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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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  Medical Device Sterilization Methods and EtO

  Sterilization is a critical process in the medical device industry as it provides a reliable way to ensure that devices are free from harmful microorganisms when they are used on patients. This blog talks about the categories of sterilization currently used on medical devices in manufacturing settings. It also addresses concerns surrounding the use of ethylene oxide (EtO), an indispensable method for sterilizing heat and moisture sensitive devices.

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  Interesting 2025 Medtech Trends

  Predicting the trends of a new year is always interesting and a bit unpredictable. We asked our medical device design and development professionals to submit their most interesting medtech trends for 2025 and the reasoning behind their prediction. The results were surprisingly focused on two major trends: Home Healthcare and Wearable Devices. Within these categories, several technologies were identified including edge computing, IoT, and connected devices. In no particular ranking, here are our 2025 predictions:  

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  Considerations for Including Tissue Biopsies in Clinical Trials

  The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance document, Considerations for Including Tissue Biopsies in Clinical Trials, issued in January 2025. It provides recommendations for sponsors, investigators, institutions, and Institutional Review Boards (IRBs) on the safe and ethical incorporation of tissue biopsies in clinical trials.

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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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  Bio Break: How to Successfully Pivot in Medical Device Development

  In the world of medical device development, unexpected challenges often lead to critical product pivots. In this episode of Bio Break, Nick and Joris discuss one of the most dramatic pivots they’ve encountered—transforming a lab-developed test (LDT) into a lateral flow assay to expand its market reach.

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  Bio Break: The Science of Cryopreservation

  Cryopreservation is essential in biological research, regenerative medicine, and stem cell therapies. But freezing biological materials isn’t as simple as placing them in a freezer. Nick and Joris dive into this fascinating process in this episode of Bio Break, using a real-world example—Nick’s frozen beverage can, which burst due to water expansion.

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  Bio Break: Understanding Continuous Glucose Monitors

  Continuous glucose monitors (CGMs) are revolutionizing how people track blood sugar levels in real time. But how do they work, and where exactly do they measure glucose? Nick and Joris explore the science behind CGMs, explaining the difference between blood glucose monitoring and interstitial fluid measurement.

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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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