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Human factors validation testing shows you’ve done your due diligence to mitigate identified hazards and the resulting harms your device might cause users and patients. For the majority of [...]

A medical product company’s lifeblood is their product pipeline. Keeping it full of high quality opportunities is one of the most important jobs of the executive team. If you’re running an [...]

People use your medical device differently than you think they do.  It doesn’t matter what you say during training, or write in a manual or formal “instructions for use” document.  Personal [...]

"Just don’t make it look medical." As we research what people want in a home health product, this is what we hear most frequently. Typically, this distaste for a medical look becomes a bedrock [...]

In developing a new medical device, some start-ups proceed with a high degree of confidence that their core technology engineering prototype should become faithfully transformed into the actual [...]

In developing a medical device, agreement on a design approach brings with it no guarantee that the product will ultimately appear and function as expected. sometimes subtle viewpoint differences [...]