- AliveCor makes a portable EKG reader — the kind of electric heart monitoring that’s standard in hospitals — and it’s been FDA-cleared.
- Former Google executive and current AliveCor CEO Vic Gundotra explains what he learned during a ‘painful’ two-year FDA clearance process.
Vic Gundotra embarked on his health tech startup journey with the confidence of a tech industry veteran boasting years of experience.
Despite leading high-profile projects at Google and Microsoft, Gundotra got a harsh reality check when he tried to steer his startup through a foreign and challenging regulatory landscape.
“I learned that as a former Google executive I was grossly misinformed about how medicine works and had to learn some painful lessons by making some mistakes that probably doubled the process,” Gundotra told Business Insider in an interview.
Gundotra’s startup, AliveCor, makes a $200 wristband that connects to the Apple Watch and allows users to take a medical heart reading, or EKG test. The KardiaBand, which was released on Thursday is the first Food and Drug Administration-cleared accessory for the Apple Watch.
Getting the FDA clearance was critical. And it was a lengthy process full of stumbling blocks.
“It was about a year and a half, two years ago that we announced the KardiaBand for the Apple Watch. That first-generation product got regulatory approval in Europe but we never got regulatory FDA approval in the United States,” Gundotra said.
“We’ve been working with the FDA building that product for two years now,” he continued.
“I’ll take blame myself,” Gundotra said. “Those errors that cost us the extra year is my fault.”
Gundotra’s experience is one that may become increasingly common in Silicon Valley, as the tech industry seeks to transform new markets like healthcare and transportation. For starry-eyed tech execs accustomed to playing by their own sets of Read More Here