Lessons Learned in the Development and Introduction of Closed Loop Systems

Christopher Kovalchick, PhD, is the Director of Systems Engineering within the Research Development (R&D) organization for Abbott’s diabetes care business, based in Alameda, California. He joined the company in 2023 when Abbott acquired Bigfoot Biomedical and has since played a pivotal role leading the Systems Engineering strategy and execution across Abbott’s FreeStyle Libre portfolio including sensor-based glucose monitoring products, as well as their associated applications and cloud software. Dr Kovalchick has spent his career developing connected and combination product technologies within several medical device, drug delivery and pharmaceutical organizations including Becton Dickinson and Eli Lilly. He has led development activities from innovation through commercialization across nearly all aspects of diabetes management including glucose monitoring, algorithm development, and closed-loop/open-loop insulin delivery.Dr Kovalchick earned his PhD in mechanical engineering and his master’s degree in Aeronautics from the California Institute of  Technology, and his bachelor’s degree in engineering mechanics from the Johns Hopkins University.

Henrik Bengtsson is Senior innovation Lead at Novo Nordisk's Bio Innovation Hub on Kendall Square, Boston. Dr Bengtsson has worked for Novo Nordisk for 22 years and has received a lifetime award for producing 100+ patents. This has been done together with his team including many PhD & Postdoc students. Prior to entering the medical device field, Dr Bengtsson invented a new type of amplifier and was part of starting up the company Bang & Olufsen ICEpower A/S focused on bringing professional audio solutions to market. Today his main interests include innovative new medical device concept development, data science, modeling and digital health.

TBA

Steven Russell, MD, PhD is Chief Medical Officer of Beta Bionics, Associate Professor of Medicine at Harvard Medical School, and attending physician at Massachusetts General Hospital. He received a BS in Biochemistry from Trinity University, and a PhD in Biological Chemistry and an MD from the University of Texas Southwestern Medical Center. He completed a residency in Internal Medicine and fellowship in Endocrinology, Diabetes, & Metabolism at the MGH, and a postdoctoral fellowship at the Joslin Diabetes Center. He is an adult endocrinologist and diabetologist with more than 20 years of experience and currently maintains a clinical practice managing diabetes in the outpatient and inpatient settings at MGH on a part-time basis. Dr. Russell collaborated with Dr. Edward Damiano’s group at Boston University to develop a wearable bionic pancreas for automated blood glucose control, testing and refining it over 20 pre-pivotal clinical trials he directed, including in type 1 and type 2 diabetes and cystic fibrosis-related diabetes. He was the Clinical Director for the Insulin-Only Bionic Pancreas Pivotal Trial published in the NEJM in September, 2022. Dr. Russell joined Beta Bionics as CMO in November, 2022. The bionic pancreas, now the iLet Bionic Pancreas system, was cleared for use by the FDA on May 19, 2023. Beta Bionics announced the 10,000th iLet patient start on the August 15, 2024.

Ben Lane is part of the management team at Key Technologies and serves as the company’s VP of Product Development. He has consulted for clients in the medical, industrial, and energy industries for more than 30 years, and his work has contributed to the advancement of precision diagnostic instruments, therapeutic devices, and drug delivery systems across a range of applications and markets. He has managed projects ranging from early-stage technology assessment and product architecture definition to full scope product development, resulting in successful FDA approval and launch. Recent examples include an at-home molecular diagnostics product, a novel large volume drug delivery platform, and a sample-to-answer sequencing instrument. Ben is named on numerous patents in the IVD, MedTech, and drug delivery markets, and has authored several technical articles. He holds an MS in Mechanical Engineering from the University of Pennsylvania and a BS in Physics from Haverford College.