THRIVE

70% of 510(k) submissions receive a deficiency letter on the first review cycle.

For Human Factors submissions specifically, that number climbs to 90%.

If you're leading a MedTech product through FDA clearance, those aren't the exception. That's the landscape you're operating in.

The instinct when a deficiency letter lands is to start fixing things immediately. In our experience, that's exactly what you should not do. Jumping into remediation before you understand the root cause means you’ll fix the wrong things and face a second deficiency letter. Fix the right things in the wrong order, and you'll waste months. Either way, you're back to square one.

In our latest article, we lay out the five root causes behind the vast majority of Human Factors deficiencies — from poorly structured URRAs to cross-document inconsistencies that undermine an otherwise credible evidence package — and a structured Phase Zero diagnostic framework for understanding precisely where your submission failed before you spend a dollar on remediation.

Whether you're staring at a deficiency notice right now or building the submission that you hope will never get one, this is the diagnostic framework worth adding to your toolbox.

Read the full article here: https://hubs.ly/Q046FTdq0

If your team is navigating a 510(k) deficiency and needs expert eyes on the evidence package, reach out directly. We're here to help you get to clearance — efficiently, and the first time.

Happy International Women's Day!

While we celebrate the incredible contributions of women in society, let’s also talk about the world women have been designed out of.

Women are 51% of the population.

And yet the world around us — the products we use, the spaces we move through, the systems we rely on — has been designed primarily by men, and for men.

This isn't a philosophical point. It's a measurable, documented reality.

When women are absent from design teams, entire physical and emotional needs become invisible. The consequences show up in products that don't fit women's bodies. In workplaces designed around a full-time worker who has no caregiving responsibilities. In cities where street lighting, public transport, and spatial design were never built with women's safety in mind. In medical devices sized for male hands. In voice recognition software that was trained predominantly on male voices.

We have been designing a world for half the population and calling it universal.

On International Women's Day, this is the goal worth naming: design a world that works for all of us. Not because it's the right thing to do — though it is — but because the cost of getting it wrong falls on most of the population, and that is a failure we can no longer afford to ignore.

To every woman in design, engineering, research, architecture, human factors, and innovation: your presence in that room matters more than you're often told. Keep going — you are the difference makers, enriching lives and making the world a safer place!

And to every organization serious about this: the question isn't whether you need more women in design. The question is what's stopping you, and what are you prepared to do about it?



—

Hello! We're THRIVE, a people-centered innovation firm.

We work with ambitious brands to create products, services, and experiences that win hearts and drive growth.

Our work gives leaders, teams, and organizations the courage and conviction to move confidently forward and design what's next.

Learn more about how THRIVE can help you tackle your toughest challenges at https://hubs.ly/Q045ZhKT0