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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Theranostics combines diagnosis and therapy into a single targeting system, using one ligand to attach to two different radioactive payloads, one for imaging and one for treatment. It represents a significant shift in how cancer is being identified and treated. But the theranostics delivery workflow tells a different story.
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Ariana and Mark walk through what separates a clinical prototype from a proof-of-concept build, what determines how much testing and documentation you actually need, and where the regulatory line between significant risk and non-significant risk falls.
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Ariana and Mark explore how prototype strategy helps teams reduce technical risk and accelerate progress.
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Ariana Wilson and Mark Drlik explore how bias can enter the development process and why engineers and manufacturers must actively work to prevent it.
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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.
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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.
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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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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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In medical device development, verification is both a safeguard and a stress test, not just for the product, but for the process.
