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Medical Device Design Case Study: FEA Modeling Techniques Support R&D

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We recently assisted a Southern California biotechnology company that is developing a novel immunotherapy for treating cancer. Immunotherapy is an exciting emerging field and we were happy to be involved in this potential game-changing technology. This client had strong intellectual property and a strong team of scientists with deep experience and expertise. They came to us with a need to deliver a biologic payload to a target in tissue – and to combine the payload injection with electroporation, in order to stimulate cellular uptake.

Our client had a deep understanding of the theoretical science, but virtually no experience in medical device development, and didn’t want to hire an internal engineering team. At the beginning of our engagement, the project scope was to build a medical device to assist in the delivery and activation of their biological agent. While the end goal of this project was a commercial-ready device, there were multiple phases the project had to pass through to make commercialization possible, and not all of the phases were clear when the project began.

At the outset, it was important that REV.1 engineers developed a deep understanding of the science of electrical fields and electroporation. While injection dynamics and device delivery were well in our wheelhouse, and even the science of electroporation was not entirely new to our highly-experienced team, this project required us to quickly deepen our understanding of this specific application in order to make this project partnership successful.

Though not in the original scope of the project, REV.1 medical device engineers found it helpful to utilize FEA modeling techniques to better understand the electrical field around the device when the electrical stimulation was activated. When we shared these theoretical 3-D visual computer models with the client for the first time, they were intrigued – probably at first just by the vivid colors and graphics of the FEA.

However, it soon became evident that the models brought a different level of understanding to the device and the technology. The entire team (on both sides) began to recognize the immense value that these models brought to the project, not just for their great visuals!

The models developed by REV.1 could be used to better predict and prescribe a specific application of electrical potential to the tissue, helping this experienced team of scientists better understand the electrical field that would be created when the device was delivered in living tissue. Our efforts paid off, and the models also allowed us an early opportunity to vet different design configurations for the product.

Multiple rounds of bench and in-vivo testing followed – to prove the computer modeling, and the scientific theories in “real world” application. REV.1 engineers developed mechanisms specifically for these activities, months before a commercial device was developed.

By creating new tools and techniques specific to our client, the design and development of the device was accelerated and the deeper understanding of each element set us and our client on a much better path.

If your medical device requires specialized solutions for its design challenges, get in touch. At REV.1 Engineering, we innovate unique ways to analyze designs to ensure success – 2x Faster than building an in-house team. Give us a call at 951.696.3933, connect with us on LinkedIn, or send us an email at info@rev1engineering.com, and let’s overcome your medical device design challenges.