High-Volume US-BASED Insertion Tube & Medical Device Contract Manufacturing

Precision-Engineered Shafts, Flexible Sub-Assemblies & Commercial-Scale Production (up to13mm OD)

Accelerate your medical device innovations with precision-engineered OEM insertion tubes and flexible shaft sub-assemblies. Manufactured in our Sturbridge, Massachusetts facility, Optim’s custom, biocompatible tubing and scope components are built for optimal kink resistance, smooth navigation, high torque response, and structural integrity.

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FDA-Registered Facility

ISO 13485:2016 Certified

100% US-Based Manufacturing

Up to 13mm OD Capabilities

50+ Years of Expertise

Specialized OEM Insertion Tube Engineering & Manufacturing

Purpose-Built for Navigation, Kink Resistance, and High Torque Response

Optim specializes in custom flexible insertion tubes, braided shafts, and flexible sub-assemblies designed for endoscopic, catheter, and minimally invasive diagnostic devices. We support mass commercial manufacturing with outer diameters up to 13mm OD, providing superior mechanical performance and long-term durability.

  • Precision Engineering

Engineered for exceptional torque response, smooth steerability, pushability, and structural integrity across complex endoscopic and catheter architectures.

  • Tailored Biocompatible Printed Tubing

Fabricated using advanced, medical-grade polymers and metals featuring high lubricity and full USP Class VI biocompatibility.

  • Accelerated Speed-to-Market

Leverage our vertically integrated domestic manufacturing capabilities to lower unit costs, eliminate foreign supply chain delays, and streamline commercial launches.

  • Robust Verification

Fully compliant with ISO 13485 standards, featuring rigorous testing for flex cycles and leak resistance.

  • An Active FDA-Cleared Device Manufacturer

We design, register, and build our own commercial endoscopes, meaning we understand FDA compliance, audit readiness, and production consistency firsthand.

Custom Engineering Capabilities & Technical Specs

Flexible Shaft Architecture Built for Complex Clinical Demands

Versatile Outer Diameter (OD) Range

Standardized and custom profiles up to 13.0 mm OD provide sizing flexibility tailored to your specific diagnostic and therapeutic device requirements.

Structural Braided & Coil Reinforcement

Stainless steel wire braiding and coil-reinforced shaft designs prevent ovalization and kinking while maximizing column strength, torque transmission, and pushability.

Biocompatible Surface Coatings

Industry-leading integrated hydrophilic & low-friction polymer coatings reduce insertion force, enhance tactile control, and ensure smooth tissue access.

Resilient Flexible Sheathing Materials

Medical-grade Pebax, Polyurethane, Silicone, and custom blends deliver superior lubricity, full USP Class VI compliance, and resistance to High-Level Disinfection (HLD).

Responsive Articulation & Sub-Assembly

Integrated precision bending sections, control wire guides, and distal tip assemblies provide responsive 2-way and 4-way directionality in active diagnostic and surgical shafts.

Mass Production Scalability

Transition smoothly from early-stage prototyping to full-scale commercial manufacturing, ensuring a seamless design transfer that satisfies high-volume market demands.

The US Domestic Advantage: Quality, IP Protection & Cost Control

Eliminate Offshore Supply Chain Risk with an FDA-Registered Manufacturing Partner

Partnering with a domestic, FDA-registered contract manufacturer eliminates the risks associated with foreign supply chains, quality variations, and regulatory misalignment.

Full Regulatory Assets Provided

Every contract manufacturing program includes Full Drawing Sets, complete Device Master Records (DMR), and fully traceable Device History Files (DHF) to simplify your audit trail and regulatory submissions.

Cost Control Through DFM

Because we are the direct manufacturer, our Design for Manufacturability (DFM) process eliminates unnecessary assembly steps and material waste, reducing total cost of goods sold (COGS).

Intellectual Property Protection

Your designs, trade secrets, and patents remain 100% your property under strict US legal protections.

From DFM & Prototyping to High-Volume Mass Production

A Streamlined 5-Step Path to Commercial Readiness
Step 1 – Design for Manufacturability (DFM) & PROTOTYPING
We review your mechanical designs, material choices, and tolerance stack-ups to optimize component geometry for scalable commercial production.
STEP 2 – Design Transfer & Process Validation
Execution of formal Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) alongside custom tooling and fixture development.
STEP 3 – Mass Production
Scalable, lot-controlled manufacturing utilizing automated wire braiding, extrusions, laser welding, and micro-assembly.
STEP 4 – 100% Quality Inspection & HIPOT Testing
Every insertion tube and sub-assembly undergoes rigorous dimensional, articulation, and hipot testing prior to release.
STEP 5 – Packaging, Labeling & Delivery
Custom clean-pack or sterile-barrier packaging with full UDI-compliant labeling and Certificate of Conformance (CoC).
Ready to Scale Your Insertion Tube or Flexible Device Assembly?

Request a Custom OEM Quote or Engineering Proposal

Submit your project parameters below to receive a custom Request for Quote (RFQ) or engineering consultation from our Sturbridge, MA team.