The FDA/Xavier MedCon speakers are hand-selected by the MedCon Strategic Committee to deliver purpose-driven content that dives below the surface, challenge status quo, engage attendees in collaborative dialog, and provide practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussion. Additional MedCon 2020 speakers and moderators are being added often.
Vice President, Strategic Business Development, Global Medical Health Services (MHS)
TÜV SÜD Product Service
Dr. Akra is vice president at TÜV SÜD Product Service responsible for the global teams of active implantable, cardiovascular, orthopedic, aesthetic devices and clinical. He is involved in the development of different guidance documents, standards and regulatory documentation at the European and international level. Dr. Akra represents TEAM NB and NB MED in various task forces in Europe.
SB RegConsult LLC
Steve spent 36 years in industry, with 30+ years of increasing Regulatory responsibility for pre- and post-market regulatory support of devices, IVDs, biologics, drugs, and combination products. His formal regulatory leadership began in 1992, when he joined Allergan as Director, Worldwide Regulatory. In 1994 he joined Baxter’s Fenwal Division as Vice President, Regulatory Affairs. In 2005 Steve joined BD’s Corporate Regulatory team, culminating in the position of Senior Director, Regulatory Policy for the company. Steve has extensive experience on a wide range of regulatory issues, and often served as a senior contact with FDA on critical matters. He was active on a variety of regulatory policy issues through his involvement in AdvaMed and various industry coalitions, including the Combination Products, Clinical Decision Support, and 510(k) coalitions. Currently, Steve provides Regulatory Strategy and Compliance support to medical device, IVD, biologics, and drug manufacturers. Steve obtained his Ph.D. in immunology from Kansas State University and holds an MBA in general management from the University of St. Thomas in St. Paul, Minnesota.
Global Quality Leader – Drug Delivery System Development
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.
Executive Director & Partner
Gert is an expert in European regulations based on 15 years 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 over the last 15 years he has been awarded as Fellow of RAPS.
Director, Office of Regulatory Programs, OPEQ
CAPT Sean M. Boyd serves as the Director for Regulatory Programs in OPEQ at FDA’s Center for Devices and Radiological Health (CDRH). In this capacity, he is responsible for managing the Center’s quality initiatives, as well as regulatory compliance and enforcement programs for the medical device industry.
Prior to joining the Office of Compliance in 2015, led and transformed many aspects of CDRH’s electronic product radiation control program. 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.
CAPT Boyd is an active duty commissioned officer in the United States Public Health Service (USPHS). He is also the Team Commander for one of two Washington DC-based medical response teams (PHS-1 Rapid Deployment Force); and has deployed in response to several disasters and crises, both domestically and abroad. His experience also includes serving as Executive Officer of the Monrovia Medical Unit (an Ebola Treatment Unit) in Liberia, Africa; where the USPHS Commissioned Corps provided care to healthcare workers infected with Ebola Virus Disease.
OMDRHO Division 1 Director, Compliance Branch
Gina Brackett was selected as the Director of Compliance Branch for Division of Medical Device and Radiological Health (OMDRHO), Division 1 in March of 2018. She has been with the FDA for 28 years and prior to her current position served as a Compliance Officer in the Cincinnati District Officer from 2002-2018. She was a Medical Device Specialist forseven years and during this time was 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.
Senior Director, Regulatory Affairs
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.
NSF PROSYSTEM GmbH
Sandra Bugler is the Managing Consultant for Clinical Affairs at NSF PROSYSTEM GmbH, which is one of the world's leading consulting and service companies in medical technology. After successfully completing her Master of Science degree in Medical Engineering, Ms. Bugler worked in the areas of Regulatory and Clinical Affairs.
At NSF PROSYSTEM she established a team of Clinical Affairs specialists. Since then, her professional focus has been on clinical evaluations and clinical investigations. As author and reviewer of numerous clinical evaluations, she has successfully implemented the new requirements of the Regulation (EU) 2017/745 and the 4th revision of MEDDEV 2.7/1 in her projects. In addition, Ms. Bugler has experience in the implementation of processes and the approval of medical devices. She also conducts trainings on clinical affairs topics for manufacturers.
Cybersecurity Program Manager
Dr. Carmody is the Cybersecurity Program Manager for the Center for Devices and Radiological Health, serving as co-chair of CDRH’s Cybersecurity Working Group. The Cybersecurity Working Group is an interdisciplinary team responsible for the FDA’s final pre- and post- market cybersecurity guidances as well as incident response. Seth joined CDRH in 2011 as a medical device reviewer.
Senior Researcher and Research Program Coordinator
LCDR James Coburn is a Senior Researcher and Research Program Coordinator in the FDA’s Center for Devices and Radiologic Health (CDRH). He currently leads the Agency’s Additive Manufacturing Core Facility and his primary research focuses on patient-based design factors for additively manufactured medical devices as well as manufacturing variability with advanced manufacturing methods. He also performs research and reviews in human factors and rehabilitation devices, using advanced computing, and motion capture to assist patient recovery. LCDR Coburn Co-chairs the Agency’s Advanced Manufacturing Technologies Working Group, which is responsible for coordinating Agency research, technical knowledgebase, and interactions with external stakeholders across medical product areas. As part of this effort, LCDR Coburn performs outreach to industry and consumer stakeholder groups that are using emerging and innovative technologies, such as the Manufacturing USA Institutes of America Makes and NIIMBL.
Investigator, Medical Device Specialist
Ben has been with the FDA since 2000 conducting both domestic and foreign inspections of medical device manufacturers. Ben has conducted numerous industry presentations and has worked with other government agencies such as FBI, US attorney’s office and DOJ. Prior to joining FDA, he held positions of certified Senior Clinical Research Coordinator, CCRC, at Case Western Reserve University/ University Hospitals, Andrologist / Embryologist at Mt. Sinai Hospital and has conducted NIH sponsored research at the Cleveland Clinic Foundation. Ben is a graduate of Miami University, Oxford, OH.
Vice President, Regulatory Affairs
Mike Ebers is Vice President, Regulatory Affairs at STERIS Corporation in Mentor, Ohio. Mike has responsibility for FDA and international medical device submissions as well as US EPA and international disinfectant registrations. Mike also provides support to the STERIS compliance group with meeting both FDA and international requirements.
Mike received his Bachelor’s degree in chemistry from Missouri State University and his M.A. in Business Management from Webster University in St Louis, MO.
President and Principal Regulatory Consultant
Clinical Research Consultants, Inc.
Barbara Fant, Pharm.D. is the President and Principal Regulatory Consultant of Clinical Research Consultants, Inc. (CRC), and has 30 years of experience in pharmaceutical and medical device research and development. Dr. 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. Dr. Fant has successfully filed over a hundred IDE’s, pre-IDE’s, 510(k)’s, and PMA’s with the FDA to bring investigational products to the marketplace. Dr. Fant 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. Dr. Fant holds a B.S. in pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati.
Principal Deputy Director, Office of Product Evaluation and Quality
Dr. Owen Faris is the Principal Deputy Director of the Office of Product Evaluation and Quality (OPEQ) in the Center for Devices and Radiological Health at the FDA. Dr. Faris received his B.S. in Mechanical Engineering from Rice University, and his Ph.D. in Biomedical Engineering from Johns Hopkins University. Dr. Faris joined the FDA in 2003. Prior to his current role, Dr. Faris was the Director of the CDRH’s Office of Clinical Evidence and Analysis, an office within OPEQ. In his role as Principal Deputy of OPEQ, Dr. Faris oversees and guides CDRH’s decisions and actions related to pre and post-market activities across OPEQ’s seven Offices of Health Technology as well as the Office of Clinical Evidence and Analysis and the Office of Regulatory Programs.
OMDRHO Division 1 Director, Investigations Branch
Arduino “Dino” Frankovic is currently the Director of Investigations for the Office of Regulatory Affairs’ (ORA) Office of Medical Devices and Radiological Health Operations (OMDRHO) Division 1. Dino has been with the FDA since 2002 as a Consumer Safety Officer, Supervisory Consumer Safety Officer and his current position as Director of Investigations all spent in the New York District Office. Dino began his career in private industry working for a small medical device manufacture of cardiovascular diagnostic devices. In his twelve years with the firm he wore multiple “hats” that included serving as a regulatory, production and service manager. In his role as regulatory manager Dino was involved in the development and implementation of the firm’s overall quality system, submission of 510 (k)’s and ensuring the firm’s compliance with the FDA’s quality system regulations, the European Medical Device Directive, and ISO 13485 standard. In 2002 Dino decided to join the FDA as a consumer safety officer, where he focused on medical device inspections, both domestic and foreign. Dino graduated from the New York Institute of Technology, Old Westbury, NY in 1990 with a bachelors degree in electrical engineering.
Investigator, Medical Device Specialist
Laureen Geniusz has been a field Investigator with FDA for over 28 years, with about 20 years of that as a Medical Device Specialist. She has a B.A. degree from Bowling Green State University with a major in biology/chemistry. She has worked on numerous legal cases and has worked jointly on potential criminal cases with the AUSA and local FBI. She routinely conducts domestic and international inspections and has been involved with numerous regulatory actions, such as: Warning Letters, Seizures, and Injunctions. She has also trained numerous field investigators and was an internal performance auditor.
Principal Regulatory Consultant
Clinical Research Consultants, Inc.
Dennis Hahn, RAC, was most recently Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices. He was responsible for ensuring global regulatory policies are appropriately interpreted, effectively communicated and efficiently implemented in the ETHICON surgical device businesses.
He has worked in the medical device industry for over 30 years, the past 23 in Regulatory Affairs. Mr. Hahn has broad experience with in the registration of medical devices globally, with numerous product approvals to his credit, in the US, Japan, China, Brazil, European Union and other regulated markets around the world. He received his Bachelor of Engineering degree in chemical engineering from the Stevens Institute of Technology.
VP, Johnson & Johnson Sterility Assurance
Johnson & Johnson
Senior Manager Quality - Product Security
Tyrone is a Senior Manager responsible for Product Security and Quality integration at BD. Tyrone leads a global quality network geared towards the implementation and standardization of existing and emerging product security (cybersecurity) requirements for medical devices. He also helps develop emerging policies, regulations and business unit specifications while maintaining Product Security compliance and objectives across BD. Tyrone holds a Bachelor of Science in Management and Information Systems from Rutgers University in New Jersey. When Tyrone isn’t glued to his computer screen, he enjoys spending time with family & friends, reading, playing basketball, and thrill seeking through sports like skydiving, snowboarding and Spartan races.
Vice President of Regulatory Affairs
Acting Deputy Division Director, Division of Immunology and Hematology Devices, Office of In Vitro Diagnostics and Radiological Health
Partner, FDA and Life Sciences Practice
King & Spalding
Amanda Klingler is a partner in King & Spalding’s Washington, D.C., office and is a member of the firm’s FDA and Life Sciences practice. As a partner in our FDA and Life Sciences practice, Amanda advises pharmaceutical and medical device clients in a wide range of regulatory matters, enforcement actions, civil litigation and compliance counseling.
Amanda represents clients in a variety of FDA regulatory matters, enforcement actions, civil litigation, internal investigations and compliance counseling. She also counsels clients on adverse event reporting, quality system and manufacturing processes for drugs and medical devices, factory inspections, recalls, product labeling, and advertising and promotion issues. Amanda has also assisted in the negotiation and management of several consent decrees of injunction for pharmaceutical, medical device, food companies and compounding pharmacies. In addition, Amanda is experienced in handling FDA issues in product liability litigation, including the development of supporting evidence, writing briefs, and preparing fact and expert witnesses to testify.
Associate Director, Regulation, Policy and Guidance Staff, Office of Product Evaluation and Quality
Angela Krueger is the Acting Deputy Director for Engineering and Science Review in the Center for Devices and Radiological Health’s Office of Device Evaluation (ODE). In this role, she provides direction for premarket review policies and programs within ODE.
Prior to serving as the Acting Deputy, Ms. Krueger was ODE’s Associate Director for Guidance and Regulations and provided oversight of all guidance and regulation efforts for the office. Ms. Krueger has also served as a regulatory advisor and policy analyst in ODE and as CDRH’s Product Jurisdiction Officer. She started her career at FDA as a scientific reviewer in the Division of Cardiovascular Devices in 2002. Ms. Krueger holds degrees in chemistry and journalism from Butler University, Indianapolis.
OMDRHO Division 1 Recall Coordinator
Andrew Lang serves as a Recall Coordinator in the Office of Medical Device and Radiological Health Operations (OMDRHO), Division 1. He has been working in this position since March 2018. Andrew has been with the FDA since August 2009. Prior to working as a Division Recall Coordinator, Andrew served as an Investigator for the Cincinnati District as well as the Dallas District, and he was most recently a Compliance Officer in the Cincinnati District. Andrew received a bachelor of science degree in biology from Mount Union College in Alliance, Ohio.
Export Policy Specialist
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.
Senior Director - Aseptic Processing & Terminal Sterilization
Johnson & Johnson
Program Coordinator, Medical Device Single Audit Team, Division of International Compliance Operations, Office of Compliance, Center for Devices and Radiological Health, Office of Medical Products and Tobacco
LCDR Neil A. Mafnas is the Program Coordinator for the Medical Device Single Audit (MDSAP) Team in the Center for Devices and Radiological Health, Office of Compliance, Division of Import Compliance Operations. As part of the MDSAP Team, LCDR Mafnas’ duties focus on serving as the lead MDSAP project manager, ensuring that the international consortium successfully executes program operations and deliverables. LCDR Mafnas is also charged with training and outreach for FDA staff, and serves as an MDSAP CDRH liaison for FDA’s Office of Regulatory Affairs. During his career, he conducted Quality System (QS) regulation reviews of Establishment Inspection Reports (EIRs), classified Medical Device Recalls, led Health Risk Assessments of device failures, investigated and processed medical device complaints, assisted with regulatory cases and provided inspectional guidance to FDA District Offices. LCDR Mafnas spent just over six years as an active duty U.S. Air Force Logistics Officer. He received a bachelor of science degree in biology from the University of Texas at Arlington and a master of science degree in health sciences from the University of Central Florida.
Divisional Director, Office of Medical Device and Radiological Health Operations, Division 1
Joseph Matrisciano Jr., “Joe,” is a professional engineer and attorney with over 25 years of managerial experience, nearly 15 of which at FDA. Joe is currently serving as Director for FDA’s New England District Office and Director of the Office of Medical Devices and Radiological Health Operations Division 1. Previously, Joe served as Director of Engineering at FDA’s Winchester Engineering and Analytical Center, FDA’s sole field engineering laboratory responsible for medical devices and radiation emitting products and safety. Joe has served in numerous managerial roles at FDA with responsibilities for various field investigative, compliance and laboratory operations within FDA.
Prior to joining FDA, as a registered professional engineer, licensed attorney and registered patent attorney, Joe held various management and senior level positions in private industry, encompassing engineering, legal as well as intellectual property disciplines.
Lead Quality System & Compliance Consultant
King & Spalding
Mr. Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. While at ORA, Mr. Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting. Mr. Niedelman specializes in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.
Director, Division 1: Division of Submission Support, Office of Regulatory Programs
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.
Director, Division of Digital Health, Office of Science of Technology
Bakul Patel is Director for Division of Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel is leading regulatory policy and coordination of scientific efforts for digital health, software and emerging technologies. Mr. Patel also led the creation of the globally harmonized regulatory framework for “software as a medical device” (SaMD) at the International Medical Device Regulators Forum (IMDRF). Mr. Patel is the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC). Mr. Patel is currently leading the software precertification program in collaboration with all stakeholders to reimagine a regulatory approach for Digital health. Mr. Patel earned an M.S. in electronic systems engineering from the University of Regina, Canada, and an M.B.A. in international business from The Johns Hopkins University.
Investigator, Medical Device Specialist
LCDR Thomas A. Peter serves as a Medical Device Specialist in Division 1 of ORA’s Office of Medical Device and Radiological Health Operations. He is also a commissioned Engineer Officer in the U.S. Public Health Service 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 a former member of ORA’s Medical Device Foreign Inspection Cadre and helped develop ORA’s Medical Device Investigator Certification exam. LCDR Peter holds three ASQ certifications and is a member of the ASQ Certified Biomedical Auditor (CBA) Certification Exam Committee. He earned his Bachelor and Master of Science degrees in Biomedical Engineering from the University of Michigan.”
Compliance Officer/Biomedical Engineer
Tim Philips is a Compliance Officer with FDA’s Office of Medical Device and Radiological Health Operations, Division 2/C, Minneapolis District, where he coordinates advisory and enforcement actions against violators of the Food, Drug and Cosmetic Act. After receiving a degree in biomedical engineering from the University of Iowa in 1986, Tim worked as a Patent Examiner at the U.S. Patent and Trademark Office in Washington, DC, reviewing patent applications for respiratory and diagnostic devices. He joined FDA's Minneapolis District in 1988 and served for 12 years as a field investigator specializing in medical device quality system inspections. In August 2000, Tim accepted his current position as a Compliance Officer. In 2015, he was named FDA’s Compliance Officer of the Year for his role in two precedent-setting FDA enforcement actions. Tim is a frequent speaker and instructor on FDA-related subject matter.
Director, Xavier Health
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in chemistry from Xavier University, and a Ph.D. in organic chemistry from the University of North Carolina – Chapel Hill.
National Device Expert
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.
Director, Regulatory Policy, Corporate Regulatory Affairs
As part of the Public Policy and Government Affairs team located in Washington DC, Fatemeh monitors the US regulatory landscape for emerging regulatory policy issues of importance to BD, and interacts on behalf of the Company with FDA. She represents BD in industry working groups and coalitions to advance BD's goal of helping patients access safe and innovative medical technology. Fatemeh joined BD after over 11 years in the Center for Devices and Radiologic Health (CDRH) at the US 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 early 2018, she served as a Policy Analyst 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 and she worked closely with AdvaMed in addressing industry questions and concerns regarding 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.
Caroline Rhim has nearly 10 years of experience in the medical device and public health sectors. She provides strategic and hands-on regulatory consulting services for clients looking to introduce innovative medical devices to patients. Prior to joining NSF, she served as Branch Chief for anterior spinal devices at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). Dr. Rhim’s extensive regulatory experience includes leading the scientific and regulatory review of premarket submissions for a wide array of novel products in the areas of orthopedic and cardiovascular devices. At the FDA, she was also integral in streamlining the premarket and postmarket review processes, as well as classification efforts for posterior cervical screw systems. Dr. Rhim received Bachelor and Master of Science degrees in materials science and engineering from the Massachusetts Institute of Technology and a doctorate degree in biomedical engineering from Duke University.
Executive Vice President, Medical Devices & Combination Products (and Vice President Regulatory Affairs, MDMA)
Heather Rosecrans brings more than 30 years of public health and medical device experience to Greenleaf Health Inc. Prior to joining Greenleaf, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). In this role, 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.
Dr. Saltman obtained his undergraduate degree from Harvard University, his M.D. and Ph.D. degrees from Columbia University, and trained in general and cardiothoracic surgery on the Harvard/Deaconess Surgical Service. Dr. Saltman is a fellow of several professional societies, has published more than 100 peer-reviewed articles, has a master’s degree in Health Informatics, and is a certified Quality Improvement Associate of the American Society for Quality.
He has worked part-time since 2008 as a Medical Officer in FDA’s CDRH Offices of Device Evaluation and Compliance, leaving his practice in 2017 to work at FDA full-time, now in Clinical and Scientific Policy. His current focus is on developing decision analysis tools that incorporate benefit-risk into CDRH reviewers' work regarding medical device availability, compliance, and enforcement actions, and on developing a new, proactive medical device shortages prevention program.
Vice President of Quality and Regulatory Affairs
Fisher & Paykel
Deputy Director, Office of Strategic Partnerships & Technology Innovation
Vice President, Global Quality Assurance and Regulatory Affairs
Thermo Fisher Scientific
Peter Shearstone joined Thermo Fisher Scientific in 2018 as Vice President, Global Quality Assurance and Regulatory Affairs (QARA), and is responsible for leading the company’s global, corporate QARA team to ensure our products are safe and comply with their intended use. Headquartered in Waltham, Massachusetts, Thermo Fisher is the world leader in serving science; our mission is to enable our customers to make the world healthier, cleaner and safer.
Prior to joining Thermo Fisher, Peter worked in executive-level quality and regulatory roles for 30 years, most recently at Sysmex America, where he served as Vice President, RA/QA/Clinical and Medical Affairs. Prior to that, he held QA leadership roles at Abbott Diagnostics and Siemens Healthcare.
Peter holds a bachelor's degree in biology from Salem State University in Salem, Massachusetts.
Director of the Center for Devices and Radiological Health (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.
Quality Manager Paper Sector
Head of IVD
Sue leads Qserve’s IVD service, she has over 30 years’ experience in the Medical Deviceand IVD industries including extensive notified body experience.Key areas of expertise include IVDD and IVDR regulations, QMS implementation, internal, supplier and compliance audits, risk management, training, and working with small start-up and multinationals.
Sue has worked for several IVD companies ranging from start up to large multinationals, where she has held positions in R&D, manufacturing and quality assurance. Sue worked for 3 notified bodies establishing two from scratch. Sue haired the European IVD Notified Body Working Group coordinating the notified body responses to the regulations. Sue also participated in the Commission IVD Technical Work Group for many years.Sue is an experienced trainer on a variety of IVD topics and particularly enjoys creating workshops to improve hands on experience with the requirements.
VP, Chief Information Security Officer
At BD, Rob serves as Chief Information Security Officer and strategic leader for both enterprise information security and product security organizations. Rob started his career in the Software Engineering department of Siemens Corporate Research and then worked on remote service platforms for medical devices in Siemens Healthcare Diagnostics. Rob was a member of the Department of Health and Human Services (HHS) Health Care Industry Cybersecurity Task Force which delivered its final report to U.S. Congress in June of 2017. As a continuation of the task force, established under U.S. Presidential Policy Directive 21, Rob served as a Chair for the Healthcare Sector Coordinating Council (HSCC) Med Tech Cybersecurity Risk Management Task Group aimed at establishing a voluntary framework, maturity model, and joint plan for improving cybersecurity for medical technology. In the spirit of transparency and collaboration, Rob has worked closely with the FDA on the common vulnerability scoring system for healthcare and sharing security best practices, in addition to the Department of Homeland Security on coordinated vulnerability disclosure. Rob is a Certified HealthCare Information Security and Privacy Professional (HCISPP) and has degrees in Computer Science from Montclair State University.
NSF PROSYSTEM GmbH
Mr. Julian Thorns has around 20 years experience in the medical devices branch and is employed more than 10 years as managing consultant at NSF PROSYSTEM GmbH. He leads the consulting and software division of NSF PROSYSTEM GmbH and he is responsible for the operative business. In addition to his qualification as Lead Auditor, Mr. Thorns advises many established companies in the medical industry and offers expert support for the implementation of current regulatory topics such as the implementation of the new Medical Devices Regulation and the In Vitro Diagnostics Regulation. Mr. Julian Thorns focuses on national and international registrations for medical devices and related technical documentation, usability, risk management, post-market surveillance, vigilance as well as quality management and project management. Furthermore, strategic consulting and support for authority inspections (including MDSAP) are his core competencies. Mr. Thorns also acts as a trainer including training services for different industry training providers.
Executive Vice President, Medical Device International Services
Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She is 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.
Group Manager – Devices Regulatory Affairs
Graeme is Group Manager for Devices Regulatory Affairs at the Medicines and Healthcare products Regulatory Agency (MHRA). He is responsible for teams dealing with notified body oversight, clinical investigation approval, compliance investigations, borderline and classification issues and implementation of new EU medical device legislation.
Graeme has been a civil servant for 15 years and has spent his career working primarily on healthcare policy. He has previously held Deputy Director roles at the Department of Health and spent 18 months as Private Secretary to the Secretary of State for Health.
Graeme has a Master’s degree in biochemistry from the University of Oxford.
Director, Office of Medical Device and Radiological Health Operations
Jan Welch serves as director of the Office of Medical Device and Radiological Health Operations, within the Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA). Ms. Welch leads organizational change to a commodity-based program emphasizing specialization and vertical integration of regulatory processes.
Ms. Welch previously led the Office of Compliance in FDA’s Center for Devices and Radiological Health, overseeing the assessment and enhancement of medical device quality through broad-based FDA change initiatives and daily operations. She was also a quality system expert providing expert opinion on medical device legal cases; developing and presenting extensive training on the quality system regulations, and representing FDA and the U.S. in several international guidance and standards activities.
Previously Ms. Welch worked at the Office of Compliance in the Center for Biologics Evaluation and Research. Before joining FDA, she worked for the American Red Cross, the National Institutes of Health,, and Vanderbilt University Medical Center.
Ms. Welch holds a Bachelor of Science in biology from Wake Forest University in Winston-Salem, NC, and a Master of Health Science in immunohematology from the Medical University of South Carolina in Charleston, SC.
Divisional Vice President of Medical, Clinical, Quality and Strategic Support
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.
Cyber Safety Advocate
I Am The Cavalry
Beau Woods is a Cyber Safety Innovation Fellow with the Atlantic Council, a leader with the I Am The Cavalry grassroots initiative, and Founder/CEO of Stratigos Security. His work bridges the gap between the security research and public policy communities, to ensure connected technology that can impact life and safety is worthy of our trust. He formerly served as Entrepreneur in Residence with the US FDA, and Managing Principle Consultant at Dell SecureWorks. Over the past several years in this capacity, he has consulted with the energy, healthcare, automotive, aviation, rail, and IoT industries, as well as cyber security researchers, US and international policy makers, and the White House. Beau is a published author, frequent public speaker, often quoted in media, and is often engaged for public or private speaking venues.
Vice President, Global Quality
Assistant Director Clinical and Scientific Policy Staff