Presents
AI Summit took place November 13-14 2024
Cincinnati, Ohio
Strategic Committee for AI Summit
The AI Summit program is carefully curated by experts across the healthcare products industry to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. We thank them for their hard work and dedication to this important event.
Pat
Baird
Pat Baird is the Head of Global Software Standards at Philips, where he describes his role as “Policy Engineering” – addressing the unmet needs and challenges of regulators and developers by creating standards, white papers, and training. He is passionate about artificial intelligence in healthcare and co-chairs several AI committees, including those for AAMI, ISO/IEC TC215, CTA, MITA, and MDIC.
Matthew
Diamond
Matthew Diamond, MD, PhD serves as Chief Medical Officer for Digital Health at FDA’s Center for Devices and Radiological Health (CDRH). As senior clinical expert at the Digital Health Center of Excellence, he leads digital health policy development and implementation, particularly for emerging technologies like artificial intelligence.
Brian
Edwards
Brian Edwards serves as Regulatory Fellow at Boston Scientific’s Global Advocacy Group, focusing on Digital Health, Cybersecurity, and Medical Device Software. With over 30 years in medical devices and 25 in Regulatory Affairs, he leads global advocacy for Digital Health, AI/ML, and Quality Systems. He holds degrees in Chemical and Biomedical Engineering and has led Regulatory Affairs across multiple medical sectors.
Lacey
Harbour
Lacey Harbour is a Molecular Biologist turned Regulatory, Quality, and Clinical Strategist, experienced in bringing diverse medical devices to market. She specializes in validating machine learning algorithms in healthcare, focusing on safety and effectiveness. Through AFDO/RAPS involvement, she advocates for state-of-the-art medical care while ensuring patient safety and global accessibility.
Eric
Henry
Eric Henry, Senior Quality Systems and Compliance Advisor at King & Spalding’s FDA and Life Sciences practice, brings 30 years of industry experience. He advises clients on regulatory compliance, quality systems, audits, M&A due diligence, and serves as an expert witness. Previously, Henry led global quality, compliance, and technology organizations for several medical device companies of varying sizes.
Cindy
Ipach
Cynthia Ipach, President and CEO of Compliance Insight, Inc., founded the company in 2000. With over 30 years in pharmaceuticals, medical devices, dietary supplements, and biologics, she has guided hundreds of companies through FDA compliance. Starting in Analytical Research and Development, she moved to Regulatory Affairs and Quality Assurance before serving as Director of Scientific Affairs at Pharmacia. Recently, she co-leads AFDO/RAPS’s AI in Operations Group, developing AI maturity models for healthcare.
Rohit
Nayak
Rohit Nayak leads Electronic Registry Systems and advises early-stage companies. A strategic leader in digital innovation, he’s grown healthcare tech companies from startup to acquisition, including an ePrescribing company bought by Quest Diagnostics. He formed Baxter’s global Digital Health team and at Quest Diagnostics led healthcare analytics P&L growth. His expertise spans digital health, commercial execution, and P&L management across Fortune 500 and emerging companies.
Alison
Sathe
Alison Sathe, Senior Vice President of Data Strategy & Analytics at Redica Systems, leads the company’s data and AI initiatives. With 20+ years in medtech and a biomedical engineering background, she has held executive regulatory and quality roles at both startups and established companies. Her expertise spans FDA interactions, submissions, clearances, and compliance. An entrepreneur, she founded ClearMark, an electronic QMS platform for medical devices, and Regulatory Mark, a consulting firm.
Cassie
Scherer
Cassie Scherer serves as Senior Director of U.S. Regulatory and Global Digital Health Policy at Medtronic, leading policy initiatives for digital health technology and AI/ML-enabled products. Previously, she held key positions at the U.S. FDA, including Associate Chief Counsel in FDA’s Office of Chief Counsel and Director of Strategy and Regulatory Operations in CDRH’s Office of the Center Director.
Matthew
Schmucki
Matt serves as Associate Director for data automation and engineering at Vertex Pharmaceuticals, managing manufacturing data analytics across internal and external partnerships. With 15+ years supporting various pharmaceutical products, he brings expertise from startups to major pharma companies. He holds a mechanical engineering degree from University of Cincinnati and Doctorate in Business Intelligence, and guest lectures at Xavier University’s Quality Science programs.
Bradley
Thompson
Bradley Thompson serves as shareholder at Epstein Becker & Green and Chairman/Chief Data Scientist at EBG Advisors, advising on FDA regulatory issues and leading the firm’s AI practice. He has counseled trade associations, taught Food & Drug Law at Indiana University, and held legal committee leadership roles. He holds degrees from Illinois and Michigan universities, including a Master’s in Applied Data Science.
Mohammed
Wahab
Mohammed Wahab leads Quality Assurance for Non-Product Software Validation and Cybersecurity at Abbott, bringing 25+ years of expertise in Software Engineering and Healthcare. His career spans key roles at GE Healthcare and Allscripts, and he co-founded fintech startup Casheer as CTO. He holds degrees in Computer Science and Electronics and Instrumentation.
