Posts Tagged ‘Unique Device Identification’

Reporter: Aviva Lev-Ari, PhD, RN

BIOMEDevice Boston Conference 2013
April 10-11 2013, Boston, MA


New conference format for 2013…

Don’t miss out on 2013’s new and improved BIOMEDevice Boston Conference.

Choose from six seminar sessions across the two day conference that will deliver crucial insights and guidance on biomedical regulations, design engineering, new biomaterial innovations and product development for the medical device industry.

Six Solution Packed Seminars

April 10, 2013 April 11, 2013
10:00-11:45am Seminar 1
Advanced Technology and Device Innovation
Seminar 4
Accelerating Speed to Market 
1:00-2:45pm Seminar 2
Intelligent Design for Implantable Devices
Seminar 5
FDA Regulatory Guidance and Updates
3:15-5:00pm Seminar 3
New Innovations in Drug Device Combination Products
Seminar 6
Human Factors: Enhancing Usability and Managing Risk

Conference Speakers

Jay Crowley, Senior Advisor Patient Safety, FDA

Jay Crowley is Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He is interested in developing and implementing new methods and techniques for identifying and resolving problems with the use of medical devices. Jay has held variety of positions over his 25 years at FDA. Currently, Jay has responsibility for implementing the Unique Device Identification requirements of the 2007 FDA Amendments Act and 2012 FDA Safety and Innovation Act. He holds a master’s degree in risk analysis and a bachelor’s degree in mechanical engineering.

Emmanuel Nyakako
, Senior VP of Global Quality & Regulatory Affairs, Zimmer Inc


Matthew Myers, PhD, Research Physicist, FDA 

Matthew R. Myers received his doctorate in Applied Mathematics from the University of Arizona. He worked in the research and development laboratory of Corning Glass Works, where he performed mathematical modeling of fiber drawing and other processes involving molten glass. Dr. Myers was later employed as an acoustics consultant with BBN Systems and Technologies. In 1990, Dr. Myers joined the Center for Devices and Radiological Health of the U. S. FDA. He has performed mathematical modeling in the areas of drug delivery, cardiovascular implants, virus transport, and most recently, therapeutic ultrasound. His current research areas include noninvasive methods for pre-clinical testing of focused-ultrasound surgery devices, and modeling of debris retention in reusable medical devices. Dr. Myers also performs consulting reviews on device submissions involving fluid flow and acoustic wave propagation, most recently applications to treat Parkinson’s disease and Essential Tremor with therapeutic ultrasound.

Dr. Thomas J Webster, Associate Professor, Divisions of Engineering and Orthopaedic Surgery, Brown University 

Thomas J. Webster’s degrees are in chemical engineering from the University of Pittsburgh (B.S., 1995) and in biomedical engineering from Rensselaer Polytechnic Institute (M.S., 1997; Ph.D., 2000). He is currently the Department Chair and Professor of Chemical Engineering at Northeastern University in Boston. He has graduated/supervised over 109 visiting faculty, clinical fellows, post-doctoral students, and thesis completing B.S., M.S., and Ph.D. students. To date, his lab group has generated over 9 textbooks, 48 book chapters, 306 invited presentations, at least 403 peer-reviewed literature articles, at least 567 conference presentations, and 32 provisional or full patents. His H index is 47. Some of these patents led to the formation of 9 companies. He has received numerous honors including, but not limited to: 2002, Biomedical Engineering Society Rita Schaffer Young Investigator Award; 2005, Coulter Foundation Young Investigator Award; 2011, Oustanding Leadership Award for the Biomedical Engineering Society (BMES); and Fellow, American Institute for Medical and Biological Engineering.

John (Barr) Weiner, Associate Director of Policy, Office of Combination Products, FDA 

John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a BA from Princeton University and a JD with honors from the Columbia University School of Law.

Olivia Hecht
, Senior Marketing Manager, Wireless & Networking, Philips Healthcare

Olivia Hecht is currently Sr. Manager of Technology and Platforms Integration, for Philips Healthcare Patient Care and Clinical Informatics. She came to the healthcare industry with over 20 years in the information technology sector working in product management and product marketing for companies such as Bay Networks, an early innovator in network infrastructure; RSA Security, a leader in enterprise security; and Legra Systems, a start up manufacturer of enterprise Wi-Fi equipment. She has a Masters degree from the Massachusetts Institute of Technology and Bachelor of Science in Biology.

Joel Kent, Regulatory Affairs Manager, GE Healthcare 

Joel Kent, RAC (Canada, EU and US) is currently Manager, Regulatory Affairs for GE Healthcare, Healthcare Systems Patient Care Solutions business. He has 18 years experience in regulatory affairs covering a variety of medical devices. He holds a Bachelor of Science degree in Electrical and Biomedical Engineering from Duke University and a Master of Science in Biomedical Engineering, Worcester Polytechnic Institute. Mr. Kent has nine publications related to pulse oximetry and gastric tonometry and has been granted two US and Japanese Patents for Remote Sensing Tonometric Catheter Apparatus and Method. He is a lecturer at Northeastern University, Boston, MA and is an IEEE Senior Member and American Society for Quality (ASQ) Senior Member. In addition, he is a Regulatory Affairs Professional Society (RAPS) member serving as Vice-Chair of the RAPS Boston Chapter and member of the RAPS 2008-2011 Annual Conference Committee and RAPS Annual Conference Preconference workshop committee on Latin America Medical Device Regulations in 2012. Speaking engagements have included the RAPS Annual Conferences, Medical Devices Summit East 2011, 2012 and 2013 and the 11th annual AdvaMed Emerging Growth Company Council conference.

Pat Baird, Product Design Owner, Baxter Healthcare

Pat Baird is a Product Design Owner at Baxter Healthcare, with oversight responsibility for over $400M in installed medical devices. His previous roles included software developer, function manager, program manager, and engineering department manager. Drawing on 20 years’ experience in product development, he has published and presented over 30 papers on topics such as software development, change management, stakeholder management, and risk management. He is currently the co-chair of the AAMI Infusion Pump Standards committee, chair of the Assurance Case Technical Information Report Working Group, a US representative to the IEC standards committee, founder of the Infusion Systems Safety Council and the Coalition of Organizations Reporting Adverse Events. He has earned multiple industry awards for his work to advance patient safety. He recently completed a Masters in Healthcare Quality and Patient Safety at Northwestern University in Chicago.

Dr. Eric Ledet, Associate Professor, Rensselaer Polytechnic Institute

Eric Ledet is an Associate Professor in the Department of Biomedical Engineering at Rensselaer Polytechnic Institute where he has taught medical device design and maintained an active research program in orthopaedic biomechanics for the last 9 years. Prior to joining RPI, he served as Director of the Orthopaedic Research Program at the Albany Medical College for 9 years. He has served as a consultant to medical device companies for 15 years and is currently principal partner in three medical device startup companies. He earned a bachelor’s degree in mechanical engineering from the University of Arizona and a Master of Science and doctorate in biomedical engineering from Rensselaer Polytechnic Institute.

Judith K Meritz, Associate General Counsel, Covidien

Jeffrey Morang
, Human Factors Engineer and User Experience Analyst, Siemens Healthcare Diagnostics

Jeffrey Morang is a Human Factors Engineer for the Point of Care line of instruments at Siemens Healthcare Diagnostics. Jeff received his MS in Human Factors and Ergonomics from San Jose State University. Jeff has experience as a researcher in aeronautical human factors, focusing on human perceptual and cognitive performance, for the Virtual Airspace Modeling and Simulation Project at the NASA Ames Research Center. After graduation, he joined Future Combat Systems project at British Aerospace Systems responsible for mapping soldier roles and assessing their cognitive and physical workloads using real-time usability testing methods. Jeff has brought that expertise to his current position at Siemens where his team is responsible for employing a synergistic design and testing methodology on behalf of a variety of end users in the relatively new area of healthcare called Point of Care.

George Papandreou, VP Quality, Lutonix, CR Bard 

George Papandreou, Ph.D., is Vice President of Quality at Lutonix, a subsidiary of C.R. Bard. In his current position, George is working on drug-coated balloons for the treatment of peripheral artery disease. George has extensive experience in formulation, analytical characterization and process development. He has a proven record in the commercialization of advanced drug delivery concepts, such as drug/device combination products, and has contributed in the approval of novel therapeutic solutions, such as the CYPHER® Sirolimus-eluting Coronary Stent. He has defined the strategy to address Chemistry Manufacturing and Controls issues, and has significant expertise in troubleshooting complex technical and quality issues during research, development and manufacturing of drug products. George has earned a Ph.D. in organic chemistry, and has co-authored of over 35 publications, as well as applied and issued patents.

Eric Roden
, Associate Director, Operational Excellence, B. Braun Medical 

Marjorie Shulman
, Director, 510(K) Premarket Notification Staff, FDA

Rahul Sapreshker, Associate Professor- Electrical Engineering & Computer Science, MIT

Roger Narayan, Professor, Biomedical Engineering, North Carolina State University

Dr. Roger Narayan is a Professor in the Joint Department of Biomedical Engineering at the University of North Carolina and North Carolina State University. He is an author of over one hundred publications as well as several book chapters on processing and characterization of biomedical materials. He currently serves as an editorial board member for several academic journals, including as editor-in-chief of Materials Science and Engineering C: Materials for Biological Applications (Elsevier). Dr. Narayan has been elected as Fellow of ASM International, AAAS, and AIMBE.




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