MI MedTech Innovation, LLCIrvine, California

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Microcatheters, guide and balloon guide, aspiration, delivery and support catheters.

Nine catheter product types in active production in a Class 10,000 cleanroom, across cardiovascular, neurovascular, peripheral, pulmonary and radial access indications.

Discuss your device → See the product list

In-house production with the associated engineering experience available on your program.

Technicians assembling catheters at microscope stations, seen through the cleanroom doors
Products
NineIn active production in house
Coating
In houseHydrophilic, applied and tested
Testing
On siteSimulated use, in the same building
Assembly
Class 10,000ISO 7 cleanroom, ISO 13485
Products Coverage grid By body area Build capabilities Coating & cure

Built in house

Products in production, by indication.

Listed by product rather than by indication. Each entry states the primary engineering constraint and the process steps performed in house.

PRODUCT 01

Microcatheters

Small-lumen distal access through tortuous anatomy. The stiffness gradient from shaft to distal tip decides whether the device tracks or prolapses, and at thin wall the lumen still has to stay open through tight bends. Assembled under magnification, in fixtures that hold concentricity through cure.

Neurovascular
PRODUCT 02

Support catheters

Built to back up a guidewire and cross what the wire alone will not. Column strength to advance and push through resistance, without giving up the flexibility to follow the vessel. Tip and transition design is where these are won or lost.

NeurovascularPeripheralPulmonary
PRODUCT 03

Delivery catheters

Carrying a therapy to the target and releasing it predictably. Lumen integrity along the full working length, repeatable deployment, and enough push transmission that a long shaft does not buckle before the tip moves.

CardiovascularPeripheralPulmonary
PRODUCT 04

Guide catheters

The stable path everything else travels through. One-to-one torque response from hub to tip, back-up support at the ostium, and a lumen large enough to work through without sacrificing wall integrity.

NeurovascularRadial access
PRODUCT 05

Balloon guide catheters

A guide catheter with an inflatable balloon for proximal flow arrest. Everything a guide has to do, plus a bonded balloon, a separate inflation lumen and joints that stay leak-tight through inflation cycles. One of the more demanding constructions we build.

NeurovascularRadial access
PRODUCT 06

Aspiration catheters

Built for ingestion under vacuum. Maximum lumen at minimum profile, and a distal end that stays open rather than collapsing when suction is applied. Lumen-to-wall ratio is the governing design constraint.

NeurovascularRadial access
PRODUCT 07

Guide sheaths

Access and a working channel in one device. A dilator-to-sheath transition that does not catch on entry, hemostasis that holds through a long procedure, and an inner diameter that stays usable at a profile the vessel tolerates.

CardiovascularPeripheral
PRODUCT 08

Diagnostic catheters

Shaped tips that reach and seat reliably, torque that responds one-to-one, and shape retention after repeated manipulation and reshaping. These ship in volume, so assembly repeatability is a cost question as much as a quality one.

NeurovascularRadial access
PRODUCT 09

Arterial and venous catheters

Access devices for both sides of the circulation. Atraumatic tip geometry, dependable hemostasis, and constructions built for consistent, repeatable assembly at volume.

Neurovascular

Coverage at a glance

Product and indication coverage.

Devices matching a row are within current production experience. Adjacent constructions frequently share process steps and should be scoped directly.

ProductCardio­vascularNeuro­vascularPeripheralPulmonaryRadial access
Microcatheters
Support catheters
Delivery catheters
Guide catheters
Balloon guide catheters
Aspiration catheters
Guide sheaths
Diagnostic catheters
Arterial and venous catheters

By body area

Index by indication.

What we actually do to a device

Process capabilities.

Process steps performed between released design and packaged device. Coating and cure are detailed separately below.

CapabilityWhat it coversWhere
Concept to prototypeTurning a physician's concept or a napkin sketch into hardware you can hold and test.Phase 1–2
Complex catheter designShaft construction, transitions, tip geometry, lumen layout and hub design for the target anatomy.Phase 1–3
Design for manufacturabilityMaking a working prototype into something technicians can build repeatably from real supply-chain parts.Phase 3
Adhesive bonding & UV cureBond joint design, controlled dispensing, UV spot cure at the joint, and fixturing that holds geometry through cure.Cleanroom
Lamination & reflowLarge-format oven for lamination, reflow and thermal coating cure across full working-length assemblies.Oven
Cleanroom assemblyMicroscope-level assembly of finished devices by trained medical device technicians.Class 10,000
BraidingAutomated, programmable braiding for braid-reinforced shaft constructions — consistent pick count and pattern across a build.Automated
Laser inspectionAutomated laser inspection for dimensional verification and defect detection, performed without contacting the device.Automated
Dimensional verificationLaserLinc Triton 330 non-contact laser micrometry for OD and ovality, logged rather than hand-recorded. No contact means no deformation of soft tubing.LaserLinc
Packaging & seal verificationSterile barrier pouch sealing inside the cleanroom, with seal peel and integrity testing.Cleanroom
Leak & integrity testingLumen and joint integrity on in-process and finished assemblies.At bench
V&V and clinical buildsVerification, validation and clinical-quantity builds under the ISO 13485 quality system.Phase 4–5

Hydrophilic coating

Hydrophilic coating, cure and verification on site.

Coating is commonly outsourced, making shipping cycles the rate limiter on lubricity and durability iteration. All three steps are performed on site: two automated dip-coating systems, a large-format lamination and reflow oven, and coated device testing.

Two automated hydrophilic dip-coating towers with touchscreen controls and multi-position dispense manifolds
Two automated dip-coating systems
Hydrophilic coating towers beside a large stainless double-door lamination and reflow oven
Lamination & reflow oven
The line

Coat, cure, verify, iterate

All four steps are performed within the classified space, eliminating inter-facility transfer and the associated schedule and traceability exposure.

Coat

  • Two automated dip systems. Programmable draw profiles — entry rate, dwell, withdrawal rate — so coating thickness is set by a recipe rather than by whose hand is on the device
  • Multi-position dispense. Several devices per run, and primer and topcoat layers handled in sequence
  • Two systems, not one. Run a production batch on one while you iterate a formulation or a draw profile on the other

Cure

  • Large-format lamination and reflow oven. Controlled thermal profile across the full working length of the assembly
  • Batch processing oven in the same space for adhesive cure, anneal and additional thermal steps

Verify

  • Non-contact dimensional check. LaserLinc Triton 330 laser micrometry before and after coating — no contact means no deformation of a soft, freshly coated surface
  • Coated device testing on site for lubricity and durability behavior
  • Simulated use to see how the coated device actually tracks, in the same building it was coated in

Iterate

  • Same-week turnaround on a failed result. When lubricity or durability comes back wrong, the next draw profile runs days later, not a month later
  • Across a program that compounds. Four coating iterations at a week each instead of a month each is roughly three months off a development timeline
Where it matters

Indications where coating is a functional requirement

On the following device types, coating performance governs whether the device reaches the target.

Device families

  • Neurovascular. Tortuous distal anatomy where coating friction and trackability are the same conversation
  • Radial access. Small, spasm-prone vessels in an awake patient — coverage and durability over the full insertion length drive patient tolerance
  • Peripheral. Long working lengths and repeated manipulation, so coating durability over cycles matters as much as initial lubricity

What we need from you

  • The coating chemistry and supplier you intend to use, or the requirement if you have not selected one yet
  • Substrate material and device geometry, including working length
  • Your acceptance criteria — the lubricity and durability numbers the coating has to hit
  • Any validated test method you already have, so we measure the way you measure

The other on-site step

Simulated use testing on site.

Track, deployment and retraction behavior evaluated before design freeze, with the responsible engineer present.

Issues identified at the bench are corrected within hours; the same issues identified during a clinical build affect the program schedule.

Technicians assembling catheters at microscope stations in the Class 10,000 cleanroom
Build, coat, cure and test under one roof

Next

Next steps.

DESIGN

The five-phase program

Concept to clinical build on a gated path with named milestones. Most programs join at phase 3, when a working prototype cannot yet be manufactured.

See the phases → SPACE

Contract cleanroom space

Start with one subassembly, or take benches and a private room. Staffed by our technicians or your own, for a single build or as long as the product runs.

Space, staffing & terms → EQUIPMENT

On-site resources

Every piece of equipment, utility and logistics capability in the building — and an honest list of what is not.

Check your process →

Discuss your device

Submit device type and current development stage.

Include indication, construction and the specific technical constraint. Responses are written by engineering staff with experience in the relevant device type, including where the requirement falls outside current capability.

Discuss your device → 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

Device inquiries submitted here receive a response by the next business day.