Resource Centre

Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.

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  • A close-up of a lateral flow test with a dropper releasing a liquid sample into the test well. The background features a blurred whiteboard with scientific diagrams. Bold text on the image reads "Big Pivot: From LDT to Lateral Flow," emphasizing the transition from lab-developed tests (LDT) to rapid lateral flow diagnostics.

    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.

  • Two men sit at a table discussing glucose monitors, with the text "How Glucose Monitors Really Work" overlaid on the image. One man gestures while speaking, and both have coffee mugs labeled with their names. The background features a whiteboard with blurred writing.

    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.

  • Common Mistakes for Medical Device Projects A businessman wearing a blue suit and an orange tie is pointing at a transparent virtual interface with hexagonal icons. The central hexagon displays the words "REGULATORY COMPLIANCE." Surrounding it are four smaller hexagons with white icons, including a scale inside a gear (symbolizing legal and ethical standards), a stack of binders (representing documentation), a checklist (indicating compliance requirements), and a person next to a legal symbol (denoting regulatory oversight). The background is blurred with a brick wall visible.

    Common Mistakes for Medical Device Projects

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

  • 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!

  • ASTM D4169 Options packaging plant line and signal.

    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.

  • Close-up of a printed circuit board (PCB) with multiple connectors, sensors, and electronic components. The board has a purple solder mask with various capacitors, resistors, and ICs mounted. Colored caps on the connectors indicate different sensor inputs, with red and white wires attached. Visible traces and test points suggest a complex design, likely for a medical or industrial application.

    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.

  • 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.

  • Two professionals discussing strategies for repurposing medical devices into new market sectors, sitting at a table with mugs featuring their names (Nick and Joris) and a star logo. The background is a blurred office or laboratory setting. The overlay text reads, 'New Markets Ahead! Repurposing Medical Devices,' in bold purple and black fonts, emphasizing innovation and market expansion.

    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.

  • Three team members collaborating at a workstation in a modern office environment. One person in a blue shirt is pointing at a computer screen displaying a colorful 3D model, while another operates the mouse. The workspace features a green wall, shelving with supplies, and a small plant on the desk, creating a dynamic and engaging atmosphere.

    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.