MedCon 2022 Speakers

Bassil Akra

Chief Executive Officer, Akra Team GmbH

Karen Archdeacon

Compliance Officer, FDA-OMDRHO-ORA

Carlos Arglebe

Siemens Healthineers

Patrick Axtell

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

Patrick Axtell, Ph.D., 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. He graduated from The University of Illinois in Chicago in 2007 with a doctorate’s degree in biomedical engineering with a specialization in neural engineering.

Patrick was a reviewer for restorative and neurological devices for six years and is now the Senior Tools and Templates Engineer for OPEQ.  While at the FDA, Patrick has developed several templates  and  tools  intended  to  aid  reviewers in the evaluation  and  processing  of  several  types  of  medical  devices. He has also  developed templates intended for use in constructing 510(k)s and other submission types. 

Pat Baird

Philips

Edwin Bills

Ed Bills Consultant

Francis Blacha

Global Quality Leader-Drug Delivery System Development, Eli Lilly

Francis Blacha is currently Global Quality Leader, Drug Delivery System Development, Device Manufacturing and Diagnostics for Eli Lilly and Company. Previous to joining Lilly, Francis held various leadership positions in Quality at Pfizer and Glaxo Inc. Francis has over 25+ years of quality assurance/quality control experience in pharmaceuticals and medical devices. He has extensive experience in guiding project teams in all aspects of risk management and the application of design control requirements throughout the product lifecycle for combination products, diagnostics and medical devices. In addition to frequently presenting at industry forums on the topic of risk management, Francis currently serves on the strategic committee for MedCon, an annual medical device conference co-sponsored by FDA and Xavier University. Francis received his B.A. in chemistry from Catawba College and his M.S. in chemistry from North Carolina State University.

Dennis Black

BD

Gert Bos

Executive Director & Partner, Qserve Group

Gert is an expert in European regulations based on his hands-on working in the field, as auditor, product reviewer, regulatory specialist, and Head of notified body. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.

From his Ph.D. in biomaterial sciences, and postdocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS.

RADM Sean M. Boyd

Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, FDA-CDRH

RADM Sean M. Boyd serves as the Director for the Office of Regulatory Programs in FDA’s Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ). In this capacity, he is responsible for managing the Center’s review programs that ensure the public has access to high-quality, safe and effective medical devices.

Prior to joining the Office of Product Evaluation and Quality in 2019, RADM Boyd contributed to transformation efforts that built CDRH’s total product lifecycle structure and function, promoting the quality and safety of medical technology from product development to end of life. He received his undergraduate degree in biomedical engineering from Boston University and his master’s in public health from the Uniformed Services University of the Health Sciences.

RADM Boyd is an active duty commissioned officer in the United States Public Health Service (USPHS), and as a Flag Officer holds the title of Assistant Surgeon General within the Department of Health and Human Services. He is also a former Team Commander of Washington DC-based public health and medical response teams, where he led response and recovery efforts for several disasters and crises, both domestically and abroad.

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 a certified as a Level II Performance Auditor and conducted numerous complex medical device inspections. Gina is on numerous workgroups and has helped developed new procedures to assure a smooth transition since ORA’s program alignment in May of 2017. She graduated from Thomas More College, Crestview Hills, Kentucky, with a bachelor’s degree in biology and an associate’s degree in chemistry.

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. Bill is involved with several of the STERIS business units including medical device manufacturing, instrument repair and industrial contract sterilization, providing regulatory expertise to each.

Bill received his Ph.D. in the Cellular and Molecular Basis of Disease from Case Western Reserve University and his B.S. in Biology from Wilkes University.

Koen Cobbaert (Invited)

Senior Manager – Quality, Standards & Regulations, Philips

Kelly Coleman, Ph.D.

Distinguished Toxicologist, Medtronic

Katie Crawford

Quality System Manager, Boston Scientific Corporation

Cynthia Culmo

Principal Consultant, Culmo Compliance Consulting

Taylor Dieringer

Risk Management Quality Engineer, MEDIcept

Aaron Dunbar

Director of Corporate Quality Systems, Boston Scientific Corporation

Aaron Dunbar is Director of Corporate Quality Systems for Boston Scientific Corporation (BSC). He has a key leadership role in driving company Quality Culture and the promotion of a work environment that supports the BSC Quality Policy and Quality System. Aaron’s responsibilities include oversight of multiple global quality system processes, the Global Regulatory Compliance team, External Corporate Audit Support team, and management of Corporate Notified Body relationships.

He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Quality Management standards committee and working groups. He is chair of the Committee on Standards Strategy (CSS) which provides company member insight and guidance into the current and future strategic priorities for the domestic and international standards program for AAMI.  Aaron is  responsible for BSC’s membership with Pathway for Patient Health and is an industry volunteer in the organization’s Quality Science Education program.

Aaron was previously a Quality System Manager for BSC Global Quality Systems. Prior to that he held roles of Global Compliance Manger and Quality System Manager for Tornier, Inc., and Medical Device Specialist and Investigator for the U.S. Food and Drug Administration – Minneapolis District Office.

Lenore Faulhaber

Principal Scientist, Global Product Stewardship, Procter & Gamble

Lenore has over 20 years of hands-on regulatory experience in both the pharmaceutical and medical device fields. She has successfully managed and executed IND, NDA and 510(k) submissions and has experience in guiding both pharmaceutical and medical device project teams to ensure regulatory compliance and successful FDA interactions. Lenore has developed internal regulatory guidance documents, SOPs, and has trained personnel to assure compliance. She has worked closely with QA organizations in hosting FDA audits to successful outcomes and has provided industry opinions to be considered in public comment to proposed regulations. Lenore holds a Ph.D. in Biological Sciences from the University of Cincinnati and an M.B.A. from the University of Cincinnati.

Matt Graf

Director, Quality Assurance and Global Quality Systems, Cook Medical

Michelle Glembin

Medical Device Senior Operator, FDA-OMDRHO-ORA

Ed Heierman

Informatics Software Architect, Abbott

Eric Henry

King & Spalding

Mike Hoffman

Shortages Lead, FDA/CDRH/OPEQ

Sabina Hoekstra

Regulatory Strategy Principal, TÜV SÜD

Randy Horton

Orthogonal

Wendy Jackson

Pr. Quality System Engineer, Boston Scientific Corporation

Jessica Johnston

Sr. Director, Global Community Affairs, BD

Melissa Kann

Director, Regulatory Affairs, Stryker

Melissa Kann is the Director, Regulatory Affairs at Stryker Instruments based in Kalamazoo, MI. Melissa leads the global RA teams responsible for providing regulatory support and guidance in order to gain market access within certain target markets including the US, EU and Canada. Melissa is actively involved with advocacy initiatives within the US and the EU; currently she is the co-chair of the 3rd party repair working group at AdvaMed.

Indira Konduri

Deputy Director, Division of Market Intelligence Office of Regulatory Programs, Office Product Evaluation & Quality, FDA – CDRH

Mark Leahey

President & CEO, Medical Device Manufacturers Association (MDMA)

Mark Leahey is the President & CEO for the Medical Device Manufacturers Association (MDMA), a national trade association in Washington, DC that represents hundreds of research-driven medical technology companies. His responsibilities include advocating on behalf of the entrepreneurial sector 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. He has lobbied for more reasonable and predictable regulatory pathways for innovators, a full repeal of the medical device tax, a more timely and fair reimbursement process, and worked to open access in the hospital marketplace for all medical devices. Mr. Leahey also serves on the Board of Directors for the Fogarty Institute, a leading medical technology incubator. He is a member of the Massachusetts Bar and a graduate of Georgetown University, the Georgetown Law Center and Georgetown’s McDonough School of Business.

Dan Lyon

Global Director of Product Security, Boston Scientific Corporation

Michael Maier

Medidee

Steven Mandernach

Executive Director, Association of Food and Drug Officials (AFDO)

Ed Margerrison

Director, Office of Science and Engineering, FDA-CDRH

João Martins

Associate Director, Regulatory Affairs Strategy, Abbott

Damien McPhillips

Director Quality, Global Software and Digital Health, Boston Scientific Corporation

Natalie McRoberts

Magnetosphere Ltd

Elizabeth Miller

Associate Commissioner of the Office of Medical Products, ORA / OMPTO

Dr. Elizabeth Miller rejoined the Food and Drug Administration in March 2020 as the Assistant Commissioner for Medical Products and Tobacco Operations in the Office of Regulatory Affairs (ORA). In this role, Dr. Miller 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.

Prior to assuming her current position, Dr. Miller was the Vice President for U.S. Public Policy & Regulatory Affairs at  U.S. Pharmacopeia (USP), where she worked closely on FDA regulatory issues and was responsible for helping develop and achieve USP’s regulatory science and intelligence, government affairs, and public policy programs’ goals. She also created strategic change initiatives focused on impacts and results based on engagement with federal, state, and international regulators, as well as senior leadership in industry, academia, and patient-focused alliances.

Before assuming that position with USP in in 2016, Dr. Miller worked in the FDA’s Center for Drug Evaluation and Research (CDER) in 2007 in the Office of Unapproved Drugs and Labeling Compliance (OUDLC). She began her work at CDER 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 her initial time at the FDA, Dr. Miller worked at USP as a scientific liaison on medication safety standards for nomenclature, labelling, and packaging, and as the director of drug information for the USP Drug Information publication. She began her pharmacy career as a clinical pharmacist at MedStar Washington Hospital Center in Washington D.C. 

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

Joshua Nipper

Director, Division 1: Division of Submission Support, Office of Regulatory Programs, FDA-CDRH

Josh joined ODE in 2002 in the Gastroenterology and Renal Devices Branch, where he primarily reviewed hemodialysis, obesity, and endoscopic devices. Josh moved to the Division of Radiological Health in OIR in 2010, where he reviewed ultrasound devices, medical imaging software, and other medical imaging devices. Beginning in 2013, he took on the role as branch chief of the General Surgery Devices Branch 2 in the Division of Surgical Devices, which focused on laparoscopic, electrosurgical, ablative energy, and robotic assisted surgical devices. Josh started as the Director of the PMA staff in January of 2016. Josh received his bachelor’s degree in biomedical engineering in 2000 from Vanderbilt University and his master’s degree from the University of Florida in 2002.

Brendan O’Leary

Acting Director, Digital Health Center of Excellence, FDA DHCoE CDRH

Szymon Perkowski

Head of Quality, BetterOmics

Marla Phillips

CEO & President, Pathway for Patient Health

Phil Pontikos

National Device Expert, FDA-OMDRHO-ORA

Phillip Pontikos is a Medical Device National Expert working for the Office of Regulatory Affairs (ORA) of the Food and Drug Administration. Mr. Pontikos joined FDA in 1994 as an Investigator in the Brunswick, Ohio Resident Post of Cincinnati District. In 2000, Mr. Pontikos moved to the Columbus, Ohio, where he currently resides.

Mr. Pontikos previously held the position of Cincinnati District Medical Device Specialist until January 2010 when he became the Medical Device National Expert. Mr. Pontikos is responsible for conducting medical device inspections domestically and abroad. He is a Level II Certified Medical Device Investigator and Medical Device Performance Auditor. Mr. Pontikos has assisted in the development and actively participates as a trainer for numerous FDA courses including Computer Aided Inspections, Basic Medical Device, Industrial Sterilization for Drugs/Devices, and Process Validation. He has also served as a mentor and acting Supervisor. Mr. Pontikos has also given numerous lectures at various medical device and pharmaceutical conferences.

Mr. Pontikos received a bachelor’s degree in physics with a concentration in computer hardware systems from Kent State University.

Abby Pratt

Senior Vice President, Global Strategy & Analysis and Staff Lead, Supply Chain, AdvaMed

Arnab Ray

Abbott

Fatemeh Razjouyan

Director of Regulatory Policy, International and Harmonization / Global Regulatory Policy, Medtronic

As part of Medtronic’s global regulatory policy team in Washington DC, Fatemeh is actively shaping the global regulatory landscape to promote harmonization. She represents Medtronic in industry working groups and coalitions to advance Medtronic’s goal of helping patients access safe and innovative therapies. Fatemeh was previously the head of U.S. regulatory policy in B.D. Prior to that, she held various roles in the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration (FDA). Fatemeh’s CDRH experience includes serving as a Lead Scientific Reviewer and Biomedical Engineer in the Office of Device Evaluation, including assignments in the Office of Combination Products, the Office of the Commissioner, and the Office of the Center Director, where she worked on new regulations and policy. From 2013 to 2018, she served as a policy analyst and program manager in the Office of In Vitro Diagnostics and Radiological Health (OIR), where she led OIR’s 510(k) review program, trained review staff, drafted guidance documents and work instructions regarding the 510(k) program, and assisted in the implementation of the Medical Device User Fee Act (MDUFA) and regulatory policy for the 510(k) program. During her tenure at OIR, Fatemeh was the public face of OIR on several FDA policy issues, including OIR 510(k) review practices. Fatemeh is the recipient of multiple awards during her tenure at the FDA. Fatemeh received her B.S. in biomedical engineering and M.S. in electrical engineering from George Washington University. 

Chris Reed

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

Debara Reese

Consumer Safety Officer, FDA-OMDRHO-ORA

Anne Reid

Acting Program Director of the Office of Medical Devices and Radiological Health, ORA – OMDRHO

Linda Ricci

Division of All Hazards Response, Science and Strategic Partnerships, FDA – CDRH

Thor Rollins

Senior Director of Toxicology and E&L Consulting, Nelson Labs, LLC

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, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements.

Rosecrans’ accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA) and Food and Drug Administration Modernization Act (FDAMA). Rosecrans’ extensive experience at CDRH, and specifically the 510(k) office, enabled her to become one of the nation’s leading experts on the program. Rosecrans’ tenure also allowed her to play a pivotal role in the program’s development and reform. Rosecrans has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with CMS and other regulatory agencies.

Aftin Ross

Senior Project Manager, Staff Fellow, FDA-CDRH

Amanda Rucker

Cook Medical

Michael Ryan

Deputy Director, Office of Regulatory Programs, FDA CDRH OPEQ

Scott Sardeson

International Regulatory Affairs and Quality Compliance Director, 3M

Brian Savoie

Vice President, Education & Professional Development, Regulatory Affairs Professionals Society (RAPS)

Jeff Shuren

Director of the Center for Devices and Radiological Health, FDA-CDRH

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. Dr. Shuren received his B.S. and M.D. degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He received his J.D. from the University of Michigan. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.

Josh Silverstein

Regulatory Advisor, Office of Device Evaluation, FDA-CDRH

Stephen Smith

FDA

Connie Soves

FDA

Nicole Taylor-Smith (Invited)

Vice President, Global Regulatory Policy, Medtronic

Keisha Thomas

Associate Director for Compliance and Quality, FDA-CDRH

Melissa Torres

Associate Director for International Affairs, FDA OCD-CDRH

Kim Trautman

Managing Director and Vice President, MEDIcept Inc.

Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. Most recently, she was focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program.

Ms. Trautman was previously Associate Director for International Affairs in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485.

Erik Vollebregt

Axon Lawyers

Monica Wilkins

Vice President Regulatory and Quality, Abbott

Monica joined Abbott in 2007 and provides strategic support and technical expertise to the medical device Divisions within Abbott. Prior to joining Abbott, Monica worked for the Food and Drug Administration (FDA). In her 12 years of FDA related experience, she held the positions of Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator. Prior to FDA, her career included 14 additional years of employment in the regulatory, computer, healthcare, and pharmaceutical industries holding the positions of Research Assistant, Quality Control Technician, Microbiologist, Supervisor, Manager, Specialist, Director, and Consultant. Monica has a bachelor’s degree in microbiology from the University of Texas at Austin.

Yu Zhao

Founder & President, Bridging Consulting LLC

In 2022, this conference was co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.