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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  • Artificial intelligence ECG waveform with neural network overlay illustrating AI arrhythmia detection model

    ECGNet – An example application of Machine Learning for Heart Rhythm Diagnostics

    Electrocardiography (ECG) remains the gold standard for non-invasive cardiac assessment, providing a vital window into the heart’s electrical health. By recording electrical impulses through surface electrodes, clinicians can identify life-critical conditions such as arrhythmias, myocardial infarctions, and conduction abnormalities.

  • Fingertip pulse oximeter measuring SpO2 and heart rate using optical detection in a wearable medical device.

    Optical Detection in Wearable Devices

    Wearable medical and wellness devices are increasingly commonplace in the healthcare field. For example, devices such as smartwatches incorporate sensors to provide continuous health tracking data to their users.

  • Medical device bioburden thumbnail showing gloved hand holding a device with arrow pointing to a petri dish illustrating bacteria before sterilization validation

    Medical Device Bioburden and Sterilization Explained

    Nick and Nigel explore how much bacteria can exist on devices and why it matters. They explain that bacteria are everywhere.

  • Bacterial endotoxin testing concept showing syringe and horseshoe crab representing LAL test for medical device safety

    Bacterial Endotoxin Testing Explained

    Bacterial endotoxin testing plays a critical role in medical device safety. In this Bio Break episode, Nick and Nigel take a surprising…

  • Sterile assurance level concept showing gloved hands opening a sterile medical device pouch with “Truly sterile?” text overlay

    Sterile Assurance Level Explained

    Nick and Nigel walk through how sterile disposables are processed and verified before they reach the field.

  • 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.

  • Thumbnail showing a cartoon sandwich icon with the text “Sandwich ELISA?” and a red arrow pointing to the sandwich.

    Sandwich ELISA Assay Explained

    The sandwich ELISA assay is one of the most common ELISA formats used in diagnostics. Nick and Nigel walk through the method step by step using simple visuals and plain language.

  • 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.

  • Medical device data management displayed on a connected healthcare tablet

    Data Management Is Now a Core Device Requirement

    When I was starting out in medical devices, the discussion focused on the possibility of an internet of things and the promise of “big data” about everything.