Medical DeviceQualified Supplier Directory

Nitinol Devices & Components

47533 Westinghouse Dr.
Fremont, 
CA  94539  us
Tel: 510/683-2000
Fax: 510/683-2001

Nitinol Devices and Components, Inc. designs, develops, and manufactures nitinol devices and components for medical use, including many of the most successful products on the market today. Since 1991, NDC has also been a fully integrated supplier of superelastic and shape memory nitinol materials, including wire, tube, sheet, strip and bar stock.

Our products are produced in ISO 13485 series registered facilities, with in-house control of all manufacturing processes: from the drawing of precision wire and tubes, to laser cutting, expansion, and surface finishing of medical devices and components.

To assist our customers in bringing competitive products to market quickly and cost effectively, NDC employs many of the most cited and renowned experts in nitinol engineering. (See Reference Materials). We assist startups to Fortune 50 companies in everything from material selection to prototype design, product development to corrosion testing, and regulatory approval to lean manufacturing.

Come to NDC, and get it right the first time.

Component Design, Development, & Manufacturing

NDC offers turnkey solutions for nitinol projects at any stage. Our engineers will work with you and your print—whether draft or locked, prototype or production-ready—to create an efficient, FDA-friendly path to low-cost volume manufacturing. Our capabilities include:

  • Laser Machining
  • Laser Welding
  • Profile & Surface Grinding
  • Burr-free Cutting
  • Deburring
  • Forming/Shape Setting
  • Stamping
  • Electropolishing & Passivation
  • Surface Treatment
  • Machining

We support these activities with our own services:

  • Transformation Temperature Tuning
  • Mechanical Properties Testing
  • Finite Element Analysis
  • Radial Force & Crush Testing
  • Fatigue Testing & Analysis
  • Corrosion Testing
  • Failure Analysis

For components requiring additional manufacturing services, NDC will work with a select group of suppliers to provide you with turnkey outsourcing.

Medical Development Services

Let NDC put decades of Nitinol design, testing and processing experience to work for you. NDC offers the following contract services for our customers:

Development Services

  • Finite Element Analysis (FEA) for design exploration, virtual experiments, stress and fatigue analysis, including regulatory submission support & consulting
  • Process development and optimization, including forming, heat treatment, and state of the art surface finishing
  • Engineering specifications, solid models, and tooling to support reliable and robust manufacturing
  • Test, measurement, and inspection plan development

Testing Services

  • Mechanical Tensile Testing per ASTM F2516
  • Thermal Testing (DSC or LVDT) per ASTM F2004 & ASTM F2082
  • Potentiodynamic Corrosion Testing per ASTM F2129
  • Galvanic Corrosion Testing
  • Fatigue Testing & Analysis
  • Radial Force & Crush Testing
  • Auger Electron Spectroscopy
  • Hydrogen Analysis
  • Scanning Electron Microscopy
  • Metallurgical Cross Section Analysis
  • Specialized & Custom Designed Test Development based on customer demands

Regulatory Support

  • Expert assistance with the daunting task of submissions to regulatory agencies in the US and Europe  
  • As an extension of your regulatory department, we can provide technical support during and after your submissions and filings

Right-Track Wrong-Track Analysis

The goal of our Right-Track Wrong-Track Analysis is to provide engineers with exceptionally cost-efficient advice early-on in the development process, before tens or hundreds of thousands of dollars are wasted on mistakes a few words from our experts could have prevented.

Materials

NDC produces Nitinol superelastic and shape memory materials in the following range of sizes (See Materials):

Wire (round)                0.001” – 0.250” OD

Wire (rectangular)       0.004” – 0.080” thick

Tube                            0.006” – 0.600” OD

Strip (rectangular)       0.010” – 0.500” wide; 0.002” – 0.040” thick

Sheet                           0.500” – 20” wide; 0.003” – 0.125” thick

Bar                              0.250” – 3.50” OD

Surface possibilities are black and light oxide, bright polished, etched, and ground. Materials may be in the straight annealed condition, as drawn condition, or full annealed condition. Not all sizes are available in the superelastic (straightened) or as-drawn condition. Typical final Af of our superelastic alloy (SE508) materials is <15C; while the final Af of our shape memory alloy (SM495) is 60-70C.
(See Material Properties)

NDC stocks many different sizes of wire and tube for immediate shipment. Please contact our Sales Coordinators and they will be happy to provide you with the right material.

NDC is now proud to offer another industry first: nitinol continuous sheet. Continuous Nitinol sheet is available in thicknesses from 0.003" to 0.020" and in widths up to 3.0". It can be supplied on spools or cut to length to fit your manufacturing process. Ideal for stamping, etching and laser cutting; our sheet has the tightest gage tolerances in the industry (typically ±0.0003" or better). Its smooth, light oxide surface allows for efficient processing and surface finishing.

Quality

NDC is ISO 13485:2003 certified.

NDC welcomes audits from our customers and our Quality Manual is available for customers upon request.