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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Nigel Syrotuck breaks down REACH SVHC compliance for teams working with material suppliers and compliance questionnaires.
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Nick and Nigel breaks down what actually goes into the cost of getting a sterilized device into a user's hands, and why up to 30% of costs can sit in places most teams don't plan for.
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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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Nigel Syrotuck breaks down the realistic medical device V&V cost and schedule for terminally sterilized devices, picking up after design freeze and walking through each major phase of the process.
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Graphical mind maps created in online whiteboards offer a low-barrier, highly collaborative approach to early risk analysis in medical device development.
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This medical vs wellness example shows how device classification can directly change functionality. Even when hardware is similar, what the device is allowed to do can be very different.
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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.
