The Strategic Committee is responsible for setting the vision, strategy and scope for the Healthcare Products Collaborative Artificial Intelligence Initiative.
Part of the strategy of the Artificial Intelligence Initiative is to utilize the annual Healthcare Products Collaborative AI Summit to bring industry members together to advance the understanding of the industry on how best to make use of artificial intelligence, and to establish industry work teams that will collaboratively address AI challenges and develop AI solutions.
Jeff
Ballyns
Jeff Ballyns, Ph.D., is Associate Director of Regulatory Policy at Becton Dickinson and Company (BD), which designs, manufactures, and sells medical devices, including in vitro diagnostic products. He is responsible for regulatory policy requirements impacting BD businesses. Before BD, Dr. Ballyns worked at the FDA’s Center for Devices and Radiologic Health (CDRH) for eight years as a lead reviewer, Branch Chief, and Division Director, overseeing radiological imaging devices and AI image analysis software. He holds bachelor’s and Ph.D. degrees in mechanical and aerospace engineering and biomedical engineering from Cornell University.
Bob
Banta
In his current role, Bob authors global medical device quality standards and common quality practice documents. He also provides oversight to changes to the Lilly device QMS in order to support Lilly digital device initiatives (including AI/ML-based SaMDs). Bob also provides global device quality support with respect to medical device QMS auditing, risk management governance including medical device cybersecurity risk governance, product lifecycle management (PLM), and device regulatory surveillance. He has twice presented at past FDA/Xavier University Global Medical Device Conferences on SaMD QMS and risk management. He is a member of the AAMI Device Security Working Group (SM-WG05 – Device Security WG) which was responsible for authoring AAMI TIR97:2019/Ed.1 Principles for medical device security – Post-market security management for device manufacturers; the SM-WG05 Group is currently drafting a proposed new American National Standard—AAMI SW96, Standard for medical device security—Security risk management for device manufacturers. Bob is also a member of the AAMI Artificial Intelligence (AI) Committee. He has worked for Lilly for the past 19 years with prior extensive experien
Steve
Frigon
Steve Frigon is a Senior Clinical Systems Analyst at The Christ Hospital in Cincinnati, Ohio, with 21 years of experience in Application Development, Data Integration, and Data Management in the Pharmaceutical and Healthcare industries. He develops technology strategies in interoperability, web services, and Digital Health, focusing on AI explicability, validation, and adoption to build trust in patients and physicians. Before joining The Christ Hospital, Frigon was a Data Integration Consultant with HC Tech, Inc., and a Data Integration Manager at Mercy Health.
Lacey
Harbour
Lacey Harbour is a classically trained Molecular Biologist turned Regulatory, Quality, and Clinical Strategist. Her experience includes the Clinical Laboratory, R&D, Pharmaceuticals, and Medical Devices industries. Leveraging a diverse background, she has led or supported teams that have brought orthopedic, in vitro diagnostic, SaMD, dental, physiotherapeutic, and other FDA Class I to Class III devices to the global market with high quality. Starting from the exposure of validating predictive systems in the operational and diagnostic sides of the clinical laboratory, proving safety and effectiveness of machine learning algorithms in the total product life cycle of healthcare has been a passion for many years. As an advocate of protecting patients while taking a risk-based, least burdensome approach, Harbour considers joining think tanks like AFDO/RAPS as an honor. Her goal is to ensure that the future of medical care is state of the art while maintaining safety and effectiveness and, hopefully, encouraging global accessibility of good healthcare products.
Eric
Henry
Eric Henry is a 30-year industry veteran currently serving as Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding. In this role Henry advises King & Spalding clients on a variety of regulatory compliance matters including Quality System establishment and remediation, establishment of quality organizations, audit and inspection management and response, compliance-related due diligence reviews for M&A, training, and serving as an expert witness during litigation. Before he joined King & Spalding, Henry led global quality, compliance, and technology organizations for several large and medium-size medical device companies.
Timothy
Hsu
Cindy
Ipach
Cynthia Ipach, President and CEO of Compliance Insight, Inc., founded the company in 2000. With over 30 years of experience in pharmaceuticals, medical devices, dietary supplements, and biologics, she has supported hundreds of companies in FDA compliance. Ipach started in Analytical Research and Development and transitioned to Regulatory Affairs and Quality Assurance. Before starting Compliance Insight, she was Director of Scientific Affairs at Pharmacia. Recently, she has been active in AFDO/RAPS’s AI in Operations Group and co-led the development of AI maturity models and white papers on AI in healthcare.
Cindi
Linville
Cindi Linville is the Director of Quality for Best Sanitizers, and has worked at Best Sanitizers for nine years. Prior to working at Best Sanitizers, Cindi was the Facility Quality Assurance Manager for Avnet. She has a degree in IT Security, Electrical Engineering, Organizational Management, and a Masters in Business Management. Overall, Cindi has worked in Quality for over 20 years. Cindi also has ASQ certifications as a Quality Engineer, Biomedical Auditor and in Pharmaceutical GMPs.
Toni
Manzano
Manzano is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-leading CPV and Biomanufacturing groups at the PDA, and he teaches AI subjects at the University (OBS and UAB). Manzano is a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and an AI expert with the United Nations for biopharma. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud. Manzano is a Physicist, Master in Information and Knowledge Society, and postgraduate in quality systems for manufacturing and research pharmaceutical processes.
Mac
McKeen
Mac McKeen has 30 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study, and regulatory approval of cardiovascular devices and is currently a fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize. He also serves as an adjunct professor at the University of Minnesota instructing a 4000 level course and graduate level course on medical device development and is also a faculty director within the College of Continuing and Professional Studies. He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed, MDIC, RAPS and Medical Alley. He holds a B.S. in Industrial Technology from Iowa State University and an M.B.A. from the University of Dallas and is RAC certified.
Rohit
Nayak
Rohit Nayak leads Electronic Registry Systems, Inc., a cancer informatics firm. He also serves as an advisor and board member for various early-stage companies and nonprofits. Nayak is a strategic global leader with expertise in digital innovation, commercial execution, and P&L management across Fortune 500 and emerging growth organizations. He has successfully led a healthcare tech start-up from inception to acquisition by a Fortune 500 company. Previously, Nayak formed Baxter’s global Digital Health team and held key roles at Quest Diagnostics, where he grew a P&L for healthcare analytics solutions. He co-founded an ePrescribing software company, later acquired by Quest Diagnostics.
Steve
Niedelman
Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. While at ORA, Mr. Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting. Mr. Niedelman specializes in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight an
Bakul
Patel
Bakul Patel is the Senior Director of Global Digital Health Strategy & Regulatory at Health@Google, overseeing global regulatory strategy and engagement. He aims to harness digital health to revolutionize healthcare by preventing and predicting disease. Before Google, Patel was the Chief Digital Health Officer at the FDA, where he shaped digital health regulations and coined the term “software as a medical device” (SaMD). He led initiatives like the software precertification pilot and AI/ML-based software framework. Patel has diverse leadership experience in telecommunications, semiconductors, wireless, and IT. He holds an MS in electronic systems engineering from the University of Regina and an MBA from Johns Hopkins University.
Marla
Phillips
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in chemistry from Xavier University, and a Ph.D. in organic chemistry from the University of North Carolina – Chapel Hill.
Matthew
Schmucki
Matt is the Associate Director for data automation and engineering for Vertex Pharmaceutical’s manufacturing data and analytics applications. He supports both internal manufacturing and external contract manufacturing partnerships by setting up standardized data ingestion mechanisms for data analytics. Over the past decade and a half, Matt has supported many types of products from oral solid dose to combination products, with companies ranging from startups and CMOs to top pharmaceutical and biopharmaceutical companies. Matt is a mechanical engineer from the University of Cincinnati with a Doctorate in Business Intelligence. Matt is also a Guest Lecturer for Xavier University for both the Quality Science Regulations and Industrial Product Development programs. These lectures introduce undergraduate students to concepts and practices fundamental to the pharmaceutical and medical device industries.
Mohammed
Wahab
Mohammed Wahab has over 21 years of experience in software engineering, compliance, and healthcare. He has led teams at Abbott Laboratories, GE Healthcare, and Allscripts, contributing to efficiency improvements and designing an Agile-based Quality Management System at Abbott. Currently, he heads the Quality Assurance organization for a Professional Services Business Unit at Abbott, focusing on business and clinical insights using data science and analytics. Wahab was also the co-founder and CTO of Casheer, a fintech startup in the cryptocurrency space. He holds a master’s degree in computer science and a bachelor’s degree in electronics and instrumentation.
