Overview

Custom-engineered structural plastic supports designed for internal chassis, housing mounts, and mechanical assemblies in diagnostic and clinical medical devices. Built strictly to customer CAD specifications (ISO 2768-m/f tolerances). Direct contract manufacturing for medical OEM equipment builders requiring high dimensional stability, electrical insulation, and chemical resistance.

Specifications

Parameter	Standard Capability / Range
Machining Tolerance	Up to ±0.015 mm (CNC Milling/Turning)
Injection Molding Tonnage	80T – 550T (Cleanroom molding available)
Available Sizes	Custom dimensions from 10 mm to 800 mm
Surface Finish	Ra 0.4 μm to 1.6 μm, as-machined or bead-blasted
Standard Compliance	ISO 13485, ISO 9001, RoHS, REACH
Material Grade Compliance	USP Class VI, FDA compliant raw materials, ISO 10993 tested resins

Features

High Strength-to-Weight Ratio: Replaces traditional metal brackets (aluminum/stainless steel) to reduce overall medical device weight without sacrificing structural rigidity.

Electrical Insulation: Non-conductive properties eliminate grounding hazards near sensitive electronic sensors and patient-monitoring circuits.

Chemical & Sterilization Resistance: Withstands repeated exposure to hospital-grade disinfectants, EtO (Ethylene Oxide) gas, gamma irradiation, and autoclave steam (grade-dependent).

Low Friction & Wear Resistance: Self-lubricating polymer grades minimize mechanical wear in moving diagnostic scanner assemblies.

Biocompatible Options: Raw materials certified for non-toxic, non-irritating contact surfaces in clinical environments.

Materials & Manufacturing

Material Options
PEEK (Polyetheretherketone): High thermal stability, extreme chemical resistance, and superior mechanical load-bearing capacity for surgical robots.

POM / Delrin (Polyoxymethylene): Excellent dimensional stability, low moisture absorption, and high fatigue resistance for internal gears and sliding supports.

Ultem (PEI - Polyetherimide): High dielectric strength, flame retardancy (UL94 V-0), and retention of physical properties under thermal loads.

Medical-Grade Polycarbonate (PC) & ABS: High impact strength and clarity for structural housing mounts.

Manufacturing Processes
5-Axis CNC Machining: For low-to-medium volume production, rapid prototyping, and complex geometries with tight tolerances.

Precision Injection Molding: For medium-to-high volume production utilizing multi-cavity hardened steel molds, ensuring part-to-part consistency.

In-House Annealing: Thermal stress-relief processes executed between machining steps to eliminate warping in structural components.

Applications

Diagnostic Imaging Equipment: Internal insulating brackets and alignment rails for MRI and CT scanner sub-assemblies.

In-Vitro Diagnostics (IVD): Fluidic manifold supports and structural chassis mounts in automated blood analyzers.

Surgical Robotics: Lightweight mechanical linkage arms and precision joint spacers.

Patient Monitors & Infusion Pumps: Rigid internal housing frames and impact-resistant mounting blocks.

Customization

Engineering Review: DFM (Design for Manufacturability) feedback provided within 24 hours of CAD submission.

Secondary Operations: Threaded insert installation (Keenserts, helicoils), sonic welding, laser engraving for traceability, and custom sub-assembly integration.

Packaging: Cleanroom bag sealing, antistatic packaging, and customized labeling per OEM requirements.

QC

Dimensional Inspection: CMM (Coordinate Measuring Machine) verification, optical comparators, and pin gauge testing per AQL 1.0 sampling standards.

Material Traceability: Full material lot certs (CoA) and FDA/USP Class VI documentation supplied with every shipment.

Process Control: Statistical Process Control (SPC) monitored during volume injection molding runs. Cleanroom inspection stations equipped with 10x magnification.

FAQ

Q: What file formats are required for an accurate quotation?

A: 3D CAD files (STEP, IGES, Parasolid) alongside a 2D technical drawing (.PDF) specifying critical tolerances, surface finishes, and material grades.

Q: Can you provide FDA-compliant or USP Class VI documentation?

A: Yes. All raw materials are sourced from certified primary resin manufacturers (e.g., Victrex, Ensinger, Sabic) with full batch documentation provided upon delivery.

Q: What is your typical lead time for prototype vs. production runs?

A: Prototypes via CNC machining typically ship in 5 to 7 business days. Production injection molding tooling and initial sample runs (T1) require 3 to 5 weeks depending on geometry complexity.

Q: Do you sign NDAs before reviewing proprietary medical designs?

A: Yes. We execute mutual Non-Disclosure Agreements (NDAs) prior to receiving any CAD data or engineering specifications.