Former Google exec Vic Gundotra had a 'painful' two-year process working with the FDA - and other startups should pay attention
- 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."
One key to working with the FDA is that slide decks aren't what the agency is looking for - it's looking for clinical evidence.
"They don't care about your word. They care about clinical evidence. You have to follow their process and don't fool around with them. As a tech executive, it took me a year to make some mistakes and learn. I've been humbled through the process, but hey, we did it, we got there," Gundotra said.
Another issue is that tech designers are creating products like KardiaBand and associated software that potentially have a wide range of applications, but the FDA is very specific about what it's clearing.
"Our product allows you to get the electrocardiogram and send it to your physician, and your physician can make any diagnosis they want," Gundrota said.
"Our software that automatically interprets and says 'this EKG looks like this,' that is only FDA-cleared for normal sinus rhythm and possible atrial fibrillation," Gundotra said. "If I want to say something else, I can't until I get FDA clearance. So we went after the most common arrhythmia," he continued.
Lessons for Silicon Valley
Gundotra's old firm, Googl,e is making lots of bets on healthcare startups. And the giant that makes the platform he's building on, Apple, for example, is running large-scale medical studies using its software, and is said to be looking to handle clinical data as the first step to a real attempt to break into the medical market.
Navigating the most difficult aspects of the regulatory process seems to be a priority for Apple, according to documents obtained through FOIA by MobiHealthNews.
"[Apple COO] Jeff [Williams] has asked me to lead the thinking (or at least the conversation) on the intersection of the regulatory landscape (as it currently exists and where we hope we might be able to influence its movement) and our products and platforms," Robin Goldstein, a special projects attorney for Apple, said in an email seen by MobiHealthNews.
In 2015, Michael O'Reilly, an Apple employee, sent an email to an FDA official asking: "I have a question about FDA approval for apps that provide a diagnosis. Do you have time for a brief call today or tomorrow?"
O'Reilly works at Apple on "health special projects" and was previously Apple's VP of medical technology, according to his LinkedIn profile.
New rules of the road
In Silicon Valley, the most successful companies are those who have mastered the art of iterating. The idea is to ship a "minimum viable product" in order to be the first to market. Once the product is released, the companies move quickly to improve it, eradicating bugs and polishing imperfections - often based on feedback, or complaints, from users of the product.
That isn't the way medicine works. And the big tech giants may eventually need to accept that fact.
"I have learned a lot in the last two years, painfully. Medicine is not 'move fast and break things,'" Gundotra said, referring to the famous Facebook slogan.