Discerning Jurors Offer Experience and Expertise

MDEA 2007

Kouros Azar, MD, is a biomedical engineer and a practicing plastic surgeon with a specialization in complex reconstructive and aesthetic surgical techniques. He holds several patents on technologies used in the operating room. Azar has previously served as head engineer and scientist for all collaborative projects in the departments of otolaryngology and biomedical engineering at the Cleveland Clinic Foundation.

Gail Baura, PhD, is a professor at Keck Graduate Institute in Claremont, CA, where she teaches classes in the medical devices and diagnostics track. She is one of the nation's foremost experts on system theory applied to patient monitoring. In her previous position as vice president for research and chief scientist at Cardiodynamics (San Diego), she managed projects that used system theory to improve device performance and invent diagnostic parameters for new markets. Baura holds 15 U.S. patents.

Walter Greenleaf, PhD, is a research scientist with a focus on the use of simulation technology to improve physical medicine and neurological and cognitive rehabilitation. He is president of Greenleaf Medical (Palo Alto, CA), a firm that focuses on developing new diagnostic and analytic technologies for medicine. He has expertise in medical applications of virtual reality, telemedicine technology, clinical informatics, point-of-care data collection via handheld devices, and ergonomic evaluation technology, as well as rehabilitation technologies.

Warren Grundfest, MD, holds appointments at the University of California at Los Angeles as a professor of bioengineering and electrical engineering in the School of Engineering and as a professor of surgery in the School of Medicine. His research interests include minimally invasive surgery, microendoscopy, laser technology, biologic spectroscopy, and noninvasive optical diagnostics. He holds 15 patents and has two more pending. Grundfest is also a consultant to the FDA Office of Device Evaluation and to the U.S. Army's West Coast Telemedicine and Advanced Technology Research Center (TATRC).

Ogan Gurel, MD, is chairman of Aesis Research Group LLC, a firm that provides comprehensive consulting and research services on investing in and developing next-generation life sciences companies. His work has been published in the Journal of Molecular Biology and the European Molecular Biology Organization (EMBO) Journal. Gurel is currently on the faculty at Roosevelt University (Chicago), where he has taught cellular and molecular biology, bioinformatics, and mathematical modeling. He is also experienced in international medical relief work, having served during the NATO military campaign in Kosovo as well as in Turkey after the massive 1999 earthquake.

Edmond Israelski, PhD, is human factors program manager for Abbott Laboratories (Abbott Park, IL). He has participated in the user interface design and evaluation of infusion pumps, drug-delivery systems, glucose meters, vascular intervention devices, and diagnostic testing systems. As part of his post, he created an infrastructure to embed human factors process steps in all aspects of the design and evaluation of new products. Israelski is a board-certified human factors professional and holds 15 patents.

Craig Jackson, PhD, is president of Hemosaga Diagnostics Corp. (San Diego). Prior to founding Hemosaga Diagnostics, Jackson served as president and director of R&D for Reagents Applications Inc. (San Diego) and as scientific director for the American Red Cross Blood Services (Detroit). He has written more than 75 original papers, has contributed to more than 30 textbooks, writes regularly for both professional and trade journals, and holds several patents. He is a member of Working Group 1 of the Joint Committee for Traceability in Laboratory Medicine (JCTLM).

Pascal Malassigné is a professor of industrial design at the Milwaukee Institute of Art and Design and a research industrial designer at the Milwaukee Veterans Affairs Medical Center. He is also an adjunct assistant professor of rehabilitation at the Medical College of Wisconsin in Milwaukee. He is one of the nation's foremost designers of assistive and mobility products for the elderly and those with disabilities. For the past 22 years, his research has been funded by the U.S. Department of Veterans Affairs and has led to the design of products such as commode-shower wheelchairs, bathing fixtures, prone carts, and bedrails.

Jerry McVicker, PhD, is scientific director of Midland Bioproducts Corp. (Boone, IA), which develops human and veterinary diagnostic assays. McVicker is also an assistant professor in the animal science department at Iowa State University (Ames, IA). He has published a number of papers on topics ranging from animal fertility diagnostics to bovine immunoglobulin G detection. He holds patents on two antibody testing methods. Before joining Midland in 1993, McVicker was assistant manager of research and development and quality control for Fort Dodge Animal Health (Fort Dodge, IA).

Mary Beth Privitera is a codeveloper and a faculty member in the Medical Device Innovation and Entrepreneurship Program at the University of Cincinnati. Privitera is an assistant professor of biomedical engineering and an adjunct instructor of industrial design. She is currently a principal of Mad Design USA (Cincinnati), an international design firm specializing in consulting for the medical device industry. Its tasks include product design, usability, ethnographic and ergonomic analysis, marketing communications, physician training materials, and identity design. She holds four patents and several provisional patents and has published and lectured on a variety of topics, including transdisciplinary or collaborative design, innovation methodology, and surgical techniques.

E. William Schneeberger, MD, is a cardiothoracic surgeon at the University of Cincinnati Medical Center's department of surgery. He is engaged in research to treat cardiac failure and surgical treatment of atrial fibrillation. Since joining the University of Cincinnati in 2003, he has worked on three medical device development projects and has proctored new procedures for the surgical treatment of atrial fibrillation. His current research involves studying Doppler-wire-derived measurement of coronary flow reserve, coronary-pressure-wire-derived fractional flow reserve, and intravascular ultrasound imaging. He is also working on the development of a mechanical heart-assist device.

Michael P. Schollmeyer, DVM, is director of clinical research at CHF Solutions Inc. (Brooklyn Park, MN), a firm that makes an extracorporeal hemofiltration system to treat fluid overload in postsurgical or congestive heart failure patients. Among the clinical research studies Schollmeyer has been involved in are the first cardiac and vascular stents and the first implantable cardioverter-defibrillator. He developed the first investigational device exemption (IDE) trial for carotid stents, the first IDE trial on metabolic pacing, and the first IDE trial for use of urological stents in certain applications. He has received three patents for coinventions: two pacing leads and an electrosurgical blade.

Robert Virag is founder and principal of two medical device consulting firms—Trifid Medical Group LLC and Alveoli Medical LLC (both in Chesterfield, MO)—that provide research, development, and engineering management services for anesthesiology, critical-care and respiratory devices. For Trifid, he advises clients on all aspects of medical device design, development, and commercialization. For Alveoli, he has teamed with inventors to develop novel adjuncts to mechanical ventilation and offers testing services for respiratory equipment manufacturers. Virag is an inventor named on 19 U.S. patents. He also serves CDRH as a U.S. agent for devices, representing international device manufacturers.

Herbert Voigt, PhD, is president and a fellow of the American Institute for Medical and Biological Engineering (Washington, DC) and president of Alpha Eta Mu Beta, the national biomedical engineering honor society. He is a professor in the biomedical engineering department at Boston University and also a research professor in the university's department of otolaryngology. He has received grants for hearing research, for providing research experience for undergraduates in biomedical engineering, and for enhancing internship opportunities for biomedical engineering undergraduates.

Michael Wiklund is president of Wiklund Research & Design Inc. (Concord, MA), a firm that helps companies develop safe, effective, usable, and appealing medical products. He is an adjunct associate professor in the department of mechanical engineering's engineering psychology program at Tufts University. Wiklund frequently contributes to MD&DI and is a member of its Editorial Advisory Board. He has published numerous articles, books, and technical papers. His most recent book, Designing Usable Medical Devices, was published in 2005.