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 2019 speakers and moderators are being added often.
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.
Consumer Safety Officer
Consumer Safety Officer
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.
Deputy Director for Regulatory Affairs, Office of Compliance
CAPT Sean M. Boyd serves as the Deputy Director for Regulatory Affairs in the Office of Compliance 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 has been with the Food and Drug Administration since 1990. Prior to taking the compliance officer position, she was the Medical Device Specialist in the Cincinnati District Office for seven years. She is still a medical device performance auditor; and the majority of her case work involves medical device firms. She graduated from Thomas More College with a bachelor’s degree in biology and an associate degree in chemistry.
Senior Director, Regulatory Affairs
Bill Brodbeck is 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. He is the Regulatory lead for sterility assurance products (SAPs) including biological indicators & chemical indicators as well as Vaporized Hydrogen Peroxide (VHP) Low Temperature Sterilization Systems.
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. He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) sterilizations standards committee.
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, Global Regulatory Policy & Intelligence
Johnson & Johnson
Executive Vice President, Regulatory Compliance
David Elder brings more than 30-years of extensive regulatory experience to his role as Executive Vice President for Regulatory Compliance at Greenleaf Health.
A 23-year veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), David served as a senior FDA official with prominent roles in domestic and foreign inspections; recalls and emergencies; and compliance actions involving hundreds of situations. He has testified in federal court and before Congress, initiated and approved enforcement actions, and represented the FDA during national media events. Additionally, David has received numerous honors, including the Distinguished Service Medal.
David began his FDA career as an Investigator in the Boston District Office where he conducted domestic and foreign inspections and investigations in various program areas. He was selected as a Compliance Officer and later as the Director of the Compliance Branch with responsibility for assessment of inspection reports, initiation of compliance actions and evaluation of compliance action effectiveness.
David transferred to FDA headquarters when he was selected as the Director of the FDA Office of Enforcement in 2003, a position he held for the next six years. In this Senior Executive Service position, David led the Office with responsibility for agency enforcement policy, agency recall policy and operations, and enforcement strategy and case review. In 2009, David transferred from the Office of Enforcement to the Office of Regional Operations where he led the Office with responsibility for policy and operations related to foreign inspections, domestic inspections, import operations and field science. In both roles, David served as a principal advisor to FDA’s Associate Commissioner of Regulatory Affairs.
Prior to joining Greenleaf, David served as Vice President with PAREXEL International. During this time, he traveled to client locations across the U.S. and in 14 foreign countries, conducting audits and mock inspections; providing training, coaching and mentoring; advising clients with the development and communication of corrective actions that meet FDA expectations and that achieve and sustain compliance.
At Greenleaf, David will continue to provide strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems, developing compliance strategies, ensuring inspection readiness, assisting industry clients and legal counsel in developing and communicating corrective actions plans in response to compliance issues, and performing due diligence activities. David also continues to communicate expert advice through presentations at FDA and industry conferences and through articles published in industry journals.
David received a B.S. degree in electrical engineering from Boston University and attended executive management courses at Harvard University.
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 has also served as the ophthalmic technical reviewer for one of the most highly respected notified bodies in Europe for awarding CE mark certification.
Dr. Fant is an active member of the ophthalmic community. 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.
Dr. Fant frequently trains established companies in the process of medical device development, FDA regulations, and Good Clinical Practices; and provides customized in-house training on various aspects of regulatory and clinical affairs for several leading educational providers.
Dr. Fant holds a B.S. in pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati.
VP LOCs & Global Quality Lead
Georges France is Vice President and Global Quality Lead for the Local Operating Company (LOC) at GSK Consumer Healthcare. he is responsible for setting up and managing Quality for all LOCs at Consumer Healthcare. Prior to joining GSK, Georges was Global in-Country Quality Head at Novartis OTC. Georges joined Novartis in March 2012. Previously he worked at Pﬁzer as a Vice President of Global Quality Strategy and Global Aﬃliates Quality. Prior to that, he worked at Wyeth for 12 years, spending the ﬁrst six years in the French aﬃliate as the head for QA and Regulatory aﬀairs. In 2005, Georges became Vice President, Quality and Compliance in Europe, Middle East and Africa. Earlier in his career, Georges spent six years with Fisons, a company in the United Kingdom that specialised in asthma. He joined Schering Plough when Rhone Poulenc Rorer acquired Fisons. Georges holds a Doctorate in Pharmacy and a post-graduate degree in Pharmacology and completed the INSEAD Advanced Management Program. He was EPFIA topic leader in the Expert working Group for the ICH Q10 guidelines as the ICH Q8, Q9 and Q10 IWG, today he is an EFPIA Expert for ICH Q12.
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, Cincinnati District
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.
Quality Assurance Consultant
Rania brings to Qserve more than 12 years of experience in product development, quality engineering, and quality management system development. Rania has held various positions in small and large medical device companies, developing a diverse range of devices; including neuro-regenerative and interventional devices, dental restorative devices, and video integration capital systems.
At the beginning of Rania’s career, she worked at DEKRA Notified Body (formerly KEMA) where she gained strong foundations in EU regulations, CE technical file assessments and auditing to ISO 13485 and the EU-MDD. This experience has significantly shaped Rania’s career as later she held Quality Engineer positions, in which she developed a passion for quality while always integrating the underlying regulations for the everyday tasks of what she accomplished. Rania did not separate the field of quality from regulatory, and that made her an exceptional and a go-to engineer in both Integra Lifesciences and Zimmer Biomet for product development, quality engineering, and regulatory guidance.
Rania has an extensive hands-on experience in successful delivery of quality engineering results. She has been leading activities such as design control cycle, risk management, sterilization, biocompatibility and shelf life studies, design verifications, process validations, test method validations, sampling plans, CAPAs, NCs, post-market surveillance, internal and supplier audits. Prior to Zimmer Biomet, Rania constructed and implemented a quality management system in a startup company to resolve FDA 483s and a US FDA warning letter, and 6 months later, she passed an FDA inspection conducted by one of the toughest inspectors in the US.
Rania has a bachelor’s degree in biomedical engineering from Drexel University and a master’s degree in applied statistics from Rochester Institute of Technology. Rania is a Certified Quality Engineer by the American Society of Quality and she is a Certified ISO 13485:2016 Lead Auditor.
Recalls Acting Branch Chief, Office of Compliance
Head of Global Regulatory Affairs
Laila Gurney is the head of global regulatory affairs at GE Healthcare, where she leads the regulatory affairs function in developing competitive global go-to-market strategies that align with business priorities, and ensures postmarket regulatory compliance. Prior to this, she held leadership roles within GE Healthcare, including as regulatory leader for GE Healthcare's imaging business, MICT & DGS businesses and the Central and Canadian RA organizations. Laila also has served as national Director, Regulatory and Quality at Cardinal Health Canada and Director of Clinical, Quality and Regulatory Affairs for PreMD Inc. Laila is currently a Director on the Board of Directors of the Regulatory Affairs Professional Society (RAPS). She served on the Global Harmonization Task Force Study Group 3 (Quality Systems) as secretary from 2009 to 2012. Laila holds the US and EU RAC credentials.
Director, Regulatory Policy Innovation
Johnson & Johnson Medical Devices
Dennis Hahn, RAC, is currently the Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices. He is 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.
Vice President of Research and Development and General Manager for CoolSculpting
Brad Hauser has served as Vice President of Research and Development and General Manager for CoolSculpting at Allergan since the ZELTIQ Aesthetics acquisition in April 2017. Previously at ZELTIQ, he served as the Senior Vice President of R&D from January 2017 to April 2017 and as its Vice President of R&D from July 2015 to January 2017. Mr. Hauser joined ZELTIQ in December 2013 as Vice President of Product and Clinical Strategy. Prior to joining ZELTIQ, he held multiple leadership roles in the aesthetic industry, including Executive Vice President of Commercial Operations for Cutera, Director of R&D at Medicis and Managing Director of Product and Clinical Marketing at Solta Medical. Mr. Hauser received his Bachelor of Arts in Human Biology from Stanford University.
Senior Program Lead, Regulatory Affairs
Ruth is a Senior Program Lead in Regulatory Affairs, responsible for Ethicon’s Endoscopic & Mechanical Franchises. Ruth has responsibilities related to new product development as well as lifecycle strategies and registration activities. In addition, Ruth develops and executes worldwide regulatory strategies to ensure registration and market access of products globally. SHe brings significant experience to this role with a strong background in medical device regulatory affairs. She has been working in the global regulatory affairs environment for over 10 years.
Ruth graduated from Aston University, United Kingdom, with a B.Sc. (Hons) in biology/computer science and an M.Sc. in telecommunications technology. She is a current member of the Regulatory Affairs Professional Society (RAPS) and has obtained her Regulatory Affairs Certifications (RAC) in the US, EU, and global areas.
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.
OMDRHO Division 1 Recall Coordinator
Deputy Center Director for Science, Acting Director for ODE, Acting Director for the Office of Compliance
Dr. William Maisel is a professional in the field of health science. Dr. Maisel currently serves as the Assistant Director for Science and Chief Scientist at the FDA’s Center for Devices and Radiological Health. In this position, he provides leadership in the implementation, development, management, execution, and direction of the Center’s broad national and international biomedical science programs. A major focus in his position is to ensure the safety of medical devices.
Dr. William Maisel is very well-educated in his profession. William received his bachelors of science from the prestigious Massachusetts Institute of Technology. He would go on to attend Joan & Sanford I. Weill College of Cornell University where he received his Doctor of Medicine. William later attended Harvard School of Public Health where he received his Master of Public Health.
Prior to joining the FDA, Dr. William Maisel was an Associate Professor of Medicine at Harvard Medical School. He holds more than 15 years of clinical experience as a Board-certified cardiologist. Dr. Maisel has published over 120 research manuscripts, book chapters, and scientific abstracts on regulatory science, device innovation, and medical device safety and effectiveness.
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.
US VP Regulatory Compliance
Mindy has broad and multi-faceted experience in medical device international regulatory affairs and quality management, having worked for a start-up, large global company and two notified bodies. Mindy’s enthusiasm for regulatory compliance, communication skills and leadership skills make her an effective project manager and engaging trainer. Mindy’s hands-on experience as a development engineer, notified body auditor and technical file reviewer, global certification manager, and regulatory and business executive has led to a practical approach in developing and implementing regulatory strategies and quality procedures; auditing; and writing and reviewing clinical evaluation reports, technical documentation, and clinical investigation protocols and applications.
Executive Director, Regulatory Services, Medical Devices and IVDs
At NSF International, Robyn has the role of Executive Director for regulatory consulting, with a focus on IVDs. She has more than 30 years of experience in the field of IVDs. She has served as senior scientist in large diagnostic laboratories, been the regulator of IVDs with the Australian Therapeutic Goods Administration (TGA) and until recently, was a senior technical officer for Prequalification of IVDs at World Health Organization (WHO) where she played a significant role in developing an assessment procedure suitable for use in emergencies (the EUAL). She has been a member of Australian government laboratory standard setting activities and has been a strong contributor to a number of GHTF and IMDRF working groups. In 2009, Robyn efforts towards laboratory science in Australia were recognized when she was awarded the Distinguished Service Award by The Australian Society for Microbiology.
OMDRHO Division 2 Director, Compliance Branch
Senior Vice President, Quality Assurance, Regulatory and Engineering Services
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.
Associate Center Director for Digital Health
Bakul Patel is a digital-health visionary and entrepreneurial leader focused on creating, shaping, and implementing national and international public health strategies. He has over 28 years of experience in leadership business development, marketing, product management, assessing long and short term needs, establishing objectives, improving organizational performance, and resource management.
Patel is an excellent collaborator, experienced in building effective cross functional teams by establishing and maintaining working relationships with diverse set of internal and external stakeholders. He has strong management, technical and regulatory skills in identifying, analyzing, managing, and solving highly complex issues, policies, procedures, federal regulations, and legislative matters in relation to Food Drug and Cosmetic Act. Patel has a detailed understanding of the regulatory infrastructure needed to balance regulatory requirements with national needs while developing policies and regulations.
He has expertise in medical device regulations, product development processes, software engineering, embedded systems, wireless communication systems, and robotics and control systems. Patel holds a master's degree in electronics engineering, M.B.A. in international business, Six Sigma, and Black-belt certified.
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.
Director, Regulatory Affairs
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.
Worldwide Director Market Access and Reimbursement - Diabetes Care
Dr. Jim Prodafikas joined Becton Dickinson in 2018 as the Worldwide Director of Market Access and Reimbursement for the Diabetes Care business. Jim began working in the pharmaceutical industry for Roche in 2002 and spent the first 12 years of his career in varying roles of increasing scope and responsibility in clinical development and medical affairs, ultimately focusing on medical affairs activities as they relate to reimbursement with AstraZeneca. This lead him to his role as a Global Market Access lead for Merck for the Hospital/Acute Care business. He holds a B.S. in Biochemistry from University of Rochester, and a Ph.D. in Pharmacology from the State University of New York – Buffalo.
Executive Vice President, Medical Devices & Combination Products (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.
District Recall Coordinator
Medical Officer, Office of Compliance
Adam E. Saltman, M.D., Ph.D. 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. In 2013, he joined FDA as a Medical Officer in the CDRH Office of Compliance. In addition to reviewing manufacturer recalls, signals, and manufacturer communications, Dr. Saltman has been leading CDRH’s cross-cutting policy revisions concerning benefit-risk and corrections and removals, projects for which he has developed decision analysis tools that advance FDA’s mission to protect and promote the public health.
Dr. Saltman is a fellow of several professional societies, has published more than 100 peer-reviewed articles, has advanced training in Health Informatics, and is certified as a Quality Improvement Associate by the American Society for Quality.
Vice President of Quality and Regulatory Affairs
Fisher & Paykel
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.
Chief of Premarket Notification (510(k)) Section
Marjorie Shulman is the Director for the Premarket Notification (510(k)) Program in the Office of Device Evaluation (ODE), Center for Devices and Radiological Heath (CDRH), Food and Drug Administration. Ms. Shulman has been with CDRH since 1984. Before serving on the 510(k) Staff she was on the Premarket Approval Staff. Ms. Shulman is also the Reclassification/Classification Coordinator for CDRH. Some of her 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), FDA Modernization Act (FDAMA) and the Food and Drug Administration Safety and Innovation Act (FDASIA). Ms. Shulman has been on numerous policy setting groups within the FDA. Most recently she has been very active with the 510(k) Working Group whose mission it is to evaluate the 510(k) program and explore actions CDRH could take to enhance 510(k) decision making, 21st Century Cures and reauthorization of MDUFMA. Ms. Shulman received her undergraduate degree from the University of Maryland, University College, and received her MBA from Hood College in May 1997.
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.
Vice President, Health Guidance Organization
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.
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.
Since the beginning of CE marking more than 24 years ago, Klaus is the Managing Director of MEDCERT GmbH, a German Notified Body for the Medical Devices Directive 93/42/EEC. Before he founded MEDCERT GmbH in 1993, we was working for more than 10 years in Regulatory Affairs and Quality Management for 3M and Johnson & Johnson in Germany.
Unlike most other Notified and Certification Bodies, MEDCERT focus exclusively on medical and the medical devices industry. With subsidiaries in China, Malaysia and in the USA, MEDCERT is one of the top 10 Notified Bodies today.
Klaus holds a master’s degree in biomedical engineering from the Technical University of Berlin.