Originally Published MD&DI September 2009
CONTRIBUTORS
Meet the Experts
MD&DI's contributing authors are well-respected authorities in their fields. And they are essential to the success of our publication. Meet this month's expert contributors.
Jennifer B. Davis is counsel for Hyman, Phelps & McNamara (Washington, DC). She has a law degree from Emory University School of Law (Atlanta) and a BA in psychology from Duke University (Durham, NC). She is admitted to practice law in Georgia and the District of Columbia. She is a member of the American Bar Association. Contact her at jdavis@hpm.com.
Leo Eisner is the head of Eisner Safety Consultants (Portland, OR), a firm that specializes in helping clients through the product safety and international regulatory processes. He is a registered professional engineer with experience in the product safety arena. Leo is the convener of SC62D JWG9 “Lens Removal and Vitrectomy Devices for Ophthalmic Surgery.” He is also a member of RAPS, AAMI, ASQ, and IEEE. He can be reached at leo@eisnersafety.com.
Jim Fitzgerald is executive vice president of sales and marketing for Vesta (Franklin, WI). He leads the company’s global efforts to collaborate with new and existing customers. He has an MS in management from the Kellogg Graduate School of Management at Northwestern University (Chicago). Reach him at jfitzgerald@vestainc.com. 
Jeffrey N. Gibbs is a director at the law firm Hyman, Phelps & McNamara. Previously, he served in the Office of the Chief Counsel at FDA, where he became an associate chief counsel for enforcement. He is a graduate of the New York University School of Law. He can be contacted via e-mail at jng@hpm.com. 
Kevin Gingerich is director of marketing services for Bosch Rexroth Corp. (Buchanan, MI). He has written extensively on assembly technologies and techniques, and is the coauthor of the company’s guidebook Lean Manufacturing: Principles, Tools, and Methods. Reach him at kevin.gingerich@boschrexroth-us.com. 
Garry Lee is president of Global Advantage (Richmond Hill, ON, Canada) a company that offers product safety and EMC compliance services. He has significant experience in software validation, risk management, TPP/Health Canada Regulation, MDD requirements, and ISO 9001 audits. Lee is an active member of the Professional Engineers of Ontario, the Association for the Advancement of Medical Instrumentation, and the Canadian Biomedical Engineer Society. He was also part of a workgroup that assisted in the development of IEC 60601-1. Reach him at garry@globaladvantage.ca.
Mark Leimbeck is program manager, health sciences, for Underwriters Laboratories (UL; Northbrook, IL). His main responsibilities include developing an overarching certification model for medical devices and coordinating implementation of the model globally. He has also been a contributor in several training and development programs at UL, including quality, technical and management training courses.He is a member of the American Society for Quality and is a Registered Professional Engineer. Contact him at mark.a.leimbeck@us.ul.com.
Bill St. Onge is director of manufacturing for KMC Systems (Merrimack, NH), an Elbit Systems of America company. St. Onge has transitioned both build-to-print jobs and programs that were designed at KMC Systems to the production floor. Contact him via e-mail at bill.stonge@elbitsystems-us.com.
Frank Pawlowski is manager of advanced technology and solutions at KMC Systems. He is exclusively involved with the management and development of medical instruments. He has put together many multidisciplined development teams to design a range of instruments. Reach him at frank.pawlowski@elbitsystems-us.com. 
Charlie Whelan is a director of Frost & Sullivan’s North American healthcare consulting practice (San Antonio). Focusing on the medical device and patient monitoring sectors, Whelan has partnered with such companies as Medtronic, 3M Healthcare, and Johnson & Johnson. Reach him at cwhelan@frost.com.
Alpaslan Yaman, PhD, is a principal consultant for Biotech, Pharma & Device Consulting LLC (Parsippany, NJ). He is a certified black belt and has a PhD in pharmaceutics with a minor in physical chemistry from the University of Missouri. Contact him at ayaman@biopharmadvice.com.
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