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

    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

    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 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

    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

    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.

    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.

  • Thumbnail showing gene therapy delivery challenge with disrupted DNA pathway

    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.

  • Indirect ELISA explained with antibody model showing enzyme linked immunoassay detection

    Nick and Nigel walk through how indirect ELISA works, why it uses two antibodies instead of one, and when this approach makes the most sense in real diagnostic workflows.

  • Nick from StarFish Medical demonstrating antigen detection using a toy antibody model to explain how monoclonal antibodies bind antigens in ELISA diagnostics

    Nick and Nigel break down the ELISA assay explained in simple, practical terms using everyday models.