MedCon Strategic Committee
The MedCon Conference 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.
Francis Blacha
Eli Lilly and Company
Francis Blacha is Senior Vice President, Quality for Eli Lilly and Company in Indianapolis, Indiana. In this capacity, he has responsibility for the Lilly Device Quality Management System, Device Regulatory Compliance, and Quality oversight for Lilly’s Drug Delivery System Development, Connected Care and Digital Health organizations. Before joining Lilly, Blacha held various leadership positions in Quality at Pfizer and Glaxo Inc. He has more than 30 years of quality assurance/quality control experience in pharmaceuticals and medical devices plus extensive experience in guiding teams in all aspects of risk management and the practical application of design control/product realization requirements throughout the various product type life cycles.
Gert Bos
Qserve Group
Gert Bos is an expert in European regulations based on his hands-on work in the field as auditor, product reviewer, regulatory specialist, and Head of notified body. He has led the Notified Bodies in Brussels for many years, and strongly supported the regulatory debate with the EU Commission, EU Parliament, and the EU Council of Ministers. Bos combines strong experience in quality, compliance, and regulations with a pragmatic, result-driven approach at both operational and strategic levels.
Sean Boyd
FDA
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.
Gina Brackett
FDA
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 certified as a Level II Performance Auditor and conducted numerous complex medical device inspections. Brackett is a member of numerous workgroups and has helped develop new procedures to assure a smooth transition since ORA’s program alignment in May of 2017.
Bill Brodbeck
Steris
Bill Brodbeck is Senior Director, Regulatory Affairs at STERIS Corporation in Mentor, Ohio. He shares the responsibility for FDA submissions and interactions while helping to maintain compliance with FDA requirements, guidance, and processes. Brodbeck is involved with several of the STERIS business units including medical device manufacturing, instrument repair, and industrial contract sterilization, providing regulatory expertise to each.
Aaron Dunbar
Boston Scientific
Aaron Dunbar is VP, Quality Systems & Post Market, Boston Scientific. He has 20 years of comprehensive experience driving regulatory compliance and quality system regulations and standards across the medical device and healthcare industries. Dunbar is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Quality Management standards committee and working groups. He has previously held roles at Boston Scientific Corporation, Tornier, Inc., and was a Medical Device Specialist and Investigator for the U.S. Food and Drug Administration – Minneapolis District Office.
Eric Henry
King & Spalding
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.
Shannon Hoste
Pathway for Patient Health
Shannon Hoste is the Chief Scientific Officer for Patient for Pathway Health, an assistant professor in the Quality Science Education program at Pathway for Patient Health, and she’s active on several international standards committees for medical devices.
Formerly, Hoste 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, and ANDA pathways; as well as data to support IND and IDE requests.
Susan Matthias
FDA
Susan Matthias is a Consumer Safety Officer, Special Assistant in Office of Medical Device and Radiological Health (OMDRHO). She is responsible for assisting the program director with a wide variety of coordination and administrative projects, managing the program’s strategic direction, and providing expertise as a subject matter expert. Prior to this position, she was a Device Specialist for eight years in OMDRHO’s central division, and maintains her Level II certification. She has worked for FDA since 2008. Prior to joining FDA, Matthias was the manufacturing manager for a mid-size medical device firm, where she managed production supervisors and manufacturing operations personnel. She also held various engineering and project management roles at industrial and automotive firms.
Phil Pontikos
FDA
Phillip Pontikos is a Medical Device National Expert working for the Office of Regulatory Affairs (ORA) of the Food and Drug Administration. He joined FDA in 1994 as an Investigator in the Brunswick, Ohio, Resident Post of Cincinnati District. In 2000, Pontikos moved to Columbus, Ohio, where he currently resides.
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. Pontikos has assisted in the development of 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.
Fatemeh Razjouyan
Medtronic
As part of Medtronic’s global regulatory policy team in Washington, D.C., Fatemeh Razjouyan is actively shaping the global regulatory landscape to promote harmonization. She represents Medtronic in industry working groups and coalitions to advance its goal of providing patients with safe and innovative therapies. Razjouyan 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). From 2013 to 2018, she led the 510(k) review program in the Office of In Vitro Diagnostics and Radiological Health (OIR) in CDRH, where she trained review staff, drafted guidance documents and work instructions, and assisted in the implementation of the Medical Device User Fee Amendments (MDUFA) and regulatory policy for the 510(k) program.
Heather Rosecrans
MDMA
Heather Rosecrans brings more than 30 years of public health and medical device experience to Greenleaf Health, Inc. 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, she 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.
Kim Shoemaker
Johnson & Johnson MedTech
Kim Shoemaker is an accomplished Global Regulatory Affairs Leader with more than 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 the world.
Prior to joining Ethicon, her experience stretched across multiple disciplines within the medical device industry including IVD R&D, Quality Assurance/Design Control, and International Regulatory Affairs.
Kim Trautman
Medical Device, IVD and Combo Product Expert
Kim Trautman, former Associate Director of International Affairs at FDA, is an experienced medical device, IVD, and combination product expert with over 30 years of industry and regulatory agency experience.
An expert in global medical device regulations, she wrote and harmonized the current FDA Quality System Regulation. Trautman was also on the FDA authoring committee for 21 CFR Part 4 and FDA Combination Product GMP guidance documents. In addition, she developed the International Medical Device Single Audit Program (MDSAP) and consortium from conception through its pilot. Trautman is a 25-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF).
Monica Wilkins
Abbott
Monica Wilkins joined Abbott in 2007, where she provides strategic support and technical expertise to the medical device divisions within Abbott. Prior to joining Abbott, she worked for the Food and Drug Administration (FDA). In her 12 years of FDA-related experience, Wilkins held the positions of Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator. Before joining FDA, Wilkins’ career included 14 additional years of employment in the regulatory, computer, healthcare, and pharmaceutical industries in positions including Research Assistant, Quality Control Technician, Microbiologist, Supervisor, Manager, Specialist, Director, and Consultant.
Jessica Zeller
Edwards Lifesciences
Jessica Zeller is Vice President – Quality, Regulatory, Environmental, and Public Affairs Counsel at Edwards Lifesciences based in Irvine, California. Zeller is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. She routinely counsels on global medical device regulatory compliance matters and quality systems concerns, including interacting with government regulators. She was previously FDA’s inaugural ORA Ombudsman, focusing on problem-solving with respect to FDA’s field offices, including inspections, imports, and other agency processes and procedures. Additionally, Zeller has served as the Deputy Director of Compliance and Enforcement for FDA’s Center for Tobacco Products, as a litigation attorney in FDA’s Office of Chief Counsel, and as the lead FDA lawyer for Procter & Gamble.
