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  Key Elements for Medical Device Development Project Review Meetings

  How to ensure team members leave project review meetings feeling seen, heard, understood, and hopeful about future projects. This article discusses four proven project review elements that deliver a game plan to address key issues and drive improvements.

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  Using CM&S to Improve Medical Device Development

  Computational modelling and simulation (CM&S) has been used for decades as an assistive tool for medical device design and development. Real-world examples of gathering evidence for submission to regulatory bodies, investigating fluid dynamics, structural, thermal, electro-magnetic, fluid-structure interactions, and other multiphysics problems.

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  Medical Device Vibration Analysis and Testing Reduce Risk

  The impact of vibration on medical devices can be understood through a combination of vibration analysis and testing. This article reviews medical devices most susceptible to vibration, provides basic theory and methods of vibration analysis, and summarizes the benefits of using modal analysis when developing medical devices.

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  Heart valve simulation shifts the treatment paradigm

  Simulation technologies are revolutionizing the field of heart valve repair and replacement, offering unprecedented insights and capabilities. Enhancing our understanding of valve mechanics, improving device design, optimizing surgical techniques, and enabling personalized treatments, simulations are paving the way for better cardiovascular care and patient outcomes. This article explores the transformative role of heart valve computational simulation in understanding, and treating heart valve diseases.

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  Starting Medical Device Projects on the Right Foot

  Four areas that can make or break a new medical device development project from the start. Experts identify actions and offer advice that helps ensure new medical device projects start on the right foot.

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  FDA Guidance on Computational Modeling and Simulation in Medical Device Submissions

  Summary of nine-step process for developing and assessing the credibility of CM&S for regulatory submissions in the FDA Guidance Document “Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions (17th November 2023)”.

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  Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

  Laboratory Developed Tests vs. In Vitro Diagnostics Joris van der Heijden and Nick Allan dive into FDA’s new regulations.

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  Bio Break: Core Facilities for Medical Device Development

  In this episode of Bio Break, Joris van der Heijden and Nick Allan discuss the critical role of specialized facilities in the successful development of medical devices. From testing laboratories to clean rooms, they explore the infrastructure needed to support innovation and ensure safe, effective products reach the market.

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  Medical Device Optical Breadboard Prototype Tips

  Tips for building a medical device optical breadboard prototype. When designing a medical device made of complex, multi-functional mutually interacting subsystems it’s best to de-risk those subsystems instead of coming up with a paper design, assembling it, and hoping it works first time. De-risking individual subsystem behaviours one at a time enables more-focused assessments and improves troubleshooting.

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