Process Capabilities

Norman Noble, Inc. is a 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 team provides development partnership through our dedicated technical, metallurgical, and engineering functions. By applying our technology and experience in stent manufacturing, we can take a 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 Laser Machining of Bioabsorbable polymers, Nitinol, and other exotic alloys using our Noble S.T.E.A.L.T.H. SM (System To Enable Ablation Laser Technology Haz-free) technology.
  • Our Process Development Center (PDC) develops and validates the most efficient manufacturing processes required to machine innovative medtech product concepts to exact drawing specifications.

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.
  • Dedicated tensile testing equipment with temperature controls, BFR (Bend and Free Recovery) and DSC (Differential Scanning Calorimeter) for AF analysis.

Automated Annealing:

  • Argon Atmosphere Retort Annealing Furnaces for 316L stainless steel stents with 3 temperature zones and computer-controlled cycles.
  • Capable of temperatures up to 1,100 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 & EN ISO 13485:2012 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 cleanroom with adaptable microenvironments for tighter particulate control.
  • Controls temperature, humidity, and microbial growth.
  • Lot-specific Endotoxin (Pyrogen) reports available.

Requests for quotations on all stent machining services can be emailed to sales@normannoble.net or through our RFQ page.

 

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

 

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