MedCon 2022 Committee

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

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

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, 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 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

VP, Quality Systems & Post Market, 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.  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

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

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

Chief Collaboration Officer, 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

Consumer Safety Officer, Special Assistant in Office of Medical Device and Radiological Health (OMDRHO)

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, she was the manufacturing manager for a mid-sized 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. She graduated from the University of MN with a Bachelor of Science degree in Mechanical Engineering.

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

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 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. 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 holds a bachelor’s degree in biomedical engineering and a master’s degree in electrical engineering from the George Washington University.

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, 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 Vice President, MEDIcept Inc.

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.

As Managing Director and Vice President, Kim is an integral part of the MEDIcept executive management team. She provides strategic client consulting services, develops business relationships with new clients, and leads the MEDIcept Training Immersion Program, developing the next generation of medical device consultants.

An expert in global medical device regulations, she wrote and harmonized the current FDA Quality System Regulation. Kim was also on the FDA authoring committee for 21 CFR Part 4 and FDA Combination Product GMP guidance documents. In addition, Trautman developed the International Medical Device Single Audit Program (MDSAP) and consortium from conception through its pilot. She is a 25-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF).

After retiring from FDA, she established an Authorized MDSAP Auditing Organization and launched a new Notified Body for EU IVDR/MDR Designation. She currently serves on the Board of Directors at the Regulatory Affairs Professionals Society (RAPS), has been on TC 210 Working Group 1 for ISO 13485 since its 1994 inception, and is a member of the ASTM E55 Combination Product Definitions standard. Kim also serves as the College of Engineering Vice Chair for the Industry & Professional Advisory Council at Penn State.

Trautman received her M.S. in Biomedical Engineering from the University of Virginia and her B.Sc. in Molecular Cell Biology from the Pennsylvania State University.

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.