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
I'm a mom first.
Becoming a parent 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, I created a space to contribute to the world in more than one way.
Today, I consult selectively with teams building regulated digital health products. I draw on years of experience in medical device development, regulatory strategy, usability, and cross-functional leadership, but my goal isn't dependency---it's empowerment. I believe deeply in sharing knowledge, building confidence, and helping teams understand why and much as how, so they're equipped to lead long after our work together ends.
I believe education is powerful, and access to it is vital. That believe is what inspired me to create this space: a place to share practical, accessible, and free educational content for people navigating regulated digital health. I also offer paid services on a limited basis, knowing my time is finite---but my commitment to connection, learning, and meaningful collaboration is not.
I'm drawn to people and companies who value integrity, curiosity, and thoughtful innovation---especially those working to solve real clinical problems and improve health literacy along the way.
Contact
I'm always looking to meet new people and companies.
Connect with me on LinkedIn.