Medtech is a big market and the interest in modeling and simulation is on the rise. The FDA is promoting the use of modeling and simulation for regulatory submissions, including to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study, and to predict product safety.
By using the modeling and simulation software COMSOL MultiphysicsÒ, engineers and scientists can create and test designs and processes virtually, taking into account all factors that impact the safety and efficacy of medical devices and treatments. This streamlines the development and regulatory processes for creating new and better products while reducing costs and the need for in vitro and in vivo testing.
Computational models are only useful if they accurately represent their real-world counterparts. The human body is complex, and when simulating medical devices and pharmaceuticals, the modeling software has to account for the way these devices and drugs interact with the human body. Multiphysics simulation software is the answer.
From the very beginning, COMSOL has developed the COMSOL Multiphysics software with multiphysics as the central requirement. All of the specialized add-on modules work seamlessly through the platform product, and users can take comfort in knowing that if a new add-on module is released in a new software version, it will work with the rest as usual. This means that the user interface is consistent regardless of engineering application and physics phenomena, so once a user is accustomed to the modeling workflow, they do not need to relearn it if they want to model another device or treatment product that involves different physics phenomena than what they were first working on.
Similarly, simulation engineers across teams and departments may work on different models and at some point decide to share them with each other. Since both teams can use COMSOL Multiphysics for their application area, they can easily open and work with each other’s models if desired.
For simulation in the medical device field, add-on products provide specialized functionality and multiphysics couplings for fluid flow, heat transfer, structural mechanics, electromagnetics, and other physics involved in modeling the complexity of the human body and biomedical applications.
In addition to providing simulation engineers with modeling software they can use, COMSOL Multiphysics also includes the Application Builder, which makes it possible to create custom simulation apps. These apps can further be turned into standalone apps through COMSOL Compilerä and then used by colleagues in the R&D workflow who are not experts in modeling and simulation but who would benefit from using it to test design changes and get quick answers during the development process. There is no limit to how many standalone apps a user builds and they can distribute them to anyone they want.
There are many examples of how the COMSOLÒ software is used in the biomedical field, but here are two.
One prominent company in the medical device space developed a heart pump called a left-ventricular assist device (LVAD). It has been described as “the most complex device ever implanted into a human being” and was designed to compensate for the weakened muscle in the left side of the patient’s heart and avoid the potentially fatal pooling of blood. Design challenges include requiring a significant amount of power to pump the entire bloodstream, having to be small enough to fit inside the patient’s chest, and being bio- and hemocompatible. Developing and optimizing the design involves accounting for electromagnetics, heat transfer, and fluid flow, so the team turned to the COMSOL Multiphysics software to model and analyze their designs.
More recently, the COMSOL Multiphysics software was used by a consulting firm to guide the production of mRNA vaccines. Lipid nanoparticles (LNPs) are used in a variety of pharmaceutical applications, including mRNA vaccines as well as cancer therapies, analgesics, and photodynamic therapies. The delivery efficacy of mRNA vaccines depends on the size of the LNPs (small LNPs are better at penetrating tissue) and dosing (high doses are necessary due to low delivery yield). Researchers could run iterative experiments to meet these requirements, but the team showed that a simulation-guided design process would complement the experimental work and could ultimately save on cost and time as well as aid in finding more innovative solutions.
COMSOL is a global provider of simulation software for product design and research to technical enterprises, research labs, and universities. Its COMSOL Multiphysics® product is an integrated software environment for creating physics-based models and standalone simulation apps. A particular strength of the software is its ability to account for fully coupled multiphysics phenomena. Add-on modules provide specialized functionality for electromagnetics, structural mechanics, acoustics, fluid flow, heat transfer, and chemical engineering. Interfacing tools enable the integration of COMSOL Multiphysics simulations with all major technical computing and CAD tools on the CAE market. All add-on products from the product suite connect seamlessly through the COMSOL Multiphysics platform for a modeling workflow that remains consistent across engineering fields.
In the near future, COMSOL is set to release the next version of the software: COMSOL Multiphysics version 6.2. Among other things, this version will introduce new functionality for creating and using surrogate models, which can be used in simulation apps to yield very fast solution times and ultimately a more interactive experience for the app user. The ability to use surrogate models in place of otherwise complex models coupled with new functionality for setting automatic updates through external sensors, databases, and web services means that COMSOL’s users will also be able to build effective digital twins.
Additionally, COMSOL will keep boosting productivity by introducing faster solvers, new multiphysics modeling capabilities, and improved collaboration tools.
COMSOL, COMSOL Multiphysics® & COMSOL CompilerTM are trademarks or registered trademarks of COMSOL AB.