Nicole is the Program Director for MedTech Innovator. Nicole grew up in Michigan before attending Boston University to study Biomedical Engineering as Trustee Scholar. In 2020, Nicole completed her PhD at Harvard University, working on interdisciplinary medtech projects between the Wyss Institute for Biologically Inspired Engineering and Mass Eye and Ear hospital. After graduating, Nicole launched a startup company, Beacon Bio, based on her PhD work as a Gliklich Healthcare Innovation Scholar. Following Beacon Bio’s acquisition by Desktop Metal, Nicole served as the Vice President of Biofabrication in their Desktop Health division. Nicole’s accolades include the Collegiate Inventors Competition Graduate Winner (2018), the Baxter Young Investigator Award (2020), the Lemelson-MIT Student Prize (2021), and the MIT Technology Review Innovators Under 35 (2023).

Arezou Azar is a global regulatory, quality, and program management executive with deep expertise in AI/ML-driven digital health, SaMD, and medical devices. She currently serves as VP of Compliance and Program Management (PMO) at Cardiosense, where she leads FDA Breakthrough, De Novo, and 510(k) submissions, global regulatory strategy, AI/ML best practices, quality systems, and company-wide program governance. Previously, she was Chief Compliance Officer and VP of Regulatory, Quality, and Program Management at Cardiologs, where she spearheaded the successful FDA clearance and global launch of its AI-powered cardiac algorithms, and served as Quality and Regulatory Advisor at AppliedVR. Arezou holds a Ph.D. in Biomedical Engineering from Johns Hopkins and Drexel University and completed executive education in Product Management at the University of California, Berkeley. With proven leadership in FDA and international approvals, QMS development, risk management, and executive-level program delivery, she is recognized for driving complex, high-impact product launches in fast-paced, global environments.

Carmen Brown is a Regulatory Affairs Manager at Proxima Clinical Research, Inc., where she leads regulatory strategy for drug products, medical devices, and complex combination products. With a Master’s in Public Health and a Bachelor’s in Chemistry, she brings deep expertise across oncology, in vitro diagnostics (IVDs), and diverse therapeutic areas. Her career began in quality control as a QC Analyst and Stability Coordinator, where she gained hands-on experience with solid oral dosage forms, injectables, antineoplastics, and biologicsm, building a strong scientific foundation that now informs her regulatory guidance.

Cody is the Co-Founder and CEO of DermaSensor, a health technology company that has raised $27 million and in May 2024 launched America’s first automated skin cancer detection device for use by all one million physicians. As a bioengineer and entrepreneur, Cody has spent all of his career bringing new health technologies to physicians and patients. He is a frequent speaker at health technology and entrepreneurship events, and Cody was included on the Forbes 30 Under 30 in healthcare.

Prior to joining DermaSensor, Cody led commercial efforts for a Silicon Valley medical device screening and monitoring startup. His first industry role was in a leadership development program at Genentech, after which he stayed at Genentech to lead commercial strategy efforts in the US oncology pricing strategy group. During his graduate work at Stanford, he co-founded a health technology startup with two other graduate students, raising an angel round, participating in the StartX program, and completing a licensing deal with Stanford.

Cody earned a Bachelor of Arts degree in economics as well as entrepreneurship in the engineering track (bioengineering focus) from Brown University. He then completed a Masters of Science in Bioengineering, for which he completed his graduate research at Stanford University.

Dr. Susan Alpert has served as a consultant and in the management of a number of start-up medical technology companies as well as a consultant to several investment groups in the medical technology space. She is the principal of SFADC LLC, a consulting firm to companies seeking FDA authorization for their products. In her eight-year career with Medtronic, she held many positions, including six years as Senior Vice President, Chief Regulatory Officer of Medtronic. In that role, Dr. Alpert was responsible for all Medtronic’s global regulatory efforts. Prior to joining Medtronic, Dr. Alpert served as Vice President of Regulatory Sciences for C.R. Bard, Inc. She also previously worked at the Food and Drug Administration (FDA) where she held a variety of positions in the centers dealing with drugs, devices, and radiological health and foods, including six years as the Director of the Office of Device Evaluation.

Dr. Alpert is a Microbiologist and Pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.

Dr. Alpert completed her undergraduate degree at Barnard College, Columbia University, and holds a Master’s degree and PhD in Biomedical Sciences from New York University. She received her Medical Degree from the University of Miami and completed her clinical training at Montefiore Medical Center and at Children’s National Medical Center.