Peter Diamandis, founder of the X-Prize and co-founder of Singularity University, says that “Many people who try to do big bold things in the world find out it's not about the money or the technology: It's about the regulatory hurdles that will try and stop you.”
Amen to that.
That was the thesis of a piece I wrote a month or so ago questioning why in the world The Clearing House wanted to force new regulation on innovators in financial services and payments. My point then, and now, is that innovators in a highly regulated sector like financial services and payments can’t get out of the starting blocks unless they live with existing rules and regulations - and that we have a lot of built-in checks and safeguards that keep bad actors at bay and bad things from happening to consumers. As Diamandis implies, the more money that young companies have to spend on hiring compliance experts, the less they have to spend on product development and innovation. If we want more, not less, innovation, that’s the way it needs to stay.
So, one theory is that Theranos, knowing this, kept a lid on what they were doing purposefully.
As it stands today, the bar for proving success in medical technology is incredibly high – as it should be anytime that human beings and their health and well-being are directly involved. It’s, thankfully, not possible for med-tech innovators to simply throw new invasive innovations like diagnostic testing in the market, watch what happens and then pivot if people start getting sick (or worse). The FDA is tasked with making sure that consumers don’t literally become human guinea pigs as innovators try for the moonshots that get and keep them motivated.
But critics argue that the old model in matters of med-tech – develop, prove, document, trial – and then go out and raise money – is broken. In addition to slowing things down, the odds are greatly reduced that anyone other than big pharma with deep pockets can fund innovation. That, they say, only forces companies like Theranos to operate in secrecy for years – and seek funding from well-heeled private investors and VCs who as a condition of giving money, then want to occupy their boards.
So maybe Theranos did the really smart thing, just like Uber, and engaged in “permissionless” innovation. Once everyone was hooked on its simple and effective tests, it could stare down the regulatory beast in D.C. just like Uber stared the beast down in New York City recently.
Or maybe (and more likely) the big bets on Theranos were just the result of groupthink at work.