What I-tek Medical does

I-Tek Medical is a privately held medical device contract design, development, and manufacturing services company headquartered in White Bear Lake (St. Paul), Minnesota. Founded in 2009 and operating with 11–50 employees, the firm targets medical device OEMs and emerging medical device companies with a full-service capability stack spanning design-for-manufacturability, prototyping, precision machining, molding, sterile barrier packaging, process validation, and full Class I/II/III device assembly, labeling, and sterilization coordination. Its facility is FDA-registered, ISO 13485:2003 certified, and equipped with Class 5 and Class 7 cleanrooms, enabling it to serve as FDA office of record and provide seamless QMS integration for startup clients.

The company has developed a distinct specialty in optical-based medical devices for minimally invasive surgery, anchored by its proprietary MILES (Medical Illumination Lighting Enhancement System) — a patent-pending illumination fiber paired with the compact I-150 LED light source — and a complementary Fiber Optic Tapers product line offering up, down, and double tapers with custom tip geometry. Underlying capabilities include 5–110 ton in-house molding, multi-axis CNC and wire EDM machining, robotic production cells, and custom tooling design, reducing supply chain dependencies for low-to-mid volume production.

I-Tek generates revenue primarily through project-based contract design, development, and manufacturing engagements with multi-year contract cadence, augmented by tooling design/production services and an Accelerator/Incubator program that rents office, conference, and storage space adjoining its production facilities to emerging medical device companies. Pricing is quote-based and not publicly disclosed. Go-to-market is sales-led, direct B2B, and reinforced by Medical Alley Association membership in Minnesota's medical device ecosystem; there is no disclosed digital marketing, international channel presence, or external funding.

Name

I-tek Medical

Legal name

I-Tek Medical

Website

https://i-tekmedical.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

I-Tek Medical is an FDA-registered, ISO 13485-certified medical device contract design, development, and manufacturing firm serving OEMs and emerging device companies, with a specialty in optical illumination products for minimally invasive surgery.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Optical Instruments & Lenses (3827)

akta.pro primary industry

Single-Use Surgical Devices & Procedure Packs (Disposable instruments, drapes, kits) (HLAHADAM)

akta.pro secondary industry

Open & Minimally Invasive Surgical Instruments (Handheld, Laparoscopic, MIS) (HLAHADAA)

Keywords

• Contract medical manufacturing
• Medical device design
• Sterile barrier packaging
• Optical fiber manufacturing
• Precision medical machining

Headquarters

HQ city

White Bear Lake

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Supply Chain, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Design and Development Services: Early involvement in development process partnering with customer's in-house staff to ensure manufacturability and cost effectiveness. Services include creating prototypes, developing tooling, producing pilot devices, establishing manufacturing procedures, designing work cells, and identifying automation options.
2. Contract Manufacturing Services: Full assembly of medical products including guide wires, pacing leads, catheters, infusion sets, surgical devices, fiber optics, RF bag manufacturing, tubing sets and complex devices. Services include cleaning, packaging, UDI labeling with FDA required validations, and sterilization coordination.
3. Accelerator/Incubator Space Rental: Over 2,000 square feet of office space built out with multiple offices, conference room and storage spaces adjoining management, lab and production facilities. Infrastructure in place with FDA office of record and QMS integration capabilities.
4. Tooling Design and Production: Custom tooling and fixtures designed and produced for proprietary device elements or internal production and quality requirements. Includes jigs, retention devices, gauging, and production tooling.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels1 record

Core offering

I-Tek Medical provides end-to-end contract design, development, and manufacturing services for medical devices, including prototyping, precision machining, molding, sterile barrier packaging, assembly, UDI labeling, sterilization coordination, and process validation. The company also markets its own line of optical-based illumination products (MILES system, Illumination Fiber, I-150 LED Light Source, and Fiber Optic Tapers) for minimally invasive surgical procedures, supported by FDA GMP compliant, ISO 13485 certified facilities with Class 5 and Class 7 cleanrooms.

Product overview

I-Tek Medical is a contract design, development, and manufacturing services company offering a focused portfolio of optically-based medical devices for surgical illumination. The core product line centers on the MILES (Medical Illumination Lighting Enhancement System) — a patent-pending illumination system comprising the Illumination Fiber and I-150 LED Light Source — designed for minimally invasive surgical procedures. Supporting the illumination product line are Fiber Optic Tapers, optical components that enable customized light delivery for various diagnostic and interventional applications. Together, these products address the surgical challenges of limited space, insufficient lighting, and anatomical variability in minimally invasive procedures.

Differentiator

Problem solved

Functional benefit

Products and services

• Contract Design and Development Services

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• Medical Alley AssociationcoreStrategic or Co-development PartnerI-Tek Medical is a proud member and supporter of the Medical Alley Association, the leading industry association for medical technology companies in Minnesota. Membership provides industry visibility, networking opportunities, and positioning within the medical device ecosystem.

Scale indicators5 records

Recent moves5 records

Expansion highlights3 records

Broad incumbents

• Integer Holdings: One of the largest medical device contract manufacturers globally, offering design, manufacturing, and supply chain services across cardiovascular, surgical, and orthopedic markets. Comparable as a broad incumbent CDMO competing for similar OEM outsourcing work.
• Vesta (formerly MedPlast): Large medical device contract manufacturer with extensive capabilities in molding, assembly, and packaging. Comparable as a larger incumbent in the same CDMO space.
• Stryker (Surgical Illumination): Major surgical device company with an installed base of surgical light sources and illumination accessories. Comparable as a downstream buyer/competitor for surgical illumination technology such as MILES.
• Olympus Surgical Technologies: Major endoscopic and surgical equipment manufacturer with its own illumination systems and fiber optic light delivery products. Comparable as a downstream OEM that both supplies and competes with illumination technologies.

Direct peers

• Tecomet: Specialty medical device contract manufacturer focused on orthopedic, surgical, and minimally invasive instruments. Directly comparable to I-Tek's precision machining and assembly capabilities for surgical OEMs.
• Avalign Technologies: Medical device CDMO providing design, engineering, and manufacturing services for surgical instruments, implants, and single-use devices. Closely comparable in scale and service breadth to I-Tek.
• Helix Medical (a Flexan company): Medical device contract manufacturer specializing in silicone and thermoplastic molding, assembly, and packaging for surgical and minimally invasive devices. Comparable in cleanroom-based assembly and disposable device focus.
• Cadence Inc. Medical device contract manufacturer serving surgical, orthopedic, and advanced therapy markets with precision machining, finishing, and assembly. Comparable as a mid-sized specialty CDMO.
• Mack Molding: Contract manufacturer offering plastic molding, machining, and full device assembly for medical device OEMs. Comparable in vertically integrated molding-to-assembly services.

Emerging players

• Invuity (now part of Stryker): Developer of advanced surgical illumination and single-use lighted instruments for minimally invasive surgery. Directly comparable as a competitor in the surgical illumination fiber space where MILES competes.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/i-tek-medical
• Xx.com/itekmedical

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about I-tek Medical