What could go wrong? Startup sells med device before getting regulatory approval
Scanadu, maker of a medical tricorder, is just the latest example of a Silicon Valley company that generates hype without demonstrating substance.
The company raised funds and sold its device on Indiegogo before it got approval from the U.S. Food and Drug Administration to do so. This week, Scanadu announced that it will shut down the device in order to comply with regulations. As you might imagine, customers are not happy.
Wrong order!
Sell medical device-> Finish medical device -> Seek regulatory approval https://t.co/mRyRSwmGI9— Christina Farr (@chrissyfarr) December 19, 2016
@chrissyfarr correct order:
develop medical device→test device→improve→FDA approval→go to market→continue improvements→upgrade— HealthIT Policy (@HITpol) December 19, 2016