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 2018 speakers and moderators are being added often.
Director, Regulatory Policy and Technology Corporate Regulatory Affairs
Steve has spent over 25 years in industry, with 20+ years of increasing responsibility for pre- and post -market regulatory support of biologics, devices, drugs, and combination products. His formal regulatory experience began in 1992, when he joined Allergan Pharmaceuticals as Director, Worldwide Regulatory, and Responsible Head for the company’s Botox biologic.
In 1994 he joined Baxter’s Fenwal Division as Vice President, Regulatory Affairs, and for the next 10 years he led a global regulatory team with responsibility for the division’s 510(k), PMA, and NDA products used in blood component processing and delivery. While at Baxter Steve also gained extensive experience with CE marking of medical devices in the EU, including Class III devices incorporating medicinal products. In 2005 Steve joined Becton Dickinson and Company (BD) as Director of Regulatory Affairs in BD’s Corporate research center, BD Technologies, where his responsibilities included providing support for technology development efforts in areas including diagnostics, cell and tissue technologies, and advanced diabetes care. In 2011 he also took on responsibility for the Women’s Health and Cancer Regulatory team in BD’s Diagnostics Systems business. In August 2014 he transitioned to a new Corporate Regulatory Affairs role as Director, Regulatory Policy, Technology, and Communications for BD. He is active in a number of medical device and IVD policy issues on behalf of BD through his involvement in AdvaMed and several industry coalitions.
Steve obtained his Ph.D. in immunology from Kansas State University and has an MBA from the University of St. Thomas, 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.
Deputy Director for Regulatory Affairs, Office of Compliance
FDA - CDRH
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.
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.
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.
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.
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.
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.
Senior Director, Global Technology
Chris hold degrees in chemical, biomedical engineering, and project management. He has 25 Years in industry with experience in commercial and development areas. Chris has held varying technical and operational roles including Development Site Director in Cincinnati, Sr. Director in Global Engineering, and Global Serialization Program Manager.
Executive Director, MDSAP Regulatory Certification
Brian Ludovico has over 20 years’ experience in medical quality systems and certification requirements. He was formerly with the certification body TUV Rheinland North America (TRNA) Group for 21 years, most recently as the certification manager. He was responsible for the management of the Canadian Medical Devices Conformity Assessment System (CMDCAS) and the Medical Device Single Audit Program (MDSAP).
Assistant Director for Science, Office of the Center Director
FDA - CDRH
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.
Global MDSAP Manager
BSI Group America
Patricia L. Murphy is the Global MDSAP Manager, at BSI, with responsibility for all aspects of the Medical Device Single Audit Program. Patty will be responsible for maintaining BSI’s leadership role as the MDSAP program moves from the Pilot Phase into the Operational Phase. This will be accomplished by continuing to develop the competence of our assessment staff to meet the needs of our customers. Patty has worked in Medical Devices and Quality Assurance for over 25 years. Patty’s most recent role has been as VP of Quality Assurance and Regulatory Affairs for a US based Medical device manufacturer. Prior to that, she worked as Director of Quality Assurance, Principal Consultant and Certification Manager for a EU-based Certification Body.
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.
University of Cincinnati, College of Law
Professor O’Reilly has been involved with FDA issues since 1974. He authored the standard reference encyclopedia on FDA for westgroup.com, which the U.S. Supreme Court quoted with the words, “The experts have written…”. He chairs the FDA committee of the American Bar Assn., is on the editorial board of the Food & Drug Law Journal, formerly chaired the programs committee of the Food & Drug Law Institute, and was keynote speaker at the FDA’s midwest celebration of its 100th anniversary in 2006. Before his academic career, he was principal FDA legal adviser for Procter & Gamble, and is the last active member of the team that negotiated the terms of the 1976 medical device amendments. He has published 51 texts and 215 articles since 1977.
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.
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.
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, Regulatory and Quality Systems
Meridian Bioscience, Inc.
Susan has over 25 years of experience in the in vitro diagnostic device (IVDD) industry. Since joining Meridian Bioscience, she has been responsible for the quality oversight of Meridian’s diagnostic and Life Science affiliates in the US and Europe. She has extensive experience in due diligence assessments, design controls, quality auditing, process development, regulatory submissions and product training for both the IVDD and blood products industries. Susan earned her Bachelor of Science Degree from Arizona State University and her Master of Science Degree from the University of Cincinnati. She has authored numerous journal articles on blood group serology and has served as an editor for several reference books.
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.
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.
Nancy Singer founded Compliance-Alliance LLC in 2004 to specialize in the professional development for government, association and business professionals. She has taught over 1700 people how to improve their communication practices. She is on the faculty of George Washington University Medical School and Health Science Program, and she has taught classes at Johns Hopkins University, University of Southern California, and Harvard Symposia. Previously she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.
Associate Director for International Affairs, Center for Devices and Radiological Health
CDRH - FDA
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, Regulatory Affairs
April Veoukas is Director, Regulatory Affairs in Abbott Laboratories’ Quality & Regulatory corporate division. During her more than twenty years at Abbott, she has held positions in research and development, technology acquisitions, and regulatory affairs. In her current position, she has responsibility for a cross-business forum comprised of regulatory leaders, representing Abbott in trade associations, regulatory intelligence, and formulating company responses to proposed regulatory policies.
April earned a juris doctorate from DePaul University College of Law and a bachelor of science in biology magna cum laude from Loyola University of Chicago. She holds a Certificate in Health Law from DePaul University College of Law. April is a member of the Regulatory Affairs Professional Society (RAPS) and the industry co-chair of the AdvaMed 510(k) Working Group and the AdvaMed Benefit-Risk Subgroup.
Sr. Director, Quality & Technical Services
Michael Viscido is currently the Sr. Director, Quality & Technical Services for Mallinckrodt, Inc. in the Hospital Therapies business unit. In this role, he is responsible for leading the development and implementation of Supplier Quality Systems, Internal Quality Compliance, Quality Engineering, Product Monitoring & Technical Services activities in addition to providing site quality leadership for both domestic and international sites.
Mr. Viscido holds an M.S. in engineering management, is a Senior Member of the American Society for Quality (ASQ), holds 4 ASQ Certifications (CQA, CQE, CRE, CQM) and is RAPS RAC-US certified. He has over 25 years of experience in the practice of Quality Assurance in the Medical Device and Pharmaceutical Industries and serves on the George Washington University Regulatory Affairs Program Advisory board.
Senior Manager, Informatics & Analytics
Abbott Laboratories, Diagnostic Division
Mohammed has over 18 years of experience in Software Engineering and Healthcare industry. In addition to leading teams that delivered healthcare products at Abbott Laboratories, GE Healthcare and Allscripts, Mohammed also designed a modern Agile based Quality Management System at Abbott. Mohammed also leads a team that develops algorithms for efficient Complaints Investigations.
Mohammed was also the Founder and CTO for Casheer, a Fintech startup in Crypto Currency space. Mohammed holds a Masters Degree in Computer Science. And also has a Bachelors Engineering degree in Electronics and Instrumentation.
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.