Advanced FEA for Implantable Medical Devices

Finite Element Analysis (FEA) is a powerful method for predicting the physical response of a structure under specified loading. FEA provides a “virtual” prototype that can be used for checking many aspects of a design’s performance throughout the product development process, saving both time and money.

Modern commercial FEA software packages such as ABAQUS are capable of solving the most sophisticated problems facing the design and development of implantable medical devices. Such FEA problems require the consideration of nonlinear material behavior, complex contact interaction, structural instabilities, multi-axial loading, just to name a few.

At ECHOBIO LLC, we regularly apply FEA to implantable medical devices and surgical instruments. We provide expert consulting services in the follow areas:

• Fatigue simulations and fracture analysis
• Design and product optimization
• Failure analysis and root cause determination
• FDA submissions and regulatory documentation
• Feasibility and due diligence

Nitinol Material and Process Engineering

Nitinol is an intermetallic alloy comprised of approximately equal parts of nickel and titanium. It can be thermomechanically processed to provide either shape memory or superelastic characteristics. Almost all medical applications of Nitinol utilize the superelastic form where Nitinol has large recoverable strains at body temperature.

Nitinol requires exceptional care and attention to detail to achieve these unique properties. It is essential to establish appropriate processing parameters for Nitinol to optimize target performance properties including radial force, fatigue resistance and biocompatibility.

At ECHOBIO LLC, we work with customers to leverage our Nitinol materials expertise in the follow areas:

• Electropolishing and surface finish
• Material selection and thermo-mechanical processing
• Mechanical testing, characterization and analysis
• Rapid prototyping