Last week, HBO premiered a documentary titled The Inventor: Out for Blood in Silicon Valley,
detailing the rise and fall of the now defunct Theranos and its former CEO Elizabeth Holmes. Since the documentary aired, Holmes and the company have once again become a hot topic of discussion.
The demise of Holmes’ once $9 billion company centered around the fact that Edison, a device that was supposed to test for more than 200 diseases from a single drop of a patient’s blood, didn’t work.
Despite protests from those developing the device, Holmes continued the “fake it until you make it,” philosophy, which ultimately resulted in Theranos completely dissolving in 2018.
But the story brings up a bigger issue for the medtech industry – how do you tell management an idea is bad, or it isn’t working? To find out the answer, MD+DI spoke with Stephanie Whalen, an Engineer with Swope Design Solutions and Bryce Rutter, PhD, founder and CEO of Metaphase Design Group.
Whalen suggests one of the first things those defining devices should do is clearly define the problem a company is hoping to solve.
“Instead of labeling something as impossible (an entrepreneur, for example, thrives on making the impossible a possibility), clearly and objectively describe the risks involved in attempting the approach,” Whalen, told MD+DI.
She also said that empathy also plays a significant role.
“Speaking of stakes and stakeholders, try to understand the product as a whole system as much as possible, rather than one subsystem or component,” Whalen said. “It will, again, help you better empathize with management, so you can more effectively understand your point of view, and make sure solutions offered are compatible with the corporate strategy or with individual's goals, etc.”
Age is More Than A Number
Rutter told MD+DI that it isn’t uncommon for age to play a role in being a barrier in having conversations about a project that isn’t going well.
“Unfortunately, age seems to confer wisdom,” Rutter said. “People assume that you’re older and have more experience. That’s not the case. People who are serving up results that are not desirable can be of any age. But that is an added challenge of younger people trying to deliver bad news.”
He added, “Another challenge with a younger person is just having access to the right person who can kill an idea, just because it’s a bad idea. They might have to report up the chain and they’re concerned with issues of going around their immediate boss. Their immediate boss might not be listening to them. They’re looking at a dead idea and they’re trying to get it to someone’s ears who’s going to pay attention. The hierarchy within an organization presents a challenge for a younger person because they’re typically lower on the food chain. With the older crowd, in many cases those things are muted to a certain extent or eliminated. That makes things better, but now you’re in the room with the person you’ve got to serve up [the bad news] to.”
And that scenario leads to a totally different set of issues. However, Rutter said in his experience he has developed a one-size-fits-all strategy, regardless of age, to help deliver the bad news.
“Everyone has kind of fallen in love with the idea, because it’s in R&D already,” he said. “So now you’re telling me my baby is ugly. There’s a lot of emotion there. What I have found to be the most effective tool is removing the emotion that can be intrinsic in any one-on-one conversation.”
Rutter noted, “You take a one-minute video that is comprised of maybe 30 five second clips that highlight the problem, so they can see directly from the consumers point of view. My experience has been that they look up at you and go ‘holy cow we’re screwed. So now it’s not my opinion. I have removed myself out of that emotional confrontation or that emotional dialogue. Now it’s the voice of the customer getting through to the suit [upper management] to really hear what they’re saying.”
If All Else Fails
In The Inventor: Out for Blood in Silicon Valley, Tyler Shultz, a whistleblower and former employee of company was awestruck by Holmes. At one-point Shultz said Everyone worshipped the ground she walked on, she could do no wrong. She was the next Steve Jobs, according to the HBO documentary. Shultz was a young hopeful seeking to change the world but eventually began to see the problems with Theranos’ Edison technology and left.
Rutter said, “I think when you’re part of the R&D team, whether you be an industrial designer, or a human factors person, or an engineer, or anyone – and you know that there’s total ignorance and refusal to accept the facts, then you have a moral dilemma. And that moral dilemma is you know this thing is going to blow up eventually. The moral question is do you want to be there and be a part of that fire – do you want to participate in the charade. I think that most people would say no.”
Whalen noted that the person must also consider their mental health and how the work environment is impacting them.
“Lastly, don't forget to focus on your own mental health, and don't let a toxic work environment get to you (as best as you can),” she said. “I don't think there is any shame in taking a step back or leaving entirely if the situation is damaging to your mental health.”