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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  • Female professional doctor showing medical test result explaining prescription using digital tablet app visiting senior woman patient at home sitting on sofa. Elderly people healthcare tech concept

    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:  

  • Mammalogist doctor examines a woman breasts and lymph nodes during appointment. Skillful oncologist puncture of mammary glands of young patient under review ultrasound for diagnosis of breast cancer.

    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    The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance document, Considerations for Including Tissue Biopsies in Clinical Trials, issued in January 2025.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.

  • A person adjusting a medical device in a clinical setting.

    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.

  • 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.