The Power of Objective Evidence

A Lesson from a Breakthrough FDA Submission

In the world of FDA submissions, there’s a phrase we hear often (sometimes with a sigh):

“Objective evidence.”

Those who’ve worked through post-market compliance audits know this well. To an FDA auditor or reviewer, a document can matter more than what’s in it. It’s not about what you know; it’s about what you can show.

We were reminded of this recently while guiding a client through the Breakthrough Device Designation process. The science was solid. The communication was clear. Everyone agreed the device had merit. And yet, we kept hearing the same thing from the FDA:

“You haven’t provided any evidence.”

At first, we pushed back. Of course we had! We had described the study outcomes, summarized the data, and explained the clinical relevance. But in hindsight, the FDA wasn’t wrong.

We had shared a conclusion, not the actual data.

What changed everything was a single slide. Just a simple chart of data points. Not more scientifically sound than the summary we’d already shared, but visibly objective. With that in hand, the FDA quickly moved forward, and our client secured their Breakthrough Designation.

The Lesson: Evidence needs to be seen, not just believed.

This experience served as a fresh reminder that what’s obvious to you isn’t always obvious to others. Not in regulatory work. Not in business. Not in life.

Whether it’s an FDA reviewer, an investor, or a teammate, people need help connecting the dots. Not because they aren’t capable, but because clarity often requires proof.

At in2being, we help companies make their evidence visible, whether that means designing a regulatory strategy, presenting clinical data, or translating complex findings into language that moves a review forward.

We’re honored to help innovators bring life-changing technologies to the people who need them most.

Final Thought:

We’re all working to build something meaningful in our lives, our country, and our time on this planet. Let’s lead with kindness and help others see what we see.

I’m grateful to share this world and this moment in time with you.

Let’s make it a good one together.

Need help turning your findings into clear, compelling submissions? We’re just a call away. You don’t have to navigate FDA communication alone.