For most of my career I've focused on getting medical devices to market. At Bluestocking Health, my goal is to elevate and amplify the message of exciting Medical Technologies in order to help them stay on the market and to improve people's lives.

I like to talk...a lot. I like to talk at conferences, in videos, to classrooms, at technology incubators, with my friends, and now, as part of Bluestocking Health. As much as I like to talk, I also like to listen. Other facts about me: I graduated from UC Berkeley with a degree in Molecular & Cell Biology, I earned my doctorate in Neuroscience at Stanford, I was an FDA reviewer in the Center for Devices & Radiological Health, I received my Regulatory Affairs Certification (US) in 2014, and I became a proud RAPS Fellow in 2024.

Over the last someteen years, I have been actively involved in hundreds of FDA pre-submissions and premarket submissions for a wide array of medical device companies. I founded my first company (AcKnowledge Regulatory Strategies, LLC) in 2014 that was later purchased in 2021. After the acquisition, my team continued to work with small to large medical device companies to support all device types during the product life cycle. I started Bluestocking Health in 2025 to start more conversations about medical devices, science, clinical evidence, and healthcare. Want to discuss MedTech? Let's talk about it.

Check out my LinkedIn Bio here: https://www.linkedin.com/in/allisonkomiyama/

Meet The Advisors / Contributors