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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    Clarifying ASTM D4169 Options – It’s all in the details

    ASTM D4169 is a standard test method for performance testing of shipping containers and packaging systems. It evaluates the ability of shipping units to withstand the expected distribution environment. FDA recognizes it as a consensus standard as part of sterility testing that is commonly applied to all sorts of medical devices.

  • Close-up of a printed circuit board (PCB) with multiple connectors, sensors, and electronic components. The board has a purple solder mask with various capacitors, resistors, and ICs mounted. Colored caps on the connectors indicate different sensor inputs, with red and white wires attached. Visible traces and test points suggest a complex design, likely for a medical or industrial application.

    Medical Device PCB Design Tips – Design for Debugging

    Getting a PCB (Printed Circuit Board) for a medical device right the first time is almost impossible. Datasheets can be misleading, or assumptions and architectures change. As a result, modifications are almost inevitable. Sometimes the modification is as simple as swapping resistors or adding capacitors. Other times it involves tacking on new circuits you had no idea you needed.

  • FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment of Medical Device

    This blog explores key highlights of the Chemical Analysis for Biocompatibility Assessment of Medical Devices draft guidance, focusing on its scope, testing methodologies, and recommendations for reporting. In September 2024, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Chemical Analysis for Biocompatibility Assessment of Medical Devices.

  • Two professionals discussing strategies for repurposing medical devices into new market sectors, sitting at a table with mugs featuring their names (Nick and Joris) and a star logo. The background is a blurred office or laboratory setting. The overlay text reads, 'New Markets Ahead! Repurposing Medical Devices,' in bold purple and black fonts, emphasizing innovation and market expansion.

    Bio Break: Strategies for Expanding Market Reach

    Nick and Joris explore the fascinating world of repurposing existing medical device technologies for new market sectors. As engineers and innovators, we often focus on creating brand-new solutions, but what about leveraging tried-and-true technologies to expand into untapped markets? This strategy not only opens doors to new revenue streams but also maximizes the potential of existing innovations.

  • Three team members collaborating at a workstation in a modern office environment. One person in a blue shirt is pointing at a computer screen displaying a colorful 3D model, while another operates the mouse. The workspace features a green wall, shelving with supplies, and a small plant on the desk, creating a dynamic and engaging atmosphere.

    Fluid-Structure Interaction (FSI) Modeling is Transforming the Medical Device Industry  

    Fluid-structure interaction (FSI) modeling is transforming the medical device industry by simulating complex dynamics between biological fluids and medical devices. In a field where safety and precision are paramount, FSI modeling offers engineers and researchers a powerful tool to design, test, and optimize devices in a virtual environment before physical prototypes are created or clinical trials are conducted. 

  • Two laboratory professionals in cleanroom attire, including hair covers, masks, and gloves, working in a high-tech lab. One person is using a microscope at a workstation, while the other operates a machine in the background. The environment is clean and well-organized, featuring advanced scientific equipment and tools.

    8 Cleanroom Best Practices to Maintain a CLEAN State 

    Cleanroom best practices are crucial to maintain a contamination-free environment, especially in industries like pharmaceuticals, semiconductors, biotechnology, healthcare, and medical devices. Here are some essential guidelines for ensuring your cleanroom is indeed clean.

  • A team of professionals sitting in a conference room, engaged in a discussion. A large screen displays a colorful 3D design, while a whiteboard on the wall shows notes and diagrams. The table is equipped with laptops, notepads, and engineering tools, emphasizing a collaborative work environment.

    Medical Device Design Transfer Process

    Medical device design transfer is a critical phase in the development process, marking the transitory phase from the design and development stage to manufacturing.  This phase ensures that the medical device continues to meet its safety, effectiveness, and regulatory compliance once production begins.  It is the final phase in the development process and sometimes overlooks or underestimates the amount of time and effort required to ensure that final manufactured devices meet requirements. 

  • Laboratory setting with test tubes and beakers, overlaid with futuristic medical and scientific icons, representing biotechnology and data-driven research.

    Benefits and Role of Systems Engineering in Medical Device Development

    Systems-thinking must always be present in medical device development. Systems Engineers (SEs) live where complex development needs managing. In a very small project team people can communicate continuously and tightly enough that everybody understands where they’re headed and what’s going on.

  • Medtech Entrepreneur Webinars

    2024 Top Medtech Entrepreneur Webinars

    2024 Medtech Entrepreneur Webinars feature both standard expertise webinars and livecast recordings from Playbook events in Vancouver, Canada and Newport Beach, California.