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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  • Multiple computer monitors displaying financial and data analytics charts, graphs, and numerical data in a high-tech setup, indicating real-time monitoring and analysis in a professional workspace.

    Understanding Human Errors in Medical Device Root Cause Analysis

    Root Cause Analysis (RCA) is a cornerstone process for identifying and resolving nonconformities in the medical device industry. Yet, a critical aspect often overlooked is the role of human error. In her online-exclusive article “Understanding Human Errors in Medical Device Root Cause Analysis” for Medical Product Outsourcing (MPO), StarFish Medical’s Vinky Kohli examines how integrating human factors into RCA can lead to safer devices and improved processes.

  • 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 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 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.

  • 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.

  • Biocompatibility Evaluation ISO 10993-1 Accessibility Alt description: FDA sign in front of FDA building that says "U.S. Department of. health and Human Services Food and Drug Administration"

    FDA Guidance on Biocompatibility Evaluation ISO 10993-1

    Review of FDA Guidance on Using ISO 10993-1 integrating biocompatibility evaluation within the risk management process, as outlined in the FDA Guidance Document  Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.