Bio Break: Understanding Clinical Trials – Key Steps and Expert Insights

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Bio Break: Understanding Clinical Trials – Key Steps and Expert Insights

In this engaging episode of Bio Break, Nick and Joris dive into the complexities of clinical trials as a critical component of medical product development. Whether you’re a developer embarking on your first trial or a seasoned professional seeking guidance, this discussion provides actionable insights and resources to streamline the process.

Nick explains the importance of starting with the Clinical Laboratory Standards Institute (CLSI), a trusted resource for comprehensive guidance documents that address every facet of trial design. He highlights CLSI document ACP 1782, which details methodologies for determining the limit of blank, limit of detection, and the essential limit of quantification—crucial factors for validating medical diagnostics.

The conversation also touches on addressing environmental substances that could interfere with trial results. From chewing gum to caffeine, CLSI’s EP7-A2 guidance document offers a framework for evaluating interfering compounds in diagnostics, ensuring reliable data even in challenging conditions. For developers working with saliva-based tests or other sensitive diagnostic tools, these guidelines are indispensable.

Precision and bias are also at the forefront of trial considerations, and Nick mentions EP15-A2, a vital CLSI resource for understanding and accounting for these metrics in trial setups. From power calculations to designing interference panels, the discussion underscores how these documents empower developers to create robust, reproducible studies.

If you’re navigating the intricacies of clinical trials, this episode is your gateway to essential knowledge. Learn how leveraging the right resources can elevate the quality and reliability of your medical device development process.

Understanding Clinical Trials – Key Steps and Expert Insights

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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.

Two men sit at a table discussing the science behind freeze-drying. One of them holds a jar of freeze-dried coffee, illustrating the topic. The text overlay reads "The Science Behind Freeze Drying" in bold letters. A whiteboard with diagrams is visible in the background, reinforcing the technical discussion.

Bio Break: The Science of Freeze-Drying

Nick and Joris dive into the fascinating world of freeze-drying, exploring how this process extends shelf life and maintains the integrity of various products—including reagents used in in vitro diagnostics and even instant coffee!