CAPT Sean Boyd
Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA (invited)
Capt. Sean Boyd is an active duty commissioned officer in the United States Public Health Service (USPHS). He currently serves as the Acting Director of the Office of Compliance in FDA’s CDRH. In this capacity he is responsible for managing the Center’s quality, regulatory compliance, and enforcement programs for the medical device industry. Previously, CAPT Boyd served as the Deputy Director of the Division of Radiological Health in the Office of In Vitro Diagnostics and Radiological Health at CDRH. He began his career in 1994 as an engineering analyst in FDA’s Winchester Engineering and Analytical Center, joining CDRH in 1999 as a compliance officer. CAPT Boyd progressed through several branch and division management positions within the Center, and has been responsible for a variety of premarket, compliance, surveillance and outreach programs over the course of his career. He received his undergraduate degree in Biomedical Engineering from Boston University and his Master’s Degree in Public Health and Preventive Medicine from the Uniformed Services University of the Health Sciences. CAPT Boyd is also Team Commander for one of two Washington DC-based medical response teams (PHS-1 Rapid Deployment Force); and deployed in response to several disasters and crises, both domestically and abroad. This experience includes the USPHS Commissioned Corps Ebola Response in 2015, where he served as Deputy Officer in Charge of the Monrovia Medical Unit in Margibi County, Liberia. Past deployments also include serving as Team Commander at Brookdale Hospital (Brooklyn, NY) in 2012 following Hurricane Sandy, Lead Safety Officer at Federal Medical Center (College Station, TX) in 2008 following Hurricane Ike, and Corps Liaison to the HHS Secretary’s Command Center (Washington, DC) in 2005 following Hurricane Katrina.
Principal Medical Research Manager of Regulatory Affairs at NAMSA (invited)
Stephan is a results-oriented professional with over 20 years of progressively increasing responsibility and demonstrated success achieving EU, US-FDA and worldwide Regulatory Medical Device approvals and registrations.
Staff Fellow, Office of the Center Director, CDRH, FDA (invited)
Dr. Carmody is the Cybersecurity Program Manager for the Center for Devices and Radiological Health, serving as co-chair of CDRH’s Cybersecurity Working Group. The Cybersecurity Working Group is an interdisciplinary team responsible for the FDA’s final pre- and post- market cybersecurity guidances. Seth joined CDRH in 2011 as a medical device reviewer.
Executive Vice President, Regulatory and Quality Solutions LLC (R&Q)
Lisa Casavant is Cofounder and Executive Vice President of Regulatory and Quality Solutions (R&Q), an industry-leading regulatory and quality consulting firm that helps medical device and combination product companies bring safe and effective products to market… and keep them there. Lisa has been championing R&Q’s mission of improving lives since 2008, and has helped grow R&Q’s team to more than 100 industry experts who thrive in an entrepreneurial, collaborative, and fun-loving culture. Having a thorough understanding of the ever-changing global regulations is only half of it. Lisa is truly set apart by her success implementing regulations at multinational medical device companies, delivering business-balanced solutions for their business-balanced demands. R&Q’s clients look to Lisa and her team for forward-thinking insight and industry-best implementation of regulatory affairs. Lisa holds a Masters degree in Mechanical Engineering from the University of Delaware, along with a Bachelor of Science degree in the same subject from West Virginia University.
Program Director, CfQ & PCBR, MDIC (invited)
Stephanie Christopher, MA, has a background in health communication, public health project management and communication education and training. Stephanie joined MDIC in 2013 and manages MDIC’s patient centered benefit-risk assessment, patient engagement and quality initiatives. Prior to joining MDIC, Stephanie worked for seven years with an academic public health team working on interventions to improve the quality of communication between physicians and parents of newborns with abnormal newborn screening results. In 2012-13, Stephanie went on leave from her academic position to do a special assignment for the Food and Drug Administration Center for Devices and Radiological Health (CDRH), updating and training staff on a new risk communication process. Stephanie has also served as an adjunct instructor at Marquette University, teaching introductory communication courses. Stephanie earned her Bachelor of Arts in Communication-Print Journalism from Pacific Lutheran University in Tacoma, Wash. and Master of Arts in Science, Health, and Environmental Communication from Marquette University in Milwaukee, Wis. Stephanie is also a Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals.
Sr. Quality Director, CVRx Inc.
Al is the Sr. Director of Quality Assurance and Quality Systems at CVRx. CVRx uses Barostim Therapy to treat drug resistant hypertension and heart failure. He developed, implemented, and has continued to improve the quality system at CVRx over the past 10+ years. CVRx has received European, FDA and Australian approvals for their quality system. In addition, Al has participated in the MDIC and AdvaMed Case for Quality efforts over the past 5 years. Throughout this time CVRx has volunteered to pioneer new Case for Quality programs developed in conjunction with FDA to improve the quality of medical devices in general and the CVRx product line specifically, including a pilot Critical to Quality assessment and pre-pilot and pilot assessments to the CMMI MDDAP criteria for the Voluntary Medical Device Manufacturing and Product Quality Program. Prior to CVRx, Al worked for Medtronic for more than 16 years in various divisions and management roles primarily in the area of quality and reliability. He developed and implemented new quality systems at two of these divisions. Key to these systems has been the implementation of appropriate risk management activities and techniques to assure the quality and reliability of the product being produced as well as regulatory compliance. Al has a Bachelor of Science degree in Electrical Engineering from Iowa State University and a Masters of Business Administration degree from the University of Colorado.
President and Cofounder, Regulatory and Quality Solutions LLC (R&Q)
Maria Fagan is Cofounder and President of Regulatory and Quality Solutions (R&Q), an industry-leading regulatory and quality consulting firm that helps medical device and combination product companies bring safe and effective products to market… and keep them there. Maria and partner Lisa Casavant launched R&Q in 2008 and the firm has now serviced more than 175 clients. R&Q continues to grow and has ranked on the Inc. 5000 fastest-growing private companies list multiple times. Maria has worked in regulated industry for over 30 years, and in the last 25 years she has focused on medical device quality and regulatory. Prior to founding R&Q, she held positions of increasing responsibility at MEDRAD Inc. (now owned by Bayer), a medical device manufacturer in both quality and regulatory arenas. MEDRAD is a two-time winner of the Malcolm Baldridge quality award. She received a B.S. degree in Mechanical Engineering from the University of Pittsburgh and holds a certificate in Business Management from Carnegie Mellon University. Her international experience includes Regulatory Director of Europe, Middle East, and Africa for MEDRAD which included regulatory submissions, post-surveillance activities, and more.
Executive Vice President of RA/QA, Cynosure
Connie has more than 25 years of experience in medical devices including class III sterile implantable devices, radiation oncology and lasers. Currently she is the senior VP of Regulatory Affairs with Cynosure. Prior to this role, she was the VP of Regulatory Affairs and Corporate Compliance with Cutera, Inc. Previously Connie was the VP of RA and QA at Xoft, Inc. and VP of RA and QA at Lumenis. She has extensive international submission experience, including Japan and China. Connie regularly teaches international regulatory and complaint handling classes for ASQ. Connie’s proudest personal accomplishment is that she is a certified scuba instructor and certified handicapped scuba instructor who volunteers to teach handicapped vets how to scuba dive through the Wounded Warrior program.
Anne Le Rouzo
West Coast Regional Director & Certification Project Manager/Lead Auditor, LNE/G-MED North America, Inc. (invited)
Anne is the Lead Auditor for Voluntary and Regulatory Certification in the medical devices field. She is also the evaluator of Class III medical device and provides: technical evaluation, clinical evaluation and risk management strategies, specialized in non active implants.
Director, Division of Enforcement, Office of Compliance, CDRH, FDA (invited)
William MacFarland is the director of the Division of Enforcement within the Office of Compliance. In this position, he is responsible for overseeing the division’s 33 member review staff who review PMA manufacturing sections, Establishment Inspection Reports, recall classifications and compliance cases. Previously, Mr. MacFarland worked in CDRH’s Office of Device Evaluation as both a reviewer and Deputy Division Director in the Division of Cardiovascular Devices. Prior to his current work at FDA he was a consultant with Quintiles Consulting where he was responsible for providing clients with strategic regulatory guidance and managed their 510(k), PMA and IDE projects. Additionally, he developed medical product test strategies, provided review of non-clinical protocols and reports, and provided guidance on compliance with design controls throughout medical device development. Mr. MacFarland has also worked for Angiosonics, Inc. of Morrisville, NC as Director of Regulatory Affairs. Mr. MacFarland received his MBA from University of Maryland in College Park, MD, and his MS in Biomedical Engineering from Case Western Reserve University in Cleveland, OH. He received his BS in Electrical Engineering from Clarkson University in Potsdam, NY. Currently he maintains a professional engineers license in Maryland and is an ASQ Certified Quality Engineer, Certified Biomedical Auditor, Certified Software Quality Engineer, Certified Six Sigma Black Belt, Certified Manager of Quality/Organizational Excellence and Certified Reliability Engineer.
Acting Director, Office of Compliance, CDRH, FDA (invited)
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.
President of the Medical Device Practice, NSF Health Sciences; former Director of the Los Angeles District, FDA
Elaine Messa is president of the Medical Device Practice at NSF Health Sciences. She has over 30 years of experience in FDA regulation of medical devices, and has focused on developing and implementing compliant quality systems for medical devices in the U.S. Elaine brings in-depth and broad knowledge of the compliance and regulatory environment, including quality systems, corrective action plans, and managing Form 483 and warning letter responses. Elaine’s career at FDA spans almost 30 years as an investigator, supervisory investigator, and director of the Investigations Branch. Her most recent position at the agency was as director of the Los Angeles District, which was responsible for the largest medical device workload in the U.S. During her FDA tenure, Elaine established an industry grassroots group and developed technical joint training efforts with local regulatory associations. She chaired the ORA/CDRH Medical Device Field Committee, representing field activities and interests with CDRH. She also helped develop and implement regulations, guidance, policy and compliance programs, including the medical device quality system regulation, warning letter pilot, and quality system inspection technique. As a result of this work, she received two FDA Awards of Merit, the Agency’s highest award.
Lead Quality Systems and Compliance Consultant, King & Spalding LLP; former FDA Deputy Associate Commissioner for Regulatory Operations
Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the FDA. 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. 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 consults with manufacturers, importers, new product developers, as well as with firms involved in or facing enforcement actions. Mr. Niedelman retired from the FDA 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. Additionally, Mr. Niedelman assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. 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 also served on the Steering Committee to the Pharmaceutical cGMP for the 21st Century” initiative as well the Counterfeit Drug Task Force. Prior to joining the Office of the Associate Commissioner, he was the Director and Deputy Director of FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities to ensure fair implementation by FDA’s five product centers. During his tenure, Mr. Niedelman presided as the Chairman of FDA’s Compliance Policy Council. He currently participates as a member of the Medical Devices Committee at the Food and Drug Law Institute and as a member of the Editorial Review Board for FDAnews GMP publications directed at the pharmaceutical and medical device industries. Mr. Niedelman has also served as Vice President of the FDA Alumnae Association.
President, Ombu Enterprises LLC
Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Dan is now President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Gregory Pappas, M.D., Ph.D.
Associate Director for National Devices Surveillance, Office of Surveillance and Biometrics, CDRH, FDA (invited)
Gregory Pappas, M.D., Ph.D recently joined the FDA as the Associate Director for Medical Device Surveillance at CDRH. He previously served as the Senior Deputy Director of HAHSTA (HIV/AIDS, Hepatitis, STD, and TB Administration) for the District of Columbia, Department of Health. He has worked professionally in over 30 countries. Dr. Pappas served as the Noordin M. Thobani Professor at the Aga Khan University, where he was the Chairman of the Department of Community Health Sciences in Karachi, Pakistan. While serving as Medical Director of the Futures Group, he designed and implemented the monitoring and evaluation plan for the antiretroviral program of AIDS Relief, working in nine countries in Africa and the six countries in the Caribbean. Dr. Pappas served in a variety of positions over a 17 year period in the Department of Health and Human Services including his role as Senior Policy Advisor to the Assistant Secretary for Health/Surgeon General, David Satcher. For ORC Macro, as Deputy Director of the Demographic and Health Survey (DHS), he planned and implemented innovative surveys in Uganda, Mali, Uzbekistan, and Dominican Republic. Dr. Pappas received his MD and PhD (Anthropology) from Case Western Reserve in Cleveland, Ohio. After his clinical training, he came to Washington D.C., first for a fellowship in Epidemiology, then continuing as a scientist at the National Center for Health Statistics/CDC. At NCHS he worked on many of the large national data systems and led the National Health Survey of Pakistan, a nationally representative health examination survey of over 16,000 sample persons. Dr. Pappas is author of numerous articles, including his work in the New England Journal of Medicine “The increasing disparity in mortality between socioeconomic groups in the United States” and his book with Cornell University Press, “The Magic City: unemployment in a working class community.” Dr. Pappas served as Chair of the Science Board and member of the Executive Board of the American Public Health Association. His book “Megacities and Global Health” (APHA Press) with Omar Khan was published in 2012.
Executive Director of Medical Device Education and Training, NSF Health Sciences; former Medical Device Specialist and Senior Investigator at ORA and International Team Lead at CDRH, FDA
Robert (Rob) Ruff joined NSF International as the Executive Director of Medical Device Education and Training in December 2017. Rob has over 30 years of experience in the medical device and public health sectors. Prior to joining NSF International, Rob worked in the orthopedic device manufacturing industry and completed a long, distinguished career with the US FDA. Rob was a highly regarded district Medical Device Specialist and Senior Investigator in FDA’s Office of Regulatory Affairs (ORA), where he conducted investigations for a broad range of device technologies. During this time, he was a member of the ORA Medical Device Investigator Certification Board, where he co-developed ORA’s Level II medical device investigator certification program. From ORA, Rob was recruited by FDA’s Center for Devices and Radiological Health to lead an international team of subject matter experts tasked with the development, implementation, and maintenance of the Medical Device Single Audit Program (MDSAP). Rob’s in-depth knowledge of the MDSAP now serves as a valuable asset to NSF clients marketing products around the globe. Rob’s extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). Training has been a hallmark of Rob’s distinguished career, having developed FDA’s computer-based training for QSIT, the Quality System Regulation, and the Medical Device Reporting Regulation. Mr. Ruff received many awards for his honorable service with the FDA.
Sr. Principal Advisor, Regulator Affairs, RCRI
Carol Ryerson, is a Senior Principal Advisor at Regulatory and Clinical Research Institute, Inc. She has 30 years of experience in the medical device and diagnostic industry and has held senior positions in Regulatory and Clinical Affairs at Eastman Kodak, Ortho Clinical Diagnostics, Genzyme Diagnostics and Sekisui Diagnostics. She holds a Bachelor’s degree in Chemistry from the College of the Holy Cross, and a Ph. D. in Biochemistry from M.I.T. (Massachusetts Institute of Technology). In her consulting practice, she assists clients with developing global regulatory strategies, negotiating with FDA, and preparing for and executing premarket submissions to the FDA, EU and other international authorities. Dr. Ryerson was recently elected to a three-year term on the board of the Association of Medical Diagnostics Manufacturers.
President, Quality Lean Solutions
Jim Shore is the Principal of Quality Lean Solutions, a Consultant Firm that specializes in Medical Device companies, Supplier Quality and Lean Manufacturing principles. Mr. Shore is co-author of “Proactive Supplier Management in the Medical Device Industry” (2016: Quality Press). Jim has 25 years of quality and supplier management experience in medical devices, semiconductor, aerospace and defense for firms and organizations including Titan Medical, Nypro Healthcare, Boston Scientific, Aspect Medical, Brooks Automation, Raytheon and ACMI Gyrus (now Olympus). He is Six Sigma Black Belt and Quality Manager/Operations Excellence-certified by the American Society for Quality (ASQ), as well as an ASQ-certified Quality Auditor and Mechanical Inspector. A veteran of Operation Desert Storm, he served in the U.S. Marine Corps for more than 15 years.
Technical Director, BSI Americas Inc. (invited)
Dr. Ibim Tariah is the Technical Director for BSI Healthcare with more than 23 years of experience in the medical device industry. In the last 14 years, since coming to BSI, Dr. Tariah has been providing regulatory expertise in the area of long term implantable devices for clients needing technical documentation assessment and reviews in compliance with the European Medical Device Directive (MDD). He also acts as a liaison with regulatory authorities including MHRA, EMA, Medical Products Agency (Sweden), FDA, Health Canada and Therapeutic Goods Administration (TGA).
Vice President Manufacturing Quality, Cardinal Health
Karl Vahey is currently the Vice President Manufacturing Quality with Medtronic. Karl has 25 years of experience in the medical device industry and has worked in manufacturing, quality assurance, regulatory affairs and quality systems compliance. His current responsibilities include overseeing quality operations and quality compliance for 16 manufacturing facilities in North and South America and Europe. Prior to this Karl was Senior Director of Regulatory Compliance, Covidien. This role included the following responsibilities: quality compliance activities such as conducting audits, development of best practices and providing general support as appropriate to Covidien facilities (manufacturing, distribution centers and technical service centers) and third-party suppliers in EMEA, Latin America and Asia Pacific. Karl was also heavily involved in the development of corporate quality system training programs such as process validation, CAPA, internal audits, change management and the implementation of these corporate training programs to all international sites.
Program Manager for the Case for Quality, Office of Compliance, CDRH, FDA (invited)
Francisco Vicenty or Cisco is the Program Manager for the Case for Quality within the Office of Compliance at FDA’s Center for Devices and Radiological Health. This effort is part of the CDRH strategic priorities for 2016 and 2017. This strategic priority will improve access and outcomes for patients by engaging industry, payers, providers, and patients in order to increase focus on the quality and performance of medical devices.