By: Richard Park

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 updated information about materials and components used in IVD products can access the online listings via the IVD Technology Web site at www.ivdtechnology.com.

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.

Tobias Polifke, PhD, is cofounder of and managing director at Candor Bioscience GmbH (Weissensberg, Germany). Since 1997, he has been working on developing ligand binding assays for research and clinical immunodiagnostic use. Before launching Candor Bioscience, he worked in the development of protein arrays, including lab-on-a-chip fluidics for point-of-care clinical diagnostics. He can be reached at t.polifke@candor-diagnostics.com.

Emily Berlin is senior marketing manager for the diagnostics business 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 can be reached at emily_berlin@pall.com.

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.

David Pearman is marketing manager in the hemostasis/POC divisions at Helena Laboratories Corp. (Beaumont, TX). Previously he was sales manager at Response Biomedical Corp. (Burnaby, BC, Canada), and 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 and symposia 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@helena.com.

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 has a PhD in pathology and laboratory medicine from the University of California, Los Angeles. He can be reached at michaelca@gen-probe.com.

Patrick Gaillard, MBA, is president of Oyster Bay Pump Works (Hicksville, NY). He previously held manufacturing and operations management positions at diagnostics manufacturing companies, which provided experience in the development of manufacturing operations and equipment for product manufacturing and new product launches. He also worked as a management consultant in the management advisory services group at Deloitte Touche. He can be reached at pgaillard@obpw.com.

Fred Ennis is president of Polymer Science Inc. (Monticello, IN). The company specializes in providing custom coating, converting, and packaging solutions for the global healthcare industry. He has more than 15 years' experience working with converting and packaging of IVD components. With an education in mechanical engineering, he has devoted 20 years to working extensively in the medical device and electronics industries. He can be reached at fennis@polymerscience.com.

Brian Raehsler is director of sales and marketing at Aspect Automation (St. Paul, MN). He has worked in the field of custom automation, facilities, and developmental technology programs for more than 20 years. He can be reached at brian.raehsler@aspectautomation.com.

Troy Tradup is marketing and communications manager at Aspect Automation. He has worked in the field of custom automation for five years. During his spare time, he writes fiction, plays, and screenplays. He can be reached at troy.tradup@aspectautomation.com.

Joe Elliott is senior director, operations at Corgenix Inc. (Broomfield, CO). He has worked for more than 18 years with companies that have performed contract manufacturing. Previously, he was a manufacturing manager at Sandoz Pharmaceuticals where he managed each operations department, including granulation and dispensing, finished dosage, and packaging. He also worked at several of Ralston Purina's U.S. sites, and held management positions in both production and quality control. He can be reached at jelliott@corgenix.com.

Lisa King is marketing manager at Medical Device Consultants Inc. (MDCI; North Attleboro, MA). A marketing communications professional with more than fifteen years of experience in the device and IVD industry, she currently manages business development and marketing efforts at MDCI. Previously, she was marketing manager at Boston Biomedica Inc. (now SeraCare Life Sciences). She can be reached at king@mdci.com.

Ron Warren is principal consultant at MDCI. He has more than 22 years of regulatory and clinical affairs experience, with specific expertise in assisting IVD clients with novel and innovative technologies. Previously, he held senior regulatory affairs positions at Smith & Nephew Wound Management, Advanced Tissue Sciences Inc., and Sorin Biomedical Inc. He can be reached at rwarren@mdci.com.

Gail Radcliffe, PhD, is an independent consultant and president of Radcliffe Consulting Inc. She has more than 20 years of experience in assisting medical device and IVD companies with technical, marketing, regulatory, and business development issues. She has held senior scientific and clinical positions at Gene-Trak Systems, where she developed and conducted clinical studies for molecular diagnostic assays, and at Cytyc Corp. She can be reached at gradcliffe@charter.net.

Conclusion

This year's guide offers a wealth of information for diagnostics manufacturers. Although the editors have made every effort to ensure the accuracy of the information included in the guide, it cannot be guaranteed. We therefore encourage readers to bring omissions or errors to our attention by contacting the Editor, IVD Technology, 11444 W. Olympic Blvd., Los Angeles, CA 90064; phone 310/445-8595; fax 310/445-4269; or e-mail richard.park@cancom.com.