FEA and CFD based Simulation and Design for Medical and Biomedical ApplicationsFEA 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. 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.
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.
Enteknograte engineering team use advanced CAE software with special features for mixing the best of both FEA tools and CFD solvers: CFD codes such as Ansys Fluent, Siemens StarCCM+ and FEA Codes such as ABAQUS, Nastran, LS-Dyna and the industry-leading fatigue Simulation technology such as Simulia FE-SAFE, Ansys Ncode Design Life to calculate fatigue life and MSC Actran and ESI VA One for Acoustics and VibroAcoustics simulations.
With combination of deep knowledge and experience in sophisticated FEA and CFD based simulation and design tools and coupling with 1D System modeling Software such as Matlab Simulink, Enteknograte engineers can solve any problem with any level of complexity in Medical and Biomedical applications Design and Optimization.
FEA and CFD Based Simulation
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.
Engineering Simulation Laboratory
FEA and CFD Based Simulation
FEA and CFD for Medical and Biomedical Engineering
Enteknograte also has many years of industry and research experience in FE modeling and CFD modeling that lead to overcome any complicated problem. We combine this experience with our long standing expertise in metallurgy, polymer science, and failure analysis to provide our clients with a unique perspective for addressing complex computational projects required in the medical device industry. We use FEA and CFD for simulating Biomedical Engineering problem:
Digital Twin for Orthopedics, Dental and Medical Device Industry
Our solution portfolio provides an open, integrated environment for device development, manufacturing, and service of orthopedic and dental devices. Our proven solutions ensure device quality, traceability and regulatory compliance across the lifecycle. The key differentiators of our portfolio and engagement strategies for medical device manufacturers are Digitalization, Realization and Simulation. Digitalization: “Digitalize” across the multi-disciplinary, software and hardware mechatronic domains, utilizing our data-centric approaches and automation, instead of document-centric procedures, thereby creating Digital Twins and Digital Threads, making product and process knowledge explicit, accessible, and re-usable.
Realization: Great ideas are nice, but ideas have little value until they can be transformed them into “realized” manufactured devices with high quality, and high confidence in their ability to perform safely and effectively in the healthcare delivery value chain. Simulation: Digital Twins predict and optimize the operating performance of your devices, as well as manufacturing and service operations. Work out quality and volume production ramp-up issues early, digitally, and avoid expensive rework driven by late stage non-conformances and complaints
FEA Analysis of Orthopedic Implants
Multidisciplinary simulation provides a methodology for the analysis of complex engineering systems and subsystems, exploiting the synergism of mutually interacting phenomena such as thermal and structural loading. Multidisciplinary analysis also enables the chaining of analysis sequences so that the output state of one sequence can be used as the input state for the next. Multidiscipline simulation solutions for medical device tests include:
- Material Nonlinearity
- Thermal Temperature Cycling and Radiation
- Durability Fatigue Life
- Motion and Biomechanics
- Drop Test, Fluid Structure Interaction (FSI)
- Packaging Seal Strength
- Deformation, Contact
Enteknograte’s expertise covers technical issues from all major joint replacement interventions and orthopedic bone trauma. Specific FE experience includes the following:
- Models have been developed analyzing hip, knee, ankle, shoulder, elbow, wrist, finger and toe joint replacements
- Experience developing models to analyze fracture fixation for trauma
- Subject-specific anatomy based on medical imaging
- Non-homogeneous bone moduli based on bone mineral density
- Robust contact algorithms for implant and bone interactions
- Customized implant geometries
- Virtual experiments to simulate implantation of devices
- Parametric analysis to account for variations in design, surgical, and patient factors
- Topological shape optimization for load bearing medical devices
- Development of kinematic gait models for the evaluation of orthotic and high performance footwear
FEA Simulation of Spine Implants
Enteknograte conducts FE modeling to evaluate in situ stress states of implantable spinal devices and surrounding biological structures, and to explore natural and device associated spinal kinematics. Results from these analyses, combined with data from our retrieval collection and cadaveric spine simulator, provide valuable insight into performance and potential failure modes for spine implant devices.
- Subject-specific anatomy based on medical imaging
- Non-homogeneous bone moduli based on bone mineral density (via calibrated CT)
- Robust contact algorithms for implant and facet interactions
- Analysis of total disc replacement impingement mechanics
- Evaluation of implant functionality
FEA Analysis of Craniomaxillofacial and Plastic Surgery
Enteknograte engineers have development FE models of both craniomaxillofacial and plastic surgery reconstructive procedures including:
- Evaluation of wound closure forces and tissue strains for plastic surgery
- Finite element modeling tool development for surgical planning and preparation
- Analysis of bone stress and resorption surrounding dental implants
- Development of models to analyze fracture fixation and healing for craniomaxillofacial applications
- Qualitative evaluation of the risk for implanted device migration in soft tissue
FEA Simulation 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
Special FEA and CFD Medical Applications:
- Rotary blood pumps (CFD)
- Blood oxygenators (CFD)
- Blood heat exchangers (CFD)
- Cardiac catheters (CFD)
- Thermal balloon catheters (CFD)
- Atherectomy devices (CFD)
- Miniaturized implantable renal assist device (CFD)
- Miniaturized Blood Oxygenator (CFD)
- MEMS drug delivery catheter (CFD)
- Laparoscopic fluid delivery device (CFD)
- Cover for blood cell separator (FEA)
- Spinal implants (FEA)
- Surgical cooling device (CFD)
- Replacement lens for cataracts surgery (FEA)
- Contact lens on cornea (FEA)
- Particle deposition in the human lungs (CFD)
- Percussion bed simulation (FEA)
- Effect of mandibular repositioning device on airway of patients with obstructive sleep apnea (CFD)
- Magnetic stem cell separation device (CFD)
- Thermal modeling of human skin (CFD)
- Medical imaging machine frame (FEA)
- Connector design for breathing apparatus (FEA)
- Predicting air flow patterns within the surgical suite for infection control (CFD)
Considering complexity and needs to have new procedure and constitutive equation, we must try to develop new FEA and CFD based software to overcome engineering challenges.
FEA and CFD based Programming needs experience and deep knowledge in both Solid or fluid mechanics and programming language such as Matlab, Fortran, C++ and Python.
Enteknograte’s engineering team use advanced methodology and procedure in programming and correct constitutive equation in solid, fluid and multiphysics environment based on our clients needs.
We use subroutine’s with programming languages such as Fortan, C and Python in CFD and FEA sofware such as Abaqus, Ansys, Fluent and Star-ccm+ to add new capability and Constitutive equation.
Enteknograte use Mathematical Methods and Models for Engineering Simulation. We, focuses on numerical modelling and algorithms development for the solution of challenging problems in several engineering sectors specialized in the development of software for the numerical discretization of partial differential equations, linear algebra, optimization, data analysis, High Performance Computing for several engineering applications.
Real world Simulation: Combination of experience and advanced analysis tools
Calling upon our wide base of in-house capabilities covering strategic and technical consulting, engineering, manufacturing ( Casting, Forming and Welding) and analytical software development – we offer each of our clients the individual level of support they are looking for, providing transparency, time savings and cost efficiencies.
Enteknograte engineers participate in method development, advanced simulation work, software training and support. Over experiences in engineering consulting and design development, enables Enteknograte’s engineering team to display strong/enormous client focus and engineering experience. The Enteknograte team supports engineering communities to leverage CFD-FEA simulation softwares and methodologies. It leads to the creation of tailored solutions, aligned with the overall product development process of Enteknograte clients.
CAE Simulation: CFD, FEA, System Modeling, 1D-3D coupling
Integrated expertise covering every Equipment component analysis. From concept through to manufacture and product launch, and for new designs or Equipment modifications, we provide engineering simulation expertise across projects of all sizes. Simulation has become a key enabling factor in the development of highly competitive and advanced Equipment systems. CAE methods play a vital role in defining new Equipment concepts.