• 

  Visual Project Management Improves Manufacturing Performance

  Ensuring on-time medical device manufacturing builds are done in a timely manner requires coordinating across several teams including engineering, manufacturing, and quality. Visual Project Management (VPM) and Manufacturing Production Schedules (MPS) help improve manufacturing performance and meet build delivery deadlines.

• 

  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.

• 

  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.

• 

  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.

• 

  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.

• 

  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.

• 

  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)”.

• 

  Bio Break: Innovations in Drug Delivery Systems

  In this episode of Bio Break, Joris and Nick explore groundbreaking innovations in drug delivery systems, focusing on how advanced technologies are transforming the precision and effectiveness of medical treatments. From delivering medications to hard-to-reach areas like the brain to targeted oral delivery, this discussion highlights solutions that are redefining modern healthcare.

• 

  Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

  In this episode of Bio Break, Joris van der Heijden and Nick Allan dive into the FDA’s new regulations surrounding Laboratory Developed Tests (LDTs) and their impact on the medical device industry. As LDTs grow in complexity, including applications like genetic testing and AI-driven diagnostics, these regulatory changes mark a significant shift for laboratories, developers, and healthcare providers.

There are no posts to show