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  FDA Final Guidance on Remanufacturing of Medical Devices: Key Takeaways and Implications

  In May 2024, the FDA released an updated guidance document to help manufacturers, third-party service providers, and healthcare facilities determine whether their modifications fall under the category of remanufacturing. This guidance enables these entities to continue ensuring patient safety, regulatory compliance, and the effectiveness of remanufactured medical devices.

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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 Options for this standard test method of performance testing shipping containers and packaging systems are explored.

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  FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Device

  This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.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

  In the webinar "Grand Challenges in Neuroscience" from January 21, 2025, Dr. Jacob Hooker, Lurie Family Professor of Radiology and Scientific Director at the Lurie Center for Autism at Massachusetts General Hospital, joins Nick Allan, Bio Services Manager at StarFish Medical, to discuss some of the biggest hurdles in neuroscience today. The conversation explores the complex interplay between chemistry, biology, and medical device engineering, offering insights into the latest innovations in neurotherapeutics, molecular imaging, and non-invasive drug delivery technologies.

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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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