Services: FEA, design, modeling, simulation, analysis
ECHOBIO LLC is experienced in all aspects of engineering implantable medical devices and provides a range of expert services to suit your needs, timing and budget.
Our FEA and medical implant design expertise is supported by over twenty years of hands-on mechanical testing and physical prototyping. We have a laboratory, high-speed fatigue test systems, small-scale production equipment, machine shop, and a long list of custom research and proprietary equipment available.
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 to optimize for many aspects of a design during the product development process, saving both time and money.
Modern commercial FEA software packages are capable of solving the most sophisticated problems facing implantable medical devices. Such FEA problems require consideration of nonlinear material behavior, complex contact interaction, structural instabilities and multi-axial loading, and many other factors.
At ECHOBIO LLC, we specialize in applying FEA to implantable medical devices and products. We provide FEA services such as:
- Fatigue simulations and stress analyses
- Modeling of complex shapes and non uniform loads
- Failure analyses and design optimization
- Design and product development
- FDA submissions and regulatory documentation
- Feasibility, strategy and due diligence
Material, Fatigue and Validation Testing
FEA simulations require calibration to accurately predict structural response. This is usually done with a stress-strain or force-deflection curve obtained through an experiment. Additional experimental input is required to define the limits of the material, for example, how many cycles at a given load will the material withstand.
In addition to the input requirements for FEA, effective simulations require rigorous coordination with experimental results. This is particularly important for regulatory submissions where validation of the results obtained through the use of FEA is emphasized.
ECHOBIO LLC offers the following services to support our clients in developing and getting regulatory approval for their implantable medical devices:
- Material characterization
- Finished device and component performance testing
- Single and multi-component durability testing
Nitinol Material and Process Engineering
Nitinol is an intermetallic alloy comprised of approximately equal parts of nickel and titanium. It can be thermomechanically processed and 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 and a unique mechanical response.
Establishing the material and manufacturing specifications to achieve these desired properties and to maintain them through the product life cycle can be a challenge. Implantable medical devices generally need to be compressed to small diameters and then released to perform at much larger diameters.
Nitinol products require precise specifications to achieve target performance such as radial force, fixation and fatigue resistance.
At ECHOBIO LLC, we leverage our Nitinol materials expertise and provide the following services:
- Rapid prototyping and design evolution
- Material selection and thermo-mechanical processing
- Product design and thermo-mechanical process optimization
