In Silico Medical & Biomedical Device Testing: Finite Element, CFD & Electromagnetic Simulation and Design, Considering FDA & ASME V&V 40

FEA & CFD Based Simulation Design Analysis Virtual prototyping MultiObjective Optimization

FEA and CFD based Simulation design and analysis is playing an increasingly significant role in the development of medical devices, saving development costs by optimizing device performance and reliability, reducing benchtop tests and clinical trials, and helping to speed the regulatory approval process. Developing increasingly complex medical devices requires increasingly capable tools for simulation and testing. Our deep portfolio of simulation and testing solutions allows medical device developers to generate digital evidence of device performance across a range of engineering disciplines, throughout the product life cycle.

Enteknograte offers a Virtual Engineering approach with CFD and FEA tools such as Ansys Fluent and Siemens StarCCM+ for flows simulation and FEA Codes such as Abaqus, Ansys, Nastran and LS-Dyna, encompassing the accurate prediction of in-service loads, the performance evaluation, and the integrity assessment including the influence of manufacturing the components for In Silico Medical & Biomedical Device Testing with Finite Element & CFD Simulation, Considering FDA & ASME.

Enteknograte Biomedical Engineers use advanced FEA and CFD tools for simulating: Orthopedic products, Medical fasteners, Ocular modeling, Soft tissue simulation, Packaging, Electronic systems, Virtual biomechanics, Knee replacement, Human modeling, Soft tissue and joint modeling, Hospital equipment, Laser bonding, Ablation catheters, Dental implants, Mechanical connectors, Prosthetics, Pacemakers, Vascular implants, Defibrillators, Heart valve replacements.

medical device Finite element cfd comsol FEA abaqus ansys comsol siemens Star-ccm+ fluent ls-dyna

FDA submissions require a comprehensive audit trail which includes:

  • Records of all simulation data
  • Revision management and control
  • Correlation with physical test results
  • Proven repeatable methods
  • Software version tracking

To ensure confidence in the simulation and reliability of the analysis results, medical device manufacturers must ensure that the CAE analyst is using the most current CAD geometry, specify the correct material properties, and apply the appropriate environmental loading conditions. They must also create the proper mesh type and size, record the version of the analysis software, and correlate results with physical test data. These criteria must be preserved and managed for FDA compliance purposes and for the benefit of enhanced enterprise productivity.


FDA Describes the Format for Reports on Computational Modeling and Simulation

This guidance’s main objective is to make sure sponsors provide all the details necessary to assess if a model has the necessary credibility to be used as reliable scientific evidence in regulatory decision-making. Additionally, the document offers a consistent vocabulary that regulators and the device industry can use when organizing, debating, and evaluating the various components of a computational modeling research.

The majority of the guidelines, which is applicable to the majority of physics disciplines, describes the report’s overall format. The guidance also includes a number of appendices that offer comprehensive reporting recommendations for CFD, FEA, electromagnetics (EM), ultrasound, heat transfer, and optics in order to help the user. For instance, the appendix on computational electromagnetics advises the user to provide a synopsis of the governing equations used (for instance, Maxwell’s equations) and details on the electrical characteristics of the device and tissues being represented.

FEA and CFD based Simulation and Design for Medical and Biomedical Applications
medical device CAE simulations FDA ASTM starndard Testing FEA CFD Simulation abaqus ansys ls-dyna comsol 2
Star-ccm+ applications in insilico testing within the medical and biomedical industry

Reporting of Computational Modeling Studies in Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff

For many years, computational modeling and simulation (CM&S) studies have been used by sponsors to support device design/development and have been reported in medical device submissions. These studies have traditionally been used in the areas of fluid dynamics (e.g., calculate shear stress in ventricular assist devices), solid mechanics (e.g., determine maximum stress locations in a hip implant), electromagnetics and optics (e.g., radiofrequency safety in magnetic resonance imaging, fluorescence for fiber optic spectroscopy devices), ultrasound propagation (e.g., absorbed energy distribution for therapeutic ultrasound), and thermal propagation (e.g., temperature rises with radiofrequency and laser ablation devices).

The purpose of this guidance document is to provide recommendations to industry on the formatting, organization, and content of reports of CM&S studies that are used to support medical device submissions. Moreover, this guidance is also for FDA Staff, to improve the consistency and predictability of the review of CM&S studies and to better facilitate full interpretation and complete review of those studies. The FDA guidance used in conjunction with ASME V&V 40. The ASME V&V 40 standard is an FDA-recognized standard that provides a risk-based framework for establishing the credibility requirements of a computational model. 


The risk-informed credibility assessment framework, as defined by the ASME V&V 40 standard for In Silico Medical Device Testing

Another reason for the limited utilization of simulation results in regulatory submissions was the need for consensus on the evidentiary bar required to establish sufficient credibility of a computational model. The American Society of Mechanical Engineers (ASME) verification and validation (V&V) subcommittee on computational models of medical devices (ASME V&V 40 subcommittee) was formed in 2011 to address this critical need.

Comprised of members from the medical device industry, industry service providers, software developers and the FDA, the group developed the risk-informed credibility assessment framework. The main tenet of the framework is that high-risk decisions based on a computer model require more validation than lower-risk decisions.

Therefore, the ASME standard guides how the user determines the amount of V&V that is required to establish model credibility. This standard complements the ASME V&V standards for FEA, CFD and heat transfer.




Orthopedic Implant medical device finite element simulation abaqus ansys ls-dyna msc nastran design
artery catheter Cardiovascular Siemens PLM Simcenter STAR-CCM Medical Biomedical CFD Simulation

Medical Device Electromagnetic Performance and Safety

Advanced electromagnetic simulation technology has indeed revolutionized the field of medical device development and validation. By leveraging computational modeling tools, device manufacturers can assess and validate the electromagnetic performance, safety, and compliance of their products in a virtual environment.

Some key applications and benefits of advanced electromagnetic simulation in the context of medical devices:

  • Antenna Design and Placement: Simulation tools enable the design and optimization of antennas used in medical devices such as wireless communication systems, implantable devices, and wearables. Virtual validation allows for efficient exploration of various antenna designs and their optimal placement, improving device performance and reducing the need for physical prototyping.
  • Signal and Power Integrity Assessment: Electromagnetic simulation aids in analyzing signal integrity issues, such as crosstalk, electromagnetic interference, and power distribution problems. By identifying and mitigating these issues early in the development process, manufacturers can optimize the functionality and reliability of their medical devices.
  • EMI/EMC Evaluation: Electromagnetic Interference (EMI) and Electromagnetic Compatibility (EMC) are critical aspects of medical device safety and regulatory compliance. Advanced simulation tools can predict and evaluate EMI/EMC issues, allowing designers to identify potential interference sources and optimize device shielding, grounding, and filtering techniques.
  • MRI Design: Magnetic Resonance Imaging (MRI) compatibility is crucial for devices used in proximity to MRI scanners. Electromagnetic simulation helps in assessing the behavior and potential hazards of medical devices in MRI environments. It enables designers to optimize device performance while ensuring patient safety and minimizing potential image artifacts or interference.
  • Charged Particle Devices: Simulation tools can evaluate the behavior of charged particle devices, such as electron accelerators or proton therapy machines. By simulating the electromagnetic interactions and particle trajectories, manufacturers can optimize device design, improve treatment accuracy, and ensure patient safety.
  • Human Exposure Compliance: Electromagnetic simulation can assess the exposure of virtual human models to electromagnetic fields generated by medical devices. This allows manufacturers to evaluate compliance with human exposure guidelines and optimize device designs to minimize potential risks
Low Frequency electromagnetics including wireless charging Biomedical simulation ansys maxwell
medical device CAE simulations FDA ASTM starndard Testing FEA CFD Simulation abaqus ansys ls-dyna comsol

As part of our promise to excellency, we have experts with FDA's guidance for Reporting Computational Modeling and Simulation (CM&S) Studies in Medical Device Submissions.

Medical applications are typically subjected to a wide range of complex environmental and biological loading conditions.The variability of these conditions makes the physical testing of all possible scenarios both difficult and time-consuming. By using FEA and CFD multidisciplinary and multiphysics simulation technology, our engineers can study a greater number of real-world design behaviors with higher accuracy.

Finite element analysis of Orthopedic Implants

An orthopedic implant is a device surgically placed into the body designed to restore function by replacing or reinforcing a damaged structure. For the treatment of back pain, orthopedic implants such as bone plates and bone screws are used in spinal fusion surgery and fixation of fractured bone segments, as well as implant components used for hip and joint replacement. The material used in orthopedic implants must be biocompatible to avoid rejection by the body. Other risks associated with orthopedic implants include implants coming loose or breaking in the bone causing painful inflammation and infection to surrounding tissue.

Finite element and CFD analysis and Digital Twin for Orthopedics, Dental and Medical Device Industry

Enteknograte has expertise in finite element (FE) analysis of biomaterials, containers and closures, drug delivery systems including injectors, implantable and patch pumps, medical device components. We specialize in developing and validating detailed computational models for due diligence, ideation, concept selection, requirements identification and generation, design evaluation and optimization, generating design output elements for verification. We assist clients solve a variety of challenges associated with device design, design optimization, and interaction with calcified and soft tissues.

Finite element & CFD analysis of Cardiovascular Implants

Enteknograte can develop FE models of various cardiovascular implants for evaluating design, manufacturing, and delivery procedures, along with clinical performance. Modeling experience includes the following: Cardiovascular and peripheral stents—self-expanding and balloon expanding, Vena cava filters, Abdominal aortic aneurysm (AAA) grafts, Artificial heart valves and devices—percutaneous (TAVI/TAVR) and surgically placed, Ventricular reconstruction modeling User-defined material models for shape memory alloys, Device life predictions using implant-vessel interaction models, Bridge to implant or destination therapy LVADs.

Finite element analysis of Craniomaxillofacial and Plastic Surgery

Enteknograte offers a Virtual Engineering approach with CFD and FEA tools such as Ansys Fluent, StarCCM+ for flows simulation and FEA based Codes such as ABAQUS, Ansys, Nastran and LS-Dyna, encompassing the accurate prediction of in-service loads, the performance evaluation, and the integrity assessment including the influence of manufacturing the components.

Finite Element Analysis of Durability and Fatigue Life

Vibration Fatigue, Creep, Welded Structures Fatigue, Elastomer and Composite Fatigue with Ansys Ncode, Simulia FE-Safe, MSC CAEFatigue, FEMFAT
Durability often dominates development agendas, and empirical evaluation is by its nature time-consuming and costly. Simulation provides a strategic approach to managing risk and cost by enabling design concepts or design changes to be studied before investment in physical evaluation. The industry-leading fatigue Simulation technology such as Simulia FE-SAFE, Ansys Ncode Design Life and FEMFAT used to calculate fatigue life of multiaxial, welds, short-fibre composite, vibration, crack growth, thermo-mechanical fatigue.

Multi-Phase Flows CFD Analysis

Multi-Phases flows involve combinations of solids, liquids and gases which interact. Computational Fluid Dynamics (CFD) is used to accurately predict the simultaneous interaction of more than one combination of phases that can be gases, solids or fluids. Typical applications involve sprays, solid particulate transport, boiling, cavitation, state-changes, free surface flows, dispersed multiphase flows, buoyancy problems and mixed species flows. For example, the risks from flow or process-induced vibration excitation of pipework are widely acknowledged in onshore process plants, offshore topsides and subsea facilities.

Hydrodynamics CFD simulation

Coupled with FEA for FSI Analysis of Transient Resistance, Propulsion, Cavitation, Vibration and Fatigue
System properties such as mass flow rates and pressure drops and fluid dynamic forces such as lift, drag and pitching moment can be readily calculated in addition to the wake effects. This data can be used directly for design purposes or as in input to a detailed stress analysis. Coupling Hydrodynamic CFD Simulation in Ansys Fluent, Siemens Star-ccm+ and MSC Cradle with structural finite element solver such as Abaqus and Ansys,to solve Cavitation, Vibration and Fatigue induced by hydrodynamics fluctuation, Transient Resistance, considering two way FSI (Fluid Structure Interaction) coupling technology.

Integrated Artificial Intelligence (AI) & Machine Learning - Deep Learning with CFD & FEA Simulation

Machine learning is a method of data analysis that automates analytical model building. It is a branch of Artificial Intelligence based on the idea that systems can learn from data, identify patterns and make decisions with minimal human intervention. With Artificial Intelligence (AI) applications in CAE, that is Mechanical Engineering and FEA and CFD Simulations as design tools, our CAE engineers evaluate the possible changes (and limits) coming from Machine learning, whether Deep Learning (DL), or Support vector machine (SVM) or even Genetic algorithms to specify definitive influence in some optimization problems and the solution of complex systems.
Enteknograte offers a Virtual Engineering approach with CFD and FEA tools such as Ansys Fluent, StarCCM+  for flows simulation and FEA based Codes such as ABAQUS, Ansys, Nastran and LS-Dyna, encompassing the accurate prediction of in-service loads, the performance evaluation, and the integrity assessment including the influence of manufacturing the components.
heart valve Ansys ls-dyna simulation design finite element fea

Multibody Dynamics

Robots Dynamics, Control Systems, Advanced Machinery, Full Vehicle MBD and NVH
Multibody dynamic analysis is important because product design frequently requires an understanding of how multiple moving parts interact with each other and their environment. From automobiles and aircraft to washing machines and assembly lines - moving parts generate loads that are often difficult to predict. Complex mechanical assemblies present design challenges that require a dynamic system-level analysis to be met. Accurate modeling can require representations of various types of components, like electronic controls systems and compliant parts and connections, as well as complicated physical phenomena like vibration, friction and noise.

Electromagnetic Multiphysics

FEA & CFD Based Simulation Including Thermal Stress, Fatigue, and Noise, Vibration & Harshness – NVH for Electric Motors
Enteknograte Finite Element Electromagnetic Field simulation solution which uses the highly accurate finite element solvers and methods such as Ansys Maxwell, Simulia Opera, Simulia CST, JMAG, Cedrat FLUX, Siemens MAGNET and COMSOL to solve static, frequency-domain, and time-varying electromagnetic and electric fields includes a wide range of solution types for a complete design flow for your electromagnetic and electromechanical devices in different industries.

Ansys HFSS: Multipurpose High Frequency Electromagnetic Field Simulator for RF, Microwave and Wireless Design

Ansys HFSS is a 3D electromagnetic (EM) simulation software for designing and simulating high-frequency electronic products such as antennas, antenna arrays, RF or microwave components, high-speed interconnects, filters, connectors, IC packages and printed circuit boards. Engineers worldwide use Ansys HFSS software to design high-frequency, high-speed electronics found in communications systems, advanced driver assistance systems (ADAS), satellites, and internet-of-things (IoT) products.

Ansys Maxwell: Low-Frequency Electromagnetic Simulation for Electric Machines

Ansys Maxwell is an electromagnetic field solver for electric machines, transformers, wireless charging, permanent magnet latches, actuators, and other electromechanical devices. It solves static, frequency-domain and time-varying magnetic and electric fields. Maxwell also offers specialized design interfaces for electric machines and power converters. It includes 3-D/2-D magnetic transient, AC electromagnetic, magnetostatic, electrostatic, DC conduction and electric transient solvers.

Acoustics and Vibration: FEA and CFD for AeroAcoustics, VibroAcoustics and NVH Analysis

Noise and vibration analysis is becoming increasingly important in virtually every industry. The need to reduce noise and vibration can arise because of government legislation, new lightweight constructions, use of lower cost materials, fatigue failure or increased competitive pressure. With deep knowledge in FEA, CFD and Acoustic simulation, advanced Acoustic solvers and numerical methods used by Enteknograte engineers to solve acoustics, vibro-acoustics, and aero-acoustics problems in automotive manufacturers and suppliers, aerospace companies, shipbuilding industries and consumer product manufacturers.

FEA Based Composite Material Design and Optimization: MSC Marc, Abaqus, Ansys, Digimat and LS-DYNA

Finite Element Method and in general view, Simulation Driven Design is an efficient tool for development and simulation of Composite material models of Polymer Matrix Composites, Metal Matrix Composites, Ceramic Matrix Composites, Nanocomposite, Rubber and Elastomer Composites, woven Composite, honeycomb cores, reinforced concrete, soil, bones ,Discontinuous Fiber, UD Composit and various other heterogeneous materials.

Additive Manufacturing and 3D Printing

FEA Based Design and Optimization with Simufact, Abaqus, ANSYS and MSC Apex for powder bed fusion (PBF), directed energy deposition (DED) and binder jetting processes
With additive manufacturing, the design is not constrained by traditional manufacturing requirements and specific number of design parameters. Nonparametric optimization with new technologies such as Artificial Intelligence in coupled with Finite Element method, can be used to produce functional designs with the least amount of material. Additive manufacturing simulations are key in assessing a finished part’s quality. Here at Eneteknograte, dependent of the problem detail, we use advanced tools such as MSC Apex Generative Design, Simufact Additive, Digimat, Abaqus and Ansys.

Heat Transfer and Thermal Analysis: Fluid-Structure Interaction with Coupled CFD and Finite Element Based Simulation

We analyze system-level thermal management of vehicle component, including underhood, underbody and brake systems, and design for heat shields, electronics cooling, HVAC, hybrid systems and human thermal comfort. Our Finite Element (LS-Dyna, Ansys, Abaqus) and CFD simulation (Siemens Start-ccm+, Ansys Fluent , Ansys CFX and OpenFoam) for heat transfer analysis, thermal management, and virtual test process can save time and money in the design and development process, while also improving the thermal comfort and overall quality of the final product.