MD&M West 2013 boasted an impressive speaker line-up. View the roster below.
Stanton J. Rowe has been chief scientific officer since 2008 and also serves as corporate vice president, advanced technology. He joined the company in 2004 when Edwards acquired Percutaneous Valve Technology, of which he was president and CEO and helped to found in 1999. Previously, Rowe was corporate vice president of business development and strategic planning for Datascope and was vice president of business development for Johnson & Johnson’s interventional systems division (JJIS), responsible for the company’s coronary stent development efforts. At JJIS and the related Cordis Corporation, Rowe held a variety of positions with increasing levels of responsibility, including heading the company’s business development, advanced technology, worldwide clinical research, and marketing groups. Rowe joined Cordis after having held several positions in product management for various medical device companies. He is on the board of directors of both Remon Medical Ltd. and Biomerix. Rowe received his bachelor’s degree from the University of Alabama.
Kim joined Tandem in August 2007, bringing more than 30 years of healthcare experience in finance, marketing management, sales and strategic planning. Prior to joining Tandem, he was Chairman, Chief Executive Officer and co-founder of Biosite Incorporated, a medical diagnostic company that was acquired by Inverness Medical Innovations for $1.8 billion in June 2007. Prior to founding Biosite, he held various finance, operations, research management, sales management, strategic planning and marketing positions with Hybritech Incorporated and Baxter Healthcare.
Kim has been active in the medical device and diagnostics industry over the last 12 years, serving on the board of directors for innovative, young healthcare companies such as SenoRx and MediVation Incorporated. He holds a Masters of Business Administration from Loyola University Chicago's Graduate School of Business.
Marc J. Madou and his group research and fabricate micro- and nano-machines with chemical and biological applications. Recent projects include a compact disc to conduct medical tests. Through a series of tiny reservoirs and channels, doctors might one day run medical tests with Madou's novel CD by popping it into an ordinary CD player. Madou is also conducting experiments with a "smart pill" – an implantable device that senses the patient's need for a certain drug and delivers the right amount of medicine at any moment. Another project involves building fractal-like carbon electrodes for improved electrochemical devices such as fuel cells, batteries and biosensors. Madou is the author of Fundamentals of Microfabrication, considered the bible for microscale research.
Daniel Kraft is a Stanford and Harvard trained physician-scientist, inventor, entrepreneur and innovator.
Dr. Kraft has over 20 years of experience in clinical practice, biomedical research and healthcare innovation. Daniel chairs the Medicine track for Singularity University and is Executive Director for FutureMed, a program which explores convergent, exponentially developing technologies and their potential in biomedicine and healthcare.
Following undergraduate degrees at Brown and medical school at Stanford, Dr. Kraft was board certified in the Harvard combined Internal Medicine and Pediatrics residency program at the Massachusetts General Hospital and Boston Children's Hospital. He went on to complete Stanford fellowships in hematology/oncology & bone marrow transplantation, and extensive research in stem cell biology and regenerative medicine. He has multiple scientific publications (including in Nature and Science), medical device, immunology and stem cell related patents through faculty positions with Stanford University School of Medicine and as clinical faculty for the pediatric bone marrow transplantation service at UCSF.
Dr. Kraft recently founded IntelliMedicine, focused on enabling connected, data driven, and integrated personalized medicine. He is also the inventor of the MarrowMiner, an FDA approved device for the minimally invasive harvest of bone marrow, and founded RegenMed Systems, a company developing technologies to enable adult stem cell based regenerative therapies.
Daniel is an avid pilot and serves in the California Air National guard as an officer and flight surgeon with an F-16 fighter Squadron. He has conducted research on aerospace medicine that was published with NASA, with whom he was a finalist for astronaut selection.
David L. Gollaher, Ph.D., co-founded CHI in 1993. Previously, he was a senior executive at Scripps Clinic and Research Foundation. Earlier in his career, he served on the faculties of Harvard University, University of California, San Diego, the Graduate School of Public Health at SDSU, and the Overseas School of Rome. He is an award-winning historian of science and medicine, and has written three books and numerous articles in the fields of health policy, the economics of biomedical research and development, bioethics and the history of medicine. Gollaher completed his undergraduate studies at the University of California and earned his master's and doctorate degrees from Harvard University. Subsequently, he was a Fellow of Harvard's Houghton Library, the National Endowment for the Humanities, and the Massachusetts Historical Society. Presently, he serves on the boards of CHI, the J. David Gladstone Institutes and sits on the California Council on Science and Technology (CCST) and the Biotechnology Advisory Committee of the California Commission for Economic Development (CED). Gollaher is also a co-founder and board member of Vision Robotics Corp., and holds five patents for vision-based autonomous robotic navigation software.
Following extensive experience working for Notified Bodies, in medical industry and her involvement with Quality Management Systems, and Regulatory Affairs, Korina joined KARA & Associates in 2003 as a Partner and a Senior Regulatory Consultant. In addition to her consultancy role, Korina actively serves as a qualified BSI, SGS, Nemko, and TUV SUD instructor for various courses offered.
David Amor, MSBE, ASQ CQA, is currently a Design Quality Engineer in the Implantable Electronic Systems Division at St. Jude Medical in Minnetonka, Minnesota. As a quality and regulatory consultant to the medical device industry, he has worked with large companies like Boston Scientific and smaller start-ups in developing innovative quality programs that emphasize efficiency and ease of implementation. Recently named a Top 40 Under 40 Medical Device Industry Innovator by MD+DI magazine, David is passionate about medical device development and is a Senior Innovation Fellow alumnus of the University of Minnesota's Medical Device Center, where he was involved in the submission of over 40 invention disclosures. David is also continuing his academic work, pursuing a PhD in Mechanical Engineering from the University of Minnesota where his thesis work involves the development a novel medical device. In his abundance of spare time, David likes to be sarcastic and also loves training for triathlons, where his attention deficit is mitigated by swimming, cycling and running.
Aric is a leader with over 12 years experience in various supplier management functions and 7 years experience in medical device supplier controls. Current responsibilities include managing a global supplier quality function that is responsible for processes, tools and metrics used throughout the BSC plant network. In addition, driving continuous improvement projects to ensure costs are in line with quality expectations.
A current focus of his group is to streamline inspection activities, data and documentation approvals between BSC and Suppliers through several IS applications.
Simin Bagheri is the Customer Engagement Lead for Healthtech in Corporate Engineering Services team at Celestica Inc. Before joining the Engineering Services team, Simin was a Process Development Engineer/Project manager in Advance Process Development team at Celestica's Corporate Technology where she had focused on evaluating thermal fatigue reliability and mechanical properties of a series of new generation lead free alloys in collaboration with some of Celestica's major customers and global suppliers. Simin has also been focused on developing new assembly materials and processes, particularly for lead free applications.
Simin holds a Master of Applied Science degree in Metallurgy and Materials Science Engineering from the University of Toronto. Prior to joining Celestica, Simin worked as a Technology Engineer in Global Technology Group at AMP Inc.
Gunjan Bagla is founder and CEO of Amritt Inc., a global innovation consultancy with numerous clients in the medical and related industries, including Covidien, Becton, Dickinson and Company, J&J, Clorox, Roche Diagnostics, Gojo and others. Amritt helps medical device companies to grapple with the economies of India and China.
His articles have been featured on the Harvard Business Review blog and he has appeared on BBC TV, National Public Radio, the New York Times and the Financial Times as The India Expert.
Most recently, Gunjan was a featured speaker at India's largest Medical Device Conference held in January 2013 in Ahmedabad, India.
Georgette Belair, Vice President, Össur Americas R&D; brings over 20 years' experience in Engineering, Manufacturing, and R&D. Her roles have included driving Operation Excellence at Pilkington North America, and Design Excellence at Ethicon Endo-Surgery, a Johnson & Johnson company. She most recently led the effort to instill project- and portfolio- management at CareFusion Corporation in San Diego.
Recognized as a thought leader in the Six Sigma and Medical Device R&D fields, Georgette has spoken at dozens of conferences, sharing best practices in R&D and Operational Six Sigma. She is a published author, with John O'Neill, of Implementing Design for Six Sigma, A Leader's Guide; (July 2006, ASQ Quality Press.)
She has led New Product Development teams with projects up to $40 Million, including vital products for business continuity and innovation.
Georgette holds a Bachelors Degree in Mechanical Engineering from Kettering University, Flint, Michigan, and an Executive Masters of Business from the University of Toledo, Ohio.
For over a decade Thomas has been consulting large and small device manufacturers as a regulatory consulting professional. He supports compliance efforts for both Medical device manufactures and Pharma companies using a defensible risk based approach in the areas of software design and development, requirement definition, configuration management, product and process Verification and Validation. He provides auditing and training for clients of how to establish and maintain the necessary controls in order to meet regulatory and industry best practice requirements and expectations. His consulting has included guidance for 510(k), IDE, and PMA submissions, and the optimization of current design methods and recommendations for continual improvement in accordance with the GxP. Consultations have included support for the validation of Manufacturing Processes, ultrasound therapy systems, catheter measurement systems, Sterilization Systems, genetic synthesis, and Infusion Pumps.
Albert Birkicht has a master degree in electrical engineering from the University of the Armed Forces in Munich, Germany. He is living and working since more than 17 years in Switzerland. He was an officer in the German Air Force between 1981 and 1993 and after that worked for a long time in the research and development of miniature electrical drive systems such as motors, gears and controllers. He is managing director of HARTING AG in Biel since 2007 and at the same time responsible for the 3D-MID business of the HARTING technology group, which is located in Biel under the name of Mitronics. He is member of the board of the research organization 3D-MID e.V. and chairman of the working group "electronic assembly" within the German industry association ZVEI.
As senior vice-president and general manager, Ed Boarini oversees the operations of Teleflex Medical OEM, a worldwide business specializing in value-added product development services for leading medical device manufacturers. Boarini and his team are directly responsible for identifying and meeting key customer needs, improving production efficiencies through its state-of-the-art facilities, and developing innovative business and marketing strategies for growth.
Boarini joined Teleflex Medical OEM in 2004 as Vice-President of R&D and was later appointed to his current role in 2007. With a strong commitment to and thorough understanding of the OEM customer's needs, Boarini helped integrate various OEM facilities throughout Teleflex Incorporated to create a more cohesive, customer-focused supplier environment. This has led to improved product development, market share growth, and penetration, as well as outstanding customer service.
Prior to Teleflex Medical OEM, Boarini accumulated over twenty years of executive management experience with several large medical device corporations including Baxter Healthcare, Boston Scientific, and CR Bard. He has left a legacy of double-digit growth, increased productivity and profitability, and innovative product launches.
Boarini earned a Bachelor of Science degree in Biology at the University of Illinois, Chicago and a Master of Science degree in Technology Management from Pepperdine University.
Randall Brockman, M.D., F.A.C.C, Acting Chief Medical Officer, Office of Device Evaluation, CDRH / FDA
Dr. Randall Brockman joined the FDA in 2003. Most of his time at FDA has been as a medical reviewer in the Division of Cardiovascular Devices; although, currently he is serving as the Acting Chief Medical Officer for the Office of Device Evaluation. Prior to joining the FDA, he was in private practice for 5 years. His clinical training included fellowships in cardiac electrophysiology and cardiology at the University of Maryland, and a residency in Internal Medicine at the University of North Carolina, Chapel Hill. He received both his M.D. and undergraduate degrees from the University of Virginia.
Stacey Chang is an Associate Partner at IDEO and directs IDEO's Healthcare practice. Working across several IDEO offices since 1995, he has led efforts creating new offerings in healthcare therapies and services, products and devices, research, and market strategy targeting healthcare professionals and consumers alike. Clients within the healthcare industry range from healthcare delivery institutions to major pharmaceutical and device manufacturers and medical technology start-ups. In his current role at IDEO, his responsibility centers on helping clients understand their unique contribution to the broader healthcare ecosystem and helping them develop breakthrough offerings that are as beneficial for their end users as they are for their bottom lines.
In addition to his work at IDEO, Stacey has founded financial services software companies, led instrument platform development for surgical robotic systems, and counts among his experience forays into automotive design, corporate research and academic teaching. He also actively mentors several technology start-ups in Silicon Valley. In all his engagements, Stacey is passionate about the application of design thinking and developing technology towards the betterment of the human condition.
Stacey was named to Medical Device and Diagnostics Industry magazine's "40 under 40" list of medical technology innovators in 2012. He holds an MS from Stanford University and a BS from the Massachusetts Institute of Technology
Karema Chantasirivisal is Process Development Manager at Boston Scientific Corporation. In this role, she has created and maintained a process validation system and implemented process development standards to the division. Prior to joining Boston Scientific, Karema worked as a consultant with Medical Device companies to create or improve Quality Systems and process validation processes. Her experience has included: supporting the development of a quality system, creating and maintaining a process validation system, and supporting design of experiments and characterization studies for manufacturing processes.
Mike Checketts, Director of QA/RA and Technology, AMETEK Medical Interconnects Mike joined TSE in 2002 as our Director of Engineering, bringing with him over 25 years of experience in Medical Device manufacturing and development. In 2006 he was promoted to Vice President of Technology and asked to focus on researching and applying new technologies to our products and processes. In 2008 Mike added oversight for our Quality and Regulatory activities to his role in new technologies.
Mr. Chiddix complements degrees in biology and biochemistry, with Lean Six Sigma Black Belt training, and more than 12 years of experience in Class 2 and Class 3 medical device companies - specializing in orthopedics, neurology, and vascular medicine. Whether playing hands-on roles and building teams at start-ups or leading projects and serving in management capacities at large, multi-national companies, he is keenly focused on delivering solutions to the field and bringing new products to market. To this end, one area that Olen is particularly passionate about is identifying and cultivating long-standing, mutually rewarding relationships with manufacturing partners.
In addition to serving as both a UBM Canon conference presenter and panelist at MedTech and Medical Device & Manufacturing events, Mr. Chiddix has been invited to be a key presenter at international society meetings and conferences such as the Plastics In Medical Devices conference held in Brussels. Outside of public speaking engagements, he is also a recognized subject matter expert in the areas of negotiation and partnership development. Olen was honored as a 2010 recipient of Pathway Medical's Founder's Award – an award given annually recognizing individuals who demonstrate excellence in: leadership, compassion, dedication, entrepreneurial drive, and a willingness to take risks.
Olen's strong clinical background, training as a surgical assistant, love of science, and extensive experience with: product specification, new-product introduction, relationship building, contract manufacturing, outsourcing, technology/facility transfers, risk mitigation, and supply chain optimization serve as the foundation for his approach to creative problem solving.
25 years experiences in outsourcing of medical devices, drug-device combination products and consumer electronics in project management, development, manufacturing, quality and supply chain roles. Expertise in design control, technology transfer, risk management, cost reduction, DHF, commercialization, contract manufacturing and supplier relations in US, EU, the Caribbean and 6 Asian countries. Manage global cross-functional NPI and outsourced product development and manufacturing. Yong has worked on drug-device combination products (PFS, AI), drug delivery products (pumps and disposables), catheters (cardiovascular, neurovascular, urology), introducers and battery powered urology and oncology devices. Yong has shipped 4 Class II medical devices and 4 Microsoft PC peripherals as Project/Program Manager.
Yong has been to Asia over 50 times since late 80′s and worked with many medical device and pharmaceutical suppliers in Korea, Taiwan, China, Singapore, Malaysia and India as well as suppliers in EU and the Caribbean. Yong is ASQ Certified Quality Engineer and Auditor. He has BS in Chemical Engineering from University of California, Santa Barbara and MBA from Pepperdine University.
Steve Cochran is a senior executive with more than 20 years of successful enterprise technology, M&A, product marketing and operational execution experience in a range of organizations. As Chief Technology Officer, Cochran's expertise in technology and business strategy, as well as product development and deployment is invaluable as he leads a team of global product architects, development, quality, program management and operations professionals.
Prior to joining GHX Cochran was vice president, Global Product Management at GXS, an enterprise B2B integration as a service provider where he lead the product strategy and direction for GXS's enterprise cloud services and software product offerings. Before its acquisition by GXS, Cochran was CTO at Inovis where he oversaw the modernization of the company's cloud services platform that provided enterprise architects and CIOs with a scalable and efficient way to manage their communities of trading partners, leverage cloud-based B2B applications and to better focus on their core business.
Additionally, Cochran was Group Vice President at Adaptec where he worked in the data protection and enterprise storage controller division. He has also worked for such industry luminaries as Lockheed Martin and General Electric.
Cochran received an MBA from Rollins College, Crummer Graduate School of Business in Florida and a BSEE from the University of Kentucky.
Martin Coe has been a Systems Engineer in the Medical Devices industry for 12 years. His education includes a B.S. in Electronic Engineering Technology and an M.S. in Systems Engineering from Southern Methodist University.
Martin is certified in Six Sigma Lean & Design for Six Sigma and printed wiring board design principles (IPC) and a Certified Systems Engineering Professional (INCOSE CSEP) with extensive experience in all aspects of commercial product development in various industries. His engineering work experience includes 100+ product development projects and since 2000 his focus has been on the application of Systems Engineering methodology to optimize commercial product development efforts, mainly in the Medical Devices industry. His work includes published papers, books, presentations and training courses that have been recognized by regulatory bodies, medical device organizations and professional societies including, among others, the International Council on Systems Engineering (2005-06 Technical Director, INCOSE Front Range chapter), and IEEE.
Mike has been a senior research fellow with Boston Scientific since 2004 when they acquired Advanced Bionics. At Advanced Bionics he was a chief scientist developing cochlear implants. Prior to Advanced Bionics he was a director of R&D at the Medical Research group where they were developing a mechanic artificial pancreas for diabetic patients. Before this he was working for Smith & Nephew, plc., where he was director of R&D developing novel ophthalmic and orthopedic implants. Prior to Smith Nephew, Mike worked at the Jet Propulsion labs working on novel immuno-polymeric conjugates and microgravity experiments. Mike holds his doctorate degree from the University of Southern California, California Institute of Technology.
As the executive lead for industry relations at GHX, Karen Conway works with industry associations, standards bodies, government agencies, analyst firms, academic institutions and the media to identify opportunities for hospitals and suppliers to optimize supply chain operations and improve business and clinical performance.
Prior to joining GHX, Conway served as principal of Conway Associates, a strategic communications firm built on the principles of continuous quality improvement and based on the work led by her business partner between Proctor & Gamble and Wal-Mart. She has also worked on the state and national levels as both a journalist and a lobbyist.
Conway was recently elected to the board of directors of AHRMM, the supply chain organization for the American Hospital Association. She serves on the leadership council of the Arizona State University Health Sector Supply Chain Research Consortium and as co-chair of the HIMSS Supply Chain Special Interest Group. In addition, she is active in the Strategic Marketplace Initiative (SMI) and the Medical Device Supply Chain Council and serves on the editorial board of Healthcare Purchasing News. Conway's work has been published in numerous trade publications as well as USA Today, Redbook and Parent magazines. She was also a contributing writer to the book "e-Business in Healthcare" published by Springer in 2007.
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. Crowley has held variety of positions over his 20+ years at FDA. Currently, Crowley has primary responsibility for implementing the Unique Device Identification System requirements of the 2007 FDA Amendments Act. He holds a master's degree in risk analysis and a bachelor's degree in mechanical engineering.
Mr. Daniel has more than 25 years of regulatory, clinical, and quality experience and has been a consultant for multiple medical device companies over the past 20 years.
Mr. Daniel is currently President of Daniel and Daniel Consulting, a leading West Coast medical device consulting firm that helps venture capital and angel funded companies bring products to market through the effective management of clinical study and regulatory processes. He has familiarity with a broad range of medical devices, including: implantable heart assist devices (Novacor), in vitro diagnostics (SKD), endometrial resection/ablation devices (FemRx), coronary and peripheral catheters (LuMend, FHT, Kerberos), coronary anastomotic devices (Coalescent), left atrial appendage clips (LAAx) and general surgical implantable clips (Coalescent), implantable bronchial valves (Emphasis), gastrointestinal (GERD) and bariatric devices (Endogastric Solutions), femoral access closure devices (Cardiva) and endoscopic/percutaneous robotics (Intuitive Surgical, Hansen Medical, NeoGuide, ROBODOC).
Mr. Daniel holds a BS in Microbiology from Michigan State University, a MS in Biology from the Illinois Institute of Technology (IIT) and a MBA from the University of California, Berkeley.
Vipul Davé has been working at Johnson & Johnson for over 16 years and is currently an Engineering Fellow in the Advanced Engineering, Science & Technology group in Global Supply Chain supporting Medical Device & Diagnostic companies within J&J. He became a Senior Engineering Fellow in 2010 when working at Cordis Corporation, a J&J company. Vipul's area of technical expertise is in polymers, biomaterials, medical plastics and drug delivery. He has led several programs to treat cardiovascular disease and some examples include drug eluting stents, fully bioabsorbable stents and devices, balloon catheters and vascular closure devices. He started his J&J career with Consumer Products and led several polymer projects related to oral care, wound care, skin care and personal care products. Prior to J&J, Vipul worked at Warner Lambert and was an Assistant Research Professor at University of Massachusetts Lowell in the Department of Plastics Engineering and NSF Biodegradable Polymer Research Center.
He received his B.S. in Textile Engineering from University of Baroda in India, M.S. in Polymer Science from University of Massachusetts and Ph.D. in Materials Engineering Science from Virginia Tech. After obtaining his Ph.D., Vipul spent a year as an Adjunct Assistant Professor at the Experimental Station for Biomaterials Research in Milan, Italy.
Vipul has over 14 granted US patents and over 60 filed patent applications. In addition, he has authored more than 25 technical papers that have been published in peer-reviewed journals, 30 papers in conference proceedings, and over 30 conference presentations. He has also published three book chapters in the American Chemical Society (ACS) Symposium Series, and a co-editor of MRS Proceedings on Gels and Biomaterials.
Vipul serves as the Chair of the Cardiovascular Special Interest Group, Society for Biomaterials; and a Board Member of the Medical Plastics Division, Society of Plastics Engineers.
Uwe Degenhardt is the TÜV SÜD America, Inc. Division Manager for Active Medical Devices. He has over 15 years of experience and has spent the last 9 years working out of the TÜV SÜD laboratory located in San Diego, CA. Uwe is a certified Lead Auditor for ISO13485 and the Medical Device Directive MDD93/42/EEC. He is authorized under the FDA 510k Third Party Approved program and also for Canadian Medical Device Regulations. He received a Master's Degree in Biomedical Engineering from the Technical University of Dresden in Germany where he soon began his career at the world-renowned TÜV Product Service GMBH laboratory located in Munich. He then spent over 6 years testing medical devices such as patient monitors, surgical equipment, stimulators, and ultrasound equipment, to name a few, before ultimately transferring to the California facility.
Richard DeRisio is Vice President, Global Quality Assurance and Regulatory Affairs for Covidien in Mansfield, MA. His department’s responsibilities include global quality, regulatory and compliance for Covidien’s Global Business Units, Regional Operations and Corporate QA/RA functions. Prior to joining Covidien, Mr. DeRisio was Divisional Vice President, Regulatory Affairs at Abbott Medical Optics Inc., a division of Abbott Laboratories where he had responsibility for global regulatory affairs, government affairs, reimbursement and policy. From 2003 to 2007, he held positions of Vice President, Quality & Regulatory Affairs and Vice President, Regulatory Affairs at Kinetic Concepts, Inc. Previously, Mr. DeRisio worked in corporate and operating company positions at Johnson & Johnson, Pfizer and other medical device companies. He has held leadership clinical, regulatory and quality roles for manufacturers of ophthalmic devices, mechanical heart valves, defibrillators, electrophysiology catheters, wound healing systems, robotic surgery devices and sterilization equipment. During an earlier ten-year career at FDA’s Washington offices, Mr. DeRisio worked in the Agency’s field operations headquarters and later in the Office of Compliance in the Center for Devices and Radiological Health. Mr. DeRisio is a graduate of Cornell University, where he received a Bachelor of Science degree in chemical engineering and Master of Science degree in food science and technology with a minor in microbiology. He is a member of the USC Regulatory Science Graduate Program Advisory Board and serves on the editorial advisory board for Medical Device & Diagnostic Industry magazine and on the MD&M Advisory Board. He participates on AdvaMed and MDMA committees, and is a member of AIChE and the Regulatory Affairs Professional Society. Mr. DeRisio holds the RAPS Regulatory Affairs Certification (RAC).
Mark DuVal, JD, is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical and nutritional supplement industries. His practice includes providing strategic regulatory advice, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, developing compliance programs, conducting sales training and interfacing extensively on behalf of companies with the FDA. He works with FDA on behalf of companies on 510(k)s, de novos, combination products and PMAs, clinical trial IDE negotiations, inspections, warning letters, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems and several medical device divisions working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. in Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance providing FDA, Anti-kickback, False Claims Act, HIPAA, and other advice related to the FDA-regulated industry. Mark co-founded the Minnesota Medical Device Alliance (MMDA) and has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council (appointed by then Governor Pawlenty), and The Food and Drug Law Institute (FDLI) and was Chair of the Food, Drug and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs and Services program at St. Cloud State University.
David Dykeman is a registered patent attorney, shareholder, and co-chair of the Intellectual Property Department in the Boston office of the international law firm Greenberg Traurig LLP. With over sixteen years experience in patents, intellectual property, and licensing, David's practice focuses on securing strategic worldwide intellectual property protection and related business strategy for high tech clients, with particular expertise in medical devices, life sciences, and healthcare IT, and green technologies. David also performs patent due diligence to assess patent portfolios for venture capital investment, mergers and acquisitions, and licensing opportunities. An author of over 35 articles and a speaker at over 30 conferences on intellectual property law, David was honored as one of Boston's "40 Under 40" innovative business leaders by the Boston Business Journal and was named to the "40 Medtech Innovators Under 40" list by Medical Device + Diagnostic Industry (MD+DI) magazine. David has also been named one of the top 250 Patent and Technology Licensing Practitioners in the world by Intellectual Asset Management (IAM) Magazine. David Dykeman's full biography: http://www.gtlaw.com/People/DavidJDykeman
Jackie has been working in the medical device sector for more than 25 years and currently holds the position of Global Process Owner of Standard Product Identification for Medtronic, Inc. Global Regulatory Operations.
She has been recognized in the healthcare sector as a leader in global product identification standards development and implementation, both internally to Medtronic, and to the global healthcare industry. Jackie has co-chaired the AdvaMed Auto-Identification committee since 2006, providing guidance on product identification standards related to the FDA's Unique Device Identification (UDI) legislation. She has also provided an advisory role in many other initiatives involving UDI legislation in both the United States and globally with the International Medical Device Regulators Forum (IMDRF).
Jackie is one of the founding members of GS1 Healthcare Global and has maintained a leadership role in the organization since its inception in 2005. She has also been involved in many of the GS1 Healthcare work teams developing global standards for product identification and Auto-Identification Data Capture (AIDC) in healthcare. Jackie also chairs the GS1 Healthcare Global Public Policy work group for the medical device sector. In this role, she has engaged with regulators around the world in a collaborative role to provide guidance on implementation of global healthcare standards and advocate for and influence the movement towards harmonized standards in the global healthcare supply chain.
John Felton joined Daikin America, in November 2005 as a Senior Market Development Representative and is responsible for developing applications in both the Medical and Aerospace Markets.
Globally headquartered in Osaka, Japan, Daikin Industries Ltd. is a worldwide leader in air conditioning systems, of which, fluorine chemistry is key. The fluoropolymers and fluorochemicals division has annual sales exceeding $1.2 billion.
Before joining Daikin America, John worked as an account manager for Ticona Engineering Polymers where he was responsible for customer program development, material recommendations and design assistance.
Prior to Ticona, John spent many years working for injection molding companies as well as Electronics OEMs providing design and development support.
John is a graduate of Western Washington University, holds a Bachelor of Science Degree in Manufacturing Engineering Technology and has been active in the plastics industry for over 25 years.
Approaching 28 years in the R+D Pharmaceutical/Biotech/Medical Device Industry with the last 8 years in Combination/Convergent Products with Johnson & Johnson as a Principal Scientist to a Research Fellow for 1 year focused on Consumer/Medical/Pharma Products/Processes. Career experience includes Formulation and Process Development Technology/Optimization. Cleaning/Pilot/Scale-up/Process Validation. Stability Programs/Project Management. Technical Support/Troubleshooting for Manufacturing. Scale-up/Technology Transfer of products to commercial manufacturing facilities, Process Equipment Selection/Evaluations, IQ/OQ/PQ/PPQ Validation. Formulated and executed experimental protocols to authoring patents and review of technical documents, reports and SOP/MWI's. Coordinated scheduling and execution of technical projects supporting in-house R+D studies and commercial manufactured products. Involved in modification and improvement of existing formulations and product/processing leaning technology. Monitored and documented stability studies to support formulation, processing or raw material and/or component changes. Integrated Pharmaceutical Technology Transfer Practices into a Design Control System. Ancillary functions included leading teams of technically talented scientists, engineers and technicians in formulation/process development and GLP/GMP clinical manufacturing operations. Continues to build a strong scientific background in drug/device formulation and drug process development, characterization, optimization, process validation and is a Johnson & Johnson certified black belt. Strives to increase his creativity as a scientist in order to manage and lead successful teams or be a team member by using the application of scientific principles, design/process excellence and SPC to solve complex medical/drug product or process issues.
Dan Floyd is the Sterilization Section Leader at Nelson Laboratories, Inc. For the last 18+ years he has specialized in all aspects of EO validations including cycle development, D-value determinations, bioburden resistance studies, biological indicator sterility testing, BI incubation reduction studies, comparative resistance testing, PCD development, and temperature and humidity distribution studies. Dan has performed onsite validations of sterilizers domestically and abroad both at contract sterilization facilities as well as for customers sterilizing product in house. Recently Dan has become involved with vaporized hydrogen peroxide sterilization validations and has had experience with EO, steam, dry heat, vaporized hydrogen peroxide, liquid chemical sterilants, and ozone sterilization.
Dan received his B.S. in microbiology and a minor in chemistry from Brigham Young University where he attended on a Presidential scholarship. He has been with Nelson Laboratories, Inc. since 1992. Following graduation he became a registered microbiologist with the National Registry of Microbiology.
Dan is a participating member of several AAMI working groups including industrial ethylene oxide sterilization, biological indicators, BIER/CIER vessels, and Process Challenge Devices.
Dr. Frautschi has over 25 years of experience in the Biomaterials/Medical Device industry as a researcher and consultant. His functional experience includes: Directing R&D for many Cardiovascular Medical Devices, Selection of Biomaterials, Surface Modification and Regulatory Testing. Dr. Frautschi is responsible for assisting PolyOne/NEU Customers with their many needs in the development process for Medical Device.
Marianne Gill has worked in the medical device and combination product industries for more than 25 years. As Director of Clinical Operations at CareFusion, Marianne is currently responsible for risk management pre and post product release, Pharmacovigilance and post market surveillance for numerous medical products. Her background also includes management of customer feedback into actionable data that improves the quality of care, corporate culture facilitation and ICU / home care clinical experience. Marianne has a Master's degree in Health Care Administration and lives in Poway, CA, with her husband and two children.
Mary Gray is a Regulatory Affairs Manager for DePuy Synthes, companies of Johnson & Johnson. She has been the regulatory lead for the J&J MD&D Nanotechnology Workstream Committee. Since joining the team in 2008, Mary has been instrumental in assessing the regulatory environment and has led many efforts to influence regulatory policy and standards in this evolving space.
Prior to joining DePuy Synthes, Mary has held regulatory positions with Advance Technologies and Regenerative Medicine, LLC, Bayer Healthcare, Genzyme and bioMerieux Vitek. Mary has broad experience in regulatory strategy and submissions for in vitro diagnostics, medical devices, biologics and combination products.
Mary earned a Bachelor of Science Degree in Biology from Fitchburg State College and a Masters Degree in Public Administration for Suffolk University. Mary has also achieved certification in both US and EU Regulatory Affairs from the Regulatory Affairs Professional Society.
Ed Greenberg has been in the specialty chemical area for over 35 years with both FMC Corporation and Lubrizol Advanced Materials (nee Noveon Corp, nee BF Goodrich). He has had positions in product development, technical support, market analyst, corporate global sourcing and in a variety of commercial positions in the pharmaceutical ingredients and medical device businesses. Ed has focused on developing and marketing products for high value functional excipients for various pharmaceutical dosage forms and more recently for new functional polymers for medical devices. He has been leading Lubrizol's growth in drug delivery systems for solid dose, dermal, bioadhesive, and bioresorbable polymer systems. Ed holds a B.S. from Rensselaer Polytechnic Institute and a Ph.D. from Penn State University in Inorganic Chemistry.
Gary has 18 years of experience specializing in the design and manufacturing of medical devices for Cardiology, Neurology, Pain Management, and Eye Surgery applications. In addition, he has 13 years of advanced practical engineering experience in manufacturing industries involving heavy industry and electronics. He has held key leadership positions at both site and corporate levels, leveraging skills in investigation, design, deliverables implementation, and global compliance systems.
Gary has a demonstrated history of recruiting, hiring and mentoring high performance teams to support the changing needs of the business while promoting their personal career growth. He has extensive experience in Supplier Management, Quality Systems, Auditing, CAPA, Warning Letter Remediation, Design Control, Software Development & Validation with Part 11, Technology transfer, and Precision Metrology, in the US, Canada, EU, and Asia Pacific. Today he is managing Supplier Quality for Bausch+Lomb facilities located around the world.
Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products and Medical Device Reporting issues. Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner.
Ron/Mr. Kaye leads the Human Factors Pre-Market Evaluation Team which is located in the CDRH Office of Device Evaluation (ODE) and within the Division of Anesthesia General Hospital and Infection Control Devices (DAGID). The purpose of the FDA's Human Factors Pre-Market Evaluation Team is to ensure that new medical devices are safe and effective for users. The main activity of the team is reviewing Human Factors content in new device submissions to the Agency. The HFPMET team also promotes human factors evaluation practices for medical devices, develops Human Factors Guidance, and participates with National and International Human Factors Standards development.
Ron/Mr. Kaye has a BS degree in Psychology and Biology, and a MA in Applied Psychology. He has worked in the field of Human Factors for 30 years and the last 15 at FDA's Center for Devices and Radiological Health (CDRH), Prior to joining the FDA, Ron worked with Human Factors and human performance testing, training analysis, and research on safety-critical systems such as nuclear power plant control rooms, military weapons and communications systems, aircraft cockpit systems, air traffic control systems as well as medical devices.
Ashley Kelley received her B.S. from the University of Michigan, Ann Arbor (2003) and M.S. from Stanford University (2008). Prior to graduate school, she worked for three years at Exponent, Inc. in the thermal group as a mechanical engineer investigating fires & explosions. Ms. Kelley joined Abbott Vascular in September 2008 and focused on characterizing the mechanical response of PLLA used in the Bioresorbable Vascular Scaffold (BVS) device. Her role has continued to grow to the development of other functional test methods supporting polymer material characterization and device related performance. She currently leads the Abbott Vascular BVS R&D Test Method Group.
Allan Kimble, MSc, CHMM is currently the Manager, Materials Process Validation at DePuy Synthes Companies of Johnson & Johnson in West Chester, Pennsylvania and has been with the company for 10 years. In this role he is responsible for the final chemical cleanliness of orthopedic medical devices as well as ensuring their biocompatibility.
He has developed and validated novel preparatory and analytical methods to characterize medical devices for chemical residues. He and his group validate manufacturing material removal processes as well as chemically characterize finished products to document their biocompatibility.
Allan has also worked for Vistakon, Johnson & Johnson Vision Care for 13 years in Research & Development and holds a number of patents related to that work. Prior to that, he was with Arthur D. Little Program Systems Management Company as a chemist and consultant. Allan is active with the ASTM Committee F04 on Medical and Surgical Materials and Devices, the American Chemical Society and the International Union of Pure and Applied Chemistry.
Jim Kozick, Principal Consultant, Kozick Consulting, specializes in providing Regulatory and Compliance Consulting Services to the medical device industry both domestically and international. Mr. Kozick provides the full spectrum of compliance and regulatory consulting services which include, but are not limited to: quality system compliance assessments, mock FDA audits, training, regulatory strategies, FDA communications, pre and real time FDA inspectional assistance, response to regulatory challenges/actions, and assessments under Attorney-Client Privilege.
Prior to becoming an independent consultant in 2005, Jim served both as Principal Consultant and Director of Medical Device Compliance Consulting with PAREXEL Consulting (formerly KMI), an international provider of regulatory compliance, validation, quality systems, and information system services to the pharmaceutical, medical device and biopharmaceutical industries. He served in this capacity from 2001 to 2005.
Mr. Kozick joined PAREXEL Consulting in 2001 after a 32-year career with the FDA in the Los Angeles District which included extensive experience as a FDA Field Investigator, Supervisory Investigator, and Director of Domestic Investigations. He was responsible for executing all FDA field inspection & enforcement programs, and he accomplished this through his direction of the largest field investigative operation within the FDA. During his last two years with FDA, he served on extended temporary duty as the Acting Director, Los Angeles District, exercising ultimate responsibility and final authority for all District operations.
He has given numerous presentations, workshops, and conferences on a variety of regulatory and compliance topics providing a unique FDA perspective.
Jim received his Bachelor of Science degree from St. John's University, Collegeville, Minnesota.
As an Innovation Program Manager at Medtronic, Craig Lauchner coaches and leads teams developing new surgical products and therapies through best business and design practices. He invented Assumption Storming (Brainstorming on steroids), and has taught it in the Stanford Design School, at Medtronic for many functional groups, and in university classes. He develops and teaches classes on creative tools (including Assumption Storming), ethnographic research, design sketching, visual problem solving and formative usability testing. In his work at Hewlett-Packard Craig accrued 14 patents. He has designed retail, computer, industrial and medical products, as well as extreme amusement rides. Craig graduated from the Stanford program in Product Design.
James (Rusty) Lusk has over 30 years of experience in regulated and non-regulated industries ranging from early-stage development to Fortune 100 companies. He has held senior management positions in Regulatory, Quality, Clinical Programs, and New Business Development. He is currently with Quality Systems International; a multidiscipline consulting company serving FDA & Internationally regulated industries. He is Co-Inventor of a non-invasive device intended to delay or reverse cardiovascular disease and improve quality of life and a Co-founder of LifePulse, LLC, an early-stage medical device company.
He is a past President of the Orange County Regulatory Affairs (OCRA) Discussion Group, a nonprofit organization with the mission of educating the regulatory professional, and is privileged with being a current Board member.
Domestic and international certifications:
Wenkai Ma is the director of Global Regulatory Affairs in Allergan, Santa Barbara, California. Over the past three years, she took an assignment to Beijing China as head of regulatory affairs, overseeing the development of regulatory plans and managing the key regulatory timelines and critical path activities. In this position, she gained firsthand experience on interacting and negotiating with SFDA scientific reviewers and administrative executives to facilitate the review and approval of regulatory submission in China. Before joined Allergan in 2010, Ms. Ma worked at Johnson and Johnson for 14 years, where she accumulated extensive working experience and knowledge on pre-clinical, clinical study and regulatory submissions for class III medical devices with US FDA and other international regulatory agencies.
A native of Beijing, Ms. Ma was educated in both China and the US. She received her Bachelor's degree in Environmental Engineering from Beijing Polytechnic University and Mater degree in Analytical Chemistry from University of Nevada. Currently, she is a member of China Association for Medical Devices Industry.
Wendy Mach, B.S., RM (NRCM), CQA (ASQ), CPLP-tech (ISTA), is the Packaging Section Leader at Nelson Laboratories. Since 2004, she has overseen the integrity, strength and microbial barrier tests in the packaging department. After 17 years of testing medical devices, Wendy is an expert in packaging validations, sterilization validations, and microbiology testing. Before joining Nelson Labs, she worked as a lab supervisor managing the testing of sterility, microbial limits, bioburden, limulus amebocyte lysate, and antimicrobial effectiveness. Wendy began her career as a microbiologist performing in-house verification and validation.
Wendy is on the F02 committee for flexible barrier packaging of the American Society for Testing and Materials (ASTM) and is a member of the Association for the Advancement of Medical Instrumentation (AAMI) packaging work group. She was invited to be a speaker and panelist on package testing at OrthoTec 2011. Wendy graduated with a B.S. in biology from the University of Minnesota.
Janie has over 15 years of research and product development experience in the medical device industry. Before joining SinuSys, Janie was a Director of Pre-Clinical and Emerging Clinical Research at ArthroCare Corporation, a multi-business medical device company that develops, manufactures and markets products for ENT, Sports Medicine and Spine Therapies. Previously, she was Vice President of Pre-Clinical and Clinical Development at Synvascular Inc, a start-up company, dedicated to development of a novel, biomaterial based anastomosis device. Earlier in her career, Janie spent 10 years in roles of increasing leadership responsibility in the R&D department at Guidant and then Abbott Vascular, developing novel technologies for the treatment of Heart Failure as well as Vulnerable Plaque. Janie is a co-inventor on over 15 issued and pending patents. Janie holds a Ph.D. degree in Chemical Engineering from Columbia University and a B.S. degree in Bioengineering from UCSD.
Todd McCaslin is the Strategic Sourcing Director for Boston Scientific Corporation, a leading innovator of medical devices and technologies that that are used in a broad range of interventional medical specialties.
Todd and his team are responsible for working with the 11 manufacturing locations and 7 business units within BSC to develop and apply global sourcing strategies and relationship management skills to drive value and innovation across all direct material commodities, while insuring direct linkage to BSC's overall business strategy.
He has over 30 years of experience in the Medical Device field, holding management positions in Manufacturing Operations, Quality, Process Development, and Sourcing. He joined Boston Scientific in 1984. He has held the role of Strategic Sourcing Director since 2007. Prior to BSC, he spent 4 years with Baxter Travenol.
Todd earned a Bachelor of Science degree in Microbiology from Colorado State University.
Denise McEachern, VP Global Regulatory Affairs, Bausch + Lomb Surgical
Denise McEachern has a track record of fostering product innovation and global commercialization with more than 30 years of experience in the medical devices, diagnostics and pharmaceutical industries. She has developed and implemented regulatory strategies for the approval and launch of new products in the global environment. These strategies included collaboration utilizing new and novel approaches to regulatory approval, resulting in best in class "time to market cycle" and first of a kind product claims.
McEachern holds a BS with a major in Biology and minor in Chemistry; and an Executive Juris Doctorate with a concentration in Health Law. Her current position is Vice President of Global Regulatory Affairs for Bausch & Lomb Surgical. Previous positions include Johnson & Johnson- Worldwide Vice President of Quality, Regulatory & Development Affairs and other senior executive positions in Regulatory, Clinical, Quality and Compliance at LifeScan, Inc, Cordis Corporation, and Vistakon. McEachern entered the Regulatory field with Alcon Laboratories.
Delores is a Sr. Director of Engineering for the HVT Heart Valve Business Unit of Edwards Lifesciences where she leads Engineers in the areas of New Product Commercialization, Automation, Manufacturing Process Engineering and Materials Engineering.
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.
Siobhan O’Bara, vice president, Healthcare for GS1 US, is an accomplished leader with over 20 years' experience in supply chain, logistics and operations management. Over the course of her career she has become known in the industry as a thought leader in supply chain re-engineering. Her record of successful change management, a deep industry understanding of the complexity of the healthcare supply chain, and work with data standards has added tremendous value to the GS1 Healthcare US initiatives.
Prior to joining GS1 US, O’Bara was vice president, Customer Operations and Supply Chain Systems and Solutions for Covidien, a leading global provider of healthcare products. Over the course of 15 years at Covidien, O’Bara managed supply chain functions at multiple Covidien divisions, including medical supplies, retail, imaging, pharmaceutical, and respiratory technologies. Prior to Covidien, O’Bara was part of the James W Daly Division of Cardinal Health.
Throughout her career, O’Bara has spearheaded successful programs in customer care, shared services, transportation, planning, procurement, global replenishment, distribution operations and supply chain systems, and has expertise in acquisitions, integrations and business process development. Additionally, her background includes public relations and professional writing.
O’Bara is a graduate of Johnson & Wales University, the University of Connecticut and Babson College with degrees in culinary arts, communications and business. She is often invited to speak as a subject matter expert at healthcare supply chain and operations events. She resides in Wickford, Rhode Island and is an avid gardener and chef.
Dan Olivier is president of Certified Compliance Solutions, Inc. He is an acknowledged expert in the field of medical device and pharmaceutical system validation and safety risk management with over twenty two years experience. He is a frequent speaker at conferences, author or over 20 medical device related articles, and recognized as a leading industry expert in medical device software. His company provides consulting support for validation, safety risk management, audits, training, software development, and testing services to meet the requirements of FDA regulations and ISO standards. He can be reached at email@example.com.
Lei Peng has over 20 years of experience in medical device, pharmaceutical, and epidemiological studies. Since she joined Abbott Vascular in 2002, Lei has designed a variety of clinical trials and has led a team of biostatisticians and SAS programmers on multiple successful PMA submissions. In addition, she has overseen the development of biostatics standard operating procedures. Currently, as an associate director of biostatistics, she provides statistical leadership and guidance to the endovascular programs. Lei received a M.S. in statistics from the University of Rhode Island and subsequent post-graduate training in biostatistics at Brown University.
Susan Petersen-Stejskal ("stay skull") has 30 years experience in regulated clinical research. She is currently the Vice President of Clinical Research & Regulatory Affairs at BioControl-Medical in Minneapolis, Minnesota. She has held worldwide Clinical Operations and Regulatory Affairs positions at Medtronic, Inc., Cardiac Concepts and Angeion Inc. Susan received her BS RN from the University of Wisconsin- Oshkosh in 1983. She has worked in the regulated and non regulated clinical research area since that time. She was first employed a registered nurse in the areas of oncology (bone marrow transplant) and cardiology (heart failure) at the University of Minnesota Hospital with focus on research methodology and data collection for 6 years. She then transitioned to industry-sponsored research in the heart failure area, first at Boehringer Ingelheim Pharmaceuticals in Danbury, CT.
She has extensive experience in clinical trial design and management of implantable active medical device studies in both a large and small start up company throughout Europe, Asia and the United States. She has managed over 25 products (implantable devices) though FDA approval (PMA and PMA-S), 5 of which required FDA cardio-renal advisory panel review prior to approval.
In his present role, Pleasant oversees Premier's information systems infrastructure that includes legacy, enterprise, and Web-enabled offerings.
Prior to that, Pleasant served as chief administrative officer of SunHealth, Inc., one of Premier's predecessor organizations. During his 25 years with SunHealth, Pleasant held numerous positions that included senior management consultant, relationship manager for owners in Virginia, West Virginia and Maryland, senior Human Resources executive and CIO.
Pleasant is a leading industry expert and proponent of a unique device identification system (UDI) for medical devices and products, much like the existing system for pharmaceuticals. He has worked extensively with all participants in the supply chain – from providers to distributors and manufacturers – in efforts to move the industry toward a universal product numbering system.
Pleasant is past chairman and a founding member of the Coalition for Healthcare eStandards (CHeS), a fellow member of the Healthcare Information and Management Systems Society (HIMSS), and a founding member of the College of Healthcare Information Management Executives (CHIME).
Pleasant is involved in national efforts to improve the health care supply chain and serves on the boards of GS1US, 1WorldSync, and the National Alliance for Healthcare Information Technology (NAHIT). He also is past president of the North Carolina Chapter of HIMSS and chaired HIMSS' 2006 Annual Conference Education Committee.
Pleasant is a cum laude engineering graduate of North Carolina State University and holds a master's degree in business administration from the University of North Carolina.
Frank Pokrop has worked in the drug and medical device industries for more than 20 years and has obtained these certifications: CSQE, RAC and CISA. He was previously certified as a PMP in project management and has written for MDDI, ASQ and other publications. Frank is the director of quality and regulatory affairs for CareFusion in San Diego. His background includes worldwide submissions, recall management, product launches, vigilance reporting, manufacturing operations, auditing of US and global locations and workplace investigations. He is a member of MD&DI's Editorial Advisory Board, he served on ISO TC 210, he has served as the USA co-chair for risk management and lives in Carlsbad with his wife, two daughters, and a chocolate lab.
Thor Rollins is a certified microbiologist, RM(NRCM) with the National Registry of Certified Microbiologists and has been with Nelson Laboratories, Inc. since 2002. Currently, he is the In-vivo Biocompatibility Subcontracting Section Leader, and from 2002-2006, he was the study director over cytotoxicity.
He specializes in the In-vitro and In-vivo biocompatibility tests and actively speaks on the topics through Nelson Labs external seminars, webinars and tradeshows. He presented on biocompatibility at the Northern California Biomed ASQ group meeting in 2010 and had an article published in the July / August 2010 issue of Medical Design Technology entitled The Big Three: Cytotoxicity, Sensitization and Irritation.
He is a participating member on all AAMI 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, and discussing and voting on changes to those standards. As one of a select group of experts in the industry, Thor's participation on the committees offers him insight on industry changes and helps prepare Nelson Labs and its clients for changes in testing.
Thor studied engineering at Colorado School of Mines and received his B.S. in biology with an emphasis in cell biology and genetics from Idaho State University.
Jodi Scott focuses her practice on assisting the medical device industry in navigating the complex requirements for achieving U.S. marketing authorization and maintaining compliance to the U.S. Food and Drug Administration's (FDA) quality system and other postmarket regulatory requirements. She has also spent considerable time developing and implementing strategies to manage FDA-initiated enforcement actions, such as the issuance of FDA Form 483s, untitled letters, Warning Letters, and consent degrees of permanent injunction. Additionally, Jodi assists companies in developing regulatory strategies and preparing product applications, including IDEs, 510(k)s, and PMAs; with compliance matters, including MDRs, recalls, and GMPs; in addressing regulatory due diligence issues; and with FDA training programs. Having been in industry, she counsels clients on risk management techniques for running a medtech business in today's heavily regulated environment.
Jodi has applied her healthcare background to build regulatory strategies for the development of medical devices, including ensuring clinical, quality, and regulatory compliance and providing guidance and assistance in the formation of policies and procedures related to FDA legal matters. Jodi is experienced in counseling medical device manufacturers on various FDA-related issues, such as satisfying FDA's requirements for importing and exporting medical devices through customs, evaluating FDA submission requirements, managing FDA inspections, responding to FDA enforcement actions, advertising and promoting medical devices in compliance with FDA's requirements, developing systems designed to mitigate the risks associated with the unapproved use of approved products (aka off-label uses), and developing policies and procedures designed to allow manufacturers to operate in compliance with FDA's complex QSR requirements.
Prior to joining Hogan Lovells, Jodi served for four years as senior FDA legal counsel and, subsequently, four years as principal FDA legal counsel for Medtronic, Inc., where she was instrumental in growing the company's corporate FDA legal practice to meet the needs of their business in an increasingly enforcement-minded environment.
Before joining Medtronic, Jodi was an associate with Hogan Lovells' legacy law firm, Hogan & Hartson. In this role, Jodi represented clients in negotiations with the FDA regarding clinical data requirements, clinical study design, and the necessary regulatory pathways to obtain U.S. marketing clearance/approval. Additionally, she worked with clients to prepare the necessary submissions and obtain clearance/approval. Her practice also included advising clients in addressing FDA enforcement actions and responding to FDA inquiries.
Jodi holds a degree in pharmacy but no longer practices as a pharmacist and has worked as a biochemical researcher, where she investigated the antioxidant effects of various drugs on the oxidation of human low-density lipoproteins. Prior to joining Hogan & Hartson, Jodi held numerous legal and pharmaceutical internships throughout the country.
Mark Settle, Deputy Chief - Policy and Rules Division, Federal Communications Commission
Mark Settle is the Deputy Chief of the Policy and Rules Division within the FCC's Office of Engineering and Technology. The Division is responsible for spectrum allocations as reflected in the Table of Frequency Allocations, for maintaining the Part 15 Rules for operation of unlicensed devices, and for coordination with NTIA of non-federal frequency use. These coordination responsibilities include the processing of individual frequency requests for the FCC's Wireless Telecommunications Bureau, Public Safety and Homeland Security Bureau, International Bureau and OET's Experimental Licensing Branch. The Division also reviews and evaluates the interference potential of all federal agency spectrum requests that include the use of frequencies that are shared or allocated exclusively for non-federal use. Mark is also the FCC's Liaison to NTIA's Interdepartment Radio Advisory Committee (IRAC). Prior to coming to the FCC, Mark spent 7 years working for NTIA, and 10 for the Department of the Navy.
Mike is founder and managing partner at Ops A La Carte, a Professional Consulting Company that has an intense focus on helping customers with end-to-end reliability. Mike has over 25 years of experience in reliability engineering, reliability management and reliability training. He is an experienced leader in reliability improvement through analysis and testing. Through Ops A La Carte, Mike has had extensive experience as a consultant to high-tech companies, and has consulted for over 500 companies in over 100 different industries in most of the United States and 15 countries around the world. About 30% of Ops' work is in the Medical Industry. Mike is an expert in accelerated reliability techniques and owns HALT and HASS Labs, one of the oldest and most experienced reliability labs in the world. Mike has recently completed his first book on reliability entitled "How Reliable Is Your Product: 50 Ways to Improve Product Reliability". The book was published December, 2010. Mike has authored and published 25 papers on reliability techniques and has presented these around the world including Canada, China, Germany, Japan, Korea, Singapore, Taiwan, and the USA. He has also developed and currently teaches over 30 courses on reliability techniques. Mike has a BS degree in Electrical and Computer Engineering from the University of Colorado at Boulder, and is a Certified Reliability Engineer (CRE) through American Society for Quality (ASQ). Mike is a member of ASQ, IEEE, Stanford PRN, PRG, SME, ASME, PATCA, and IEEE Consulting Society. Mike is currently the IEEE Reliability Society Santa Clara Valley Chapter Chair.
Mr. Solis started his career with FDA in 1998 as a Microbiologist and also wore the hat as a Database Administrator in the FDA Pacific Regional Lab South West. In 2003, he was responsible for setting up the IT Infrastructure for the FDA Lab in Irvine.
He was then promoted as a Compliance Officer in 2004, and worked for the Los Angeles District Imports Operations Branch. He was a Compliance Officer for 5 years and then spent 2 Years as the Supervisor for Field Operations in the Branch. Mr. Solis also served as a Watch Commander at the Prior Notice Center, which is now the Division of Food Targeting Defense, in 2005. He next took a position with FDA's Division of Imports Operations Systems Branch, (DIOP) which is an FDA HQ position overseeing all FDA Import Offices and Operations, nationally. One of his main accomplishments in DIOP was the implementation and roll out of the PREDICT/MARCS National Application.
Mr. Solis was selected to be the Director of the Los Angeles District Imports Operations Branch on November 2009. He now directs one of the Largest FDA Import Offices, nationally and oversees the largest port in the United States. One of his accomplishments for the FDA LA Port operations is the implementation of electronic communications and paperless transactions initiatives with the Trade and Importing community in the Southern California area.
Mr. Solis specializes in Imports Operations and gives local, as well as, national training on Imports Investigations. He is a member of the National Leadership Development Workgroup at FDA HQ, has served as a mentor for the Federal Executive Board in Los Angeles, member of the FSMA Workgroup at HQ and has also served as a voting member of the ORA's Information Technology Business Review Board. He also has had numerous roles in FDA Operations with other Federal Agencies, working with CBP, ICE, DEA, FBI and State and local law enforcement agencies such as LAPD. Mr. Solis holds a Masters Degree in Healthcare Administration from the University of LaVerne and a Bachelor's Degree from University California of Irvine.
Fuh-Wei Tang is a Research Advisor, in the Bioabsorbable Vascular Solutions Polymer R&D group of Abbott Vascular. Dr. Tang has broad experience in the design and development of medical devices and implants such as Drug Eluting Stents (DES) and Bioresorbable Vascular Scaffolds (BVS). His most recent focuses are in physical aging testing, solid state physiochemical characterization, radiation physical and chemical analysis of polymers, and controlled release of material and system for BVS and DES application. He has been working in characterization methods such as (1) physical aging of polymeric materials, (2) drug distribution and coating uniformity measurements in lateral and depth profile, (3) microstructure and phase dispersion characterization for controlled release mechanism evaluation, (4) micro-thermal analysis and micro-thermal transition evaluation, (5) chemical component and structure identification, and (6) radiation physics, chemistry and free radical characterization of polymers etc.
Dr. Tang has more than 20 years experience in other medical devices R&D area such as (1) formulation and process design of DES and BVS, (2) design and selection of materials used for medical application, (3) material stability and shelf life validation, (4) ionizing radiation compatibility of polymeric materials used for medical devices application, and (5) electron beam sterilizer installation and qualification.
Dr. Tang is actively participates in professional societies organized to establish industrial standards in the areas of accelerated aging programs and the selection of materials for medical devices application. He has many publications and U.S. patents to his name, and he was the recipient of the Abbott Vascular Innovator of the year Award, and one of the recipients of Abbott Volwiler Society Outstanding Research Team Award.
Dr. Tang received his BS degree in Chemical Engineering from National Taiwan University and Ph.D. degree in Chemical Engineering from University of Maryland. His Ph.D. research focused on the effects of ionizing radiation on polymeric materials.
Alexa Tatarian is currently a Study Director at Nelson Labs working in the Chemistry Department. She earned a B.S. degree in Microbiology from Brigham Young University in 2009. Alexa specializes in consulting on cleaning validations for newly manufactured medical devices and single use implants as well as material characterization and extractable/leachable studies. Alexa travels and speaks for the Nelson seminars and has participated in MD&M and BIOMEDevice trade shows. Alexa is also a member of the ASTM F04 technical committee for medical and surgical materials and devices.
Dr. Robin Sarah Tichy has developed an expertise in translating market drivers into technical solutions in the battery and charger industry. Prior to joining Electrochem (formerly Micro Power Electronics, Inc.), she applied technical and project management skills to orchestrate and implement solutions to solve vital business problems at leading organizations like Hewlett Packard and International SEMATECH, in the semiconductor, nanotechnology and MEMS verticals. Dr. Tichy received a Doctor of Philosophy from the University of Texas for her work in Solid Oxide Fuel Cells.
Marcelo Trevino is an Experienced Quality & Regulatory Compliance Senior Manager with Medtronic in the Medtronic Heart Valves Center of Excellence/Cardiac & Vascular Group. Marcelo manages Quality Systems implementation and Regulatory Compliance for the Heart Valve manufacturing operations in Orange County, California.
Mr. Trevino has an extensive knowledge of Medical Device Management Systems: ISO 13485:2003 & International Medical Device Regulations, Quality Management Systems (QMS): ISO 9001:2008 / TS 16949:2002; Environmental Management Systems (EMS): ISO 14001:2004; Information Security Management Systems (ISMS): ISO 27001:2005. These systems and regulations focus on continuous improvement, crisis management, defect prevention and the reduction of variation and waste while serving as a framework that allow companies to consistently identify and manage operational risks, increase productivity, reduce the potential for accidents, comply with legislations and continually improve performance.
He holds a Bachelor of Science in Industrial and Systems Engineering, an MBA from ITESM in Mexico and an MBA in Supply Chain Management from the W.P Carey School of Business at Arizona State University. He is also a certified QMS Auditor by the Registrar Accreditation Board and has consulted with several corporate executives in manufacturing and service firms around the world to implement different process improvement projects.
He has conducted Third Party Audits for several companies and has written several articles to assist corporations in their quest for quality and service excellence. Marcelo is a Certified Six Sigma Black Belt and Biomedical Auditor through the American Society for Quality (ASQ) and a certified ISO/TS 16949:2002 Supplier Auditor through Automotive Industry Action Group (AIAG). He has experience working on Lean Six Sigma Projects and Quality/Regulatory Compliance with many companies in the medical device, beverage, automotive, transportation and semiconductor industries in the United States and around the world.
Mr. Trevino also holds Certificates in Environmental & Sustainability Management and Regulatory Affairs Management from University of California, Irvine. He currently serves in the National Society of Hispanic MBAs (NSHMBA) Executive Board as President Emeritus.
Vivek is an electrical engineer, Computer scientist, and top-level Six Sigma Master Black Belt in software systems with over 17 years of worldwide experience in corporate R&D. Co-author of Design for Six Sigma for Software and Hardware Systems. He envisioned, created, and implemented many software development productivity, and quality solutions in Motorola, Ericson and Medtronic. Vivek has experience in creating productive software development organizations, mergers and acquisitions, and managing large organizations. Capable of seamless integration of new software acquisitions, resulting into competitive advantages and long term growth, he is a leader in many self driven initiatives, and projects which saved tens of million of dollars and improved software productivity and quality at Motorola, Ericson and Medtronic.
CEO, Co-Founder of Misfit Wearables, makers of highly wearable products. Co-Founder of AgaMatrix, makers of the world¹s first iPhone-connected hardware medical device, winner of the Red Dot and GOOD Design Awards, now in the Apple Store. Built AgaMatrix from a raw two-person start-up to shipping 15+ FDA-cleared products, 1B+ biosensors, 3M+ glucose meters for diabetics. Previously, CTO of a software start-up & worked at Microsoft Research on machine learning / linguistic technologies. Studied math (BS) at UIUC & linguistics (PhD) under Noam Chomsky at MIT. Knows some funky languages, mainly good for party tricks. Has since been pursuing his unrequited love for product design, now as patron of good design. Follow on Twitter: @SonnyVu
Glenn White has been developing new medical devices for the last decade. At Novartis he's responsible for project management of new dry powder inhalers and nebulizers. In addition to project management he has led the effort to develop a robust material selection process and rapid tooling supplier base at Novartis. Prior to working in the medical device industry he developed his plastic expertise working for IBM and Hewlett-Packard. During this time Glenn worked on high volume, tight tolerance, multi-cavity injection molding and spent time at corporate headquarters managing procurement of plastic resins for all HP divisions. He has a mechanical engineering degree from the New Jersey Institute of Technology.
Dr. Kevin White is a Managing Scientist in Exponent's Polymer Science and Materials Chemistry practice. His core discipline is electrochemistry, with extensive experience in electrochemical energy conversion, analytical chemistry, and materials science. Dr. White consults on a broad range of topics related to chemistry, materials, material processing, and failure analysis.
Dr. White addresses challenges related to battery technology, including battery-device relationships, battery material selection and testing, cell design and evaluation, performance degradation, and due diligence technology evaluation. His corrosion science practice includes material selection, processing, surface treatment and harsh environment corrosion. In addition, Dr. White consults on fuel cell electrochemistry including enzymatic and biologically based electrochemical conversion schemes.
Prior to joining Exponent, Dr. White was a Principal Research Scientist at Physical Sciences Inc. (PSI). As a member of the Materials Technology Group, his research and development efforts focused on novel architectures and materials for advanced lithium ion batteries, chemistry and coatings for corrosion inhibition in harsh environments and novel polymer processing techniques. His research yielded patents pending for a metal oxide/conducting polymer composite cathode system for lithium ion batteries and novel electrochemical energy device with power density characteristic of electrochemical capacitors and energy density characteristic of lithium ion batteries. In addition, Dr. White advanced anti-corrosion coatings for mild steel reinforcement in concrete for marine environments and the processing of polymers in functional, application driven nanoscale geometries.
Dr. White is a former NASA Fellow and is an active member of the Electrochemical Society serving as Chairman of the New England Section.
Martell Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University. He has been at Nelson Laboratories for 17 years and spent most of that time heading the Radiation Sterilization group, which is responsible for bioburden testing and radiation validation studies. He is currently a Senior Scientist for Nelson Laboratories. Mr. Winters serves on the AAMI Microbiological Methods, Sterility Assurance Level, Radiation Sterilization, General Criteria for Sterilization and Terminology Working Groups. He is currently heading the AAMI task force for a document regarding sterilization of tissue products. He is also on the AAMI Sterilization Standards Committee and on the AATB Standards Committee. In 1995 he received his Registered Microbiologist (RM) certification, and in 2001 his Specialist Microbiologist (SM) certification in consumer products and quality assurance microbiology from the National Registry of Certified Microbiologists.
Wini Wu is the President of Strategic Regulatory Partners, LLC, where she provides strategic advice to pharmaceutical and device industries. Her expertise ranges from devices, combination products, pharmaceuticals (NMEs) and orphan drugs/humanitarian devices to ad-promo compliance issues.
She was V.P. of Regulatory and Medical Affairs at Medtronic Neuromodulation and started her consultancy in 2011. Her 30-year experience in industry encompasses regulatory affairs, clinical, safety, medical affairs, program management, and compliance/quality. Half of her industry experience is in NME and biopharmaceuticals. Her combination product experience includes implantable infusion systems, transdermal patches, inhalers and devices coated with medicinal agents. She headed regulatory and related functions in global companies such as Medtronic, Inc. and 3M Pharmaceuticals as well as start up drug and device companies. Wini currently serves as the industry representative in FDA's Anesthesiology and Inhalation Devices Advisory Panel.
Wini co-chaired the device industry association (AdvaMed) Combination Product Working Group until 2011 and frequently comments on combination product policies. She is an adjunct faculty for the M.S. program for RA at St. Cloud State University, Minnesota. She is a Fellow of RAPS and is a regular speaker for conferences. Wini holds a B.S. Pharmacy degree from the University of Minnesota and a MBA from the University of St. Thomas.
As the Senior Director of Healthcare for GS1 US, MJ Wylie is responsible for leading U.S. healthcare trading partners to actively engage, adopt, and implement GS1 Standards to improve their business and supply chain operations. Her passion and focus support our healthcare industry to comply with upcoming regulations such as the FDA's Unique Device Identification (UDI) rule for enhanced patient safety.
Most recently, Ms. Wylie has consulted on global standards and UDI for multiple stakeholders. Prior to that, she worked for 10 years with Global Health Exchange (GHX) where she held various roles related to content management and global data standards with an international focus. As Executive Director of Global Data Standardization, Ms. Wylie also led GHX to be a GDSN-certified data pool for healthcare trading partners. She has worked with leading standards and advocacy organizations, as well as governments, and continues her work with global standards to improve business, clinical, and supply chain efficiencies.
Ms. Wylie graduated with a BS in technical communications from Colorado State University.
Chris Wyman, Principal Quality Engineer; Corporate SME, Statistical Techniques, Boston Scientific
A member of Boston Scientific's Global Design Assurance group, Chris is primarily responsible for the development, implementation, and stewardship of policies and procedures related to the implementation of Statistical Techniques. He has led or advised teams in the development of processes for Test Method Validation, Process Validation, Experimental Design, and Statistical Methods for Quality. He also advises teams and individuals throughout the organization on the appropriate use of statistical tools for a variety of applications, including Design Verification, Process Validation, and CAPA. He has taught numerous courses internally on Applied Statistics, Problem Solving, Measurement Systems Analysis, Design of Experiments, Process Improvement, and Process Validation Data Analysis. He was an integral member of the team that implemented Design for Six Sigma at several sites in the organization. Chris has a Bachelor's degree in Biology from Colby College and is currently working toward a Master's in Applied Statistics through the Pennsylvania State University.
Mr. Zeller has almost 20 years of medical device industry experience in sales and marketing, channel management, market development, and business development. He has lived, worked, and studied in the US, Europe, and Asia and has extensive experience launching products in international markets, particularly in Asia Pacific. He built the Micrus Endovascular business in Asia-Pacific and successfully integrated it into J&J's Codman Neuro business upon the acquisition in 2010. Mr. Zeller spent several years studying in Japan and started his career selling heart valves in Japan. He has launched a wide range of implantable and disposable cardiac, vascular, and neuro devices in Japan over the last two decades. Mr. Zeller has a Doctorate of Business Administration from the International School of Management (Paris) and an MBA from Imperial College London (London) with a specialization in BioPharma and Health Technology Entrepreneurship. He received a distinction on his DBA dissertation entitled: "European Market Entry Strategies for Venture Capital Financed Medical Device Companies: Where, When, How, and Why."
Yu Zhao is Director of Global Regulatory Affairs at Medtronic Diabetes. He has worked in the regulated industries for over 20 years in various professional and leadership roles in areas of engineering, operations and regulatory affairs, with last 9 years in Medtronic. In his current role, Yu oversees pre- and post-market regulatory activities, international regulatory, regulatory compliance and operations for Diabetes business unit in Medtronic, maker of MiniMed insulin pumps and continuous glucose monitoring systems. Previously, Yu was Senior Regulatory Affairs Manager with Medtronic Neuromodulations, responsible for bringing cutting-edge implantable deep brain stimulation, spinal cord stimulation and implantable drug pump products to global markets. Yu has had extensive experiences working with U.S. FDA, Japanese MHLW/PMDA and other regulatory bodies. Yu holds a B.S. in Electrical Engineering from Zhejiang University, an MBA and an Master of Science from Washington University.
Madhavi Ayyalasomayajula, Sr. Design Assurance Engineer, St. Jude Medical
Alonza Cruse, Director, FDA Los Angeles District
Pete Davis, VP R&D, Bard
Byron Deorosan, Associate, Exponent
Jesse Fourt, Sr. Program Lead, IDEO
Dawn Fowler, Sr. Manager of Global Labeling and Document Control, Endologix
Matthew Gande, Principal Technology Specialist, BASF
Brian Harrington, Director of Supplier Management, MicroVention
Niedre M. Heckman, Manager Regulatory Affairs, Global Regulatory Affairs BioScience, Baxter Healthcare
John F. Kalafut, Director of Research and Strategy, MEDRAD Innovations / Bayer Healthcare
Yubiao Liu, Medical Application Development Manager, Eastman Chemical
Patrick Malone, Manufacturing Operations Leader, Medtronic
Brian Mason, Lead of Medical Products Group, IDEO
Mariam Mirgoli, Director of Clinical Solutions, Abbott Vascular
Michael Morton, Sr Director, Global Regulatory Affairs, Medtronic
Coral Ramos, CAPA Leader, GE Healthcare
Don St. Pierre, Deputy Director for New Product Evaluation, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH / FDA
Chris Sarner, Project Manager, DEKRA Certification B.V.
Paul Schmidt, Senior Distinguished Engineer, Edwards Lifesciences
Mary D. Thorsness, Project Manager II Division CAPA, Baxter BioScience