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Simulia

Simulation for medical devices

February 15, 2013 By Evan Yares 1 Comment

This example of modeling and simulation of a medical device shows an aortic valve geometry (left), a model of the effect of blood flow on the valve in a blood vessel (middle), and an Abaqus finite element analysis (FEA) of the stress on the valve leaflets during the diastolic phase (right). This work was performed by Dassault Systèmes SIMULIA in conjunction with the FDA’s Center for Devices and Radiological Health (CDRH).
This example of modeling and simulation of a medical device shows an aortic valve geometry (left), a model of the effect of blood flow on the valve in a blood vessel (middle), and an Abaqus finite element analysis (FEA) of the stress on the valve leaflets during the diastolic phase (right). This work was performed by Dassault Systèmes SIMULIA in conjunction with the FDA’s Center for Devices and Radiological Health (CDRH).

It’s no surprise that simulation is becoming more mainstream. Advances in technology, plus better integration with CAD software make that a foregone conclusion.

The United States Food and Drug Administration (FDA) has been seeing an increased number of submissions accompanied by simulation data. That sounds good on its face, but what if the simulation data is faulty, or unreliable?

The FDA is tacking that problem now, by reaching out to both the medical and software industries to establish guidelines for simulation, and by building a publicly available “Virtual Physological Patient.”

Cheryl Liu, a life sciences specialist with Dassault Systemes SIMULIA group, worked with the FDA to develop the following  article about the FDA’s efforts. I don’t often merely reprint articles here, but I think this one has a special value, in helping to put context to the importance of simulation for medical devices.  My thanks to Dassault Systemes for sharing it with me, so I could share it with you.

Simulation Now Recognized by FDA
as Essential to Medical Device Evaluation

by Cheryl Liu, Life Sciences Senior Product Experience Technical Specialist,
Dassault Systèmes SIMULIA

One of the toughest design engineering challenges is making a medical device that works flawlessly with the human body. The unique anatomy and physiology of every patient create physical complexities, and ever-shifting functional parameters, that must be thoroughly accounted for when producing a therapeutic product that may need to last a lifetime.

Domestic inpatient procedures involving medical devices—stents, heart valves, dental implants, spine and joint implants, surgical tools, blood pump, endovascular grafts, drug-eluting devices and more—totaled 46 million in the U.S. alone in 2006, according to the Centers for Disease Control (CDC). It’s a global market that is growing along with aging populations everywhere.

Computer simulation, already widely accepted in many industries, is increasingly being viewed as an important tool by medical device companies and their designers. It helps them visualize what they cannot see, explore the design space more fully, refine their ideas faster and more accurately—and reduce expensive prototyping and testing.

Solid mechanics simulations can help determine proper implant size, evaluate manufacturing tolerances, compare design geometries or consider next-gen devices. Fluid dynamics can be employed to identify high-shear stresses on blood vessels, regions of low flow, and potential for blood damage. And simulation-based product development processes can be linked in automated workflows, optimizing huge quantities of design data to provide exquisitely fine-tuned results that are of particular value for creating patient-specific medical devices.

FDA sees increasing numbers of applications that include simulation

As Life Sciences engineers embrace simulation, they are achieving increasingly accurate levels of precision when evaluating device function, including the ability to evaluate aspects of device performance not possible with bench tests alone. As a result, the Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) is seeing a growing number of submissions for medical devices that include a simulation-data component.

The CDRH is responsible for regulating firms that manufacture, repackage, re-label, and/or import medical devices sold in the U.S. The submissions for these therapeutic devices typically contain data from four types of evaluation models—animal, bench, computational and human—to demonstrate a reasonable assurance of safety and effectiveness. When a company submits simulation metrics that supplement bench testing, this can help promote approval by demonstrating both the integrity of the proposed device and the required realistic device failure analysis. As the ultimate safety-and-effectiveness regulatory body between medical device manufacturers and patients, the FDA recognizes the value of such advancing technologies—and its own need to stay abreast of them—and has now begun actively encouraging the use of simulation in device evaluation.

However, the FDA has also put the industry on notice that verification and validation must go hand-in-hand with the use of simulation in applications. The CDRH is looking to quantify when a computational model is credible enough, and what its intended purpose is appropriate for a regulatory submission. Unclear reporting standards, insufficient data about geometries and boundary conditions, lack of validation metrics, incomplete understanding of physiological loads in the body, and variations in patient populations—any and all of these uncertainties can impact the relevance of simulation outputs.

SIMULIA contributes to advancement of knowledge

Noticing that a significant proportion of the applications they have seen in recent years have included simulations with Abaqus finite element analysis (FEA) from Dassault Systèmes SIMULIA, the CDRH reached out to us in 2010 for support in developing their own internal framework, and in-house expertise, for validating and regulating industry-submitted simulations.

SIMULIA presented at the FDA’s 3rd workshop on Computational Modeling of Medical Devices the same year. We continue to deliver on-site training courses to FDA reviewers about best practices in modeling and simulation and to partner with the FDA on aortic valve model development (Image 1). The FDA has also presented at our SIMULIA Community Conference and Regional User Meetings. Realizing the importance of model verification and validation (V&V), in early 2011, ASME and FDA launched the V&V 40 subcommittee to develop V&V guidelines for the medical device industry specifically; we are actively participating, along with others in the industry and software communities.

As one outcome of these efforts, the FDA will publish a guidance document titled “Reporting Computational Modeling Studies in Medical Device Regulatory Submissions” in 2013. Appendices will cover fluid and mass transport, solid mechanics, electromagnetism, control loops, thermal transport, and ultrasound. Publication date updates can be found on the CDRH website at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

The ‘Virtual Patient’ idea is born

As knowledge about the importance of simulation grows, another priority for the FDA is the creation of a publicly available ‘Virtual Physiological Patient’ of human body computer models in different disease states (Image 2). This is not intended to be a single model encompassing every function and disease at once. Rather, the project will comprise a library of verified and validated submodels and data based on the combined expertise of those groups in the relevant disciplines, i.e., cardiology, orthopedics, software and so forth.

Broad cross-industry collaboration between medical device manufacturers, academia and software companies is being harnessed for the FDA’s Virtual Physiological Patient project.
Broad cross-industry collaboration between medical device manufacturers, academia and software companies is being harnessed for the FDA’s Virtual Physiological Patient project.

The goal of the Virtual Physiological Patient project is a shared point of reference that will improve understanding of model attributes and limitations, and provide discrete models, data and simulations validated for regulatory evaluation. Peer review by experts in academic, government, and industry will ensure robust V&V and provide periodic assessment. SIMULIA is contributing expertise to a group that is developing a computational model for the evaluation of a diseased femoral artery for stent evaluation.

Newly Launched Public-Private Partnership will benefit all parties

Concurrent with the development of the Virtual Physiological Patient concept, the FDA is reaching outward to device manufacturers, software providers, and medical professionals to form a Regulatory Science Public-Private Partnership. Launched in December of 2012, the partnership is called the Medical Device Innovation Consortium (MDIC). Specific details are available at http://www.deviceconsortium.org/ .

The idea is to create an opportunity for information gathering in a pre-competitive state, i.e., not device-specific, but disease-specific.  For example, if the heart valve community were interested in a comprehensive evaluation of the structure and function of heart valves, costs could be minimized through non-profit group funding and participation in the development of tools and resources for modeling and simulating of a range of valves. All results would be shared. End-stage renal disease is another area recently identified by the FDA as a priority. Industry forums on this topic are already underway.

The medical device industry can only benefit from such endeavors. Individual device design copyrights certainly need to be protected, but the tradition of publishing evidence-based research results in order to move the entire body of medical knowledge forward has resonated in the Life Sciences throughout the history of medicine. A deep understanding of the function of the living body is critical to every medical-device developer, and sharing the data that lie at the core of that understanding can be accomplished without infringing on any one company’s patents.

The FDA views modeling and simulation as incentives to innovation that can reduce the time and cost of device design, assessment, and manufacturing. It is in all our interests—the medical device industry, the regulatory agency, and software companies—to collaborate to ensure that the power of simulation is increasingly utilized to solve the wide range of challenges in medical device development. We can all agree that the ultimate goal is the safety and effectiveness of medical devices for every physician who uses them, and every patient who needs them.

Special thanks to Dr. Tina Morrison, Dr. Nandini Duraiswamy and Dr. Donna Lochner of the FDA for their assistance in preparing this article.

For More Information: www.fda.gov

Read more about how the FDA is promoting innovation in “High Stakes Balancing Act” in COMPASS magazine www.compassmag.3ds.com.

 

Filed Under: CAD Industry News, CAE, Evan Yares, Simulation Software Tagged With: Dassault Systemes, FDA, Simulia

Ice Dream: Towing an iceberg for fresh water

January 10, 2012 By Laura Carrabine Leave a Comment

“With the world’s water resources projected to diminish by one third in the next two decades, providing pure water to an ever- increasing world population is vital,” Mougin explained. To Mougin and Mauviel, one solution would be to transport icebergs to areas that lack fresh water for drinking and even cooling purposes. The scientific challenges are impressive — capturing a large iceberg that can weigh up to 7 million tons, protecting it from melting while transporting it across the ocean, securing and optimizing the trajectory with respect to meteorological and oceanographic conditions, and breaking up the iceberg to turn it into drinking water.

Dassault Systèmes worked with Mougin and his team to simulate the iceberg’s trajectory and its evolution by taking into account data such as variations in ocean temperatures, wind force and direction, sea currents, and boat drag force. They inserted this data into a 3D model of the iceberg to simulate what would happen all along the voyage.

The critical challenge presented to Dassault Systèmes’ engineers was to demonstrate, using virtual technology, the technical feasibility of displacing the iceberg in a controlled manner while reducing its melting. The project, managed by Cédric Simard, Interactive Strategy & Marketing Project Director at Dassault Systèmes, involved a number of steps:

  1. Model the iceberg with CATIA based on a cloud of points obtained by scanning a real iceberg with radar.
  2. Calculate and simulate the way the iceberg would melt using CATIA Systems and SIMULIA.
  3. Simulate the way the iceberg would melt if surrounded by a protective isothermal “skirt” imagined by Mougin to slow the melting process.
  4. Calculate how much fuel the boats would consume depending on the winds and currents encountered along the way

Various scenarios were simulated, such as number of boats needed, different departure dates and climate conditions, and the behavior of the boats and iceberg in the event of a storm or turbulence. In addition to enabling the team to visualize these scenarios, the simulation also allowed the scientists to test how to deploy the isothermal skirt around the iceberg.

Dassault Systemes

www.3ds.com

Filed Under: Catia, Catia Blogs, Featured, PTC News, Simulation Software Tagged With: Catia, Dassault, Simulia

Fly record speeds in the v-44 Albatross

August 31, 2011 By Laura Carrabine Leave a Comment

When Verney Yacht founder Tim Clarke read about the record-setting preparations by the hydrofoil-design trimaran, I’Hydroptere, he knew a technological breakthrough was the key to winning the challenge. He decided to design his own racer. He started to create a single-hull and equip it with two rigid wing-sails. The wing sail has the ability to switch both position and function as the boat tacks becoming either a wing if horizontal to the water or a sail if vertical.

Named the v-44 Albatross, this new concept boat promises 65 knots or greater – 20% faster than the current record. To help translate the conceptual design into a physical reality, Verney’s team used Abaqus FEA software from Simulia, Dassault’s brand for realistic simulation.

Using the software, the team is able to test the boat’s performance virtually. The geometry is created in 3D to analyze the structural strength of components, their response to wind loads, and the craft’s aerodynamic characteristics. Each of the 13-meter long wing sails are comprised of two planks (inner and outer) which are able to freely align to the airflow, like a weathervane. The plank’s structure is intended to mimic the behavior of a tubular spar centered at the axis of rotation, which will have no tendency to rotate under the influence of bending loads. This requirement is essential to preserve the close coupled aerodynamic balance of the wing sails.

For this reason, a different structural approach needed to be taken. Because the wing sail design is unproven in the field, the role of FEA for virtual design and analysis is critical in the success of the project. With the use of Abaqus, Clarke and his team were able to consider many wing sail design variables when moving from the conceptual to preliminary design. Early in the design cycle, the team created some of the key models within Abaqus first and used the extensive functionality within the software’s interaction module to simplify those models. The team also used SolidWorks Premium for additional 3D modeling and product data management. With the complex wing sail structure and function, the team split the analysis into three stages. Each analysis validated the wing sail concept and indicated several design issues. When the design is complete, the v-44 Albatross will be constructed without extensive wind tunnel/tow-tank testing. So the team must ensure they get it right the on the first try.

The Verney team hopes their boat will cover the official 500-meter distance in a scant 16 seconds or less. When it does, the v-44 Albatross will fly above the water with only the keel and rudder breaking the surface.

Verney Yachts

www.verneyyachts.com

Dassault Systemes

www.3ds.com

Filed Under: 3D CAD Package Tips, CAD Industry News, CAD Package, SolidWorks, SolidWorks News & Events Tagged With: 3D CAD 2013 Summer Olympics, Abaqus, Dassault, FEA, simulationh, Simulia, SolidWorks, Verney Yachts

Dassault Systèmes delivers new realistic simulation technology in Simulia’s Abaqus 6.11 release.

May 19, 2011 By Laura Carrabine Leave a Comment

Dassault Systèmes announced new nonlinear structural optimization, coupled multiphysics, and high-performance computing technology available in Abaqus 6.11.

With new capabilities and more than 100 customer-requested enhancements, Abaqus 6.11 delivers on SIMULIA’s strategic commitment to provide scalable, high-quality realistic simulation solutions. SIMULIA customers in a range of industries—including aerospace, automotive, consumer packaged goods, energy, and life sciences—are using Abaqus to explore the real-world physical behavior of products and materials, in order to improve performance, reliability, and safety, while reducing development time and costs.  

 

The software  marks the first release of the Abaqus Topology Optimization Module (ATOM). This add-on product enables users to perform topology and shape optimization for single parts and assemblies, while taking into account large deformation, material nonlinearity and contact.

The product also introduces a new electromagnetics solution technology to solve problems requiring time-harmonic eddy current analysis, such as the hardening of a bearing surface due to induction. In addition, this release provides a new smoothed particle hydrodynamics capability for modeling violent free-surface flows, such as fluid sloshing. Additionally, customers will benefit from support for graphics processing units (GPU). 

Dassault Systemes

www.3ds.com

Filed Under: 3D CAD Package Tips, Catia, Catia Blogs, Catia News & Events Tagged With: Abaqus, Dassault Systemes, Simulia

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