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  • Writer's pictureShannon Lantzy

"Ready to submit" does not mean risk-free

"Get it to market," a friend and colleague said, relating a story about a conversation between herself, her FDA teammates, and a sponsor about a new device. "Can you say that?" her colleagues asked. "Yes, you can say that." This friend worked at the FDA for years. She repeatedly told sponsors making a medical device to "get it to market" sooner than later. She wasn't encouraging sponsors to submit a device that was unsafe. But, rather, if they had developed a good medical device, don't delay because you're afraid of what FDA is going to come back with. Almost every submission gets a hold letter. No submission will be perfect. "If it is good enough, get it to market" she advised.

Have you had mentors, bosses, coaches, and friends say the same? "It's great, just publish!" or "Don't let perfect get in the way of good enough" or "Success, not perfection." I have. A lot. It feels risky to push out this blog/newsletter to people whose opinions I care a lot about. It feels wrong not to tweak the design and re-read the prose three more times. It is scary to hit "publish."

I've coached my staff, colleagues, clients, and the occasional airplane stranger for years, saying the same thing. I have also done the opposite: I have demanded more accuracy, more perfection, more certainty. The latter has its place, but it isn't in the final moments of a submission or a publication.

Have a bias toward action, take care of the important critical elements, and then get it to market. There will be risk. Nothing is risk-free, not even a blog post.

~Shannon, the Optimistic Optimizer


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