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  Bio Break: How much does it cost to develop a medical device?

  What are the real costs of developing a medical device? In this episode of Bio Break, Nick and Joris dive into one of the most frequently asked questions they hear from clients: How much does it cost to develop a medical device?

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  Medical Device Labeling Requirements: Compliance and Best Practices

  We all know medical devices have labels, but how often do we consider their purpose and the effort required to ensure they provide the right information? Device labelling serves as the interface between the manufacturer, the user, and regulatory bodies. (Note that being from Canada, we spell labelling with two Ls.)

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  Common Mistakes for Medical Device Projects

  Common mistakes in medical device projects can create roadblocks that, if left unchecked, can snowball into costly setbacks.

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  Clarifying ASTM D4169 Options – It’s all in the details

  ASTM D4169 is a standard test method for performance testing of shipping containers and packaging systems. It evaluates the ability of shipping units to withstand the expected distribution environment. FDA recognizes it as a consensus standard as part of sterility testing that is commonly applied to all sorts of medical devices.

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  Medical Device PCB Design Tips – Design for Debugging

  Getting a PCB (Printed Circuit Board) for a medical device right the first time is almost impossible. Datasheets can be misleading, or assumptions and architectures change. As a result, modifications are almost inevitable. Sometimes the modification is as simple as swapping resistors or adding capacitors. Other times it involves tacking on new circuits you had no idea you needed.

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  FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Device

  This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.

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  Bio Break: Strategies for Expanding Market Reach

  Nick and Joris explore the fascinating world of repurposing existing medical device technologies for new market sectors. As engineers and innovators, we often focus on creating brand-new solutions, but what about leveraging tried-and-true technologies to expand into untapped markets? This strategy not only opens doors to new revenue streams but also maximizes the potential of existing innovations.

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  Fluid-Structure Interaction (FSI) Modeling is Transforming the Medical Device Industry  

  Fluid-structure interaction (FSI) modeling is transforming the medical device industry by simulating complex dynamics between biological fluids and medical devices. In a field where safety and precision are paramount, FSI modeling offers engineers and researchers a powerful tool to design, test, and optimize devices in a virtual environment before physical prototypes are created or clinical trials are conducted. 

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  8 Cleanroom Best Practices to Maintain a CLEAN State 

  Cleanroom best practices are crucial to maintain a contamination-free environment, especially in industries like pharmaceuticals, semiconductors, biotechnology, healthcare, and medical devices. Here are some essential guidelines for ensuring your cleanroom is indeed clean.

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