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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Choosing an EE partner is a program risk decision, not a staffing decision. Early architecture choices carry through to certification, and the wrong partner can cost far more than their hourly rate suggests.
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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 break 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.
