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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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.
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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.
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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.
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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.
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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.
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Nick and Nigel break down the ELISA assay explained in simple, practical terms using everyday models.
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Ariana Wilson sits down with Mark Drlik to unpack why reprocessing is often one of the hardest challenges engineers face during development.
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Nick and Nigel walk through how teams decide between ethylene oxide, E-beam, and gamma radiation sterilization.
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In MedTech, success rarely comes from invention alone. Plenty of promising technologies make it through verification and early clinical work, only to stall when the team tries to turn them into something buildable.
