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

Francis Blacha

 Senior Vice President – Quality, 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, Francis held various leadership positions in Quality at Pfizer and Glaxo Inc. Blacha has more than 30 years of quality assurance/quality control experience in pharmaceuticals and medical devices. He has 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. Blacha has given numerous lectures at various medical device, pharmaceutical, and combination product conferences.  His bachelor’s degree in chemistry is from Catawba College, and he received a master’s degree in chemistry from North Carolina State University. 

Gert Bos

Gert Bos

Executive Director & Partner, 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.

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 was awarded a Fellow of RAPS. Bos holds a doctorate in biomaterial sciences and postdocs in controlled release of drugs and gene therapy.

RADM Sean M. Boyd

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 life cycle structure and function, promoting the quality and safety of medical technology from product development to end of life.

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, D.C.-based public health and medical response teams, where he led response and recovery efforts for several disasters and crises, both domestically and abroad.

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.

Gina Brackett, OMDRHO Division 1 Director, Compliance Branch and MedCon Co-Chair, FDA-ORA

Gina Brackett

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 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. She graduated from Thomas More College in Crestview Hills, Kentucky, with a bachelor’s degree in biology and an associate’s degree in chemistry.

Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS

Bill Brodbeck

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. 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.

His doctorate in the Cellular and Molecular Basis of Disease is from Case Western Reserve University and his bachelor’s degree in biology is from Wilkes University.

Aaron Dunbar

Vice President Global QARA Compliance, Olympus 

Aaron Dunbar is Vice President Global QARA Compliance, Olympus Corporation of the Americas. He has 20 years of comprehensive experience driving regulatory compliance and quality system regulations and standards across the medical device and healthcare industries.  Throughout his career he’s held roles with responsibilities for driving company culture, the promotion of organizational core values, leading continuous improvement initiatives, meeting and sustaining global requirements, and pioneering innovative solutions that meet company and customer needs.  Aaron is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Quality Management standards committee and working groups.  From 2019 through 2022, he chaired the AAMI 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 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. 

Barbara Fant

Barbara Fant

President and Principal Regulatory Consultant, Clinical Research Consultants, Inc.

Barbara Fant is the President and Principal Regulatory Consultant of Clinical Research Consultants, Inc. (CRC). She has 30 years of experience in pharmaceutical and medical device research and development. 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. Fant has successfully filed over 100 IDEs, pre-IDEs, 510(k)s, and PMAs with the FDA to bring investigational products to the marketplace. She 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.

Her bachelor’s degree in pharmacy is from Ohio Northern University, and she holds a doctor of pharmacy degree from the University of Cincinnati.

Eric Henry

Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, 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

Shannon Hoste

Sr. Director of Human Factors & Regulatory Strategy , Agilis Consulting Group

Shannon Hoste 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 she’s 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, and ANDA pathway;, as well as data to support IND and IDE requests.

Outside of her work for the FDA, Hoste continues to build on her 25-plus-year career where she has worked in the medical device, IVD, and combination product industry as an 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.

Hoste has a bachelor’s degree in mechanical engineering from the University of Toledo, a master’s degree in management from Mount Vernon Nazarene University, and a master’s in cognitive systems engineering from the Ohio State University.

Timothy Hsu

Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative

Before becoming the Director of Health Technology Initiatives at AFDO/RAPS Healthcare Products Collaborative, Timothy Hsu was a member of the AI Initiative’s Core Strategic Team. He’s also spent several years working with the GMLP, AIO, and AI@POC teams in varying capacities under the Xavier Health Artificial Intelligence Initiative.

Hsu has served across the clinical, operational, and administrative spectrums in healthcare systems at pediatric, academic, research, and community hospitals. His roles in healthcare systems have included work in strategy, planning, perioperative, service line, and population health divisions. Hsu was a Product Manager in Clinical Intelligence at Premier Inc., where he was the product owner of Service Line Analytics, Cost Accounting, Patient Analytics, and Clinical Professional Partnerships. He was the market research strategist for healthcare market futures at GBBN Architects.

Susan Matthias

CSO Special Assistant, FDA – ORA

Phil Pontikos

Phil Pontikos

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. 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.

He previously held the position of Cincinnati District Medical Device Specialist until January 2010 when he became the Medical Device National Expert. 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. Pontikos has also given numerous lectures at various medical device and pharmaceutical conferences.

His bachelor’s degree in physics with a concentration in computer hardware systems is from Kent State University.

Fatemeh Razjouyan

Fatemeh Razjouyan

Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy, 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 helping patients access 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). Her 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, Razjouyan was the public face of OIR on several FDA policy issues, including OIR 510(k) review practices. She received multiple awards during her tenure at the FDA.

Razjouyan’s bachelor’s degree in biomedical engineering and master’s degree in electrical engineering are from George Washington University. 

Heather Rosecrans

Heather Rosecrans

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, 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.

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). Her 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. She 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. Rosecrans has also worked collaboratively with CMS and other regulatory agencies.

Kim Shoemaker, Sr. Director, Global Regulatory Affairs, Ethicon

Kim Shoemaker, RAC

Sr. Director, Global Regulatory Affairs , Ethicon

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 to world. 
 
Shoemaker 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, 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, Managing Director and VP, MEDIcept

Kim Trautman

Medical Device, IVD and Combination Products Expert

Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. Recently, she has 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.

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.

Monica Wilkins

Monica Wilkins

Vice President Regulatory and Quality, 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, she 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.

She has a bachelor’s degree in microbiology from the University of Texas at Austin.