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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  • Thumbnail with the words “Designing Out Bias” above an ECG waveform and a gloved hand holding a surgical instrument, highlighting bias in medical device design.

    Sex and Gender Bias in Medical Devices

    Sex and gender bias in medical devices remains a persistent challenge across the industry. In this episode of MedDevice by Design, Ariana…

  • Healthcare worker disposing hazardous medical waste into a biohazard container in a hospital setting

    Wasted Potential: The Reality of Medical Waste by the Numbers

    Did you know that 5-8% of total national carbon footprints come from the healthcare sector? Much of this (around 80%) is general waste – such as from office work – and the rest (~20%) requires special handling due to its dangerous nature.

  • 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 path from aliens and crabs to one of the most important quality checks in MedTech.

  • 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.