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  Tips for “Voice of the Customer” Medical Device Research in Low- and Middle-Income Countries

  7 Tips for conducting Voice of Customer medical device research in Low- and Middle- Income Countries (LMICs) is an integral component in user-centric design and development. It is increasingly an expectation of regulatory bodies.

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  Sensory Design for Medical Devices

  The medical devices in the masthead above have vastly different purposes. One thing that’s common is they all have some combination of sensory aspects. Sensory design uses affordances (perception of design features intuitively suggesting a functional task) and semantics (conveying meaning and information about the product’s use and function through sensory cues). Both can be communicated through our five senses with the most common being visual, tactile and auditory.

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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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  Bio Break: Clinical Trials for Medical Devices vs. Pharmaceuticals

  In this episode of Bio Break, StarFish Medical experts Joris and Nick break down the key differences and similarities between clinical trials for medical devices and pharmaceutical products. As the conversation unfolds, they provide valuable insights into the distinct processes and challenges associated with these two types of trials, including the complexities of combination devices that bridge both worlds.

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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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  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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