Panel Session: Catching-up With Dynamic AI: The Regulatory Conundrum
The FDA has traditionally approved software based on a static “build and freeze” model system of algorithms. However, artificial intelligence makes algorithms dynamic and ever changing. This panel will focus on:
- The FDA's evolving regulatory approach to approving and monitoring devices with integrated AI software and Software as a Medical Device (SaMD) technologies
- The impact of machine learning systems on the definition of predicate devices and patents
- The impact of new regulatory approaches on software/manufacturing design, quality control, and operations
- How regulators and software owners/manufacturers will balance market surveillance responsibilities and liability to assure patient safety
Tarek Haddad is a Technical Fellow and Senior Manager of the Predictive Analytics & Statistics Group within R&D at Medtronic. His team’s area of focus is the development of machine learning/AI algorithms and stochastic models for improving patient outcomes, efficiencies in Patient Management, and user experience for both patients and health care providers, as well as improving the efficiency of clinical trials. At Medtronic Tarek is helping to set the vision for AI, and developed the knowledge, talent, and Hardware/software infrastructure needed to develop and deploy advanced AI algorithms into Medtronic’s business. He specializes in Machine learning with a focus in Deep learning, Reinforcement learning, and Bayesian modeling and has numerous publications and patents in these areas. He chairs the Medical Device Innovation Consortium working group on “clinical trials informed by simulation and bench”. He holds a MS in Biostatistics and a BA in Mathematics both from the University of Minnesota and has a Master Black Belt in Design for Six Sigma & Design for Reliability and Manufacturing.
Ralph Hall is a principal and works in association with the Washington, D.C., office. In this role, Ralph provides consulting services to clients in the areas of FDA statutes and regulations, regulatory compliance, as well as health care policy and legislation, and particularly the application of those regulatory systems to the medical device industry.
Ralph’s rich background with drug and medical device regulation and corporate compliance matters makes him one of the nation’s foremost experts. Ralph previously served as counsel at Faegre Baker Daniels where he provided legal services, including FDA-related matters, corporate compliance, the design and implementation of multiple cross-disciplinary, corporate legal strategies, corporate law department organization and management, and general corporate counseling. Ralph has also served as General Counsel for Guidant CRM and Chief Compliance Officer for Guidant.
Ralph furthermore serves as a Professor of Practice at the University of Minnesota Law School. He received his B.A. from Indiana University and his juris doctorate from the University of Michigan where he was a Weymouth Kirkland Scholar.
Shaye Mandle has served as President & CEO of The Medical Alley Association since May, 2014. During this tenure, the association has undertaken significant transformation to focus on championing and facilitating an environment that enables health technology and care organizations to innovate, succeed, and influence the evolution of healthcare. Under Mr. Mandle’s leadership, the association’s vision is to elevate Minnesota’s Medical Alley as the global epicenter of health innovation and care.
Mr. Mandle has more than 20 years of experience in government, the private sector and academia, leading organizations, public affairs and political activities. From 2011-2014, Mr. Mandle served as the association’s EVP & COO and its VP of Government & Affiliate Relations. Prior to joining The Medical Alley Association, Mr. Mandle served as the Executive Director of the FedEx Institute of Technology at the University of Memphis, where he launched and oversaw the University Office of Technology Transfer and led the University’s corporate partnership, entrepreneurship and economic development programming. Mr. Mandle has also led business development and government affairs for the Reconnaissance and Surveillance Operation of Science Applications International Corporation (SAIC), a Fortune 500 company specializing in defense and homeland security technologies.
Mr. Mandle has served as the chief executive of two industry and economic development organizations, the Illinois Coalition for Science & Technology and the East-West Corporate Corridor Association. Mr. Mandle’s extensive policy and political experience includes leading state and federal political campaigns and having served on the policy staff of former U.S. House Speaker, J. Dennis Hastert and former Illinois Governor Jim Edgar. Mr. Mandle has a Juris Doctor, cum laude, from the Duquesne University Law School and a Bachelor of Arts from Illinois Wesleyan University.
Susan Alpert, PhD, MD is currently the principle of SFA Consulting LLC, focused on the strategies needed to place medical devices into the global market. Dr. Alpert joined Medtronic in July 2003 as Vice President of Regulatory Affairs and Compliance. She was Senior Vice President, Global Regulatory Affairs at her retirement in May, 2011 and in this role was responsible for all Medtronic global regulatory policy efforts. Prior to joining Medtronic, Susan served C.R. Bard, Inc., as Vice President of Regulatory Sciences. She also previously worked at the 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. She is a microbiologist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.
Susan is also one of the founding members of MILI’s National Industry Council and is now MILI’s executive in residence. In this new role, Alpert helps foster MILI’s close working relationships with global medical industry leaders and shares her expertise with students and affiliates.