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, PhD, serves as Associate Director of Regulatory Policy at BD, overseeing regulatory requirements for medical devices and in vitro diagnostics. Previously spent eight years at FDA’s CDRH as lead reviewer, Branch Chief, and Division Director for radiological imaging and AI software. He holds degrees in mechanical, aerospace, and biomedical engineering from Cornell University.
Bob
Banta
Bob serves at Lilly authoring global medical device quality standards and overseeing device QMS changes, particularly for digital and AI/ML initiatives. He provides expertise in QMS auditing, risk management, and cybersecurity governance. A 19-year Lilly veteran, he contributes to AAMI’s Device Security Working Group and AI Committee, and speaks at FDA/Xavier conferences on SaMD quality management.
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.
Timothy
Hsu
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.
Cindi
Linville
Cindi Linville serves as Director of Quality at Best Sanitizers, bringing 20+ years of quality experience including her previous role as Facility Quality Assurance Manager at Avnet. She holds degrees in IT Security, Electrical Engineering, Organizational Management, and an MBA, along with ASQ certifications in Quality Engineering, Biomedical Auditing, and Pharmaceutical GMPs.
Toni
Manzano
Manzano co-founded Aizon, providing AI SaaS platforms for Biotech/Pharma, and co-leads PDA’s CPV and Biomanufacturing groups. He teaches AI, advises Spanish Parliament and UN on AI in biopharma, and holds patents in data processing for regulated environments. A physicist with expertise in information systems and pharmaceutical quality, he contributes to industry publications.
Mac
McKeen
Mac McKeen serves as a fellow at Boston Scientific, bringing 30 years of medical device industry experience focused on cardiovascular devices. Previously held leadership roles at Guidant, Medtronic, St. Jude Medical, and others. He teaches medical device development at the University of Minnesota and collaborates with FDA through industry associations. He holds degrees from Iowa State and University of Dallas, with RAC certification.
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.
Steve
Niedelman
Steve Niedelman advises on FDA regulatory and enforcement matters, following 34 years at FDA where he served as Deputy Associate Commissioner for Regulatory Affairs and COO of Office of Regulatory Affairs. He previously held positions as executive VP at Quintiles Consulting and senior consultant at Crowell & Moring LLP. At FDA, he oversaw regulatory operations and served on key industry committees.
Marc
Paradis
Bakul
Patel
Bakul Patel serves as Senior Director of Global Digital Health Strategy & Regulatory at Health@Google, driving healthcare innovation through digital health technologies. Previously as FDA’s Chief Digital Health Officer, he pioneered “software as a medical device” (SaMD) regulations and led key initiatives in AI/ML software. With experience across tech sectors, he holds degrees from University of Regina and Johns Hopkins University.
Marla
Phillips
Dr. Marla A. Phillips serves as Director of Xavier Health at Xavier University, leading initiatives between FDA officials and industry professionals since 2008. Previously, she held roles at Merck culminating as Head of Quality Operations at their North Carolina facility. She holds a BS in chemistry from Xavier University and PhD in organic chemistry from UNC-Chapel Hill.
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.
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.
