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 healthcare professional wearing a surgical mask and scrubs holds a clipboard with a checklist partially completed. The text overlay reads "Clinical Trials: Expert Insights" in bold purple and gray lettering, emphasizing expertise and precision in clinical trial processes. The image suggests a focus on medical research and the methodology behind clinical studies.

    Bio Break: Understanding Clinical Trials – Key Steps and Expert Insights

    In this engaging episode of Bio Break, Nick and Joris dive into the complexities of clinical trials as a critical component of medical product development. Whether you’re a developer embarking on your first trial or a seasoned professional seeking guidance, this discussion provides actionable insights and resources to streamline the process.

  • FDA Laboratory Developed Tests Policy

    Impact of New FDA Laboratory Developed Tests Policy

    The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.

  • Drug Delivery Devices for Cell and Gene Therapies

    5 Drug Delivery Solutions for Cell and Gene Therapy (CGT) Challenges

    Drug Delivery Solutions for Cell and Gene Therapy (CGT) Challenges explores effective delivery devices and solutions for advanced CGT therapies and their unique challenges.

  • Aerosol Drug Delivery Systems graphic

    Developing Optimized Aerosol Drug Delivery Systems

    Aerosol Drug Delivery Systems, including Aerosol-based pulmonary-delivered drug devices, offer significant value by enabling targeted drug delivery directly to the respiratory system.

  • Drug Delivery System Imaging - MRI image that can be used to direct treatments to specific parts of the brain

    Choosing a Drug Delivery System Imaging Technology

    Drug Delivery System Imaging Technology options include MRI, CT, and Ultrasound. This article highlights advantages and disadvantages for each technology in guiding drug delivery.

  • 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.

  • Medical Devices for Animals Picture of a dog

    Emerging Medical Devices for Animals

    Medical devices for animals are not regulated in the same manner as those for humans. Nevertheless, they are medical devices. This article explore emerging animal medical devices.

  • A visually engaging laboratory-themed image showcasing a traditional pipette being used alongside a microfluidic device schematic. The background features a blurred lab setting with scientific equipment, emphasizing the transition from manual pipetting to advanced fluid-handling technologies. The text "Rethinking Pipettes" is prominently displayed in bold purple, with a green checkmark and a red question mark, symbolizing the pros and cons of different fluid transfer methods.

    Bio Break: The Role of Pipettes in Lab Workflows

    In this episode of Bio Break, Nick and Joris dive into a common challenge faced by researchers and product developers: the use of pipettes in laboratory workflows and the need for alternatives in non-laboratory environments. From the precision of the trusty P200 pipette to innovative solutions like microfluidics, this discussion highlights the strengths and limitations of fluid handling tools in research and beyond.