FDA Submission for Medical Device Design

Engineers who work with AltaSim Technologies bring their products to market more rapidly, at a lower cost, and with an optimized design by leveraging our guidance for implementing Multiphysics simulations. Medical devices are a special class of products for which AltaSim Technologies develops simulations. To help see the impact we have on our clients developing medical products, we have put together a brief case study of a unique solution from our simulation experts for a recent project.

Problem:

One of AltaSim’s clients is developing a breakthrough medical device for the assessment of orthopedic implants. As with most medical devices, this requires approval by the Food and Drug Administration (FDA). AltaSim developed a novel simulation methodology that generated the design for the primary sensing coil of the device. Since the design relied on AltaSim’s simulations, the FDA required that the Computational Modeling and Simulation (CM&S) work be reported. The FDA has specific reporting guidelines and has accepted CM&S results for this type of engineering calculation for many years. However, our client did not have experience reporting CM&S results.

Solution:

AltaSim leveraged our experience reporting CM&S results to the FDA and wrote critical sections of the report detailing anatomical geometry developed for the simulations, the governing equations, system material properties, discretization, and numerical implementation. AltaSim also developed graphs of key results and reviewed the limitations of the simulations.

Results:

AltaSim helped our client reduce back-and-forth iterations with the FDA and speed up the approval of their breakthrough medical device, by reporting information to the FDA on complex numerical methods. This saved our client from having to develop a detailed understanding of the numerical methods used by AltaSim.

AltaSim partners with companies to provide simulations that increase the knowledge and understanding of our clients’ engineering staff. Through these simulations, we work with our clients to develop actionable plans to solve their engineering challenges. To better understand our simulation services, visit our website for an overview. To contact us directly, please visit our Contact Us page.

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March 2024 Case Study