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The business of introducing new medical devices requires us to address enormous technical challenges that require plenty of hard work. As we strive to meet these challenges, the FDA reminds us [...]

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 [...]

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 [...]

Growing up, my parents always told me to tell the truth. And in Boy Scouts, we recited the 12 points of the Scout Law weekly before every meeting. The first point is “Trustworthy.” The idea of [...]