The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community.
With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Heath’s legacy of delivering the FDA/Xavier MedCon Conference.
The AFDO/RAPS Healthcare Products Collaborative reflects the commitment of both organizations to continue the important work Xavier Health has done to advance the industry. This new partnership will also produce Xavier Health’s other industry events—including the PharmaLink Conference, Combination Products Summit, and AI Summit.
Prior MedCon Conferences have been credited with providing open, transparent interactions with stakeholders, and the AFDO/RAPS Healthcare Products Collaborative plans to support and enhance these efforts. During the 2022 conference, attendees will:
Experience paradigm-shifting dialogue leading to practical solutions that can be implement immediately
Learn proactive and predictive methods to protect products, businesses, and patients.
Gain cross-functional insights that foster critical alignment and collaboration across organization.
Global Quality Leader – Drug Delivery System Development, Eli Lilly
Francis Blacha is currently Global Quality Leader, Drug Delivery System Development, Device Manufacturing and Diagnostics for Eli Lilly and Company. Previous to joining Lilly, Francis held various leadership positions in Quality at Pfizer and Glaxo Inc. Francis has over 25+ years of quality assurance/quality control experience in pharmaceuticals and medical devices. He has extensive experience in guiding project teams in all aspects of risk management and the application of design control requirements throughout the product lifecycle for combination products, diagnostics and medical devices. In addition to frequently presenting at industry forums on the topic of risk management, Francis currently serves on the strategic committee for MedCon, an annual medical device conference co-sponsored by FDA and Xavier University. Francis received his B.A. in chemistry from Catawba College and his M.S. in chemistry from North Carolina State University.
Executive Director & Partner, Qserve Group
Gert is an expert in European regulations based on his hands-on working in the field, as auditor, product reviewer, regulatory specialist, and Head of notified body. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.
From his Ph.D. in biomaterial sciences, and postdocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS.
RADM Sean M. Boyd
Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, FDA-CDRH
RADM Sean M. Boyd serves as the Director for the Office of Regulatory Programs in FDA’s Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ). In this capacity, he is responsible for managing the Center’s review programs that ensure the public has access to high-quality, safe and effective medical devices.
Prior to joining the Office of Product Evaluation and Quality in 2019, RADM Boyd contributed to transformation efforts that built CDRH’s total product lifecycle structure and function, promoting the quality and safety of medical technology from product development to end of life. He received his undergraduate degree in biomedical engineering from Boston University and his master’s in public health from the Uniformed Services University of the Health Sciences.
RADM Boyd is an active duty commissioned officer in the United States Public Health Service (USPHS), and as a Flag Officer holds the title of Assistant Surgeon General within the Department of Health and Human Services. He is also a former Team Commander of Washington DC-based public health and medical response teams, where he led response and recovery efforts for several disasters and crises, both domestically and abroad.
OMDRHO Division 1 Director, Compliance Branch, FDA-ORA
Gina Brackett is the Director of Compliance Branch for Division of Medical Device and Radiological Health (OMDRHO), Division 1. She has been with the FDA for over 30 years. Prior to her current position, she served as a Compliance Officer in the Cincinnati District Officer for 15 years. She was a Medical Device Specialist for seven years and during this time was a certified as a Level II Performance Auditor and conducted numerous complex medical device inspections. Gina is on numerous workgroups and has helped developed new procedures to assure a smooth transition since ORA’s program alignment in May of 2017. She graduated from Thomas More College, Crestview Hills, Kentucky, with a bachelor’s degree in biology and an associate’s degree in chemistry.
Senior Director, Regulatory Affairs, STERIS
Bill Brodbeck is Senior Director, Regulatory Affairs at STERIS Corporation in Mentor, Ohio. Bill shares the responsibility for FDA submissions and interactions while helping to maintain compliance with FDA requirements, guidance and processes. Bill is involved with several of the STERIS business units including medical device manufacturing, instrument repair and industrial contract sterilization, providing regulatory expertise to each.
Bill received his Ph.D. in the Cellular and Molecular Basis of Disease from Case Western Reserve University and his B.S. in Biology from Wilkes University.
Director of Corporate Quality Systems, Boston Scientific Corporation (BSC)
Aaron Dunbar is Director of Corporate Quality Systems for Boston Scientific Corporation (BSC). He has a key leadership role in driving company Quality Culture and the promotion of a work environment that supports the BSC Quality Policy and Quality System. Aaron’s responsibilities include oversight of multiple global quality system processes, the Global Regulatory Compliance team, External Corporate Audit Support team, and management of Corporate Notified Body relationships.
He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Quality Management standards committee and working groups. He is chair of the Committee on Standards Strategy (CSS) which provides company member insight and guidance into the current and future strategic priorities for the domestic and international standards program for AAMI. Aaron is responsible for BSC’s membership with Pathway for Patient Health and is an industry volunteer in the organization’s Quality Science Education program.
Aaron was previously a Quality System Manager for BSC Global Quality Systems. Prior to that he held roles of Global Compliance Manger and Quality System Manager for Tornier, Inc., and Medical Device Specialist and Investigator for the U.S. Food and Drug Administration – Minneapolis District Office.
President and Principal Regulatory Consultant, Clinical Research Consultants, Inc.
Barbara Fant, Pharm.D. is the President and Principal Regulatory Consultant of Clinical Research Consultants, Inc. (CRC), and has 30 years of experience in pharmaceutical and medical device research and development. Dr. Fant is nationally and internationally recognized as an expert provider of FDA regulatory and clinical services for the development and approval of corneal, refractive, intraocular, and other ophthalmic medical devices. She has over 20 years of experience in working with FDA in the management of ophthalmic clinical studies and regulatory submissions for ophthalmic, orthopedic, and diagnostic devices. Dr. Fant has successfully filed over a hundred IDE’s, pre-IDE’s, 510(k)’s, and PMA’s with the FDA to bring investigational products to the marketplace. Dr. Fant serves on several ANSI subcommittees for the development of ANSI ophthalmic standards, is a peer reviewer for several ophthalmic journals, and is a member of numerous national and international ophthalmic professional organizations. Dr. Fant holds a B.S. in pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati.
Principal Scientist, Global Product Stewardship, Procter & Gamble
Lenore has over 20 years of hands-on regulatory experience in both the pharmaceutical and medical device fields. She has successfully managed and executed IND, NDA and 510(k) submissions and has experience in guiding both pharmaceutical and medical device project teams to ensure regulatory compliance and successful FDA interactions. Lenore has developed internal regulatory guidance documents, SOPs, and has trained personnel to assure compliance. She has worked closely with QA organizations in hosting FDA audits to successful outcomes and has provided industry opinions to be considered in public comment to proposed regulations. Lenore holds a Ph.D. in Biological Sciences from the University of Cincinnati and an M.B.A. from the University of Cincinnati.
Sr. Director of Human Factors & Regulatory Strategy , Agilis Consulting Group
Shannon is the Sr. Director of Human Factors and Regulatory Strategy at Agilis Consulting Group, an assistant professor in the Quality Science Education program at Pathway for Patient Health, and is active on several international standards committees for medical devices.
Formerly, Shannon worked as Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and as reviewer within the Center for Drug Evaluation and Research (CDER). At the FDA she led reviews of Human Factors data for medical device premarket submissions through 510(k), PMA and De Novo pathways, combination products through NDA, BLA, ANDA pathways, as well as data to support IND and IDE requests.
Outside of Shannon’s work for the FDA, she continues to build on her 25+ year career where she has worked in the medical device, IVD and combination product industry as a R&D and Quality Engineer, Manager and Director. Over this time she has worked within and directed project teams in all phases of product development from front end research to post-market support; as well as architecting process improvements for design controls, risk management, requirements management, software validation, system verification/validation and the incorporation of human factors and usability into overall product development processes.
Shannon has a earned a B.S. in mechanical engineering from the University of Toledo, a M.S. in management from Mount Vernon Nazarene University, and a M.S. in cognitive systems engineering from the Ohio State University.
Lead Quality System & Compliance Consultant, King & Spalding
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 and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.
National Device Expert, FDA-ORA
Phillip Pontikos is a Medical Device National Expert working for the Office of Regulatory Affairs (ORA) of the Food and Drug Administration. Mr. Pontikos joined FDA in 1994 as an Investigator in the Brunswick, Ohio Resident Post of Cincinnati District. In 2000, Mr. Pontikos moved to the Columbus, Ohio, where he currently resides.
Mr. Pontikos previously held the position of Cincinnati District Medical Device Specialist until January 2010 when he became the Medical Device National Expert. Mr. Pontikos is responsible for conducting medical device inspections domestically and abroad. He is a Level II Certified Medical Device Investigator and Medical Device Performance Auditor. Mr. Pontikos has assisted in the development and actively participates as a trainer for numerous FDA courses including Computer Aided Inspections, Basic Medical Device, Industrial Sterilization for Drugs/Devices, and Process Validation. He has also served as a mentor and acting Supervisor. Mr. Pontikos has also given numerous lectures at various medical device and pharmaceutical conferences.
Mr. Pontikos received a bachelor’s degree in physics with a concentration in computer hardware systems from Kent State University.
Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy, Medtronic
As part of Medtronic’s global regulatory policy team in Washington DC, Fatemeh is actively shaping the global regulatory landscape to promote harmonization. She represents Medtronic in industry working groups and coalitions to advance Medtronic’s goal of helping patients access safe and innovative therapies. Fatemeh was previously the head of U.S. regulatory policy in B.D. Prior to that, she held various roles in the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration (FDA). Fatemeh’s CDRH experience includes serving as a Lead Scientific Reviewer and Biomedical Engineer in the Office of Device Evaluation, including assignments in the Office of Combination Products, the Office of the Commissioner, and the Office of the Center Director, where she worked on new regulations and policy. From 2013 to 2018, she served as a policy analyst and program manager in the Office of In Vitro Diagnostics and Radiological Health (OIR), where she led OIR’s 510(k) review program, trained review staff, drafted guidance documents and work instructions regarding the 510(k) program, and assisted in the implementation of the Medical Device User Fee Act (MDUFA) and regulatory policy for the 510(k) program. During her tenure at OIR, Fatemeh was the public face of OIR on several FDA policy issues, including OIR 510(k) review practices. Fatemeh is the recipient of multiple awards during her tenure at the FDA. Fatemeh received her B.S. in biomedical engineering and M.S. in electrical engineering from George Washington University.
Executive Vice President, Medical Devices & Combination Products, Greenleaf Health
Vice President Regulatory Affairs, MDMA
Heather Rosecrans brings more than 30 years of public health and medical device experience to Greenleaf Health. Prior to joining Greenleaf, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements.
Rosecrans’ accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA) and Food and Drug Administration Modernization Act (FDAMA). Rosecrans’ extensive experience at CDRH, and specifically the 510(k) office, enabled her to become one of the nation’s leading experts on the program. Rosecrans’ tenure also allowed her to play a pivotal role in the program’s development and reform. Rosecrans has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with CMS and other regulatory agencies.
Kim Shoemaker, RAC
Sr. Director, Global Regulatory Affairs , Ethicon
Kim Shoemaker is an accomplished Global Regulatory Affairs Leader with 25+ years’ experience in the healthcare industry. As a Senior Director at Ethicon, part of the Johnson & Johnson Medical Devices Companies, she is known for her ability to accelerate regulatory approvals and provide alternative pathways to business partners to achieve their business goals, while maintaining compliance with required regulations. With extensive global experience, she drives innovative multi-country regulatory strategies that lead to timely market entry and drive industry-leading outcomes that enable growth and advancement of patient care around to world.
Kim is recognized for her straightforward, proactive leadership style that ensures business readiness, drives clarity in challenging situations, and maintains organizational calm when issues emerge. Prior to joining Ethicon, Kim’s experience stretched across multiple disciplines within the medical device industry including IVD R&D, Quality Assurance/Design Control, and International Regulatory Affairs.
Medical Device, IVD and Combination Products Expert
Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. Most recently, she was focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program.
Ms. Trautman was previously Associate Director for International Affairs in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485.
Vice President Regulatory and Quality, Abbott
Monica joined Abbott in 2007 and provides strategic support and technical expertise to the medical device Divisions within Abbott. Prior to joining Abbott, Monica worked for the Food and Drug Administration (FDA). In her 12 years of FDA related experience, she held the positions of Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator. Prior to FDA, her career included 14 additional years of employment in the regulatory, computer, healthcare, and pharmaceutical industries holding the positions of Research Assistant, Quality Control Technician, Microbiologist, Supervisor, Manager, Specialist, Director, and Consultant. Monica has a bachelor’s degree in microbiology from the University of Texas at Austin.
This conference is co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.