Nitinol Processing Services

Capacity: Medical device OEMs rely on Norman Noble’s expertise in manufacturing ultra-precision nickel-titanium components for their breakthrough products. Norman Noble utilizes dedicated departments to machine, heat set, and electropolish complete nitinol implants and nitinol stents. Our extensive heat treating equipment includes five fluidized beds, convection air ovens, and a salt bath furnace. The process validation dept. supports all of our manufacturing services, works to meet customer requests, and provides IQ/OQ, MSV, PQ/PPQ, TMV, DOE, and risk analysis.

 

White paper download: Nitinol Implant Design & Manufacturing.

 

Product Applications: Customers use our contract manufacturing services to produce some of the smallest and most complex parts for the medical device industry. Some nitinol implant examples would include:

  • Vascular Stent Implants - Cardio, AAA, Peripheral, Neuro
  • Transcatheter Heart Valve Implants
  • Vena Cava Filter Implants
  • Atrial Appendage Closure Implants
  • Vascular Closure Implants
  • Atrial Fibulation Devices
  • Renal Denervation Devices
  • Spinal Implants and Devices
  • Extremity Screw and Plate Implants and Devices
  • Ligament Repair Anchors and Devices

 

Capabilities: Norman Noble, Inc. provides the only complete, single-source contract manufacturing of nickel-titanium products, including shape setting of nitinol for both superelastic and shape-memory material. Custom shapes of wire, ribbon, strip, sheet, tubing or bar nitinol are achieved with custom fixtures and very specific heat treat times and temperatures. Norman Noble is one of the few companies that provide all elements of nitinol manufacturing: micromachining, shape-setting, and electropolishing. Besides component geometry, we also have the capability of confirming the physical, and mechanical properties of the finished part, by means of DSC (differential scanning calorimeter), BFR (bend and free recovery), and temperature controlled tensile testing.

 

  • Machining of Nitinol - The combination of our experience and advanced machining processes makes Norman Noble, Inc. the best source for micro precision machining of nitinol products. In fact, Norman Noble machines nitinol implants and devices for many of the OEMs in the medical device industry utilizing the most advanced processes:
    • Laser Machining
    • Wire EDM
    • Swiss Machining
    • Milling

  • Shape Setting of Nitinol - What is Shape Setting?  Nitinol shape setting is the process by which the final, specified shape of the metal is configured and programmed. This requires specific thermal physics for each device depending on the end use and end-use environment. Shape setting must also take into account the type of nitinol being used, which may require different processing temperatures and exhibit different characteristics. “Superelastic” and “shape memory” types of nitinol are generally available in wire, ribbon, strip, sheet, tubing, and bar form.


    Shape Memory Nitinol Wire Placed in Hot Water to Show Transformation of Material

    To set shape, machined nitinol is constrained on a mandrel, or custom fixture. This mandrel can be made by Norman Noble or provided by the customer. Once the nitinol is fixed on the mandrel, its shape is set with a specific heat treat.  One of the most important challenges in the shape setting process is determining the proper heat treatment parameters to achieve the shape and properties of the part. Nitinol shape setting requires thermal manipulation of the nickel-titanium from martensite to austenite.  The process may require a specific austenite start temperature (As Temperature) and finish temperature Af Temperature); or a specific martensite start temperature (Ms Temperature) or finish temperature (Mf Temperature). The parameters for this phase transformation may need to be determined experimentally for each component.

    Rapid quenching is then used to finalize the process.  Either Norman Noble or the customer can specify the type of heat treatment to be used: fluidized bed, using alumina media; convection air furnace; or salt bath.

  • Electropolishing of Nitinol - Norman Noble, Inc. has spent years developing and perfecting a proprietary process for electropolishing nitinol. We are one of only a handful of contract manufacturing companies to provide this essential service. Common problems facing the machining of nitinol include: residual machining artifacts, scratches, heat affected zone, as well as gaps between the grains and sharp edges. These inherent imperfections may reduce service life and affect performance of devices, which can be especially critical for medical device manufacturing or other high-tech applications.  After machining and shape setting of nitinol is complete, a very high percentage of nitinol parts require electropolishing.
    • Most technologically advanced process for electropolishing NiTi
    • Exceptional repeatability and predictability
    • Removes dross, machining artifacts, and heat affected zones (HAZ) that result from thermo-cutting processes (e.g., laser, and EDM machining)
    • Eliminates crevices between grains
    • Smoothes sharp edges in critical areas
    • Provides lustrous finish on NiTi
    • Prolongs service life and improves performance of NiTi parts

  • ISO Class 8 Cleanroom Packaging - With this shape memory service we complete the production chain of nitinol products from micromachining through cleanroom packaging. Our 1000-square-foot, ISO Class 8 cleanroom is a modern facility for assembly and packaging of sensitive, micromachined parts and components.  The clean room can be partitioned into micro environments for particulate control as strict as the customer deems necessary. In addition, a 480-square-foot temperature-controlled secure storage area provides a room for post-sterile barrier packaging and controlled storage.

  • Nitinol technical study presented at ASM Conference

Process Development

Norman Noble’s prototype machining capabilities for nitinolshape setting are provided using dedicated equipment, located in our independent Nitinol Process Development Center. This enables our nitinol process development activities to be isolated from the production manufacturing areas. Our experienced team of engineers work within our Process Development Center to develop and validate the most efficient manufacturing process required to machine your medtech product innovations to exact drawing specifications.

 

Electropolishing Nitinol ImplantsNorman Noble’s expertise in nitinol shape setting is a result of decades of hands-on experience.  We are dedicated to improving our nitinol manufacturing capabilities, through the proprietary design of innovative nitinol machining systems & processes.  We are constantly striving to find new and better ways to manufacture our customers’ products that depend on ultra-precision micromachining. Working closely with our customers we are able to develop the most efficient, custom tooling and parameters to manufacture their products. Our Nitinol Process Development team works with our customers to manufacture very early design stage prototypes, and our technologies often enable the commercialization of next generation medtech products.  Our Nitinol PDC also works closely with our Quality & Process Validation Department and Production staff to ensure a smooth transition from prototype to production.

 

Inquiries for NiTinol Machining projects can be sent to sales@normannoble.net or visit our RFQ page. For additional information, download: NiTinol Implant Manufacturing Capabilities.

 

View our Nitinol Implant Manufacturing Capabilities

 

Nitinol Tubes for Implants

Nitinol Tubing: Please review our Nitinol Tubing Inventory List of material sizes available for Norman Noble, Inc. process development & manufacturing of NiTinol prototypes.  Additional material sizes are available based on project requirements.

 

Nitinol Shape Setting and ElectropolishingWatch our virtual tour to see our nitinol machining, nitinol shape setting and electropolishing capabilities.