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.
Assistant Director in the Division of Restorative, Repair and Trauma Devices, Office of Health Technology 6 (Orthopedic Devices), Office of Product Evaluation and Quality
Shumaya Ali serves as an Assistant Director in the Division of Restorative, Repair and Trauma Devices (Stereotaxic, Bone Growth Stimulators and Fracture Fixation Devices Team), Office of Health Technology 6 (Orthopedic Devices), Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA. Prior to joining this office, Shumaya was a Lead Consumer Safety Officer in the Office of Compliance, CDRH, where she provided leadership in the evaluation and concurrence on postmarket reviews, including Warning Letters, Recalls, and Establishment Inspection Report reviews. She joined FDA/CDRH in 2010. Prior to that she served as a Patent Examiner at the U.S. Patent and Trademark Office and Scientific Advisor/Patent Analyst at various Patent firms, where she performed technical and regulatory review of a wide variety of medical devices. Shumaya holds a Bachelor of Science in general biology from the University of Maryland College Park and a Master of Science in health communication and marketing from the George Washington University, Milken Institute School of Public Health.
OMDRHO Division 2 Recall Coordinator
Meredith Andress serves as a Recall Coordinator for medical device recalls under the Office of Medical Device and Radiological Health (OMDRHO), Division 2, Compliance Branch. She became a Recall Coordinator in March 2015 in the Florida District and transitioned to OMDRHO, Division 2, in May 2017 during FDA’s Program Alignment. She has been a frequent speaker of recall-related topics with industry for both Medical Devices and Food. Meredith has been with the FDA for 9 years and prior to her current position as Recall Coordinator, served as an Investigator in Florida District, performing inspections in various commodities. She received a bachelor’s degree in biology from Stetson University and a master’s in Public Health, with a specialization in veterinary public health, from The Ohio State University.
OMDRHO Division 1 Recall Coordinator
Cynthia Aycock serves as a Division Recall Coordinator in the Office of Medical Device and Radiological Health Operations (OMDRHO), Division 1. She has been a Recall Coordinator with Division 1 since March 2018. Cynthia has been with the FDA since November 2013. Prior to her current position, Cynthia served as an Investigator through the Detroit District Office, performing mainly inspections of medical device manufacturers. She transitioned to OMDRHO, Division 1, during FDA’s Program Alignment in May 2017. Cynthia holds bachelor of science in engineering and master of science in engineering degrees in biomedical Engineering, both from the University of Michigan, College of Engineering.
Chief Scientific Officer
BioCrossroads (on-loan executive from Eli Lilly)
Vanessa Barth, Ph.D. is currently a loaned executive from Eli Lilly assuming the role of BioCrossroads Chief Scientific Officer (BCSO). Dr. Barth brings 19 years of industrial experience with a strong emphasis in cross-functional collaboration in both scientific and operational arenas. In her current role Dr. Barth focuses on operational and strategic opportunities for BioCrossroads as well the Indian Biosciences Research Institute, and 16Tech. Most recently, Dr. Barth served as Senior Director at Eli Lilly and Company in Lilly Research Laboratories responsible for Strategic Completive Intelligence & Scientific Support. In this role, Dr. Barth built a diverse, inclusive team of competitive intelligence professionals tasked with bringing an objective and external perspective to strategy and decision-making associated with therapeutic and functional business areas in support of the research portfolio. Vanessa also led the reshaping of Lilly Research Laboratories outsourcing resulting in increased efficiency.
Vanessa received her Bachelor of Arts degree in neuroscience from Pomona College, The Claremont Colleges and her Ph.D. in medical neurobiology from Indiana University. She also holds certificates in business (Harvard), competitive intelligence (Academy of Competitive Intelligence-ACI), and (International Business Innovation Association-INBIA). Dr. Barth has extensive experience in pharmaceutical research and development, research collaborations, and outsourcing management.
Global Quality Leader – Drug Delivery System Development
Francis Blacha is currently Global Quality Leader, Drug Delivery System Development, Device Manufacturing and Diagnostics for Eli Lilly and Company. Previous to joining Lilly, Francis held various leadership positions in Quality at Pfizer and Glaxo Inc. Francis has over 25+ years of quality assurance/quality control experience in pharmaceuticals and medical devices. He has extensive experience in guiding project teams in all aspects of risk management and the application of design control requirements throughout the product lifecycle for combination products, diagnostics and medical devices. In addition to frequently presenting at industry forums on the topic of risk management, Francis currently serves on the strategic committee for MedCon, an annual medical device conference co-sponsored by FDA and Xavier University. Francis received his B.A. in chemistry from Catawba College and his M.S. in chemistry from North Carolina State University.
Executive Director & Partner
Gert is an expert in European regulations based on 15 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, and Head of notified body. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.
From his Ph.D. in biomaterial sciences, and postdocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession over the last 15 years he has been awarded as Fellow of RAPS.
Director, Office of Regulatory Programs, OPEQ
CAPT Sean M. Boyd serves as the Director for Regulatory Programs in OPEQ at FDA’s Center for Devices and Radiological Health (CDRH). In this capacity, he is responsible for managing the Center’s quality initiatives, as well as regulatory compliance and enforcement programs for the medical device industry.
Prior to joining the Office of Compliance in 2015, led and transformed many aspects of CDRH’s electronic product radiation control program. He received his undergraduate degree in biomedical engineering from Boston University and his master's in public health from the Uniformed Services University of the Health Sciences.
CAPT Boyd is an active duty commissioned officer in the United States Public Health Service (USPHS). He is also the Team Commander for one of two Washington DC-based medical response teams (PHS-1 Rapid Deployment Force); and has deployed in response to several disasters and crises, both domestically and abroad. His experience also includes serving as Executive Officer of the Monrovia Medical Unit (an Ebola Treatment Unit) in Liberia, Africa; where the USPHS Commissioned Corps provided care to healthcare workers infected with Ebola Virus Disease.
OMDRHO Division 1 Director, Compliance Branch
Gina Brackett was selected as the Director of Compliance Branch for Division of Medical Device and Radiological Health (OMDRHO), Division 1 in March of 2018. She has been with the FDA for 28 years and prior to her current position served as a Compliance Officer in the Cincinnati District Officer from 2002-2018. She was a Medical Device Specialist forseven years and during this time was certified as a Level II Performance Auditor and conducted numerous complex medical device inspections. Gina is on numerous workgroups and has helped developed new procedures to assure a smooth transition since ORA’s program alignment in May of 2017. She graduated from Thomas More College, Crestview Hills, Kentucky, with a bachelor’s degree in biology and an associate’s degree in chemistry.
Senior Director, Regulatory Affairs
Bill Brodbeck is 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
Medical Officer, Digital Health, Office of Strategic Partnerships and Technology Innovation
Matthew Diamond, M.D., Ph.D., is a sports medicine and rehabilitation physician and Medical Officer for Digital Health at FDA’s Center for Devices & Radiologic Health. At FDA Dr. Diamond serves as a senior clinical expert for digital health medical devices, and he leads a multi-disciplinary team of physicians, scientists, and engineers developing FDA policy on emerging technologies in digital health.
Dr. Diamond brings extensive experience from leadership roles at large and small technology companies, including as Chief Medical Officer at Nokia, and as Medical Director at Fossil Group and the startup Misfit Wearables. Dr. Diamond served as Vice Chair of the Consumer Technology Association (CTA) Health & Fitness Technology Board, where he promoted public health applications of mobile technology, and established an ANSI-accredited standardization committee to develop standards in digital health for wellness-related devices and apps.
Dr. Diamond served on numerous advisory boards including at the Center for Personalized Health Monitoring at UMass Amherst and at the venture firm NGP Capital. As a wearables expert, he was the chair and technical advisor for the USA Technical Advisory Group to the IEC Wearables Standards Committee. A clinical faculty member at NYU, Dr. Diamond is passionate about helping people improve their mobility and performance through a holistic approach to rehabilitation as well as technology that promotes wellness.
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, Medical Device Specialist
Laureen Geniusz has been a field Investigator with FDA for over 28 years, with about 20 years of that as a Medical Device Specialist. She has a B.A. degree from Bowling Green State University with a major in biology/chemistry. She has worked on numerous legal cases and has worked jointly on potential criminal cases with the AUSA and local FBI. She routinely conducts domestic and international inspections and has been involved with numerous regulatory actions, such as: Warning Letters, Seizures, and Injunctions. She has also trained numerous field investigators and was an internal performance auditor.
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.
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.
Professor and Assistant Vice President for Commercialization
University of Cincinnati
Jason Heikenfeld is a Professor and Assistant Vice President for Commercialization at the University of Cincinnati. In his AVP role, he leads the university’s office supporting patenting, licensing, and startup efforts. He also directs the Novel Devices Laboratory which has established highly-focused international leadership roles in an emergent technologial paradigms including electrowetting, electronic paper, and most recently sweat biosensing technology. In the first decade of his career, he already accumulated the most patents and licensees of any faculty member in the history of the Univ. of Cincinnati. He is a serial entrepreneur, and his most recent company Eccrine Systems has been recognized as a top 50 global startup by Bloomberg based on data analytics by Quid. He was an AFOSR Young Investigator, is a Senior member of IEEE and the Society for Information Display, a life-member of SPIE, a member of ASEE, and a Fellow of the National Academy of Inventors. In addition to his scholarly work, during his teaching years Prof. Heikenfeld was the highest-rated STEM educator at the University of Cincinnati. In his service roles to the University he has also led the creation of programs and coursework that foster innovation, entrepreneurship, and understanding of the profound impact that technology has on society.
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.
Vice President, Strategic Partnerships
Hylton Kalvaria is Vice President of Strategic Partnerships, leading Verana’s major partnership initiatives with medical associations, life science companies, and regulatory bodies. Hylton joins Verana from Flatiron Health, where he founded, built and led the West Coast business, representing half of Flatiron’s commercial activity. In that capacity, Hylton’s team led the design and execution of Flatiron’s first regulatory-grade projects intended for influential stakeholder audiences, including the FDA. Hylton previously held a variety of roles at Genentech and was appointed to lead a CEO-sponsored initiative focused on identifying emerging sources of real world data and utilizing those data across the Genentech organization, an initiative that led to Roche’s initial investment in Flatiron. Hylton holds an M.B.A. and B.S. in economics from Duke University.
Founder and CEO
Bernhard Kappe is CEO of Orthogonal, the leading developer of patient facing connected device solutions for medical device companies, with expertise in firmware, mobile apps, AI algorithms and cloud services.
Mr. Kappe is the author of Agile in an FDA Regulated Environment and the upcoming Best Practices for Software as a Medical Device and Connected Device Development.
He’s interviewed dozens of practitioners who have received clearance or approval for SaMD and connected devices, and has synthesized this feedback with Orthogonal’s own experience in order to lay out a set of best practices and antipatterns for developing SaMD and Connected Device solutions.
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
Andrew Lang serves as a Recall Coordinator in the Office of Medical Device and Radiological Health Operations (OMDRHO), Division 1. He has been working in this position since March 2018. Andrew has been with the FDA since August 2009. Prior to working as a Division Recall Coordinator, Andrew served as an Investigator for the Cincinnati District as well as the Dallas District, and he was most recently a Compliance Officer in the Cincinnati District. Andrew received a bachelor of science degree in biology from Mount Union College in Alliance, Ohio.
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.
Director, Division 1: Division of Submission Support, Office of Regulatory Programs
Josh joined ODE in 2002 in the Gastroenterology and Renal Devices Branch, where he primarily reviewed hemodialysis, obesity, and endoscopic devices. Josh moved to the Division of Radiological Health in OIR in 2010, where he reviewed ultrasound devices, medical imaging software, and other medical imaging devices. Beginning in 2013, he took on the role as branch chief of the General Surgery Devices Branch 2 in the Division of Surgical Devices, which focused on laparoscopic, electrosurgical, ablative energy, and robotic assisted surgical devices. Josh started as the Director of the PMA staff in January of 2016. Josh received his bachelor’s degree in biomedical engineering in 2000 from Vanderbilt University and his master’s degree from the University of Florida in 2002.
Director, Division of Digital Health, Office of Science of Technology
Bakul Patel is Director for Division of Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies.
This includes responsibilities in leading the development on policies for mobile health, health information technology, cyber security, medical device interoperability, and medical device software.
Mr. Patel also led the creation of the globally harmonized regulatory framework for “software as a medical device” (SaMD) at the International Medical Device Regulators Forum (IMDRF). The concepts, principles and vocabulary created in harmonized regulatory framework has been used as a foundation in the European union, Japan, Canada, Brazil, Australia and USFDA.
Mr. Patel is the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC).
Mr. Patel is currently leading the effort for the agency in developing an innovative software precertification program in collaboration with all stakeholders to reimagine a regulatory approach for Digital health that that aims for patients and providers to have timely access to safe and effective digital health products.
Prior to joining FDA, Mr. Patel held key leadership positions in the telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short-term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fast-paced, technology-intensive organizations. Mr. Patel earned an M.S. in electronic systems engineering from the University of Regina, Canada, and an M.B.A. in international business from The Johns Hopkins University.
Director, Division of International Compliance Operations, Office of Compliance
Dr. Cesar Perez is currently the Director for the Division of International Compliance Operations, Office of Compliance (OC), CDRH/FDA. He manages the day-to-day operations for the Division, which focuses on foreign device manufacturer and importer assessment; international audit program, compliance policy, and guidance development; and export operations and policy. From 2015-2018, he was the Branch Chief for the Surveillance and Enforcement Branch I, Division of Premarket Labeling and Compliance, OC/CDRH, responsible for enforcing premarket requirements, as well as labeling and promotion/advertising requirements for medical devices. He previously worked for more than 7 years as a Microbiologist/Consumer Safety Officer in different branches within the Office of Compliance, CDRH. He received his doctoral degree in microbiology from New York University School of Medicine in 2008.
Investigator, Medical Device Specialist
LCDR Thomas A. Peter serves as a Medical Device Specialist in Division 1 of ORA’s Office of Medical Device and Radiological Health Operations. He is also a commissioned Engineer Officer in the U.S. Public Health Service stationed in Detroit, Michigan. LCDR Peter has been performing medical device inspections since joining FDA in 2010 and has been involved in numerous high-profile cases resulting in Warning Letters and other regulatory actions. He is a former member of ORA’s Medical Device Foreign Inspection Cadre and helped develop ORA’s Medical Device Investigator Certification exam. LCDR Peter holds three ASQ certifications and is a member of the ASQ Certified Biomedical Auditor (CBA) Certification Exam Committee. He earned his Bachelor and Master of Science degrees in Biomedical Engineering from the University of Michigan.”
Compliance Officer/Biomedical Engineer
Tim Philips is a Compliance Officer with FDA’s Office of Medical Device and Radiological Health Operations, Division 2/C, Minneapolis District, where he coordinates advisory and enforcement actions against violators of the Food, Drug and Cosmetic Act. After receiving a degree in biomedical engineering from the University of Iowa in 1986, Tim worked as a Patent Examiner at the U.S. Patent and Trademark Office in Washington, DC, reviewing patent applications for respiratory and diagnostic devices. He joined FDA's Minneapolis District in 1988 and served for 12 years as a field investigator specializing in medical device quality system inspections. In August 2000, Tim accepted his current position as a Compliance Officer. In 2015, he was named FDA’s Compliance Officer of the Year for his role in two precedent-setting FDA enforcement actions. Tim is a frequent speaker and instructor on FDA-related subject matter.
Director, Xavier Health
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in chemistry from Xavier University, and a Ph.D. in organic chemistry from the University of North Carolina – Chapel Hill.
AVP, QARA - Medical Devices & Life Sciences
L&T Technology Services Limited
Rama K. Pidaparti comes with over 25 year years of industry experience, specialized in Medical Devices, Life Sciences (and related IT Solutions that support the business processes) - Domain of Quality and Regulatory compliance. A decade of Software Quality experience with Shrink-Wrapped software products in the CAD/CAM/PDM/PLM products space. Rest of it in the Quality and Regulatory compliance space spanning, HIPAA Compliance, IT Compliance (Infrastructure Qualification and Computerized Systems Validation). SoX, ITIL and Information Risk Management. Over-all compliance in the areas of Clinical Trials, Total Product Life Cycle of Medical Devices, (R&D, Product Development, DMR, DHF, DHR), Supplier Quality, Manufacturing and post Market). Also gap analysis remediation work (for warning letters and other related Regulations and Standards updates). Most recently FDA’s Case for Quality initiative adopting CMMI’s maturity model for the Medical Device Industry. Significant experience in very large programs in process harmonization, Post Market Surveillance and Global Regulatory Requirements tracking and compliance at some of the world’ largest global Medical Device manufacturers. He was an invited speaker at Life Sciences events on the topics related to Quality and Regulatory Compliance
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.
Regional Lead - Medical Devices & Life Sciences
L&T Technology Services Limited
Harikrishnan Ramaraju is Regional Lead at L&T Technology Services with over 17 years of Global Experience in the Medical Devices. Hari has played various role in Project Management, New Product Development, Digital Health, Innovation Forum, Business development and Strategic Account Management. Hari is expert in Image processing, Embedded systems and software. He has established Image processing COE and instrumental in developing multiple medical products including digital from Requirement to Commercialization in compliance to Regulatory. He has 3 patents in the field of Image Processing and Embedded systems. He has successfully converted one of the patents to fetch royalty for L&T.
Director, Quality Systems and Business Support, Abbott Quality and Regulatory
Ricky joined Abbott in 2016 and provides quality systems and technical support to all Divisions within Abbott. Prior to joining Abbott, he worked for the Food and Drug Administration (FDA). In his 32 years of FDA related experience, he held the positions of Dallas District Director, Compliance Branch Director, Compliance Officer, Supervisory Investigator, and Investigator. Ricky received his bachelor's degree in biology from St. Mary’s University, and a master’s degree in public administration from Webster University.
Executive Vice President, Medical Devices & Combination Products (and Vice President Regulatory Affairs, MDMA)
Heather Rosecrans brings more than 30 years of public health and medical device experience to Greenleaf Health Inc. Prior to joining Greenleaf, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements. Rosecrans’ accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA) and Food and Drug Administration Modernization Act (FDAMA). Rosecrans’ extensive experience at CDRH, and specifically the 510(k) office, enabled her to become one of the nation’s leading experts on the program. Rosecrans’ tenure also allowed her to play a pivotal role in the program’s development and reform. Rosecrans has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with CMS and other regulatory agencies.
District Recall Coordinator
CDR Melinda Ruiz serves as a Recall Coordinator in Division 1 of ORA’s Office of Medical Device and Radiological Health Operations. She is also a commissioned Physician Assistant in the U.S. Public Health Service stationed in NYC, NY. CDR Melinda Ruiz began her FDA career in 2010 as a Consumer Safety Officer, having performed inspections of all imported commodities with the NY Imports Division. CDR Ruiz has operated in her current role as Recall Coordinator since 2013. She previously worked as a Senior Physician Assistant with the U.S. Department of Justice Federal Bureau of Prisons and with the U.S. Department of Homeland Security/Division of Immigration Health Services. CDR Ruiz received a bachelor of science degree in physician assistant studies from The City College of New York/Sophie Davis School of Biomedical Education and a master of physician assistant studies from the University of Nebraska. CDR Ruiz practices medicine weekly as a Certified SAFE provider.
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.
Director Johnson & Johnson Regulatory Compliance
Johnson & Johnson
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.
Director, Medical Affairs, Abbott Quality & Regulatory
Hugo Xi is the Director of Medical and Clinical Affairs, Abbott Quality and Regulatory, Abbott Laboratories. He has over 15 years’ leadership experience in various clinical and medical functions including Health Economics and Outcome Research, product development, clinical studies and medical marketing.
Hugo Xi is responsible for providing leadership for medical activities across all Abbott divisions and serving as the medical expert globally to provide counsel and recommendations throughout program/product life cycle. One of his current responsibility is to lead a cross-business team of clinical subject matter experts in Abbott to prepare company for the EU MDR/IVDR.
Prior to Abbott, Hugo held leadership roles in Baxter and Becton & Dickson (BD) after his academic career at Henry Ford Health System (Detroit, Michigan). He graduated from Shanghai Medical University, also holds a Master degree in Engineering from Wayne State University in Detroit and a M.B.A from University of Michigan, Ann Arbor.
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.