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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  • An illustrated concept of assay development featuring a blurred laboratory background with a focus on a magnifying glass emphasizing the text 'LOQ vs. LOD Explained.' The image also includes an upward-pointing arrow symbolizing progress and precision in diagnostics and analytics.

    Bio Break: Understanding Limit of Detection and Limit of Quantification in Assay Development

    Dive into the world of assay development with this informative episode of Bio Break, where Nick and Joris explore two critical concepts: Limit of Detection (LOD) and Limit of Quantification (LOQ). These terms might sound similar, but their implications for clinical diagnostics and medical devices are vastly different. Whether you’re an engineer, researcher, or product developer, this video sheds light on why both LOD and LOQ are vital in ensuring the precision and reliability of diagnostic tests.

  • A medical vial with liquid and several teal-and-white capsules floating in the air, with a text overlay reading "Drug & Device: Why combine?" in a lab setting background.

    Bio Break: Drug-Device Combination Products

    In this episode of Bio Break, Joris and Nick explore the increasingly important world of drug-device combination products, discussing what they are, why they matter, and the unique challenges associated with their development. As modern pharmaceuticals become more complex, the role of engineered medical devices in delivering these therapies safely and effectively has never been more critical.

  • An illustrated flow diagram with interconnected boxes, representing platform technologies in a modern office setting. The title 'Platform Technologies Pros & Cons' is displayed prominently in bold purple and green text, suggesting an exploration of benefits and challenges in the field.

    Bio Break: Pros and Cons of Platform Technologies in Medical Device Development

    In this engaging episode of Bio Break, Nick and Joris dive into the complex world of platform technologies in product development, exploring the pros and cons of this widely discussed concept. From in-vitro diagnostics to point-of-care instruments, the term “platform” often sparks excitement—and sometimes hesitation. But what does it truly mean to build a platform-based product, and when does it make sense?

  • Colorful candy-coated chocolates float in the air against a blurred indoor background. Bold purple and black text on the left reads: "Medical Device Safety – A lesson from Van Halen."

    Bio Break: The Van Halen Secret to Medical Device Safety

    Nick and Joris dive into the surprising connection between rock bands and medical device safety. What do jelly beans and 1980s rock legends Van Halen have to do with developing safe and effective medical technologies? More than you might think.

  • Abstract image depicting financial growth in the medical device industry. A silhouetted figure points to a glowing dollar sign on a rising graph, symbolizing successful funding strategies. The design is complemented by floating dollar signs and a sleek, modern digital aesthetic.

    Bio Break: Funding Strategies for Medical Devices

    Nick and Joris tackle a topic that’s more relevant than ever—raising funds for medical device development in today’s challenging financial landscape. With economic headwinds and cautious investors, startups and even established organizations face significant hurdles in securing funding. But there are ways to mitigate these challenges, and Joris shares strategic insights to align product development milestones with fundraising cycles.

  • A close-up of a medical professional wearing blue gloves and a white lab coat, working with a combination medical device on a mannequin arm. The text overlay reads "Combination Devices in Clinical Trials: Bridging Two Worlds."

    Bio Break: Clinical Trials for Medical Devices vs. Pharmaceuticals

    In this episode of Bio Break, StarFish Medical experts Joris and Nick break down the key differences and similarities between clinical trials for medical devices and pharmaceutical products. As the conversation unfolds, they provide valuable insights into the distinct processes and challenges associated with these two types of trials, including the complexities of combination devices that bridge both worlds.

  • A close-up of a hand holding a small, capsule-shaped robotic device with visible internal components. The text overlay reads "Innovative Drug Delivery Methods Explained." The background is blurred, showing a clean, modern indoor setting.

    Bio Break: Innovations in Drug Delivery Systems

    In this episode of Bio Break, Joris and Nick explore groundbreaking innovations in drug delivery systems, focusing on how advanced technologies are transforming the precision and effectiveness of medical treatments. From delivering medications to hard-to-reach areas like the brain to targeted oral delivery, this discussion highlights solutions that are redefining modern healthcare.

  • A scientist in a lab coat and purple gloves examines a specimen under a microscope, while another scientist works in the background in a laboratory setting. The text overlay reads "And now? New FDA LDT Ruling.

    Bio Break: Laboratory Developed Tests vs. In Vitro Diagnostics

    In this episode of Bio Break, Joris van der Heijden and Nick Allan dive into the FDA’s new regulations surrounding Laboratory Developed Tests (LDTs) and their impact on the medical device industry. As LDTs grow in complexity, including applications like genetic testing and AI-driven diagnostics, these regulatory changes mark a significant shift for laboratories, developers, and healthcare providers.

  • A close-up of a scientist in a white lab coat, wearing a hairnet and blue gloves, examining a device in a biotech laboratory. In the blurred background, several other scientists in lab coats are working at lab benches. The text overlay reads "Biotech facility essentials.

    Bio Break: Core Facilities for Medical Device Development

    In this episode of Bio Break, Joris van der Heijden and Nick Allan discuss the critical role of specialized facilities in the successful development of medical devices. From testing laboratories to clean rooms, they explore the infrastructure needed to support innovation and ensure safe, effective products reach the market.