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Medcon 2023 Horz Fda

MedCon 2023 Speakers

This year’s MedCon speakers were hand-selected by the MedCon Strategic Committee to deliver purpose-driven content that dives below the surface, challenges status quo, engages attendees in collaborative dialogue, and provides practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussions.

Nelson Anderson

CDRH Portal Platform Owner, Center for Devices and Radiological Health (CDRH), FDA

Nelson Anderson is a biomedical engineer and IT product owner at the FDA. He was a lead reviewer in CDRH for cardiovascular devices for 13 years before moving into the IT realm seven years ago and is now the platform owner for the CDRH Portal, among other duties. Anderson has maintained his sanity through 20 years in the federal government by traveling and geocaching around the world; he recently returned from climbing Kilimanjaro.

Meredith Andress

Recall Coordinator, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO) Division, FDA

Meredith Andress serves as a Recall Coordinator for medical device recalls under the Compliance Branch, OMDRHO Division 2. Andress has been with the FDA for 13 years and prior to her current position as Recall Coordinator, served as a Consumer Safety Officer, performing inspections in multiple commodity areas. She received a master’s degree in public health with a specialization in veterinary public health from the Ohio State University.

Agata Anthony

Vice President of Global Regulatory Affairs and Regions QualityGE HealthCare

Agata Anthony is the Vice President of Global Regulatory Affairs and Regions Quality at GE HealthCare. In this role, she leads the regulatory affairs teams across GE HealthCare Business Units and Regions organizations and is responsible for regulatory strategy, operations and policy development for the Company. She is also responsible for quality and compliance in the Regions. Since joining GE HealthCare in 2006, Ms. Anthony held leadership regulatory positions in Patient Care Solutions, Ultrasound, Imaging and GE HealthCare Digital, managing submissions and regulatory product support throughout the entire product lifecycle.

Ms. Anthony holds a law degree from University of Silesia in Poland and LLM in International and Comparative Law from the George Washington University Law School.

Patrick Axtell, Senior Tools and Templates Engineer, Office of Regulatory Products, FDA-OPEQ/ORP–CDRH

Patrick Axtell

Assistant Director, Tools and Templates Team, Center for Devices and Radiological Health (CDRH), FDA

Patrick Axtell is a biomedical engineer and software developer at the FDA. He graduated from the College of William and Mary with a bachelor’s degree in biology, and he received his doctorate’s degree in biomedical engineering with a specialization in neural engineering from the University of Illinois in Chicago in 2007. Axtell was a reviewer for restorative and neurological devices for seven years and is now the Assistant Director for the Tools and Templates Team for CDRH. He developed the smart template, which aids reviewers in the evaluation of medical devices, and eSTAR, which guides applicants through the process of preparing 510(k)s and other submission types.

Cynthia Aycock

Division 1 Division Recall Coordinator, Office of Medical Devices and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Cynthia Aycock serves as a Division Recall Coordinator in the Office of Medical Device and Radiological Health Operations (OMDRHO), Division 1. They have been a Recall Coordinator since 2018 and worked previously as an investigator since 2013. Aycock holds a master’s degree in biomedical engineering.

Tammy Beckham

Associate Director for Resilient Supply Chain, Center for Devices and Radiological Health (CDRH)FDA

Tammy Beckham is the Associate Director of the Resilient Supply Chain Program (RSCP) within the Food and Drug Administration Centers for Devices and Radiological Health (CDRH) Office of Strategic Partnerships and Technology Innovation (OST). In this role, she leads CDRH’s work to enhance resiliency in the U.S. medical device supply chain. Dr. Beckham previously held positions in Academia as the Director of the Department of Homeland Security Institute for Infectious Diseases at Texas A&M University, as well as Dean of the Kansas State University College of Veterinary Medicine. She also has extensive experience leading U.S. Government programs, most recently serving as the Director of the Department of Health and Human Services Office of Infectious Disease and HIV/AIDS Policy, where she received the HHS Secretary’s Award for Distinguished Service for her work leading the COVID-19 Testing and Diagnostics Working Group (2021) and for work leading the Kidney Health Work Group (2020).

Augusto Bencke Geyer

Deputy General Manager of the Medical Devices OfficeBrazilian Health Regulatory Agency (ANVISA)

Augusto B. Geyer is the Head of the Office of Medical Devices at the Brazilian Health Regulatory Agency (ANVISA). Between 2017 and 2022 he served as Senior Advisor and Deputy General Manager of the Office of Medical Devices. Between 2014 and 2017 he was the Manager at the Office of In Vitro Diagnostics. Since Geyer joined ANVISA as Specialist in Regulation and Health Surveillance in 2005, he’s represented the Office of Medical Devices in international technical working groups and on various committees of IMDRF, ISO, WHO, and other organizations. Geyer’s educational background includes a pharmacy degree, specialization in sanitary law, and a master’s degree in materials science and engineering.

Aaron Bernstein

Divisional Vice President, Global Procurement, Abbott

Aaron Bernstein leads the procurement organization for Abbott Nutrition. Previously, he led procurement for Abbott’s Rapid Diagnostics division, where he launched and scaled multiple Covid diagnostic products. Prior to joining Abbott, Bernstein spent 15 years at GE Healthcare, where he held roles in product development, operations, and procurement.

Meera Bhatia

Divisional Vice President, QualityAbbott

Meera Bhatia is currently the Divisional Vice President, Quality at Abbott Laboratories.  In this role, she is responsible for Abbott’s corporate quality system and provides strategic quality support across Abbott’s divisions.  Over the course of Meera’s 23 year career at Abbott, she has held leadership positions in technical operations, design quality, and post-market product quality and commercial service across multiple In vitro diagnostics (IVD) businesses, nutrition and corporate.  Meera holds a degree in Cell/ Molecular Biology from Northwestern University. 

Francis Blacha, Global Quality Leader – Drug Delivery System Development, Eli Lilly

Francis Blacha

Senior Vice President – QualityEli Lilly and Company

Francis Blacha is Senior Vice President, Quality for Eli Lilly and Company in Indianapolis, Indiana. 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. 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.

Lindsay Bockstedt

Vice President, Global Health Economics and Outcomes Research, Medtronic

Lindsay Bockstedt is Vice President of Global Health Economics and Outcomes Research at Medtronic. In her role, Bockstedt provides overarching strategic and scientific leadership on health economics and outcomes research, real-world evidence, and health technology assessment. She focuses on leveraging real-world data to generate evidence to support medical devices and to evaluate and shape reimbursement and health policy strategies to enable access to medical technology. She received her doctorate and master’s degree in health services research and policy from the University of Minnesota, and a bachelor’s degree in public health from Rutgers University.

Gert Bos, Executive Director & Partner, Qserve Group

Gert Bos

Executive Director and PartnerQserve 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.

As technical reviewer, he has dealt 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

Director, Office of Regulatory Programs, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), 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.

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 MPH 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

Division 1/East Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), 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 Office for 15 years. She was a Medical Device Specialist for seven years; during this time, she 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 the Office of Regulatory Affairs 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 AffairsSTERIS

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.

Debra Bruemmer

Senior Manager, Mayo Clinic

Debra Bruemmer is a Senior Manager at Mayo Clinic within the Office of Information Security. She is accountable for leading a team to address cybersecurity resiliency for foundational assets (e.g., servers, workstations, applications, medical devices, IoT devices), maintain secure identity and access management practices, and uphold security principles in network segmentation. Bruemmer received her bachelor’s degree in finance from Winona State University, an MBA from Cardinal Stritch University, and she is also CISSP certified.

Daniel Caños

Office Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA

Daniel Arthur Caños is the Director of the Office of Clinical Evidence and Analysis (OCEA) in the FDA Center for Devices and Radiological Health (CDRH). Before he joined OCEA in 2019, Caños was the Director of the Evidence Development Division (EDD) in the Centers for Medicare and Medicaid Services (CMS) Coverage and Analysis Group (CAG); he was also on a part-time detail within the FDA CDRH. The EDD work included National Coverage Analyses (NCAs) and National Coverage Determinations (NCDs) involving Coverage with Evidence Development and review of FDA-approved Investigational Device Exemption studies for CMS coverage determination. Before joining CAG in 2016, Caños was an Associate Director in the FDA CDRH Division of Epidemiology. He originally came to FDA in 2008. His bachelor’s degree in psychology is from the University of Cincinnati, his MPH is from the George Washington University, and he has a doctorate in epidemiology from the University of North Carolina at Chapel Hill.

Kelly Coleman

Distinguished ToxicologistMedtronic

Kelly Coleman is a Distinguished Toxicologist, Technical Fellow, and Bakken Fellow at Medtronic, where he provides preclinical product development support. He is also a U.S. Expert on ISO Technical Committee 194’s Working Group 11, which is responsible for the medical device toxicology risk assessment standard (ISO 10993-17), and a U.S. Expert on Working Group 8, which is responsible for the medical device sensitization and irritation testing standards (ISO 10993-10 and ISO 10993-23). In this role, he co-directed a successful international round robin study proving that 3D human skin models are suitable replacements for the rabbit skin irritation test. Coleman earned a doctorate in toxicology from the University of Minnesota. He is a Diplomate of the American Board of Toxicology, a European Registered Toxicologist, a Fellow of the Academy of Toxicological Sciences, and is certified in regulatory affairs. Coleman is a past president of the Society of Toxicology’s In Vitro and Alternative Methods Specialty Section and the Medical Device and Combination Product Specialty Section. In addition, he recently served on NIH’s Scientific Advisory Committee on Alternative Toxicological Methods.

Paul Coplan

Vice President and Global Head of Medical Device Epidemiology and Real-World Data Sciences, Johnson & Johnson

Paul Coplan is the Vice President of Epidemiology and Real-World Data Sciences for Medical Devices at Johnson and Johnson, where he leads a team of 30 epidemiologists, data programmers, and health service researchers.

He has pioneered the use of epidemiology and real-world evidence to develop new vaccines, medicines, and medical technology; to assess their safety and effectiveness after marketing; and to use real-world evidence for market access and label expansion purposes. He has helped develop nine widely used vaccines, nine medicines, and several medical devices. Coplan is also an adjunct professor at the University of Pennsylvania Perelman School of Medicine, where he’s taught epidemiology for 22 years. He has authored over 100 peer-reviewed scientific articles, made 500 international medical conference presentations, conducted studies in 15 countries, and worked with the FDA, EMA, Chinese, Canadian, and other national regulatory authorities.

Coplan is a member of the National Evaluation System for Health Technology’s Data Quality Workgroup and the Medical Device Innovation Consortium Science of Patient Input Steering Committee. He has led precompetitive initiatives for collaboration between companies, regulators, and academics in creating benefit-risk frameworks for medical product evaluations; assessed the safety of HIV medications, vaccines, and opioid analgesics; established clinical trial infrastructure in Africa and Southeast Asia for HIV vaccine and microbicide trials; built and evaluated Risk Evaluation and Mitigation Strategies (REMS); and performed epidemiologic evaluation of cobalt-containing orthopedic implants. 

Coplan completed an MPH at the University of Massachusetts Amherst, a doctorate in epidemiology and biostatistics at Harvard School of Public Health, and an MBA at Wharton Business School of the University of Pennsylvania. 

Erin Cutts

Senior International Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

Erin Cutts is a senior international policy analyst at FDA’s Center for Devices and Radiological Health (CDRH). While at FDA, she has led a variety of projects related to trade and international harmonization, convergence, and reliance. Cutts’ career began as a Research and Development Engineer at a medical device start-up company, after which she joined FDA as scientific reviewer and then branch chief in the cardiovascular space. Cutts holds a bachelor’s degree in biomedical engineering from Georgia Tech.

Sue Dahlquist

Senior Director Global Strategic Regulatory & Clinical AffairsThermo Fisher Scientific

Sue Dahlquist is the Senior Director of Strategic Regulatory and Clinical Affairs at Thermo Fisher Scientific. She is responsible for leading the development of regulatory policy and advocacy efforts across Thermo Fisher and working with businesses to interpret and implement new regulations and guidance. Dahlquist has over 30 years of experience in the medical device and life science industries, including 23 years in Regulatory Affairs. Prior to joining Thermo Fisher Scientific, she worked at early-stage, mid- and large-size companies, including Smith + Nephew and Boston Scientific. She holds a bachelor’s degree in marine biology from Roger Williams University in Bristol, Rhode Island.

Aaron Dunbar, Director of Corporate Quality Systems, Boston Scientific Corporation

Aaron Dunbar

Vice President Global QARA ComplianceOlympus

Aaron Dunbar is the Vice President of Global QARA Compliance at 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. Dunbar 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. Dunbar has previously held roles at Boston Scientific Corporation, Tornier, Inc., and he was a Medical Device Specialist and Investigator for the U.S. Food and Drug Administration – Minneapolis District Office.

Barbara Fant

President and Principal Regulatory ConsultantClinical 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.

Matthias Fink

Senior Clinical Consultant, Akra Team

Matthias Fink has been a Senior Clinical Consultant with Akra Team since January 2023. He consults medical device manufacturers of all sizes on regulatory and clinical requirements with a focus on the EU MDR. Fink worked previously as a Clinical Reviewer and Manager of the Clinical Focus Team North America for TÜV SÜD Product Service in Germany and the United States. He is also a board-certified orthopedic and trauma surgeon with 17 years of experience in orthopedic, trauma, and reconstructive surgery and has extensive cardiovascular and thoracic surgery training. Fink is a presenter at national and international conferences and workshops on the clinical requirements and implementation of the EU MDR

Igor Gorlach

Partner, Healthcare/Data, Privacy and SecurityKing & Spalding

Igor Gorlach guides companies through regulatory privacy, cybersecurity, and consumer protection issues, with particular expertise in the digital health and life sciences industries and projects involving innovative or consumer-facing technology. He serves as regulatory privacy and security counsel to dozens of health and life sciences companies, varying in size from early-stage through Fortune 100. Gorlach is also the co-lead of King & Spalding’s Life Sciences Data Privacy Law Group.

Eric Henry

Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences PracticeKing & 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, and training. He also serves as an expert witness during litigation. Before joining King & Spalding, Henry led global quality, compliance, and technology organizations for several large and medium-size medical device companies.

James Hildreth

Director, Investigations Branch, Office of Medical Device and Radiological Health Operations (OMDRHO) Division 2, Office of Regulatory Affairs (ORA), FDA

James Hildreth is the Director of Investigations Branch (DIB) with the Office of Medical Device and Radiological Health Operations (OMDRHO) Division 2, in the Office of Regulatory Affairs at FDA. DIB Hildreth started his career with the FDA in 2010 in Portland, Oregon, conducting inspections of medical device manufacturers, both foreign and domestic. In 2018 he took a position as a Supervisory Consumer Safety Officer overseeing staff in the greater Los Angeles, California, area before accepting the DIB role in Atlanta, Georgia, in 2022. As DIB, he covers operations in 17 states and two territories, and oversees six groups of medical device investigators and administrative staff. Hildreth is also a Consumer Complaint Coordinator.

Matt Hillebrenner

Associate Director for Total Product Life Cycle Review Program Innovation, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA

Matt Hillebrenner is the Associate Director for TPLC Review Program Innovation in the Office of Product Evaluation and Quality at the FDA. In this role, he is part of the core leadership team developing the novel TPLC Advisory Program (TAP) Pilot. The TAP Pilot is intended to speed patient access to high-quality, safe, effective, and innovative devices through process improvements to FDA’s early interactions with device manufacturers as well as facilitation of strategic engagement between participants and critical stakeholders throughout the medical device ecosystem. Hillebrenner previously spent nearly 20 years in the Office of Cardiovascular Devices where he was responsible for overseeing the regulation of a wide range of devices and leading various strategic planning efforts.

Sabina Hoekstra-van den Bosch

Global Director Regulatory StrategyTÜV SÜD Medical Health Services

Michael Hoffman

Program Lead, Medical Device Shortages Program, Office of Product Evaluation and Quality’s (OPEQ’s) Shortages Team in the Center for Devices and Radiological Health (CDRH), FDA

Hoffman currently oversees the Office of Product Evaluation and Quality’s (OPEQ’s) Shortages Team in the Center for Devices and Radiological Health (CDRH) with responsibilities related to shortages and EUA and PEUAs. He works with stakeholders across CDRH, who are collectively focused on developing tools, processes, and policies for identifying and mitigating device shortages in the future. Hoffman has worked at CDRH since 2007, primarily in the area of neurological and rehabilitation devices, serving in various leadership roles within the Office of Neurological and Physical Medicine Devices, which included oversight and policy recommendations on activities for a wide variety of devices associated with neurology, psychiatry, and rehabilitation. He received his bachelor’s degree in electrical engineering from the University of Illinois in Urbana-Champaign and a master’s degree in biomedical engineering from Marquette University.

Shannon Hoste

PresidentAgilis Consulting Group

Shannon Hoste is the Senior 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, 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.

Outside of her work for the FDA, Hoste continues to build on her 25-plus-year career. She has worked in the medical device, IVD, and combination product industry as an R&D and Quality Engineer, Manager, and Director. She has also 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 OfficerAFDO/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.

Osman Kafrawy

Advisor, QualityEli Lilly and Company

Osman Kafrawy is an Advisor, Device Quality & Regulatory Compliance for Eli Lilly and Company in Indianapolis. In this role he supports regulatory and quality compliance for Lilly’s connected devices, medical devices, IVD, and combination products. He has led ISO 13485, MDSAP, RED, UKCA, and EU MDR certification efforts across Lilly global sites. Kafrawy has 23 years of experience in the medical device and pharmaceutical industries and holds a bachelor’s degree in biology from Purdue University.

Douglas Kelly

Deputy Center Director for Science, Office of the Center Director, Center for Devices and Radiological Health (CDRH), FDA

Mark Leahey

President & CEO, Medical Device Manufacturers Association

Mark Leahey is the president & CEO for the Medical Device Manufacturers Association (MDMA), the leading national trade association representing hundreds of innovative and entrepreneurial medical technology companies in Washington, D.C. His responsibilities include advocating on behalf of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and other federal and state agencies.

Ed Lockwood

Medical Device Specialist, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Ed Lockwood is a Medical Device Specialist assigned to the Saint Louis Missouri Resident Post.  He is a certified medical device Investigator through FDA’s certification program. He graduated from the Ohio State University in Columbus, Ohio, with a bachelor’s degree in mechanical engineering. Lockwood also served as a pilot in the United States Air Force and Ohio Air National Guard.

Michael Maier

Vice President, Strategic Regulatory and QualityVeranex

Michael Maier has 25 years of hands-on experience in the medical device industry. His work has included design and development projects, product industrialization, and regulatory and quality affairs with a strong focus on EU MDR/IVDR, Swiss Medical Device Ordinance, and MDSAP.

Ed Margerrison

Director, Office of Science and Engineering, Center for Devices and Radiological Health (CDRH)FDA

Ed Margerrison is the Director for the Office of Science and Engineering Laboratories at the Center for Devices and Radiological Health, U.S. FDA. The office is responsible for providing technical expertise and analyses in support of the regulatory processes within CDRH. In addition, the 300 scientists and engineers engage in representation of the agency on international standards organizations, provide scientific guidance for policy, and future-proof the center for technologies making their way into novel medical devices.

Previously, he was president and CEO of Ortho Regenerative Technologies, a biotech start-up based in Montreal, where he developed novel biomaterial approaches to surgical soft tissue repair. During this appointment, Margerrison steered the company to listing on the Canadian stock exchange, and started the regulatory process for the technology with the Center for Biologics at FDA.

He has also held senior positions at Zimmer Biomet (vice president of Biologics), where he was primarily responsible for the cartilage repair business, and has held other positions in both the pharmaceutical (Akela Pharma) and orthopedics (Smith & Nephew) industries.

Margerrison graduated in biochemistry from the University of Oxford and gained his doctorate in molecular genetics from St. George’s Hospital Medical School in London, U.K., where he studies the mechanisms of resistance to quinolone antibiotics.

Glenda Marsh

Senior Director, EMEA Regulatory AffairsJohnson & Johnson

Glenda Marsh is an accomplished, proactive, and versatile corporate professional with over 20 years of global experience in regulatory affairs, program management, and operations across the healthcare industry, including bio-pharm, medical devices, and consumer products. Since joining Johnson & Johnson in 2001, she has held positions of local, regional, and global responsibility and covered different J&J sectors, companies, functions, and regions (Latin America, North America, and EMEA). She has led regulatory programs from concept to approval and implementation spanning the entire medical device product life cycle. Marsh has extensive experience in leading large organizations through major regulation changes, with a focus on ensuring short- and long-term continued and timely patient access to life-saving medical technology. Since 2016, she has played a strategic leadership role in the preparation for and implementation of the EU MDR (Medical Device Regulation), and more recently, UKCA and Swiss MedDO requirements, for all J&J MedTech companies. Currently, she leads Regulatory Affairs in EU markets ensuring successful execution of the global innovation agenda as well as life cycle maintenance of an extensive medical devices portfolio. Marsh has a master’s degree in chemical engineering from Stevens Institute of Technology and a bachelor’s degree in chemical engineering from the Polytechnic School of the University of Sao Paulo.

Simon Mason

President of NESTcc, The Medical Device Innovation Consortium

Simon Mason is President of NESTcc, part of The Medical Device Innovation Consortium. NESTcc serves a dual role in the medical device ecosystem – as a Coordinating Center offering services that catalyze real-world evidence (RWE) generation for medical device and health technology research sponsors and as a Collaborative Community comprising representatives from across the medical device ecosystem working together to develop thought leadership and coalesce diverse stakeholders to advance innovation and understanding on initiatives of importance. Prior to his work with NESTcc, Mason has a history of building and selling private equity-backed healthcare services companies.

Susan Matthias

Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Susan Matthias is a Consumer Safety Officer, Special Assistant in the 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, Matthias was a Device Specialist for eight years in OMDRHO’s central division, and she maintains her level II certification. Matthias has worked for FDA since 2008. Before joining FDA, she was the manufacturing manager for a midsize 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. Matthias graduated from the University of Minnesota with a bachelor’s degree in mechanical engineering.

Karen Masley-Joseph

Senior Advisor, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Karen Masley-Joseph has over 20 years of experience at FDA in investigations, compliance, quality management systems, and leadership roles. Currently, as OMDRHO’s Senior Advisor, she collaborates with CDRH as the lead for ORA’s implementation of the proposed Quality Management System Regulation rule. Masley-Joseph holds a bachelor’s degree in chemical engineering and an MBA from Northwestern University.

Melissa Michurski

Director, Compliance Branch, Division 2, Office of Medical Device and Radiological Health Operations (OMDRHO)Office of Regulatory Affairs (ORA), FDA

Elizabeth Miller, Associate Commissioner of the Office of Medical Products, FDA-ORA-OMPTO)

Elizabeth Miller

Assistant Commissioner of the Office of Medical Products and Tobacco Operations, Division 2, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Elizabeth Miller recently rejoined the U.S. FDA in March 2020.  In her role as the Assistant Commissioner for Medical Products and Tobacco Operations, she provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical Quality Operations, Office of Medical Device and Radiological Health Operations, Office of Bioresearch Monitoring Operations, and the Tobacco Operations Staff.

Miller comes from the U.S. Pharmacopeia (USP) where she helped guide USP’s working relationship with the FDA.  At USP, she was vice president, U.S. Public Policy & Regulatory Affairs, with responsibility to deliver executive leadership for developing and achieving USP’s U.S. regulatory science and intelligence, government affairs, and public policy programs’ goals. She also created strategic change focused on impacts and results resulting from engagement with federal, state, and international regulators, as well as senior leadership in industry, academia, and patient-focused alliances.

Before rejoining USP in 2016, Miller began her federal career with FDA’s Center for Drug Evaluation and Research (CDER) in 2007 in the Office of Unapproved Drugs and Labeling Compliance (OUDLC).  She began her CDER career working on online pharmacy and health fraud issues, and ultimately served as the director for OUDLC’s Division of Nonprescription Drugs & Health Fraud.

Prior to federal service, Miller worked at USP as a scientific liaison on medication safety standards for nomenclature, labeling, and packaging, and as the director of drug information for the USP Drug Information publication. She started her pharmacy career working as a clinical pharmacist at MedStar Washington Hospital Center in Washington, D.C.

Miller holds a bachelor’s degree in biology from The Johns Hopkins University and received her Doctor of Pharmacy degree from the University of Maryland.

Rafael Padilla

Compliance Officer, Office of Medical Device and Radiological Health Operations (OMDRHO) Division 2, in the Office of Regulatory Affairs (ORA), FDA

Rafael Padilla is a Compliance Officer with the Office of Medical Device and Radiological Health Operations (OMDRHO) Division 2, in the Office of Regulatory Affairs at FDA. Padilla began his career with FDA in 2009 as an investigator in the Chicago District Office conducting inspections in the Device and BIMO program area, both foreign and domestic. Prior to starting with the FDA, he worked for a contract research organization (CRO) and later for a large medical device manufacturer. In 2015 he joined the Compliance Branch in the Chicago District Office. Padilla is also a CAG member for FDA’s internal training courses on Basic Food and Drug Law and Compliance Law.

LCDR Tom Peter

Investigator/Medical Device Specialist, Office of Medical Device and Radiological Health Operations (OMDRHO) Division 2, in the Office of Regulatory Affairs (ORA), FDA

LCDR Tom Peter serves as a Medical Device Specialist in Division 1 of ORA’s Office of Medical Device and Radiological Health Operations (OMDRHO). He is also a commissioned Engineer Officer in the U.S. Public Health Service and is stationed in Detroit, Michigan. LCDR Peter has been performing medical device inspections since joining FDA in 2010 and has been involved in numerous high-profile cases resulting in Warning Letters and other regulatory actions. He is also a former member of ORA’s Medical Device Dedicated Foreign Inspection Cadre and has served as a Supervisory Investigator and CDRH Reviewer of knee arthroplasty devices within OHT6. LCDR Peter holds five ASQ certifications and currently chairs the ASQ Certified Medical Device Auditor (CMDA) Exam Committee. He earned his bachelor’s and master’s degrees in biomedical engineering from the University of Michigan.

Michael Pfleger

Vice President, Head of External Affairs and Regulatory Policy, Alcon

James Pink

Director of Medical, Element

James Pink is Director of Medical within Element, a global testing, inspection, and certification (TIC) provider. He is responsible for driving Element’s medical end market by developing and growing its TIC services. Pink is an active researcher in data science and the ways it can reduce regulatory burden. He is also an active contributor to UK and international regulatory policy. 

Pink started in medical physics and clinical engineering at the Sheffield Teaching Hospitals NHS Trust and has held positions in R&D, product safety, regulatory affairs, and quality assurance.

Based in the United Kingdom, he’s worked for 25 years in global medical devices with international roles in healthcare, notified bodies, device development, consultancy, and medical product testing organizations.

Lauren Priest

Compliance Officer, Office of Medical Device and Radiological Health Operations (OMDRHO)Office of Regulatory Affairs (ORA), FDA

Lauren Priest joined the FDA in 2008 as an investigator for ORA in the Dallas District Office, where she conducted both domestic and international inspections, focusing on medical device and human tissue work. She later completed a detail at FDA’s China office (Beijing) conducting inspections in-country, as well as a detail at CDRH Office of Compliance as a reviewer. In 2015, Priest moved to the Denver District Office to become a Compliance Officer specializing in medical device work. As an SME, she also works on Agency policy and procedure development, and trains new FDA investigators.

Phil Pontikos, Investigator, Medical Device National Expert, FDA-OMDRHO-ORA

Phil Pontikos

National Device ExpertOffice of Regulatory Affairs (ORA), 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.

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. He 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 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.

Janet Pulver

Medical Device Senior Operations Officer, Office of Medical Device and Radiological Health Operations (OMDRHO)Office of Regulatory Affairs (ORA), FDA

Janet Pulver is the FDA’s Division 3 Medical Device Senior Operations Officer and serves as national expert in the Medical Device and Radiological Health program areas. She joined the FDA in 2008 and came to the Agency with more than 18 years of industry experience, working in quality and regulatory positions in clinical research, tissue banking, and medical devices, and as a Chemistry Medical Technologist working with IVDs. Pulver holds Certifications from ASQ (Certified Manager of Quality and Organizational Excellence, Certified Quality Auditor and Certified Six Sigma Green Belt), RAPS (Regulatory Affairs Certification), and AATB (Certified Tissue Bank Specialist). She is also an instructor and content advisor for the FDA’s Medical Device and radiological health courses.

Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization, Global Regulatory Policy, Medtronic

Fatemeh Razjouyan

Director of Regulatory Policy, International and Harmonization | Global Regulatory PolicyMedtronic

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 at BD. 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.

Chris Reed

Director, Regulatory Policy, Digital Health and Product Security, Medtronic

Chris Reed leads external cybersecurity and Digital Health policy engagement for Medtronic. He advises Medtronic product security strategy for product submissions and is a member of the Product Security Office’s executive leadership team. Reed previously spent over 21 years with Eli Lilly and Company, where he built Lilly’s product security program supporting Digital Health. He is actively engaged as a leader in many medical device security and digital health industry initiatives such as the MDIC Cybersecurity Working Group, Health-ISAC Medical Device Security Information Sharing and Coordination’s Advisory Committee, and as co-lead for the Healthcare Sector Coordinating Council’s MedTech Cybersecurity Task Group. Reed is passionate about enabling digital health innovation in a secure and safe manner to benefit patient health outcomes.

Anne Reid

Program Director, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Anne Reid is the Program Director of the Office of Medical Device and Radiological Health Operations (OMDRHO), one of five programs in the Office of Medical Products Operations within FDA’s Office of Regulatory Affairs. Reid is a career FDA federal service veteran with vast experience in technical and managerial positions across multiple commodities. She came to FDA in 1990 with an undergraduate degree in biochemistry and a master’s degree in food science and segued into FDA’s laboratory science regulatory operations. Since 2000, Reid has held supervisory and branch director positions. In 2010 she became the Deputy Director of ORA’s Southeast Region, and in 2012 she assumed the responsibilities of Acting Director for the Southeast Region. Collaterally with her Regional Food and Drug Director duties, Reid served as the Acting Program Director for both the Biologics and Tobacco programs during significant planning phases for program alignment. She became the Deputy Program Director for OMDRHO in 2017 and moved into her current position in February 2022.

Thor Rollins

Senior Director of Toxicology and E&L ConsultingNelson Labs, LLC

Thor Rollins is a certified microbiologist and biocompatibility expert who specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He is a participating member of the Association for Advancement of Medical Instrumentation (AAMI) TC 194 and related 10993 ISO committees. He also plays an active role on FDA and regulatory committees by developing standards, discussing biocompatibility methods, and voting on changes to those standards. As one of a select group of experts in the industry, Rollins’ participation on the committees offers him insight into industry changes and helps him prepare clients for changes in testing.

Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health Vice President Regulatory Affairs, MDMA

Heather Rosecrans

Executive Vice President, Medical Devices & Combination ProductsGreenleaf Health, Inc | Vice President Regulatory AffairsMDMA

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.

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.

Aftin Ross

Senior Special Advisor for Emerging Initiatives, Center for Devices and Radiological Health (CDRH)FDA

Aftin Ross is a senior special advisor for emerging initiatives. She provides leadership and coordination on a range of emerging public health issues, including medical device cybersecurity, personal protective equipment, and incident response. Ross has led FDA’s medical device cybersecurity efforts by spearheading the execution of three public workshops, serving on various interagency cybersecurity workgroups, supporting numerous cross-stakeholder efforts (e.g., the 2017 healthcare cybersecurity task force), managing the MITRE medical device cybersecurity contract, supporting the international cybersecurity policy development convener of the International Medical Device Regulators Forum, and developing medical device cybersecurity policies for FDA. Ross has a bachelor’s degree in mechanical engineering from the University of Maryland Baltimore County, a master’s and doctorate in biomedical engineering from the University of Michigan, and she is a certified Six Sigma Green Belt.

Cassie Scherer

Senior Director, U.S. Regulatory and Global Digital Health PolicyMedtronic

Cassie Scherer is the Senior Director of U.S. Regulatory and Global Digital Health Policy at Medtronic. In her position, she leads global policy work relating to digital health technology, including AI/ML-enabled products, as well as U.S. FDA regulatory policy work. Before Medtronic, Scherer served at U.S. FDA where she was Associate Chief Counsel in FDA’s Office of Chief Counsel and Director of Strategy and Regulatory Operations in CDRH’s Office of the Center Director.

Jeffrey E. Shuren

Director, Center for Devices and Radiological Health (CDRH), FDA

Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation.

Tammy Steuerwald

Global Head Regulatory Policy, Foundational Principles & Supranational OrganizationsRoche

Tammy Steuerwald is the Head of Regulatory Policy for Foundational Principles and Supranational Organizations at Roche Diagnostics. In this role, she collaborates with the global regulatory community to identify modern and flexible solutions that drive improved access to innovative healthcare products. Her work includes efforts to support regulatory convergence, implementation of Good Regulatory Practices, and Regulatory Reliance policies; this work involves organizations such as the World Health Organization and IMDRF.

Steuerwald joined Roche in 2002 and served as the Director of Quality and Regulatory where she helped ensure compliance to established post-market controls such as adverse event reporting and inspections. Prior to joining Roche, she supervised various diagnostic labs including blood banking, hematology, coagulation, and chemistry. Steuerwald holds a bachelor’s degree from Indiana University, as well as a JD and Health Law Certificate from the Indiana University Robert H. McKinney School of Law.

Troy Tazbaz

Director of Digital Health, Center for Devices and Radiological Health (CDRH)FDA

Troy Tazbaz is Director of Digital Health Center of Excellence (DHCoE) at FDA. DHCoE within the Center for Devices and Radiological Health (CDRH) is responsible for envisioning a future of safe and effective healthcare delivery with a focus on advancing public health goals with the use of technology. Tazbaz is responsible for providing leadership in technology evaluation and integration into clinical care, policy development to establish digital health guidelines, and strategic public-private institution partnerships.

Prior to joining FDA, Tazbaz was at Oracle for 11 years, holding a variety of technical and business responsibilities in building and scaling the cloud business as Senior Vice President of Industry Business Unit Strategy & Operations, and he was part of the leadership team responsible for driving Oracle’s cloud transformation across all parts of its business, process, technology, and people development.

Scott Thiel

Corporate Head of Regulatory AffairsHologic

Scott Thiel has more than 35 years of experience in the medical device, health information technology, in-vitro diagnostics (IVD), and combination product industries. He joined Hologic in January 2021 as the Global Head of Regulatory Policy & Intelligence, reporting to the VP of Global Quality and Regulatory Affairs. In his role, he drives the development of a global strategy and framework for Regulatory Policy and Intelligence facilitating all global regulatory positioning. Thiel is accountable to partner effectively across geographies and businesses to establish advocacy positions that are supportive of Hologic Divisions, patients, and stakeholders. He ensures and advocates for transparent understanding of regulatory policy and drives efficiency and speed across the enterprise. 

Keisha Thomas, Associate Director for Compliance and Quality, FDA - CDRH

Keisha Thomas

Associate Director for Compliance and Quality, Office of Product Evaluation and Quality (OPEQ)Center for Devices and Radiological Health (CDRH), FDA

Keisha Thomas is the Associate Director for Compliance and Quality in FDA’s Center for Devices and Radiological Health. She provides strategic oversight, coordination, and guidance over medical device quality, compliance, and enforcement efforts. Thomas is a coauthor of the recently proposed amendment to 21 CFR 820, “Quality Management System Regulation (QMSR),” which incorporates the requirements of ISO 13485:2016, and she is spearheading CDRH’s implementation efforts for the proposed regulation.

Thomas has been at CDRH for 20 years and has an extensive regulatory, compliance, and enforcement background, having held multiple positions in CDRH: Deputy Office Director for OPEQ/OHT1, Deputy Director for the Division of Premarket and Labeling Compliance, Deputy Director for the Division of Enforcement A, and Quality System Team Lead in the former Office of Compliance, CDRH.

Eli Tomar

Associate Director for Guidance, Legislation & Special Projects, Office of Policy, Center for Devices and Radiological Health (CDRH), FDA

Eli Tomar is Associate Director for Guidance, Legislation & Special Projects in the Office of Policy in FDA’s Center for Devices and Radiological Health (CDRH). He manages the guidance program, supervises a team of professionals engaged in the development of cross-cutting guidance and policy documents, and oversees the Center’s legislative agenda. Prior to joining CDRH in 2020, Tomar was Counsel in the Washington office of Akin Gump LLP, where he worked on a range of regulatory and policy matters spanning the healthcare and life sciences sectors. Throughout his career in the private sector, he practiced law at several international law firms. Tomar received a bachelor’s degree in political science from the University of Maryland, College Park, and his JD and MPH from the University of California, Los Angeles (UCLA), and is now surprised to find these two schools in the same athletic conference.

Kim Trautman, Managing Director and VP, MEDIcept

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.

Jarno Vanto

Partner, Healthcare/Data, Privacy and SecurityKing & Spalding

Jarno Vanto partners with his clients on key business issues spanning privacy and cybersecurity regulatory compliance and investigations, complex cross-border technology and data transactions, data and software licensing, and other technology and data licensing agreements. He counsels clients regarding global privacy and cybersecurity compliance programs and artificial intelligence system management. Vanto’s experience spans the full scope of privacy laws, including GDPR, CCPA, and emerging U.S. state privacy laws. He provides privacy compliance and data rights counseling to companies in the digital health and medical device industries.

April Veoukas

Director, Regulatory AffairsAbbott

April Veoukas is Director, Regulatory at Abbott, where she is responsible for regulatory intelligence. She represents Abbott in industry associations, formulates company responses to proposed regulatory policies, and works with Abbott businesses. Veoukas, who has a JD, is the industry Co-Chair of the AdvaMed Technology & Regulation Working Group, former Chair of the 510(k) Working Group, a member of several MDIC Steering Committees, and a former industry representative on FDA’s Medical Devices Dispute Resolution panel advisory committee.

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, 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.

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

Barbara Zimmerman

Deputy Office Director, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ)Center for Devices and Radiological Health (CDRH), FDA

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