UTP Solutions ISO 13485 certified?
Yes. UTP is ISO 13485 certified and FDA registered, and also holds ISO 9001, IATF 16949 and CMMC Level 1, all under one Integrated Management System. AS9100D is targeted for 2027.
Does UTP work with startups and emerging medtech companies?
Yes. Early-stage device companies get DFM, prototype tooling and first articles from a team that thinks like an OEM, with no minimum order.
Can UTP take over an existing mold?
Yes. UTP transfers molds from other molders and qualifies second sources. If no repairs are needed, first shots are usually ready within 3 business days.
How fast does UTP respond to a quote request?
A UTP engineer replies within two business days.
Talk to an engineer, not a call center.
Tell us what you're building and where you are. A UTP engineer replies within two business days with real guidance, not a sales pitch.