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2. Realizing That Safety and Efficacy Is More Than FDA

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Safety and efficacy, though, is about more than getting regulatory approval, Murdeshwar says. It is about ensuring whether there is really a market out there for the device.

What is the motivation for your user to switch to your device from the device you are using today? How do you avoid misinterpreting the clinical needs? Murdeshwar thinks the two questions are especially important because health professionals are conservative when it comes to switching to new devices. "It's a little naive to think the user is going to switch. They're comfortable with a device, and they've used it for years."

Safety and efficacy? "Sure it is FDA, but you have to sell this and make money," Murdeshwar says.

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[Image courtesy of Pixabay]

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