Session Organizer: Marc Horner, Ansys
The adoption of Computational Modeling and Simulation (CM&S) by medical device manufacturers continues to grow at an accelerated pace. CM&S is also increasingly utilized as part of surgical planning and clinical decision-support. These developments are driven by many factors, including on-going advancements in multi-physics and multi-scale simulation, the ubiquitous presence of AI in medical imaging, increasing support from the US FDA and other regulators in the form of CM&S guidance, and the need to stay competitive in the global marketplace. This session will focus on how computational modeling and simulation tools are leading to increased efficiency in medical device development and clinical practice.
Striking a Balance Between Patient Risk, Accuracy, and Cost in the FEA of Stent Frames
Brandon Lurie, BS, MS
Modeling and Simulation Engineer
W. L. Gore & Associates
Abstract: The geometry's discretization impacts the cost and accuracy of a finite element analysis. Smaller elements improve the simulation's accuracy and increase its total runtime. Finding and then justifying the right balance between accuracy and resources to managers and regulators is a significant challenge for engineers, especially with the proliferation of in silico experiments that can entail tens to hundreds of simulations. This presentation shares a methodology developed by representatives from Gore Medical, Medtronic, BD, and Ansys to identify an appropriate and defensible discretization based on risk, accuracy, and computational cost.
Bio: Brandon Lurie is a Modeling & Simulation Engineer at W. L. Gore & Associates. He has spent over 15 years applying FEA to stents and other implantable medical devices. Brandon has led multiple standard writing groups, including the working group for ASTM F2514, Standard Guide for FEA of Metallic Vascular Stents Subject to Uniform Radial Loading, which was published in 2021, and ASME VVUQ 40.1, An Example of Assessing Model Credibility Using the ASME V&V 40 Risk-Based Framework: Tibial Tray Component Worst-Case Size Identification for Fatigue Testing, which is on track to publish in the first half of 2025. His current focus is on developing in-house tools, processes, and technology that aid the development of implantable medical devices. Though a graduate of the University of Michigan, Brandon cannot help the University of Minnesota obtain the Little Brown Jug.
Comparative Computational Fluid Dynamics Analysis of Pulmonary Airway Flow and Surgical Outcomes for a Patient With Tracheal Stenosis
Ceyda Kara
School of Chemical Engineering
Oklahoma State University
Abstract: Tracheal stenosis, a severe narrowing of the airway, poses major challenges to respiratory function and often requires surgical intervention. This study demonstrates how computational fluid dynamics (CFD) can provide a non-invasive, efficient, and patient-specific approach to model and compare surgical strategies. Three tracheal geometries were analyzed: a diseased airway and two post-surgical configurations, simulated under four inhalation flow rates (6, 30, 60, and 120 L/min). A laminar model was used for low flow, and the shear stress transport (SST) k-ω turbulence model was applied for higher flow rates. The turbulence model’s accuracy was validated using a different airway geometry against experimental data, as shown in Figures 4 and 5 of a previously published study (MDPI Bioengineering, 2017, 4(4), 90). The diseased model showed high resistance, with pressure drops increasing from 1.96 Pa at rest to 318.9 Pa during exercise and wall shear stress (WSS) peaking at 330.8 Pa. Surgical Plan 1 reduced pressure drops by up to 47% and WSS by 97%, while Surgical Plan 2 further lowered WSS to 2.54 Pa. Airflow imbalances, such as the right lower lobe receiving 40% of total flow in the diseased model, were corrected post-surgery; Surgical Plan 2 achieved the most even distribution, with all lobes receiving 13%–29% of flow. These results demonstrate that CFD, with validated modeling techniques, can accurately simulate surgical outcomes and serve as a powerful tool for personalized pre-surgical planning in airway reconstruction.
Bio: Ceyda Kara is a freshman in the School of Chemical Engineering at Oklahoma State University. She is a member of the Computational Biofluid Biomechanics Laboratory (CBBL) led by Dr. Yu Feng, where she contributes to research on pulmonary drug delivery and computational modeling. Ceyda is a W.W. Allen Scholar and a 2025 Fleming Scholar at the Oklahoma Medical Research Foundation (OMRF), where she will conduct neuroscience research under Dr. Michael Beckstead. As part of the W.W. Allen Scholars Program, she will pursue a master’s degree at the University of Cambridge following the completion of her undergraduate studies at OSU. Her academic interests include drug delivery, computational fluid dynamics (CFD), and neurological disorders. In addition to her research, Ceyda serves as Secretary of the Society of Women Engineers (SWE) at OSU and works as an Engineering Lead Tutor at the LASSO Center. She plans to pursue an MD-PhD to bridge engineering and medicine through research, innovation, and clinical impact.
The Impact of Sex Differences on Computational Modeling, Outcome Prediction and Precision Medicine
Tinen Iles, PhD
Assistant Professor, Department of Surgery
University of Minnesota
Abstract: Accounting for sex differences plays a critical role in creating accurate computational models of human physiological systems. The impact of analyzing anatomical, chemical and other biological differences is necessary for a in silico drug testing, evaluation of medical devices, device tissue interface and creating predictive models to guide clinical decision making. This talk will focus on considerations for developing models to account for sex differences specifically as it relates to Verification and Validation (V&V) process, clinical prediction and the use of Software as a Medical Device (SaMD).
Bio: Dr. Tinen L Iles is an Assistant Professor in the Department of Surgery at the University of Minnesota Medical School. Prior to receiving her professorship, she was a scientist in the Department of Surgery focusing on cardiac research and device design. Before academia, she worked in industry focusing on neuroscience and pharmacology and continues to have interests in industrial-academic collaborations. Dr. Iles received her PhD from the University of Minnesota in Bioinformatics and Computational Biology in 2017 and is on the Graduate faculty for Biomedical Engineering, Bioinformatics and Computational Biology; she teaches and lectures on topics ranging from cardiac anatomy and physiology to applied biophotonics. The goal of Dr. Iles research laboratory is to study how devices, mathematical frameworks, and machines interface with human biology/physiology and the clinical impact of what we learn from this research by developing unique methods for translational research with a multidisciplinary approach.
Design Optimization of a Mono-leaflet Mechanical Heart Valve to Improve Hemodynamics using MOGA
Meraj Ahmed, PhD
Postdoctoral Research Fellow
Department of Civil, Construction, and Environmental Engineering
North Dakota State University
Abstract: The prosthetic mechanical heart valve (MHV) implants cause reduction in the Effective Orifice Area (EOA) leading to increased resistance to the flow of blood. Therefore, the altered hemodynamics causes activation of platelets which leads to thrombosis and thromboembolism. Hence, in the present research, the design of a three-dimensional model of mono-leaflet MHV has been optimized to improve its hemodynamic performance. A response surface optimization method using a multi-objective genetic algorithm (MOGA) has been used to optimize the design of the mono-leaflet MHV. The performance of the MHV was accessed using three parameters: Total Platelet Activation (TA), Maximum Shear Stress on the Leaflet (τmax), and EOA. The proposed method can be utilized to improve the hemodynamics of mechanical heart valves.
Bio: Dr. Meraj Ahmed is a Postdoctoral Research Fellow in the Department of Civil, Construction, and Environmental Engineering at North Dakota State University. With a robust interdisciplinary background in computational fluid dynamics and biomechanics, Dr. Ahmed has focused their research on modeling and simulation of patient-specific cerebral aneurysms, as well as the fluid dynamics of mechanical heart valves. Their Ph.D. work contributed to optimizing heart valve design by analyzing platelet activation under varying flow conditions.
In addition to computational modeling, Dr. Ahmed has experience with laboratory-based material testing, having conducted experiments during their M.Tech and Ph.D. studies, as well as mentoring undergraduate students in lab environments. Their current research also includes computational studies on the transport mechanisms of red blood cells and cancer cells, aimed at improving diagnostic and therapeutic strategies.
Dr. Ahmed has a strong passion for teaching and has taught fluid mechanics at the university level. Their combined expertise in simulation, experimentation, and teaching uniquely positions them to contribute across academia and industry, particularly in biomedical engineering, materials science, and fluid dynamics applications.
Session Organizer Bio
Marc Horner
Distinguished Engineer, Ansys
Dr. Marc Horner is a Distinguished Engineer leading technical initiatives for the healthcare industry at Ansys. Marc joined Ansys after earning his Ph.D. in Chemical Engineering from Northwestern University in 2001. Marc currently holds a number of industry leadership positions, with a focus on model credibility frameworks, regulatory science, and clinical applications. These include Vice Chair of the ASME VVUQ-40 Sub-Committee and Avicenna Alliance Global Harmonization Task Force Leader. Marc is also an Executive Committee Member of the IMAG/MSM Credible Practice of Modeling & Simulation in Healthcare project, which aims to establish a task-oriented collaborative platform that outlines credible practices of simulation-based medicine. Lastly, Marc helped to found the ASME VVUQ-80 Sub-Committee focused on computational modeling and simulation for pharma/biuopharma manufacturing,