Archives: Speakers

Divya Raman, JD, MS, PMP, is the Sr Director of Quality and Regulatory Policy, Intelligence, and Strategy at Teleflex Inc. In this role Divya leads the regulations and standards management program, advocacy and policy program, and projects to support compliance to new regulations. Divya is well-versed in the area of program management and regulatory affairs and is passionate about how those two functions effectively support medical device lifecycle management. Divya has over 12 years of experience in the medical device field in multiple functional areas, such as technical communication, regulatory affairs, and medical affairs, and 6 years of experience in the legal field.

Tarek Haddad is a Technical Fellow and Sr. Director of the AI Research Group at Medtronic, where he leads the development of AI/ML algorithms to improve patient outcomes and clinical efficiency. His team’s work on AccuRhythm AI has enhanced diagnostic accuracy for heart rhythm abnormalities in Medtronic’s implantable cardiac monitors, resulting in a 91% reduction in false alerts and 42% reduction in manual ECG review workload for clinics worldwide. This innovation has earned prestigious awards, including the Minnesota Tekne Award and MedTech Breakthrough Award in AI. Tarek has pioneered advancements in device reliability methods that have become standards for the Association for the Advancement of Medical Instrumentation (AAMI). He has also created Bayesian models used in major clinical trials, such as LEADR and Symplicity Spyral renal denervation (RDN), achieving combined cost reductions of millions of dollars. He spearheads regulatory innovations, including the Predetermined Change Control Plan, which facilitates continuous AI model updates, and Medtronic’s AI Compass program, which sets ethical standards for AI in healthcare. Tarek holds an MS in Biostatistics and a BA in Mathematics from the University of Minnesota, is a Master Black Belt in Design for Six Sigma, and holds numerous patents and publications in AI, reliability, and medical technology

Is the co-founder and CEO of HabitAware. HabitAware created its Keen2 smart bracelet to help individuals like his wife and co-founder, Aneela, “retrain their brain” away from detrimental behaviors including hair pulling, skin picking and nail biting, to positive ones. HabitAware has received research grants from the NIH and NSF for research and to validate Keen2 as a treatment for these disorders. HabitAware was the Grand Prize winner of the Minnesota Cup and is a TIME Magazine Best Invention. Prior to founding HabitAware, Sameer was a professional investor at The Blackstone Group and worked in corporate strategy at Bain and Company and Ameriprise Financial.

Lisa Griffin Vincent Ph.D., has more than 30 years of experience in scientific, regulatory, and business leadership across the healthcare ecosystem within medical technology and combination products, payers, data analytics and population health, and management and diligence consulting. Her career began serving patients as a clinical and research nurse in neonatology, neurology, cardiovascular, and infectious diseases. Her current role is Chief Regulatory, Quality, Clinical at GT Metabolic Solutions, where she serves on the executive management team. GT Metabolic is the leader in development of magnetic compression anastomosis technologies, setting a new standard in minimally invasive surgery. Dr. Vincent has expertise leading and growing functional talent and organizations along the product lifecycle, including research, clinical, regulatory, health economics, reimbursement, medical affairs, and market access. In addition, she has served in business leadership roles including, as chief operating officer for two global research companies, and as president of an outcomes research division. Her industry trajectory includes early-stage companies, such as Seismed Instruments, and PatientPoint, and large multinational organizations, such as UnitedHealth Group (UHG), Medtronic, BD, and GE Healthcare. Dr. Vincent has significant experience in the policy area and was appointed in January 2022 as an industry representative to the U.S. Department of Health and Human Services (DHHS) CMS Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). Dr. Vincent holds a B.S. in nursing, M.A. in kinesiology, and Ph.D. in health services research and policy, all from the University of Minnesota. She was awarded full scholarships from the U.S. Agency for Health Care Policy and Research and DHHS for her doctoral training, and her dissertation focused on patient adherence to complex medical therapies to maximize health and economic efficiencies and reduce disease burden

Monika McDole-Russell is a regulatory affairs leader at Medtronic, a global leader in medical technology. She has over 17 years of experience in the medical device industry, spanning R&D, Regulatory Affairs, and Quality.

As a global regulatory affairs leader, Monika develops and executes regulatory strategies for devices within Medtronic’s Endoscopy portfolio, including SaMD and devices that incorporate artificial intelligence (AI) and machine learning (ML). She works with cross-functional teams, external partners, and regulatory agencies to ensure compliance with global regulations and standards. She also advises on regulatory best practices and emerging regulatory trends.

Monika is passionate about advancing medical device innovation and improving patient outcomes. She has presented on topics relating to leadership, AI/ML, and regulatory affairs at national and international conferences, workshops, and webinars.

Pat Baird works at Philips as a Sr. Regulatory Specialist, with a focus on the use of AI in healthcare. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, whitepapers, and training to meet those needs. He co-chairs multiple committees related to artificial intelligence, is a sub-team lead for IMDRF AI committee, and current standards projects include risk management for ML systems and cybersecurity considerations for ML systems.

Victoria has worked at Eli Lilly and Company for 16 years across drug safety and clinical operations. In her current role, she leads a team of Clinical Research professionals who work to identify, evaluate, and set up investigator sites across the UK and Nordics. They are responsible for delivery of patients into trials, by forging close site relationships, across the full Lilly portfolio. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are advancing new discoveries to address some of the world’s most significant health challenges.