Hello
I'm Nikki Batista.
My goal is to drive digital health forward with experienced insight, principled leadership, and a heart for meaningful impact.
BS, MEng Biomedical Engineering
12 years of medical device experience as FDA Reviewer, Regulatory Consultant, and Industry Leader.
My Story
Becoming a mom reshaped how I think about time, purpose, and impact. I stepped away from a full-time leadership role to be present with my son, and in doing so, found new ways to contribute meaningfully.
Today, I consult selectively with teams building regulated digital health products. My work draws on experience in medical device development, regulatory strategy, usability, and cross-functional leadership—but my goal isn’t dependency, it’s empowerment. I focus on helping teams understand the “why” as much as the “how,” so they can move forward with confidence long after we’ve worked together.
I believe education should be accessible. That belief led me to create this space—a place to share practical, free resources for people navigating regulated digital health.
My time might be finite, but my commitment to learning, connection, and meaningful work is not. I’m especially drawn to people and teams who value integrity, curiosity, and thoughtful innovation—those solving real clinical problems and improving health literacy along the way.
Contact
I'm always looking to meet new people and companies.
Connect with me on LinkedIn.