MI MedTech Innovation, LLCIrvine, California

Contract cleanrooms & catheter manufacturing

Build your device in a Class 10,000 cleanroom. Next month, not next year.

ISO 13485 contract manufacturing and Class 10,000 (ISO 7) cleanroom space in Irvine, California, minutes from John Wayne Airport. Dedicated benches or a private room. Staffed by our device assembly technicians or your own. Short-term or long-term.

Request a quote → Cleanroom space

Direct access to senior engineering. No account management layer.

Open bench space inside the MedTech Innovation, LLC Class 10,000 cleanroom, with microscope stations and process equipment
Quality system
ISO 13485Medical devices, certified QMS
Classification
Class 10,000ISO 7, gowned, positive pressure
Location
Irvine, CA8 minutes from John Wayne Airport (SNA)
Availability
FlexibleShort-term or long-term engagements

What we do

Bring us your subassembly at any stage. We take it to clinical build.

Engagements start at whatever stage the device is in — a single subassembly, a process that will not scale, or a frozen design needing V&V units. Four entry points, one facility.

01 / SPACE

Contract cleanroom space

Dedicated Class 10,000 benches or a private room. Staffed by our device assembly technicians or your own team. Short-term or long-term availability.

  • Dedicated benches or private rooms
  • Our technicians or your own
  • Gowning, transfer airlock, secured storage
  • Flexible term length
Space, staffing & resources → 02 / ENGINEERING

Design & development

Concept through design freeze on a five-phase gated path, led by senior engineering with more than 17 medical device launches behind it.

  • Complex catheter design
  • Design for manufacturability
  • On-site simulated-use testing
The five-phase program → 03 / BUILD

Contract manufacturing

Prototype, verification and validation, and clinical-quantity builds assembled under an ISO 13485 quality system with senior engineering oversight.

  • V&V and clinical builds
  • Work instructions and DMR
  • Supply chain finalization
Scope a build → 04 / SURFACE

Hydrophilic coating & testing

Two automated dip-coating systems with lamination and reflow oven on site. Coating iterations turn in days rather than shipping cycles.

  • Programmable draw profiles
  • Lamination and reflow oven
  • Coated device testing on site
Discuss a coating trial →

The facility

Five zones between the parking lot and your device.

Contamination control is a sequence, not a room. Every step removes what the step before it could not — the path your product takes, and the path anyone touching it takes.

Contamination control cascadeCleanliness increases →

Reception

Uncontrolled

Gowning

Controlled entry

Transfer room

Airlock

Cleanroom floor

ISO 7 / Class 10,000

Packaged

Sealed & verified

Full facility tour → Quality & certifications →

Contract cleanroom space

Start with a subassembly. Scale to the full build.

Most engagements begin with a single subassembly — typically the step consuming bench hours or gating downstream work. The cleanroom, equipment and trained technicians are in place, so build start is measured in weeks rather than the twelve to eighteen months a qualified facility build-out requires.

Braided shaft cores, tip subassemblies, bonded hubs and strain reliefs, coated shafts, sealed component kits — built to your drawings and acceptance criteria, packaged and sealed here, shipped for final assembly. Subassembly work runs concurrent with design iteration and establishes yield and process window before the step is integrated into a finished device.

Short-term: a V&V or clinical build with a defined end date, overflow capacity, or coverage during recertification of your own space.

Long-term: ongoing production without classified space on your balance sheet. Consistent room, consistent technicians, with additional space available as volumes increase.

Cleanroom space, staffing & terms →
Gowned technicians assembling catheters at microscope stations on the Class 10,000 cleanroom floor
The same floor, in use — benches or complete rooms

Available on site

Everything you would otherwise be buying, shipping or renting.

Two automated hydrophilic coating systems, a lamination and reflow oven, and a batch oven. An automated braider. LaserLinc laser micrometry. UV curing stations, EFD dispensers, microscopes, batch oven, pouch sealer, seal peel and leak testers. Clean dry compressed air at every bench, secured storage and advance shipping.

Process requirements outside this list are identified during scoping and either sourced or specified as customer-supplied before an engagement begins.

The full resource list →
Coating & cureTwo dip coaters, lamination and reflow oven, batch oven.
AssemblyBraider, UV curing, dispensing, microscopes.
VerificationLaser micrometry, seal peel, leak testing.
LogisticsAdvance shipping, secured storage, outbound.
MedTech Innovation reception area at the Irvine facility
Reception — 8 minutes from John Wayne Airport

Location & access

Minutes from John Wayne Airport.

The facility is 8 minutes from John Wayne Airport (SNA), in the Orange County cardiovascular and neurovascular corridor. Scheduled visits are practical as single-day trips, so design reviews and build oversight happen at the bench rather than by conference call.

Engagements are staffed directly by senior engineering. There is no account management layer and no program queue — technical questions are answered by the engineer responsible for the build.

Iteration rate governs development cost until design freeze. Offshore unit cost only becomes the dominant variable once the design and process are locked.

Development program

Five phases. Five milestones. No surprises at the board meeting.

Every program we run is structured the same way, so you always know which gate you are approaching and what has to be true to pass it.

PHASE 1

Architecture

Design inputs, requirements and elements. Technical feasibility. Regulatory assessment. Conceptual configurations.

MILESTONE 1Design architecture selected
PHASE 2

Design iteration

Two to three detailed design and prototype loops. Test setup and test plan. Initial prototype evaluation.

MILESTONE 2Design concept selected
PHASE 3

Design for manufacturing

Refine for production. Lock component vendors and assembly process. Tooling, risk management, pre-validation testing.

MILESTONE 3Preliminary design freeze
PHASE 4

Verification & validation

Device master record, supply chain and work instructions finalized. Biocompatibility, cleaning, sterilization, packaging. V&V build and test.

MILESTONE 4Full design freeze
PHASE 5

Clinical ramp-up

Clinical manufacturing build, site qualification, study protocol and approval to start.

MILESTONE 5Clinical study begins
What happens inside each phase →

Built in house

Nine catheter products in active production.

Most people arrive looking for someone who already builds something close to their device. So here is the product list, with the anatomy each one serves.

MicrocathetersNeurovascular Support cathetersNeurovascular · Peripheral · Pulmonary Delivery cathetersCardiovascular · Peripheral · Pulmonary Guide cathetersNeurovascular · Radial access Balloon guide cathetersNeurovascular · Radial access Aspiration cathetersNeurovascular · Radial access Guide sheathsCardiovascular · Peripheral Diagnostic cathetersNeurovascular · Radial access
All nine products, in detail → Coverage grid →

Quality

ISO 13485, and open to audit.

Certification establishes that a quality system was audited. Supplier qualification requires more: scheduled facility tours and quality audits are available prior to engagement, including record review and process walkthrough.

Single-site operation means the process under audit is the process that runs every day.

Quality system & certifications →

ISO 13485 quality management system

Design controls, document control, record retention and change control, run to the standard your auditors already know.

Class 10,000 cleanrooms

ISO 7 hard-wall construction, gowning, transfer airlock and filtered positive-pressure downflow.

Built for audit

You are welcome to walk the floor and review the records before you commit.

Start here

Send your device, quantities and dates.

Scoped inquiries receive a written response with availability, quotation and any customer-supplied requirements. NDA in place before drawings are exchanged.

Send us a message → Schedule a visit
+1 949-336-2972 [email protected]

17151 Gillette Ave, Irvine, CA — 8 minutes from John Wayne Airport
Mon–Fri, 8:00 AM – 4:30 PM PT

Submitted inquiries receive a response by the next business day.