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MANUFACTURING

Understanding nitinol implant design and manufacturing The nickel-and titanium-alloy known as nitinol is a super-elastic shape-memory alloy responsible for major advances in medical technology over the last 15 years. When pursuing a manufacturer to produce a new Nitinol-based implant or device, it’s important to consider a number of factors.

Norman Noble, Inc.

Nitinol is a highly elastic material that’s processed to maintain a required geometry. Its properties, combined with high fatigue resistance and an ability to provide constant force over a wide range of displacements, makes it ideal for use in numerous medical implants and devices, including vascular stents (cardio, AAA, peripheral, carotid, venous, neuro), transcatheter heart valves, vascular closure implants, neurovascular clot pullers, flow diverters, vena cava filters, orthopedic anchors, and atrial fibrillation devices. As well-suited as nitinol is for vascular implant applications, few manufacturers are able to produce finished goods with it. The major barriers to working with nitinol are: Transcatheter heart valves can be fabricated using nitinol.

• Low machinability. As a raw material, nitinol is difficult to machine with conventional technologies. Multiple proprietary manufacturing processes are required to produce even the most basic nitinol-based device. • Electropolishing and passivation: To protect against the harmful release of nickel into the human body, electropolishing or passivation are required to create a protective titanium oxide layer. • Process validation: Nitinol implant manufacturing requires strict process controls and validation to meet the finished material specifications.

• Knowledge. Working with the alloy requires extensive knowledge of its mechanical properties and fatigue characteristics. www.medicaldesignandoutsourcing.com

Manufacturing Feat_5-16_Vs4.indd 43

Consider these factors when pursuing a manufacturer to produce a new nitinol-based implant or device. Raw material sourcing Before committing to any manufacturer, it’s crucial to know how they’ll source nitinol for a given project. An original equipment manufacturer’s (OEM’s) ability to supply the market with product depends directly on the contract manufacturer’s ability to 5 • 2016

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Medical Design & Outsourcing - MAY 2016  

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