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  Tips for Developing Medical Devices With Software

  Developing medical devices with software involves a wide-ranging set of unique challenges. Our software engineering team offer advice on offered advice on software in medical devices, FDA, Software as a Medical Device (SaMD), risks, cybersecurity, and Open Source software.

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  9 Ways to Use AI in Medical Device Development

  9 ways to use AI in medical device development from our experts include Connected Medical Devices, QA/RA, Developing (real time) Simulations, Expedite Design Process, Analysis and Research, Supplier Evaluations, Project Reviews, Brainstorming, and Administrative Help (Faster than Google).   

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  Six Project Manager Skills for Success in the Medical Device Industry

  A Project Manager navigating this complex medical device development landscape requires the ability to marry traditional Project Management Skills with the specificity of medical device industry practices that focus on patient outcomes and regulatory requirements. This article includes 5 skills that expert project manager, Shalaka Maind, deems crucial to medical device development success.

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  9 Biggest Productivity Drains and Their Solutions

  Can’t get your medical device development work done on time? We crowdsourced this dilemma to our employees, and they shared their biggest productivity drains and solutions. Spoiler alert: there were nine drains and five of them share the same solution.

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  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.

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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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