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  • Writer's pictureShannon Lantzy

It's not all science; lead with value

Listen to the caring voice, the angel on the right shoulder, the gut feeling. Act on what is not only scientifically right but what is good.

ProPublica conducted an investigation into a CPAP recall and found that people at the company probably knew about the black particulate matter in the devices for a very long time before reporting the problems to the FDA. Scores of analyses of the NASA Challenger accident showed a failure not of science, engineering or knowledge...but a failure to speak up.

People stay quiet for myriad reasons. Fears of retaliation, of being ostracized from the group, of being distrusted...these fears are valid and the results of speaking up are often very personally consequential. In scientific endeavors, another more insidious fear creeps in: fear of not having enough data to make a sound scientific judgment.

There are never enough data + methods to create trustworthy evidence for a perfectly sound decision. Uncertainty always remains. We can always gather more evidence and conduct more trials. But at some point, there's enough to make a decision. That point often comes with a value judgment. If I worked at a company that received reports of unidentified black particulate matter in a breathing machine, I hope I would recognize the potential negative effects and speak up quickly. Even if I didn't know the science, I hope I would question it. I hope I would speak up in a way that others could hear, well before evidence could prove there's a problem. Groupthink often gets in the way. (Fortunately, there are ways to systematically combat groupthink in organizations.)

We rarely see news reports of the near-misses caught by people willing to risk negative consequences. We should tell those stories more often. I know that a senior cybersecurity leader in a large medical device company once tipped off FDA reviewers into asking questions about the security posture of a device because they knew it needed to be fixed. I know many individuals work for the good of humans, and believe in their organization's purpose of doing the same. They speak up for not just scientific evidence, but human value. These are leaders, regardless of their position or organizational authority.

Leadership takes guts, value judgments, and a willingness to act despite undying uncertainty. Be a leader.

~Shannon, the Optimistic Optimizer

Ps. If you're asking how this relates to regulatory innovation: think of the last time someone said "What does FDA require?" Sometimes, that question comes not from a desire to learn what must be done, but to avoid doing the right thing. This happens a lot in medtech cyber. Especially at conferences.


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