Lauren Baker, PhD, founder of Insight Medical Consulting, is a strategic advisor who partners with clients throughout the product development life cycle. Before joining Suntra (formerly Sunrise Labs), she served as CEO of Boston Biomedical Associates (BBA), the company she founded to specialize in clinical research and regulatory affairs for emerging medical technologies. Her career in this space began at Boston Scientific, where she led the corporate clinical research group responsible for all global clinical trial activities.
Lauren brings broad expertise in global regulatory and clinical trial strategies, regulatory submissions, FDA liaison meetings, and product development guidance that translates business objectives into development requirements. She remains an industry leader in clinical research and regulatory affairs across multiple therapeutic areas, including cardiovascular, neurovascular, orthopedics, GI/GU, critical care, and breast imaging. Her work also extends to biologics in cell and gene therapy.
Her product expertise spans interventional medical devices, combination products, electro-mechanical devices, diagnostics, and advanced biologics. A licensed professional engineer, Lauren holds a master’s and PhD in Mechanical Engineering with an emphasis in biomedical engineering, and a bachelor’s degree in Chemical Engineering, all from Worcester Polytechnic Institute.
