SUPPLIERS MARKETPLACE
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Photo by Roni Ramos
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IVD manufacturers might well be forgiven if they do not have ready answers to questions right now about what their product-development challenges will be during the next six to twelve months. The uncertainty in the global economy during the past couple of years has made a shambles of corporate planning in many business sectors. And despite slight improvements in economic conditions, IVD manufacturers continue to feel the pinch of reduced investment and slower-than-expected growth.
However, as is often the case among companies that populate the medical technology sector of the global economy, IVD manufacturers are continuing to find ways of turning adversity into opportunity. Making use of the industry’s devotion to technological innovation and expertise in a wide range of technologies, IVD manufacturers are developing new generations of products that offer ever-greater diagnostic value while also addressing such customer concerns as test accuracy, speed, communications connectivity, and cost. To accomplish these goals, companies in the IVD sector are continually on the lookout for new technologies as well as new business opportunities.
The IVD industry’s devotion to innovation has a pervasive influence on the ways that IVD companies do business. It means that company leaders are looking not only for new product ideas, but also for fundamentally different ways of approaching their business. For instance, IVD companies need access not only to the latest developments in biochemistry and genomics, but also to the latest products in electronics and robotics, software and telecommunications, plastics molding and packaging—and a great many other fields. It also means that IVD companies are not afraid to think about their business as a global enterprise, to explore the potential of their intellectual properties in extraclinical applications, or to enter into strategic relationships that can help advance company goals.
Finding New Technologies
Fortunately for all the hard-pressed innovators in the IVD industry, there are a wide variety of supplier companies that can help. This issue of IVD Technology is dedicated to helping IVD manufacturers by offering detailed listings for hundreds of supplier companies with a specialized interest in providing the products and services that manufacturers need to get to market with their products in a timely fashion.
One factor that makes the search for suppliers so difficult is the growing complexity of IVD products. While most IVDs have in common the application of biochemicals and chemical reagents for the purpose of clinical diagnosis, the elaboration of such products to meet the needs of the marketplace is leading to the development of entirely new technologies. This issue of IVD Technology is the essential sourcebook for companies that are seeking to keep pace with the latest trends in the industry.
While this edition of the IVD Technology buyers guide can be an invaluable shelf resource throughout the year, it is not the end of the story. The IVD Technology buyers guide also exists as an interactive, Web-based system where supplier companies can update their information throughout the year. Manufacturers seeking to get updated information about materials and components used in IVD products can access the online listings.
The Experts
To help describe the categories and subcategories in this year’s buyers guide, IVD Technology once again called upon a number of industry experts. This year’s section introductions are either wholly new or updated to take into account the latest trends affecting each supplier category. The editors are grateful to each of the contributors, who are described in the following sections.
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Rook Khajenouri is the director of sales and marketing at Harlan Bioproducts for Science (Indianapolis). He has more than 20 years experience in the life sciences industry with specific emphasis in contract monoclonal antibody production for the biotech, diagnostic, pharmaceutical, and academic areas. He can be reached at rkhajenouri@harlan.com.
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Emily Berlin is global program manager, diagnostics, at Pall Life Sciences (Ann Arbor, MI). She has been working in the biotechnology field for the past 10 years. She is commercially responsible for the growth of the diagnostics business at Pall. Previously, her laboratory work included studies of coagulation and clotting cascades relating to cardiac disease. She has a bachelor of science degree in microbiology from Michigan State University and a master of business administration degree from Wayne State University. She can be reached at emily_berlin@pall.com.
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Galina Fomovska, PhD, is senior principal scientist at Pall Life Sciences. She has been working with membranes and separation materials in the field of diagnostics since 1995. She has expertise in the biomodification of membranes for the selective isolation of cell populations. In addition, she has four patents issued in the areas of sample collection, archiving, and nucleic acid detection. She has a PhD in biochemistry with a concentration in immunochemistry from the Institute of Biochemistry in Kiev, Ukraine.
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David Pearman is a sales manager at Response Biomedical Corp. (Burnaby, BC, Canada). He was previously employed at Helena Laboratories (Beaumont, TX) in sales and product management. Prior to joining Helena, he was a product manager and research scientist at GDS Technology (Elkhart, IN). He was also a manager of the hybridoma facility and a senior research scientist at American Biogenetic Sciences (Copiague, NY). He has lectured at numerous meetings during his 14-year tenure in the clinical diagnostics field. He is also a member of IVD Technology’s editorial advisory board. He can be reached at dpearman@responsebio.com.
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Michael Catania, PhD, is manager, product development, at Gen-Probe Inc. (San Diego) where he is responsible for diagnostic nucleic acid test development. Before joining Gen-Probe, he worked at Nanosphere Inc. (Northbrook, IL) where he led the scientific teams that developed their genomic hypercoagulation panel and the first FDA-approved pharmacogenomic test for warfarin sensitivity.He received his PhD in pathology and laboratory medicine from the University of California, Los Angeles. He can be reached at michaelca@gen-probe.com.
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Rick Luedke is senior product manager of automated liquid-handling robotics at Hamilton Co. (Reno, NV). He combines more than 15 years experience in product, sales, and marketing management in the life sciences industry with more than seven years practical experience in academic and clinical research. He holds a degree in genetics and cell biology from the University of Minnesota, and is a member of the Association for Laboratory Automation and Laboratory Robotics Interest Group. He can be reached at rick.luedke@hamiltoncompany.com.
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Robert P. Adams is a senior engineer at Abbott Diagnostics (Abbott Park, IL) with 25 years experience in the fields of package engineering, design, and quality assurance. He has been responsible for packaging engineering projects for new product introductions and existing product lines. He has also served on numerous teams at Abbott, including purchasing quality assurance, vendor certification, cost reduction, change control/FDA audit response, and total customer satisfaction. In 2005, he transferred to the global pharmaceutical research and development division. He can be reached at robert.adams@abbott.com.
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Rory Kelly is manufacturing engineering manager at Cholestech Corp. (Hayward, CA). In 1981, he graduated from University College Dublin, Ireland with a bachelor of engineering degree in mechanical engineering. He first worked as a plant engineer in Ireland before immigrating to the United States 20 years ago. During the past 20 years, he has worked in the semiconductor, machine tool, and medical device industries. He holds three U.S. patents and two European patents for machine design. He can be reached at rkelly@cholestech.com.
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Bill Hanna is vice president of sales and marketing at Baril Corp. (Haverhill, MA), a contract manufacturer specializing in complex precision die-cut, laser-cut, and multilayer laminated products for the medical and diagnostics industries. He has more than 20 years experience in engineered product sales, marketing and technical service in the medical, diagnostics, pharmaceutical, and semiconductor industries. He can be reached at bhanna@barilcorp.com.
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Alan Schwartz is executive vice president at mdi Consultants Inc. (Great Neck, NY). He has been consulting for the FDA-regulated industry for more than 30 years. He formerly worked at FDA as a supervisor of field investigations. He is a guest speaker worldwide on FDA compliance and has articles published in many trade magazines. He can be reached at alan@mdiconsultants.com.
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Natalya Valerio is senior vice president of mdi Consultants Inc. She has worked in both the medical device and pharmaceutical industries. She has more than 20 years experience in FDA regulatory matters. She can be reached at natalya@mdiconsultants.com.
