May 11, 2021 11:00 a.m.–4:00 p.m. EDT

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COMSOL Day: Biomedical Devices

Simulation Software's Role in Inventing, Developing, and Certifying Medical Device Designs

The application of new and innovative biomedical devices has seen an accelerated and even paradigm shift in the last decade or so. COMSOL Day: Biomedical Devices will feature many invited speakers and panelists using simulation to study medical devices.

Join us to discover how new applications, processes, and methods are being developed by startups and established biotech companies. Invited speakers and COMSOL technical staff will discuss the innovation of far less intrusive medical devices that make the medical health and well-being of people increasingly better.

Simulation software's role in developing, optimizing, and applying medical devices has now become an integral part of the reporting criterion required to ascertain a device's operation, efficacy, and safety through mechanisms such as those provided by the FDA. Invited speakers and panelists will discuss this change, along with the general trends and applications of using simulation in the biomedical device industry.

View the program below and register for free today!

Schedule

11:00 a.m.

To start, we will briefly discuss the format of the day and go over the logistics for using GoToWebinar.

11:45 a.m.

The invention, development, and application of new and innovative biomedical devices has seen an acceleration in the last decade or so. Discovering new ways, processes, and methods by a plethora of startups and established biotech companies has been complemented by transformations provided by other innovators developing less intrusive and more focused devices to make the medical health and wellbeing of people increasingly better.

Much of this has come about due to modeling practices provided by simulation software, such as COMSOL Multiphysics®, that provides the industry with more efficient ways to discover, develop, and optimize the design and operation of such devices. The integration of simulation software has now reached the stage where it has become an integral part of all reporting mechanisms required to ascertain a device's operation, efficacy, and safety through mechanisms such as those provided by the FDA. This will be discussed during this panel discussion, along with the general trends and applications of using simulation in the biomedical device industry.

Moderators: Nagi Elabassi, Veryst Engineering and Phil Kinnane, COMSOL

Panelists:

  • Ismail Guler, Boston Scientific Corporation
  • Carlos Corrales, Baxter Healthcare
  • William Torres, Exponent
  • Arlen Ward, System Insight Engineering
12:30 p.m.
Q&A/Break
12:45 p.m.

David Gross, MED Institute

Open-bore MRI systems account for approximately 18% of the global MRI installed base, compared to 3 T closed bore, accounting for approximately 19% of the global MRI installed base. The wide patient table, large opening, and open view of these MRI systems are advantageous for imaging pediatric, bariatric, geriatric, and claustrophobic patients. With the parallel growth of open-bore MRI systems and the increased prevalence of patients with implanted medical devices, it is important to consider RF-induced heating of devices in open-bore MRI systems. This presentation will highlight how we use COMSOL Multiphysics® to evaluate RF-induced heating of medical devices for MRI labeling.

1:15 p.m.

Thomas Clavet, EMC3 Consulting

Acoustic waves in the ultrasonic range are widely used in many industries, including MedTech. For instance, echography is a well-known medical imaging technique that is often prescribed to diagnose an illness or health issue.

In addition to diagnostics, ultrasound can also provide a noninvasive way to treat a condition. Focused ultrasound (FUS) devices have become a common choice to kill cancerous tumors in the prostate, breast, pancreas, liver, and brain, but other conditions also take advantage of focused ultrasound, such as neurodegenerative diseases and glaucoma. Research in the field is very important and could lead to disruptive technologies and novel treatments in years to come.

High-intensity focused ultrasound (HIFU) ablation tools are designed to produce a localized elevation of temperature and necrosis of biological tissues. Simulating the acoustics and heat transfer phenomena involved in such tools allows engineers and researchers to select the combination of parameters that will deliver the right amount of energy in the targeted zone and limit the damage to the surrounding healthy tissues. There are numerous parameters, including the size of the transducer that transmits the ultrasound, the frequency of the signal, and the duration of the treatment.

Challenges remain as well, related to the knowledge of acoustics and thermal properties of tissues, and the nonlinear effects that happen at these high frequencies and amplitudes. Thus, there is still a long way to go before having a patient-specific treatment planning simulator, but the COMSOL® software would be a solution of choice to try to reach this goal.

In this presentation, Thomas Clavet from EMC3 Consulting will discuss how HIFU can be produced and key points about how to model this multiphysics problem.

1:45 p.m.
Q&A/Break
2:00 p.m.

Andres Belalcazar, Consultant

Atrial fibrillation is an arrhythmic disease that often arises from electrical activity conducting between the pulmonary veins and the left atrium of the heart. A therapeutic mainstay using catheter electrodes relies on isolating the pulmonary veins by creating durable lesions on atrial tissue. Heat or electrical fields may be used. With the COMSOL® models presented, a couple of design variations are presented using MRI/CT image sets that illustrate the power of modeling to refine electrical and mechanical design of ablation catheters.

2:30 p.m.

Alireza Kermani, Veryst Engineering

Hemolysis caused by flow-induced mechanical damage to red blood cells is a concern in devices that involve transporting blood. Mathematical models have been proposed to estimate red blood cell damage in blood flow. We used hemolysis mathematical models to evaluate the effect of modifications to the device geometry on blood damage. We used Lagrangian and Eulerian approaches to obtain blood damage estimates based on Ref. 1.

The United States Food and Drug Administration (FDA) initiated benchmark models of typical device flow geometries, including a nozzle (Ref. 2). Multiple laboratories participated and provided experimental velocities, pressure, and hemolysis data to support CFD simulations. We used the FDA nozzle as our benchmark. Our preliminary results show that the simple power law stress relation used in this hemolysis model in both its Lagrangian and Eulerian implementations cannot accurately quantify damage at flow rates of 6L/min, as used in the FDA experiments. However, the models can predict which geometries are more prone to blood damage than others. Therefore, these models can be used to compare hemolysis in different device geometries and assess the effect of slight geometrical modifications.

References

  1. Yu, H., Engel, S. 1, Janiga, G., & Thévenin, D. A Review of Hemolysis Prediction Models for Computational Fluid Dynamics. Artif Organs 2017 Jul; 41(7):603-621.
  2. Grigioni, M., Morbiducci, U., D’Avenio, G., Di Benedetto, G., & Del Gaudio, C. A novel formulation for blood trauma prediction by a modified power- law mathematical model. Biomechanics and Modeling in Mechanobiology 2005, 4(4), 249-260.
  3. Website. U.S. Food and Drug Administration. https://fdacfd.nci.nih.gov
3:00 p.m.
Q&A/Break
3:45 p.m.

The Application Builder is included in the COMSOL Multiphysics® software and allows you to transform your models into simulation apps controlled by interfaces appropriate for what is being simulated. This type of tool is unique to COMSOL Multiphysics® and will open up the world of simulation to all engineers, operators of processes, and scientists. This session will demonstrate the use of the Application Builder and how it can fundamentally augment how your organization approaches simulation.

4:15 p.m.
Closing Remarks

COMSOL Speakers

Mao Mao
Technical Account Manager
Mao Mao is a technical sales engineer who joined COMSOL in 2015. Mao received his PhD in mechanical engineering from Northwestern University. His research focuses on the mathematical modeling of electroosmotic flow in a nanopore system. Mao also holds a bachelor's degree in thermal science from USTC, China.
Lauren Sansone
Marketing and Events Director
Lauren Sansone is the marketing and events director at COMSOL, Inc. and has been with COMSOL since 2006. She is responsible for the global event marketing of COMSOL Days, the COMSOL Conference, exhibitions, and training.
Phil Kinnane
Senior VP of Sales
Phil Kinnane is the senior VP of sales at COMSOL, Inc., and has been with COMSOL since 2000. Previously, he worked in industry and has modeling and simulation experience within a variety of engineering fields. He earned his PhD in electrochemical engineering from the Royal Institute of Technology (KTH), Stockholm.

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COMSOL Day Details

Location

This event will take place online.

Local Start Time:
May 11, 2021 | 11:00 a.m. EDT (UTC-04:00)
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Invited Speakers

William Torres
Exponent

Dr. William Torres is a senior associate at Exponent. He specializes in the use of multidisciplinary methods such as quantitative image analysis and computational modeling to promote the effective design of medical technology. He has expertise in the use of finite element analysis, computational fluid dynamics, and three-dimensional anatomical reconstruction for the mechanical analysis of biological tissues and the recreation of in vivo biological flows. Furthermore, he has extensive experience in the use of computational and experimental techniques to evaluate MRI safety and compatibility of medical devices. Throughout the course of his doctoral research at the University of South Carolina, Dr. Torres worked extensively with unique large animal models of heart failure to characterize the rate and extent of adverse remodeling secondary to different phenotypes of heart disease using noninvasive echocardiographic imaging and multiphoton histological analysis. This work motivated the intelligent design of targeted biomaterial-based therapeutics for postmyocardial infarction care to mitigate these adverse outcomes. Furthermore, he invented a clinically translatable tool for the advanced biomechanical analysis of the human heart from readily available echocardiographic imaging.

Andres Belalcazar
Consultant

Andres Belalcazar is a Minneapolis-based consultant in medical device R&D, specializing in cardiac rhythm and neuro devices, implantables, externals, and catheter-based therapies and diagnostics. He holds degrees in electrical and biomedical engineering and a PhD in biophysics from the University of Minnesota. He has worked in scientific and technology leadership roles with Guidant, Boston Scientific, St. Jude (now Abbott), and Physio-Control, among others. He has an interest in impedance and electric properties of tissues and their measurement, and has been modeling devices since 2002.

Nagi Elabbasi
Veryst Engineering, LLC.

Dr. Nagi Elabbasi is a principal engineer at Veryst Engineering, LLC, and his main area of expertise is modeling multiphysics systems. Dr. Elabbasi has extensive experience in simulating structural mechanics, CFD, heat transfer, acoustics, and coupled systems, including FSI, conjugate heat transfer, and structural-acoustic coupling. Prior to joining Veryst, he worked for nine years in finite element software development. He holds a PhD in mechanical engineering from the University of Toronto.

David Gross
MED Institute

David Gross currently manages the engineering simulations group and computational modeling and simulation (CM&S) group at MED Institute, Inc., a medical device consulting company. He graduated from Purdue University with a BS in biomedical engineering and MSE in interdisciplinary engineering. He also holds MS and PhD degrees in biomedical engineering from Ohio State University and is a licensed professional engineer.

Arlen Ward
System Insight Engineering

Arlen Ward is an industry-leading modeling and simulation expert and provides consulting services through System Insight Engineering to medical device companies of all sizes. Arlen has 17+ years of experience modeling medical applications, with a specialization in energy-tissue interaction for laser, ultrasound, RF, and electrosurgery. He trained as a mechanical engineer with a PhD from Colorado State University, where his research focused on using computational modeling and simulation to improve the performance of energy-based tools in urological surgery. Arlen has 30+ issued U.S. and worldwide medical device patents, and his field of emphasis is leveraging modeling and simulation to streamline product development cycles by shortening prototyping time and speeding up regulatory approval.

Ismail Guler
Boston Scientific

Ismail Guler is an R&D manager at Boston Scientific Corporation in Maple Grove, Minnesota, where he leads the global computational modeling & simulation services group supporting the development of medical devices and therapies that improve and save lives. He is also a part-time lecturer in the Department of Biomedical Engineering at the University of Minnesota teaching a course on computational modeling of medical devices. Prior to joining Boston Scientific, he was a member of the Team for Advanced Flow Simulation & Modeling at the Army High Performance Computing Research Center in Minneapolis. Ismail holds BS and MS degrees in mechanical engineering from Bosphorus University in Istanbul, and a MS degree in aerospace engineering from the University of Minnesota. He is a member of the ASME V&V 40 subcommittee that developed the international standard titled “Assessing credibility of computational modeling through verification and validation: Application to medical devices” and currently leads a working group on calculation verification.

Alireza Kermani
Veryst Engineering

Dr. Alireza Kermani is a senior engineer at Veryst Engineering. He has a broad background in fluid dynamics and solid mechanics and extensive experience in turbulent flow modeling, multiscale flow, building ventilation simulation, nonlinear finite element modeling, structural vibration, impact simulation and analysis, heat transfer, and soil–structure interaction. His research has included numerical simulation (CFD) of heat and gas transfer between two phases, such as atmosphere and oceans, and his work has included developing a novel computational method to quantify diffusion time scales of interfacial fluid elements.

Prior to joining Veryst Engineering, Dr. Kermani was a project director at Thornton Tomasetti, a structural engineering consulting firm headquartered in New York. He directed project teams for structural analysis, design, and evaluation, and was responsible for reviewing and approving project designs and changes. Dr. Kermani has experience in structural analysis, renovation and reinforcing existing structures, forensic analyses, condition assessments, and failure investigations for a variety of building types such as commercial, residential, new, and old constructions, in both the private and public sectors. Dr. Kermani is also an expert in impact loading analysis and protective design and has advised clients on solutions to mitigate the risk of impact loading. He has also consulted on issues involving medical devices, consumer products, sports equipment, and aviation.

Thomas Clavet
EMC3 Consulting

Thomas Clavet founded EMC3 Consulting in 2014 to support companies (including SMEs, major industrial groups, and research laboratories) in their use of digital simulation for acoustics, thermal, mechanical, and overall multiphysics applications. Thomas since specialized in piezoelectric, ultrasonic, and vibration simulation that can be used in motors, sensors, flowmeters, haptics, NDT systems, and medical devices such as the FUS probes developed with his customers.

Prior to becoming a COMSOL Certified Consultant, Thomas was a mechanical engineer in the energy industry and an application engineer at COMSOL in the UK and Ireland. He is an Arts et Métiers ParisTech engineer and holds a master's degree in mechanics and numerical methods from the Royal Polytechnic Institute (KTH) in Stockholm, Sweden.