About Us.
Dana Fashina
Based in Boston, MA, Medical Minds was founded by Dana Fashina.
An Engineering and Regulatory strategist with deep expertise in advancing software-driven and AI-enabled medical technologies in highly regulated industries. She works at the intersection of engineering, regulatory strategy, and product development, helping organizations turn complex FDA, IEC, and ISO requirements into practical development systems that allow teams to build innovative medical technologies with confidence.
Known for bridging executive vision with engineering execution, her expertise lies in bridging a gap the distance between how engineers build technology and how regulators evaluate it.
Dana helps companies design scalable development environments that support rapid innovation while maintaining the rigor required for defensible regulatory submissions.
She’s known for spotting structural problems early, solving complex technical challenges, and building operational systems that allow innovation to scale.
Her superpowers include: seeing around corners, strategic problem solving and developing efficient operations.
Arlesa Hubbard
Arlesa has a background in Medical Device Development with specific training in Regulatory Affairs, Risk Management, Design Controls, and Quality Systems management. She is passionate about developing safety systems and most recently has worked as a Risk Manager for a global pharmaceutical company, where she supported the development of various device technologies to assist in the treatment and/or management of diabetes and select rare diseases.
In her current role, she focuses on the design & development of both combination drug-device products and standalone software as medical devices, as well as their connected ecosystems.
Prior to her current position, Arlesa held roles as both Risk Management Engineer and Quality Manager for Fresenius Medical Care where she was responsible for supporting new product development and sustaining engineering activities.
Arlesa holds a B.S. in Biomedical Engineering from The University of Miami, a M.S. in Regulatory Affairs for Drugs, Devices, and Biologics from Northeastern University, and a M.S. in Systems Design and Management from MIT.
