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.
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.
Senior Director, Regulatory Strategy and Advocacy
Abbott Quality and Regulatory
Philippe represents European Industry in various European Commission expert groups and is the proud recipient of a US FDA CDRH Director’s Special Citation for his engagement with GHTF. Since 2015, he serves as an advisor to the Asian Harmonization Working Party Technical Committee.
He chairs the Post Market Surveillance and the Notified Body Working Groups of association Medtech Europe.
Philippe received a “Global Leadership Award” from the Regulatory Affairs Professional Society (RAPS) in 2010, has been elected “RAPS Fellow” in 2012 and is a member of the RAPS European Advisory Committee.
Program Operations Staff, Office of Device Evaluation
Patrick Axtell, Ph.D., is a biomedical engineer and software developer at the FDA. He graduated from The College of William and Mary with a bachelor’s degree in biology. He graduated from The University of Illinois in Chicago in 2007 with a doctorate’s degree in biomedical engineering with a specialization in neural engineering.
Patrick was a reviewer for restorative and neurological devices for six years, and now works directly for ODE management. While at the FDA, Patrick has developed several templates and tools intended to aid reviewers in the evaluation and processing of several types of medical devices. He has also developed templates intended for use in constructing 510(k)s and other submission types.
Regulatory Head of Global Software Standards
Pat Baird works at Philips as the Head of Global Software Standards. Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and working to develop standards, whitepapers, and training to meet those needs.
Past roles have included software developer, engineering manager, project manager, lead engineer, and most recently he was the Director of Risk Management at Baxter Healthcare. Drawing on 20 years’ experience in product development, he has published and presented over 50 papers regarding product development. He has an M.B.A. and a master’s in healthcare quality and patient safety from Northwestern University.
District Director & Program Division Director, Office of Human & Animal Food, East 5
Steven Barber is the District Director of the Cincinnati District office and Program Division Director for the Office of Human & Animal Food, East 5. During his 25-year career with FDA, Steve has worked in six different field offices (Chicago, Kansas City, Florida, San Juan, Baltimore, and Detroit). Within these districts, Steve served in the laboratory as an analyst conducting food and drug analyses, as an investigator conducting medical device and drug inspections, both domestically and internationally, and as a compliance officer. Steven has served as the Director of the Compliance Branch in FDA’s Detroit District Office since 2008.
Program Division Director, OMDRHO, Division 2 Central
Blake has been with the Food and Drug Administration since 1989. He was an Investigator for 12 years which included conducting foreign inspections. He accepted a Supervisory Investigator position in 2001. Following his participation in the FDA Leadership Program in 2005 and 2006 he became an Operations Director and worked directly with the Associate Commissioner for Regulatory Affairs and other agency leaders involved in ORA strategic planning, budgeting, and organizational initiatives. He became the Director of Compliance for Los Angeles District in 2009 and assumed the Director of Compliance position in Florida District in 2014. He is currently the Program Division Director for Division 2 Central within the Office of Medical Device and Radiological Health Operations. As the Director of Division 2 Central, he leads all device inspectional and compliance activities that formerly resided in the seven District Offices of ATL-DO, CHI-DO, FLA-DO, KAN-DO, MIN-DO, NOL-DO, and SJN-DO.
He graduated from Harding University with a bachelor’s degree in biology, Arkansas State University with a master’s of science degree in biology, and completed a Senior Executive Development program at George Washington University.
Sr. Director, Regulatory Policy, Corporate Regulatory Affairs
Steve has spent 32 years in industry, with 26 years of increasing responsibility for pre- and post-market regulatory support of biologics, devices, drugs, and combination products. His formal regulatory leadership began in 1992, when he joined Allergan 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 BD in Corporate Regulatory Affairs, relocating to RTP in North Carolina as Director of Regulatory Affairs at BD’s Corporate research center, known as BD Technologies. In addition to involvement in Regulatory policy and FDA liaison activities, his BDT role included Regulatory support for technology development in 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, located in RTP and part of BD Diagnostics Systems. In 2014 he transitioned to a newly created Corporate Regulatory Affairs role as Director, Regulatory Policy and is now Senior Director, Regulatory Policy 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 various industry coalitions.
Steve obtained his Ph.D. in immunology from Kansas State University and also 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.
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.
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.
Acting Deputy Director, Clinical, Office of Medical Products and Tobacco, Office of Device Evaluation
Dr. Randall Brockman joined the FDA in 2003 as a medical reviewer in the Division of Cardiovascular Devices. In 2012, he became the Chief Medical Officer for the Office of Device Evaluation, and since 2016 he has served as the Clinical Deputy Director in the Office of Device Evaluation. Prior to joining the FDA, he was in private practice for five years.
His clinical training included fellowships in cardiac electrophysiology and cardiology at the University of Maryland, and a residency in Internal Medicine at the University of North Carolina, Chapel Hill. He received both his M.D. and undergraduate degrees from the University of Virginia.
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.
Vice President and Head of Medical Device Epidemiology
Johnson & Johnson
Paul Coplan, Sc.D., M.B.A., is Vice President and Head of Global Medical Device Epidemiology at Johnson and Johnson, reporting to Jesse Berlin. He is also adjunct assistant professor in epidemiology at the University of Pennsylvania Perelman School of Medicine and a scholar in the Center for Clinical Biostatistics and Epidemiology.
He has a Doctor of Science degree in epidemiology and biostatistics from Harvard University, an M.B.A. from Wharton Business School at the University of Pennsylvania, a master of science in public health and nutrition from the University of Massachusetts, a B.S. Honors in biochemistry and physiology and a bachelor’s in medical sciences from the University of Witwatersrand.
Paul has played a key role in the successful FDA approval of eight pediatric and one adult vaccines and nine drugs over the past 24 years in drug, vaccine and biologic development research at Merck, Wyeth, Pfizer, the International Partnership for Microbicides (a non-profit pharmaceutical company), and Purdue Pharma. He has published over 72 peer-reviewed journal articles, over 400 conference abstracts/posters and has conducted studies in 15 countries. Prior to joining J&J, Paul was the Head of Epidemiology and Abuse Deterrence Research Strategy at Purdue Pharma. In this role, he was responsible for epidemiologic studies to assess real-world safety and effectiveness of Purdue’s products. He was the Chair of the 23-company collaborative Metrics Subteam for the Class REMS for Extended-Release and Long-Acting Opioid Analgesics, the chair of the 10-company Observational Studies Workgroup for studies of opioid analgesic safety required by the FDA, and the co-chair of the Benefit-Risk Assessment Special Interest Group of the International Society of Pharmacoepidemiology. He is also a Fellow of the International Society of Pharmacoepidemiology.
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.
Dr. Dreher is currently a Policy Analyst in the Clinical Trials Program at CDRH’s Office of Device Evaluation. She is responsible for policy and operations for the Breakthrough Devices Program and Early Feasibility Study Program, both of which are regulatory approaches aimed to support medical device innovation. Dr. Dreher also focuses her expertise on policy for Q-Submissions and Investigational Device Exemptions (IDEs). She has been with FDA since 2007 when she was hired as a Biomedical Engineer in CDRH’s Office of Science and Engineering Laboratories to conduct research on mechanical durability and degradation of medical devices and their materials as well as to serve as a subject matter expert for all types of pre-market review submissions. She obtained her doctoral degree from Duke University in biomedical engineering.
Global Process Owner Standard Product Identification
Jackie has been working in the medical device sector for more than 30 years and currently holds the position of Global Process Owner of Standard Product Identification for Medtronic Global Regulatory Affairs.
Jackie has been recognized in the healthcare sector as a leader and SME in global product identification standards development and implementation, both internally to Medtronic, and to the global healthcare industry. She has co-chaired the AdvaMed Auto-Identification Committee since 2006, providing guidance on product identification standards related to the FDA’s Unique Device Identification (UDI) legislation. She has also provided advisory role in many other initiatives involving UDI legislation in both the United States and around the world. Jackie has represented the medical device industry in the International Medical Device Regulators Forum (IMDRF) UDI Work Group, the China International Medical Device Regulatory Forum (CIMDR) and has also been appointed to the EU Commission EUDAMED UDI Work Group.
Jackie is one of the founding members of GS1 Global Healthcare and has maintained a leadership role in the organization since its inception in 2005. She has also been involved in many of the GS1 Global Healthcare work teams, developing global standards for product identification and Auto-Identification Data Capture (AIDC) in healthcare. Jackie also co-chairs the GS1 Global Healthcare Public Policy work group. In this role, she has engaged with medical device regulators around the world to provide guidance on implementation of global healthcare standards. Jackie is very active in advocating for implementation of globally harmonized standards for regulatory submissions of device identification information at different points in the medical device regulatory life cycle.
Chief Operations Officer
Vineet is co-founder and COO at Genetesis, an early stage medical device company building first-in-class biomagnetic imaging solutions that work quickly and passively to optimize clinical workflow and enhance clinical decision making. Vineet has helped build the company to 20 employees and develop the company’s regulatory strategy and quality management. In addition to managing regulatory and quality efforts between teams, Vineet helps lead the team towards FDA clearance and commercial launch.
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.
Principal Scientist, Global Product Stewardship
Procter & Gamble
Lenore has over fifteen years of hands-on regulatory experience in both the pharmaceutical and medical device fields. She has successfully managed and executed IND, NDA and 510(k) submissions and has experience in guiding both pharmaceutical and medical device project teams to ensure regulatory compliance and successful FDA interactions. Lenore has developed internal regulatory guidance documents, SOPs, and has trained personnel to assure compliance. She has worked closely with QA organizations in hosting FDA audits to successful outcomes and has provided industry opinions to be considered in public comment to proposed regulations. Lenore holds a Ph.D. in Biological Sciences from the University of Cincinnati and an M.B.A. from the University of Cincinnati.
Senior Director for Regulatory Affairs
Frank Fucile is Senior Director for RA at STERIS Corporation. He led Steris’ international regulatory organization from 2003 to 2016. Currently he serves as the senior advisor to the Senior Vice President & Chief Compliance Officer and Corporate Regulatory Affairs staff on FDA and international compliance and submissions. Formerly, Frank was the head regulatory executive for medical device divisions of Covidien, Pfizer and Olympus. He was co-appointed as Device Counsel for Pfizer device divisions. From 1972-1983 Frank was a senior FDA investigator specializing in drugs and devices in FDA’s Chicago District.
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.
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.
Vice President & Distinguished Engineer, Chief Information Security Officer
IBM Watson Health
Carl Kraenzel is an IBM Distinguished Engineer and Vice President, serving as the Chief Information Security Officer for Watson Health. He’s also led cloud & SaaS operations, IT security, and client support for Watson Health in 2016-2017, and for all of Watson from 2011-2015.
Carl was one of the first executives IBM originally assigned to commercialize Watson in 2011. He has since overseen global deployments of IBM Watson for hundreds of clients and partners such as MD Anderson, SoftBank Japan, Memorial Sloan Kettering Cancer Centers, Cognit in UAE, Manipal in India and more.
Prior to Watson, Carl was part of launching IBM’s Cloud business, after various activities as CTO for End User Services in IBM GTS and a Distinguished Engineer for IBM Lotus. He joined IBM when a startup he co-founded in 1993 in New Hampshire, Edge Research, was acquired by Lotus in 1994, in turn acquired by IBM in 1995.
Carl holds a B.S. in superconductive quantum physics from MIT, has championed LGBT workplace diversity, and has been both a professional actor and vocalist.
Director Regulatory Affairs
Effie Lin is the Director, Regulatory Affairs for Abbott Vascular Division. She has over 18 years’ experience working in the Biotechnology, Diagnostics and Medical Device industries. She has extensive Regulatory experience in Asia Pacific region.
Effie Lin is responsible for Abbott Vascular Regulatory Affairs Coronary Product - Core Coronary Team activities including establishing global strategy; provide guidance on Asia Pacific regulations for the division; overseeing the process of preparing vascular product submissions; managing regulatory submission process through approvals; and ensuring compliance with global regulatory and quality requirements.
Prior to joining Abbott, Effie Lin held key role in the product development of start-up companies within the healthcare industry. Effie Lin holds a doctorate degree in Pennsylvania State University, Hershey Medical Center, Pennsylvania and was a Post-doctoral Fellow in Stanford University, California.
Director of Operations
Josh has nearly a decade of experience in management of small and start-up business with four years in the medical device space. He has straddled both research and management functions within various companies and start-up teams. His academic and professional expertise has been in identifying, validating, marketing, and executing on technology based business opportunities, but has also successfully directed the implementation of quality management and information security management systems.
Josh received a master's degree in entrepreneurial biotechnology from Case Western Reserve University. He also is one of the distinguished Crocker Innovation Fellows from Brigham Young University.
Head of EU
Lachman Consultant Services
David G. Lonza is Head of EU at Lachman Consultants. Mr. Lonza is a leader with significant regional and global management experience who understands the complexities involved in the international pharma industry. He has a successful track record building and directing organizations and is recognized as an exceptional leader with strong commitment to consensus management, team building, and people development. He is adept at developing long-term strategic plans, executing strategies, and handling crises.
David Lonza’s expertise includes servicing pharmaceutical/biopharmaceutical/biotech clients to meet international Regulatory challenges and Operational Readiness.
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).
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.
Director of Compliance
IBM Watson Health
Medical device and life sciences companies are migrating regulated applications, services and devices to the Cloud in order to leverage its power, availability and scale. Watson Health is at the forefront of this transition and supports its clients and partners in navigating the complexity of global privacy, security and data governance regulations, standards and laws, while safe-guarding patient data and IP. The new paradigm must support client applications which can scale to millions of connected patients and petabytes of data in data centers worldwide. This requires fresh ideas for combining privacy, security and data governance with healthcare regulatory requirements while delivering services to patients, providers and payers.
In his current role as director of compliance at Watson Health, Murali is managing a team of privacy, security, data governance and clinical development regulatory compliance professionals. The compliance team performs risk analysis, specifies the regulatory controls and verifies and validates implementations. The team is responsible for maintaining and deploying the Privacy and Security SOPs in the Quality Management System, training, customer requests, vendor assessments, supplier audits, working closely with the Security and Commercial operations team.
Before IBM, Murali was a Director at Philips Group Innovation with global responsibility for clinical development and privacy within Philips Group Innovation (PGI). As the Senior Privacy Officer for PGI, he was responsible for the group’s conformance with the Philips Binding Corporate Rules and Privacy Laws. He has held a variety of positions in Philips: Research in Genetic Algorithms (GA) and applications, HDTV launch of Consumer Electronics and Semiconductors and managing global IT projects and multi-disciplinary teams and is a co-inventor of five patented GA applications.
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.
Fellow, Regulatory Science
Boston Scientific Corporation
Mac McKeen has over 25 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study, and regulatory approvals of cardiovascular devices and is currently a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize.
He also serves as an Adjunct Professor at the University of Minnesota instructing a 4000 level course on medical device development and is also a Faculty Director within the College of Continuing and Applied Professional Studies. He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed, MDIC and Medical Alley. He holds a B.S. in industrial technology from Iowa State University and an M.B.A. from the University of Dallas and is RAC certified.
Senior Director, Regulatory Affairs
Johnson & Johnson Vision
Audrey Munnerlyn has almost 30 years of experience in the medical device and diagnostic industry, of which 20 have been focused on Regulatory Affairs. She has held Director-level RA positions within Abbott and Johnson and Johnson, and previously served as Vice President Regulatory Affairs for Revision Optics. Audrey earned a bachelor’s degree in biochemistry and bell biology from the University of California, San Diego.
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.
Chief of Premarket Approval Staff, Office of Device Evaluation
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.
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.
Deputy Director, National Evaluation System for Health Technology Coordinating Center (NESTcc)
Medical Device Innovation Consortium (MDIC)
Rachel R. Rath, M.P.H., is the Deputy Director for the NEST Coordinating Center. She joins MDIC from the Patient-Centered Outcomes Research Institute (PCORI). Since joining PCORI in 2014, she helped build and manage the development of the PCORnet, the National Patient-Centered Clinical Research Network, a transformational effort to engage patients and leverage electronic health data to improve the speed and efficiency of clinical research in the United States. Most recently she focused her on governance, sustainability, and communications efforts to advance the mission of PCORnet. PCORI’s investment in PCORnet has exceeded $400 million from a combination of infrastructure and research investments. In March 2017, the PCORnet partners successfully launched an independent non-profit entity to advance the long-term sustainability of PCORnet. Prior to joining PCORI, she worked with disease-specific organizations including the National Multiple Sclerosis Society and the COPD Foundation and served as an Applied Behavioral Analysis (ABA) Therapist for children with Autism Spectrum Disorders.
Rachel received her M.P.H. in global health policy from The George Washington University and is currently pursuing an M.B.A. from Georgetown University.
Southeast Region, Acting Regional Food and Drug Director
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.
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.
International Regulatory Affairs and Quality Compliance Leader
Special Advisor, International Programs Division, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate
Nancy is currently working with the International Programs Division. This division is responsible for managing international projects for both pharmaceuticals and medical devices. Nancy is currently working on medical device related projects, such as the medical device single audit program (MDSAP) and the Regulated Products Submission (RPS). Nancy has been involved with medical devices harmonization activities since 1999, first on the Global Harmonization Task Force for Medical Devices and is currently involved with the International Medical Devices Regulators Forum (IMDRF) on the management committee and working groups.
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.