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  Design Patent vs Utility Patent: What’s the Difference?

  In this episode of Bio Break, Nick walks through both patent types after receiving two of his own in the mail, one of each, from the USPTO.

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  Built for Exit: What Drives MedTech Success

  Scott Phillips sits down with Mickey Urdea to examine what actually distinguishes companies that reach commercial outcomes from those that do not.

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  MD+DI: Medical Device V&V Cost and Timeline Explained

  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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  MD+DI: Hidden Costs of Medical Device Sterilization

  Nigel Syrotuck examines the hidden medical device sterilization costs that many development teams overlook when estimating the true cost of producing a terminally sterilized device.

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  Enhance Early Risk Analysis with Online Whiteboards

  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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  Keeping It Flexible Without Letting It Drift: How to Manage Early-Phase Concept Development

  Early phase concept development is a weird part of a project lifecycle. It is often the most exciting phase, because the team is exploring possibilities, generating new ideas, and turning a fuzzy opportunity into something real.

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  Preparing for Clinical Trials Under Budget and Schedule Pressure

  Clinical prototypes must not only function as intended, but also be manufactured, documented, and supported in a way that satisfies regulatory expectations and clinical realities.

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  Accelerated Aging in Medical Devices: What It Actually Tells You

  Accelerated aging in medical devices is a testing method used to estimate how a product will perform over time by exposing it to elevated conditions, most often heat. In simple terms, it is a way to simulate months or years of aging in a much shorter timeframe.

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  MD+DI: Ensuring Reliability, Security, & Performance of Remote Medical Devices in Non-Clinical Environments

  In a recent article for MD+DI, StarFish Medical Software Manager Sean Daniel explores how remote medical devices reliability is becoming a defining challenge as devices move beyond traditional clinical environments into homes, workplaces, and public settings.

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