Medical device contract manufacturing, from design transfer to validated production
Precision machining, scientific injection molding, tooling, cleanroom assembly, validation support and supply-chain execution for medical device companies, under one ISO 13485 certified quality system in the U.S.
UTP Solutions is a medical device contract manufacturer with an ISO 13485 certified quality system at an FDA-registered U.S. facility. We machine precision metal and polymer components on Swiss-type lathes, 5-axis machining centers and EDM, and mold critical components with scientific, decoupled injection molding on 16 presses from 22T to 950T, including ISO Class 8 cleanroom molding. We build our own tooling, assemble and package subassemblies and finished devices, and manage the supply chain behind them, from first article through commercial supply. Emerging device companies and established OEMs work with one accountable, engineer-led team instead of a chain of suppliers.
UTP at a glance
| Quality system | ISO 13485 certified · ISO 9001 · IATF 16949 · FDA-registered facility · CMMC Level 1 · ITAR compliant |
|---|---|
| Precision machining | Swiss-type CNC turning to 20 mm · 3-, 4- and 5-axis milling · wire and sinker EDM · grinding to ±0.0001" |
| Injection molding | 16 presses, 22T–950T · scientific (decoupled) molding · insert, overmolding, two-shot, vertical and high-temperature molding · ISO Class 8 cleanroom |
| Tooling | In-house mold design, build, repair and transfer · rapid prototype tools in about 3 weeks · end-of-arm tooling built in-house |
| Assembly and finishing | Cleanroom and controlled assembly · ESD-protected PCBA integration · wire harness and connector assembly · ultrasonic and RF welding, heat staking, UV and solvent bonding · in-house cleaning, passivation and UDI laser marking · robotic stainless steel tube bending · packaging |
| Supply chain | Managed suppliers · heat treat, polishing and anodizing through qualified suppliers · EtO and gamma sterilization coordination · inventory programs and distribution |
| Metrology | Equipment includes two CMMs measuring features to 0.0001", a Keyence vision system and a profilometer · MSA including Gage R&R · capability studies |
| Volumes | Molding from about 100 parts a year to multi-million EAU · machining from prototype through production · no minimum order |
| Response | An engineer replies within two business days |
Start where your program is
I have a concept or early design
DFM, prototype tooling and first articles that make the design manufacturable before you commit to production tools. New product introduction
I'm ready for design transfer
Process development, qualification and validation support aligned to your design history file and submission timeline. Design and engineering · Regulatory and testing support
I need a new or second source
Move a mold or machining program without a supply gap. First shots typically within 3 business days when the tool arrives ready to run. Mold transfer and second source
I'm scaling to volume
Validated processes, SPC and automation where volume justifies it, plus inventory programs that keep you shipping. Supply chain management
Capabilities
Precision machining
Swiss turning, 5-axis milling, EDM and grinding in titanium, stainless steel and PEEK.
Orthopedic implants and instruments
Bone screws, baseplates, knee system components, reamers and drivers for knee, trauma, spine, sports medicine and CMF.
Scientific injection molding
Decoupled molding in PEEK, PPSU, Ultem and other medical-grade resins, from about 100 parts a year to multi-million EAU.
Cleanroom molding and assembly
ISO Class 8 cleanroom molding, assembly and packaging with a monitored environment.
Tooling
Prototype, bridge and production molds designed, built and maintained in-house.
Assembly and system integration
Subassemblies and finished devices that combine molded, machined and electronic components.
Why device companies choose UTP
- You talk to engineers. Questions go to the people who run the process, not a call center or a quote queue.
- Metal and polymer under one quality system. Machined inserts go straight into insert molding, and machined and molded parts meet in our own assembly, so you manage one supplier and one quality agreement.
- Design transfer built from the OEM side. Our design transfer process was built from OEM experience in design controls and human factors, so user requirements carry through into manufacturing instead of getting lost in the handoff.
- U.S. manufacturing since 1974. Domestic supply with the documentation and traceability regulated programs depend on.
Medical applications
Medical device contract manufacturing questions
What does a medical device contract manufacturer do?
A medical device contract manufacturer builds components, subassemblies or finished devices to the device company's design, under a quality system such as ISO 13485. At UTP that covers DFM, tooling, precision machining, injection molding, assembly, packaging, process qualification and validation support, and the supply chain that keeps product shipping. The device company owns the design and its regulatory clearance.
Do you work with early-stage medical device companies?
Yes. Emerging device companies are a core part of our business. We help with DFM, prototype tooling and first articles early, so the design is manufacturable before you invest in production tooling, and there is no minimum order.
Is UTP ISO 13485 certified and FDA registered?
Yes. UTP's quality system is ISO 13485 certified, its U.S. facility is FDA registered, and UTP also holds ISO 9001, IATF 16949 and CMMC Level 1 certification.
Can one supplier handle both machining and molding?
Yes. UTP machines and molds in the same facility under one quality system, including insert-molded parts with machined metal inserts and assemblies that combine both.
Do you handle sterilization?
We coordinate EtO and gamma sterilization through qualified sterilization providers, along with packaging, so you receive finished product from one source.
Where is UTP located?
UTP Solutions is in Evart, Michigan, and serves medical device companies across the United States.
Talk to an engineer, not a call center.
Bring the part, program, capacity gap or supplier risk. A UTP engineer replies within two business days with the fastest credible path to qualified production.