Medical devices continue to improve the health and lives of millions of people worldwide, and simulation plays a critical role in developing them. Simulations enable engineers to assess the performance of their medical devices for a wide range of conditions with greater patient safety and less expense than in vivo or in vitro testing.
In a free upcoming webinar, Electromagnetic Heating Simulation of Knee Replacements, I will explore how using Multiphysics simulations can help assess the effect of electromagnetic heating on knee replacements. Registration is open now for the 2 p.m. webinar on April 24, 2024.
As technology evolves, it can mean life or death in the medical industry. So, when it comes to the design of medical devices, mistakes are not an option. Multiphysics engineering and simulation have helped revolutionize how medical devices and processes are designed, analyzed, and used to improve medical device performance. My company, AltaSim, uses COMSOL Multiphysics to simulate, analyze, and optimize medical device designs, helping companies to strengthen design optimization by considering multiple physical phenomena simultaneously, enhance performance
prediction to give designers a better idea of how a device will perform in real-world scenarios, reduce time to market by enabling designers to identify and address design issues early in the development process; improve safety by helping to identify potential safety issues before they are released to the market; and provide needed simulation evidence for FDA submissions.
Simulation helps with the design and engineering of medical devices on several levels, including reducing the time from conception to market, allowing the design to be massaged virtually before testing on any human, and obtaining Food and Drug Administration (FDA) approval.
One of the biggest challenges in testing is the substantial variables in the human body, and medical devices must be designed to look at as many different cases with as many variables as possible before we even consider a patient study with 100 different bodies. Medical devices use simulations to ensure patient safety, and the FDA has become very comfortable with them.
Because the FDA prioritizes patient health and safety, it has embraced technology and simulations as another part of the rigorous testing process. This is a mutual goal—no one wants to release a medical device that may eventually harm someone. Every effort made ensures the highest confidence that the device will be safe—a win-win-win.
Simulations open a wide range of testing and use-based scenarios for medical devices, some of which have previously been untestable. In the past, there was no ability to create virtual MRI testing of medical devices implanted in the human body to assess their compatibility with MRIs, which are quite inhospitable to most metals and humans who have them embedded.
Since there was no testing with virtual MRIs, the orthopedic device did all the work to ensure they function. The device would often fail at MRI compatibility, devastating the team. Imagine all the work that had gone into the device by that point – at human trials; it has already gone through conceptualization, the design phase, and virtual testing. Having it fail at MRI compatibility is incredibly frustrating for the engineering team. Now, with virtual MRI testing, we are made aware so much sooner in the process if our device is MRI-compatible. There should always be a physical test, which should be a guaranteed pass now because of all the ways we can simulate actual use scenarios.
It helps that at AltaSim, we work to ensure our simulations are accurate. We do that by having experienced simulation engineers, using well-vetted simulation software, having a solid understanding of physics to see if something doesn’t look right, and running the test. We have had several opportunities to test this theory; sometimes, the test is wrong.
At Alta Sim, we can help companies implement the solution without substantially investing time or money. Not every engineering department needs great simulators, but they can work with an outside group of great simulators.
I look forward to seeing you at the webinar next month. Knee replacements are becoming increasingly common and require less recovery time. You’ll learn why and how Multiphysics simulations have made this possible.