Meet the Experts 2271

CONTRIBUTORS

Yvonne Albright is coauthor of “CRO Partnerships: Strategies for Successful Postapproval Studies.” She is project manager, clinical operations for Covance Periapproval Services (Conshohocken, PA). Her current responsibilities include management of a CAD-device study, the first study of its kind for Periapproval. Albright has experience managing and monitoring the cardiovascular therapeutic area, health economics, chronic pain, and women's health. She has an MS in Nursing from Widener University School of Nursing (Chester, PA). Contact her at [email protected].

Chris Coghlin is author of “Solving the Outsourcing Equation.” He is president and CEO of the Coghlin Companies (Worcester, MA) and its wholly owned subsidiaries: Columbia Tech, Coghlin Precision, Cogmedix, and DCI Engineering Services. The four companies provide a range of manufacturing, engineering, and global fulfillment services to the medical device industry. Coghlin is a member of MassMEDIC and serves on the advisory board of the Massachusetts Medical Device Development Group. Reach him at [email protected].

Sara Dyson, Esq., is author of “Managing Foreign Supply Chains to Avoid Importing Risk.” She is loss control manager for Medmarc Insurance Group (Chantilly, VA), a provider of products liability insurance for the manufacturers and distributors of life sciences technology. Dyson received her JD from the University of Wisconsin Law School. Contact her at [email protected].

Joe M. Davidson is coauthor of the Business Briefing column,“Let's Make a Deal: Negotiating Transition Service Agreements.” He is managing partner of the San Diego and Del Mar Heights, CA, offices of the law firm of Allen Matkins. He is also chair of the firm's corporate practice group. He regularly represents clients in the medical device industry. Davidson has a JD from Loyola Law School (Los Angeles). Contact him at [email protected].

Mike Fritschy is author of “Managing an Offshore Outsource Project.” He is senior director, global management program, for Nypro Healthcare (Clinton, MA). He is responsible for program management offices in Clinton, Europe, and Hong Kong. He also oversees all new program introductions globally. During his 13 years with Nypro, Fritschy has held such positions as tooling engineer, program manager, director of technology, and director of program management Contact him at [email protected].

Robert Klepinski is author of the Regulatory Outlook column, “Privacy Basics: A Quick HIPAA Check for Medical Device Companies.” He is an officer with Fredrikson & Byron P.A. (Minneapolis). He practices in the food, drug, and medical device regulation; healthcare fraud and compliance; and intellectual property groups. He previously served as a regulatory attorney for Medtronic Inc and set the company's legal strategy for FDA compliance. He has been an adjunct professor at the University of Minnesota Law School. Contact him at [email protected].

Alexander Kurnellas is coauthor of “Seeking Silicone and Suppliers.” He is lead technical writer at NuSil Technology (Carpinteria, CA). He has a bachelor's degree in English from the University of California, Santa Barbara. Working in NuSil's quality assurance department for the last six years, Kurnellas has written such documents as standard operating procedures, manufacturing procedures, test methods, equipment operating procedures, and product data sheets. Kurnellas he works closely with the company's research and development, manufacturing, and marketingand sales departments on the design transfer of developmental products into standard products Reach him at [email protected].

Anne Santovito is coauthor of “CRO Partnerships: Strategies for Successful Postapproval Studies.” She is project manager, clinical operations for Covance Periapproval Services. She handles primary client communications, study plan development, employee performance reviews, and career development plans. She has managed two inpatient Phase IIIb transplant trials, a Phase IV in-patient DVT prophylaxis study, and a large cardiac device study. Santovito earned a BS in Business Administration from Bloomsburg University (PA).

Jim Stertz is author of “A Lesson in Profile Tolerancing for Complex Parts.” He is quality assurance manager for Lowell Inc. (Minneapolis). He has led the quality efforts at Lowell for 28 years, including the implementation of its ISO 9001:2000 and 13485:2003 quality management system. He serves on the automation and IT teams at Lowell. Reach him at [email protected].

Robert Umland is coauthor of “Seeking Silicone and Suppliers.” He is national sales manager for NuSil Technology. He supervises the company's sales force for North and South America. Umland has a bachelor's degree in agribusiness from the University of Wisconsin–Platteville. Contact him via e-mail at [email protected].

Nick Unkovic is coauthor of “Let's Make a Deal: Negotiating Transition Service Agreements.” He is an attorney in Allen Matkins's Del Mar Heights, CA, office. He works in the firm's corporate practice group. His practice emphasizes mergers and acquisitions for clients in the biomedical industries. He has a JD from the University of California, Berkeley. E-mail him at [email protected].

Barbara Vargas is coauthor of "CRO Partnerships: Strategies for Successful Postapproval Studies." She is senior project manager, clinical operations for Covance Periapproval Services She has extensive experience in managing and monitoring Phase II, IIIb, and IV studies in several therapeutic areas in drug, device, and observational programs. Recent experience includes a Phase IV bservational asthma program assessing several patient-reported outcomes She has a BS in nursing from La Salle University (Philadelphia) and is currently licensed as a registered nurse.

Michael Wiklund is founder and president of Wiklund Research & Design Inc. (Concord, MA), which specializes in user interface research, design, and testing. He has made substantial contributions to sections of AAMI HE75-200X. Wiklund is a member of MD&DI's Editorial Advisory Board. Contact him via www.wiklundrd.com.

Aron Yngve is market development director for Minnesota Rubber & Plastics (Minneapolis). He has more than 20 years of sales and marketing experience covering the United States, Europe, and the Far East. Yngve previously held international sales and marketing positions with Alps Electric Co., Graco Inc., and Phillips Plastics He speaks fluent Japanese. Contact him via e-mail at [email protected].