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    The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have released a draft guidance document, Considerations for Including Tissue Biopsies in Clinical Trials, issued in January 2025.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

  • Alt text: A promotional graphic from StarFish Medical featuring the title "Pre-Clinical Lessons We Wish We’d Known" in bold purple and lavender text. Below the title are headshots of three team members: Joris van der Heijden (Concept Development Lead), Paul Hulme (Human Factors Engineer), and Nick Allan (Bio Services Manager), with their names and titles displayed above each photo. The StarFish Medical logo is placed in the top left corner.

    Pre-Clinical Lessons We Wish We’d Known

    Pre-clinical studies and early-stage trials are some of the most challenging — and expensive — milestones in medical device development. Yet, many teams encounter avoidable setbacks that could have been prevented with strategic foresight and practical lessons learned from experience.

  • "A promotional graphic for a webinar titled 'Pre-Clinical Pitfalls: What Could Go Wrong with Your Drug Delivery Device?' The text is in black and purple, with 'Drug Delivery Device' highlighted in purple. Below the title, the date and time of the webinar are listed as Wednesday, February 26, 2025, at 10 AM PST / 1 PM EST in purple text. On the right side of the image, there is a close-up of a purple drug delivery inhaler device against a white background.

    Pre-Clinical Lessons We Wish We’d Known

    Experts discuss 3 pre-clinical pitfalls that could derail your drug delivery device. One small oversight could cost you millions in clinical delays.

  • Two men sit at a table in a discussion, with one holding a frozen soda can. The background features a whiteboard with faint writing, and snowflake graphics are scattered around the image. The text overlay reads, "The Science of Freezing Cells" in bold black and purple letters.

    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.

  • 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.