January 2011 Expert Contributors

Rebekkah Carney is vice president of medtech market research at Double Helix USA (Fort Washington, PA). She has spent 17 years supporting the market research needs of manufacturers of diagnostics, implants, surgical tools and disposables, capital equipment, and software and hardware. Contact her at [email protected].

Denise Dacey is principal package engineer with Ethicon Inc, a Johnson & Johnson company and is based in Somerville, NJ. Dacey has a B.S. in packaging engineering and M.S. in Packaging/Ceramic Engineering from Rutgers University. Dacey is a six sigma process excellence certified black belt. She can be reached at [email protected].

Tom Donnelly, PhD, is associate director of market research at Double Helix USA. He is an RIVA-trained moderator skilled at interviewing a variety of patient types and medical specialists. His device research includes testing human factors, acceptance, and preference, intuitiveness. Reach him at [email protected].

Daryl D. Gerke, PE, cofounded Kimmel Gerke Associates (St. Paul, MN), a firm specializing in design, troubleshooting, and training on EMI/EMC issues. He has held engineeering and management positions at Collins Radio, Sperry Defense Systems, Tektronix, and Intel. He is also a NARTE-certified EMC and ESD engineer. Reach him at [email protected].

Jonathan Kendler is a cofounder and design director of Wiklund Research & Design Inc. (Concord, MA), a consulting firm offering user interface research, design, prototyping, and usability testing services. He has designed and evaluated user interfaces for a variety of medical devices. Reach him at [email protected].

William D. Kimmel, PE, cofounded Kimmel Gerke Associates. Earlier, he held engineeering and ?management positions at Control Data Corp. and ?Sperry Defense Systems. He is also a registered a ?NART-certified EMC and ESD engineer. Contact him at [email protected].

Melody Lashlee is the director of clinical data management at Advance Research Associates Inc. (Mountain View, CA), a clinical research organization that provides data management and biostatistical services to pharmaceutical, biotech, and medical device companies. Contact her at [email protected].

Yelena Lipovetskaya is cofounder of Cospheric LLC (Santa Barbara, CA). She has more than 10 years of experience taking new technologies from concept to production, including medical devices. She has written about microsphere technology and has worked at Corning Inc. and Cardinal Health. Reach her at [email protected].

Charlie Rivera has 18 years of experience in sterile medical device packaging. He has been responsible for developing and implementing new sterile packaging equipment, process development, and system designs. He has a degree in industrial engineering from the University of Puerto Rico at Mayagüez. Contact him at [email protected].

Jeffrey K. Shapiro, JD, is a partner at Hyman, Phelps & McNamara, PC (Washington, DC). He has represented companies on FDA-related matters concerning medical devices, combination products, and human tissue products. He is the coeditor of Promotion of Biomedical Products. Contact him at [email protected].

Michael Wiklund is founder and president of Wiklund Research & Design Inc. He has made substantial contributions to sections of AAMI HE75-200X addressing software user interface design, workstation design, and mobility. Contact him at [email protected].