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
  • FDA agentic AI reviewer concept with robotic hand reviewing medical device submission documents

    FDA Agentic AI and Medical Device Reviews

    The FDA agentic AI is making headlines after the agency announced its own internal AI review tool. In this episode of MedDevice by Design, Ariana and Mark discuss what this could mean for medical device submissions and regulatory efficiency.

  • Engineers conducting pre-clinical testing of a novel medical device in a controlled laboratory environment

    The EU Breakthrough Device (BtX) Designation Program

    For manufacturers of novel devices that can make a significant impact to patient health, the goal of the program is to offer a path to streamlined and potentially faster market entry without sacrificing the rigour around ensuring safety and performance.

  • Human factors and operational controls in a medical device cleanroom

    ISO 14644-5:2025 Cleanroom Operations Explained

    With the release of ISO 14644-5:2025, Cleanrooms and associated controlled environments, Part 5: Operations, the standard places increased emphasis on operational discipline, human factors, and contamination control behaviour.

  • AI-enabled medical device software interface illustrating FDA PCCP guidance for controlled algorithm updates

    Understanding the FDA’s New PCCP Guidance for AI-Enabled Medical Device Software

    This article outlines the core elements of the PCCP framework, the types of modifications it applies to, and how the FDA expects manufacturers to use it in practice.

  • Thumbnail showing gene therapy delivery challenge with disrupted DNA pathway

    Gene Therapy Delivery Challenges Explained

    In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik explore what sits beneath that progress, focusing on how these therapies are delivered and why delivery remains one of the hardest problems to solve.

  • Smartwatch displaying heart rate and ECG-style waveform, illustrating the difference between wellness devices and medical devices in digital health regulation

    Medical vs Wellness Devices: What Really Makes the Difference?

    Ariana Wilson and Mark Drlik break down medical vs wellness devices and explain why two products with identical hardware can fall into completely different regulatory categories.

  • Visual comparison supporting clinical ventilator development and commercial device design.

    Clinical Ventilator Development Explained

    Understanding how clinical ventilator development differs from commercial ventilator design is essential for teams planning early studies.

  • Grocery store aisle with red arrows highlighting items that reveal hidden health data, illustrating how consumer shopping behavior can signal medical information.

    Consumer Health Prediction in Everyday Shopping

    Consumer health prediction shapes more of daily life than most people realize. In this episode of Bio Break, Nick and Nigel explore how retail data can reveal health information without a person ever speaking to a clinician.

  • Nick showing a biofilm conference book while Nigel listens, with overlay text reading FDA Asked For It and a red arrow pointing to the book.

    Biofilm Referencing Lesson

    When reviewing evidence for a medical device, a single citation can shape an entire submission. In this Bio Break episode, Nick shares a biofilm referencing lesson that has stayed with him since the early 2000s.