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 laboratory scene featuring a glass Erlenmeyer flask filled with bright green liquid placed on a table against a dark background. Bold text on the left reads, “He drank Bacteria!?” in large gray and purple letters, adding a sense of curiosity and intrigue.

    Bio Break: Groundbreaking Discoveries in Infectious Disease

    In this episode of Bio Break, Nick shares one of his favorite discoveries in the world of infectious disease research — the groundbreaking discovery of Helicobacter pylori and its role in causing peptic ulcers. This fascinating story showcases how persistence, scientific curiosity, and innovative thinking can lead to discoveries that reshape medical science.

  • A close-up image of a hand drawing on a whiteboard with a marker, illustrating a brainstorming or planning session. Bold text on the left reads 'Cost to develop Medical Device' with the word 'develop' highlighted in purple. The image conveys the concept of medical device development costs and design planning.

    Bio Break: How much does it cost to develop a medical device?

    What are the real costs of developing a medical device? In this episode of Bio Break, Nick and Joris dive into one of the most frequently asked questions they hear from clients: How much does it cost to develop a medical device?

  • A futuristic smartwatch displaying biometric data on its screen, set against a glowing blue background with abstract graphs. Bold text reads "Where's my Cortisol-Sensing Watch?" in a mix of grey, purple, and black fonts.

    Bio Break: Why Don’t We Have a Cortisol-Sensing Wearable Yet?

    Nick and Joris tackle a question many tech and health enthusiasts have wondered for years: Where is my cortisol-sensing smartwatch? Nick shares a nostalgic story of reading about futuristic wearable technology in Popular Mechanics as a child — devices that would one day monitor biomarkers like cortisol to track stress and overall health. Now, decades later, he and Joris break down why such a wearable device still hasn’t become a reality.

  • White and colored label rolls isolated on white background with shadow reflection. Color reels of labels for printers. Labels for direct thermal or thermal transfer printing. Abstract background.

    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.)

  • Room for sterilization of medical instruments in a modern outpatient clinic

    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.

  • 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.