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.

Archive Filters
Actions
  • Thumbnail with the text 'Will your MedTech Product succeed?' in bold black and purple font. On the right, Mark Drlik wearing glasses gestures toward a whiteboard with triple Venn diagrams labeled with terms like 'Desirability,' 'Feasibility,' 'Viability,' and 'Regulatory.'

    Venn Diagram MedTech Success – Aligning Product and Business Strategy

    Ariana Wilson and Mark Drlik break down a powerful visual framework for understanding what makes a medtech product, and the company behind it, truly successful. Using a triple Venn diagram, Mark explains how strategic alignment across feasibility, viability, and desirability can drive better product outcomes and business success in the medical device industry.

  • A close-up image of a hand drawing on a whiteboard with a marker, illustrating a brainstorming or planning session. Bold text on the left reads 'Cost to develop Medical Device' with the word 'develop' highlighted in purple. The image conveys the concept of medical device development costs and design planning.

    Bio Break: How much does it cost to develop a medical device?

    What are the real costs of developing a medical device? In this episode of Bio Break, Nick and Joris dive into one of the most frequently asked questions they hear from clients: How much does it cost to develop a medical device?

  • White and colored label rolls isolated on white background with shadow reflection. Color reels of labels for printers. Labels for direct thermal or thermal transfer printing. Abstract background.

    Medical Device Labeling Requirements: Compliance and Best Practices

    We all know medical devices have labels, but how often do we consider their purpose and the effort required to ensure they provide the right information? Device labelling serves as the interface between the manufacturer, the user, and regulatory bodies. (Note that being from Canada, we spell labelling with two Ls.)

  • 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.

  • ASTM D4169 Options packaging plant line and signal.

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

    ASTM D4169 Options for this standard test method of performance testing shipping containers and packaging systems are explored.

  • 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.