Meet the Experts 2108

CONTRIBUTORS

Stefan Menzl, PhD, wrote the Regulatory Outlook column, “Using a Notified Body to Enter the European Market,” beginning on page 42. He is the director of regulatory affairs, compliance, and clinical research for Advanced Medical Optics Inc. in Europe, Africa, and the Middle East. With more than 13 years of experience in regulatory affairs, Menzl interacts with key personnel of notified bodies, competent authorities, and European policymakers to shape the regulatory environment. He can be reached at [email protected].

Jason Crosby wrote the article “How to Make the Most of Packaging Trends,” beginning on page 54. As the medical business manager for Plastic Ingenuity Inc. (Cross Plains, WI), he is responsible for all facets of the firm's medical packaging business, including business development, package engineering, and validation issues. Crosby has presented nationally on issues related to packaging and thermoforming. He has a bachelor's degree from the University of Wisconsin–Whitewater and an MBA from the University of Wisconsin. He is a member of the Society of Plastics Engineers and the Institute of Packaging Professionals. He can be reached via e-mail at [email protected].

Nick Fotis, Wayne Taylor, PhD, and Laura Bix, PhD, wrote “Using Hypothesis Testing in Medical Packaging Validation,” beginning on page 60. Fotis is the director of the Packaging Technology Center at Cardinal Health's (McGaw, IL) clinical and medical products segment. He spent 10 years working in Baxter Healthcare's corporate packaging and, later, I.V. System's packaging groups. Fotis is a member of the Institute of Packaging Professionals, AAMI, and ASTM. He is cochair of the U.S. delegation to ISO TC198/WG 7. He can be reached at [email protected].

Taylor is the founder and chairman of Taylor Enterprises Inc. (Libertyville, IL), a company that provides software, consulting, and training on the Six Sigma approach, acceptance sampling, and statistics. He is the author of two books: Optimization and Variation Reduction in Quality and Guide to Acceptance Sampling. He is a fellow of the American Society for Quality. Contact him at [email protected].

Bix is an assistant professor for Michigan State University's School of Packaging. She is a member of the ASTM committees D-10 and F02 and is the vice chair of D10.32. Bix can be contacted via e-mail at [email protected].

William Leventon wrote “MES Extends its Reach,” beginning on page 68. He is an award-winning freelance writer based in Somers Point, NJ. In addition to his 18 years of professional writing experience, Leventon also worked for three years as an engineer. He has a master's degree in structural engineering from the University of Pennsylvania. You can contact him at [email protected].

Debbie Brandel, Barbara Grenell, and John F. X. Lovett are the authors of “Developing an In-House Reimbursement Paradigm,” beginning on page 76. Brandel is a principal with Preferred Health Strategies (PHS; Rye Brook, NY). She develops reimbursement and contracting strategies for device manufacturers. Brandel can be contacted via e-mail at [email protected].

Grenell is the president of PHS. She may be reached via e-mail at [email protected].

Lovett is a principal with PHS. He has more than 30 years of experience in healthcare. Contact him via e-mail at [email protected].