Process Capabilities

Norman Noble, Inc. is your single source supplier for stent manufacturing specializing in AAA stents, peripheral vascular stents, billiary stents and stents for neurovascular aneurysms and ischemic strokes. We have the ability to offer you a complete part or assembly with full packaging requirements, making it available for shipment to a sterilizer or customer. Our fully trained staff is your development partner with dedicated technical, metallurgical, and engineering resources. With our technology and experience we can take your product from prototype to market launch.

 


Stent Manufacturing Process

Laser Machining:

  • Capacity of 130 stent cutting systems that utilize Millennium Focus technology - the most advanced laser processing service offered exclusively by Norman Noble, Inc
  • Capable of cutting tubing with a minimum ID of .004” and maximum length of 60”
  • Athermal (HAZ Free) Laser Machining of Bioabsorbable polymers, Nitinol, and other exotic alloys using our Noble UltraLight technology
  • Fully dedicated R&D department for process development activities and manufacturing of prototypes

CNC Honing & Blasting:

  • Proprietary honing equipment for ID dross removal
  • Parts are blasted with fixed parameters and CNC movement for each strut using a rotating fixture

Nitinol Shapesetting:

  • Superelastic or Shape-memory Nitinol
  • 3 thermal process types: Fluidized bed, salt bath, and muffle furnace
  • Have dedicated tensile testing equipment with temperature controls and DSC (Differential Scanning Calorimeter) for AF analysis

Automated Annealing:

  • Argon Atmosphere Retort Annealing Furnaces for 316 L Stainless Steel stents with 3 temperature zones and computer controlled cycles
  • Capable of temperatures up to 1100 degrees Celsius

Automated Electropolishing:

  • Customized, automated electropolishing systems as well as manual systems available
  • Able to process 316 Stainless Steel, Nitinol, L605 Cobalt Chrome, and Tantalum

Final Inspection & Quality Assurance:

  • Automated inspection systems for 100% dimensional inspection, touch probe capability for measuring wall thickness and profile software that detects missing features and slugs
  • Our quality system is registered to ISO 13485:2003 and ISO 9001:2008
  • SEM for metallurgical analysis
  • Fully trained process validation staff available to help customers develop strategies and perform IQ/OQ, PQ/PPQ, MSV, TMV, DOE, and risk analysis

Cleanroom Packaging:

  • ISO Class 8 room with adaptable microenvironments for tighter particulate control
  • Controls temperature, humidity, & microbial growth
  • Lot specific Endotoxin (Pyrogen) reports available
Requests for Quotations on all medical device manufacturing services can be emailed to sales@normannoble.net or visit our RFQ page.

 

Cleanroom PackagingFinal Inspection & Quality AssuranceAutomated ElectropolishingNitinol ShapesettingCNC Honing & Blasting Laser Machining