BD Clinical Laboratory Solutions President, William A. Kozy, actuates black-belt quality and next-gen planning

Celia Stevens: How has Operation Iraqi Freedom affected BD Clinical Laboratory Solutions?William A. Kozy: Becton Dickinson and BD Clinical Laboratory Solutions have been U.S. government and Department of Defense suppliers for over 50 years. Many of our fundamental products, such as blood-collection tubes and needles, are basic product needs for treatment of military or civilian personnel impacted by war. We worked closely with the U.S. government several months ago to ensure a dedicated inventory for this purpose, and should our products be needed, we are well prepared to deliver to its requirements.Stevens: In your view, what are the key trends that will drive the future of the clinical diagnostics industry over the next five years?Kozy: New diagnostic technologies will play a greater role in how all of us personally manage our health. The omics genomics, proteomics, cellomics and molecular testing will have strong influence in the five-year time frame. Though specificity of application and timing are less certain, we believe these will be highly impactful.The demand for quicker and more accurate diagnostic information at lower costs will continue to be a key challenge. Toss in the erratic elements of a tough global economy, uncertain governmental healthcare spending around the world and constant changes in reimbursement and you have quality and cost challenges of notable levels. Companies that effectively manage this trend will do very well in the global diagnostic environment.Informatics will rapidly emerge as a basic tool of patient and diagnostic information management. More and better test data and a full healthcare profile of you as an individual will become a key part of your personal healthcare management approach. The bulk of your healthcare history, predisposition profile and current personal preventive actions will reside in your ID card. Better information systems in both hospitals and laboratories will help to manage many details from sample identification to integrated diagnostic/therapeutic pathways. The management of privacy will also be of importance.Stevens: How will those trends affect your company?Kozy: The omics and nucleic acid testing are already having an impact on BD Clinical Laboratory Solutions. In diagnostics, just about everything starts with a high-quality sample, and we are intently focused on helping customers obtain that sample in an easier, more efficient way that significantly reduces the time factors now negatively associated with some of the newer technologies. Our commitment to a solution is very high, and our joint venture with Qiagen N.V. is one example of this focus. New sample-collection tubes and devices, which are easily interfaced with affordable bench-top automation capabilities, are integral to expanded acceptance. We are also actively engaged in test expansion across new analytical platforms on the cutting edge of these technologies. Active research and development investment in matching these technologies to expected customer needs is well underway. In an environment characterized by lowered reimbursement, a shortage of laboratory technologists and strong governmental healthcare spending controls, we are constantly reviewing the capabilities in our organization that improve quality while eliminating waste and costs. The BD Clinical Laboratory Solutions business is focused on Six Sigma levels of quality and truly lean manufacturing operations. These two capabilities concentrate attention on continual improvement of customer quality, on significant reductions in process variability and on the elimination of waste. By year-end, we will have over 80 trained Black Belts and 200 Green Belts in the BD Clinical Laboratory Solutions business. This includes a number of Design for Six Sigma Black Belts who will be charged to promote Six Sigma product quality from design inception. We have 10 fully trained lean manufacturing leaders in all of our major product facilities. We strive to be real quality aggressors constantly delivering a better product to our customers at an always-affordable price. Our ability to ensure products of high quality and low variability to our customers has notable impact on their internal efficiencies and their ability to deliver clinical results of the highest reliability.We are developing devices and capabilities relative to informatics that will fit in this new diagnostic environment. BD Clinical Laboratory Solutions will be an active participant, from a base application of barcode identification of products to development of institution-wide sample identification systems that eliminate errors. We believe our efforts will create efficiencies and better information in the supply chain, and eliminate patient safety errors on the topic of sample identification and management. We have a new business entity called BD.id, which will focus exclusively on the topic of patient safety around sample identification and management. This product will be launched in late summer of 2003.Stevens: What impact will the threat of bioterrorism have on clinical microbiology products of the future?Kozy: Our customers are looking for products that will give them quick and reliable detection of bioagents that could present a threat. These products need to be capable of working in multiple environments anywhere from air monitoring in a subway to very specific identification in a highly secure lab environment. Our Diagnostic Systems teams both industrial and clinical work closely with public officials and clinicians to ensure a thorough response capability. But the reality of exactly what test is needed for which specific application remains a challenge. More regulatory guidance and participation are key to higher response capabilities.Stevens: BD is a leader in providing devices that can reduce the incidence of exposure to bloodborne pathogens. What impact has the OSHA Bloodborne Pathogen Standard had on your planning for future product development?Kozy: Before I comment, let me thank you for your comments related to our leadership in the area of safety. Since the late 1980s, Becton Dickinson and BD Clinical Laboratory Solutions have spent hundreds of millions of dollars on the activities around healthcare worker safety on everything from education to product development. The OSHA Bloodborne Pathogen Standard continues to have high impact on our product-development portfolio. In the critical area of utilizing sharps for routine blood collection, we maintain a full commitment to three-generation product planning. Stated simply, beyond the current products being used today (blood-collection needle, winged set for blood collection, lancet), we continually strive to have three next-generation ideas in the portfolio. Highly passive concepts, easy-to-use push-button ideas and many others will be available in the next few years. We expect that breadth of array will be key to meeting all customer expectations from hospital to doctors office to clinic we hope to maintain our leadership in this key area. Additionally, a full array of plastic evacuated tubes, clinically integral with the new analytical and automation technologies, is also a key safety product line.Stevens: How has the current shortage of clinical laboratory professionals affected BDs business strategy? How does your company plan to address this issue over the next five years?Kozy: Our Diagnostic Systems team has integrated efficiency and labor productivity into all of its instrument-development activity. Higher throughputs, better walkaway capability and expert information systems are core development parameters. Front-end efficiencies are especially key, and the recent launch of the BD Viper sample processor is an example of our efforts to be attentive to this issue. Several of our instrument platforms are especially well positioned to support consolidated testing, which is a likely outcome of the current labor shortage. These platforms include the BD BACTEC 960 system for tuberculosis culturing and susceptibility testing, as well as the BD Viper instrument for STD testing. The Pre-Analytical Solutions business has a small team dedicated to working directly with the top instrument manufacturers in chemistry, hematology and coagulation. We believe this partnership with key analytical leaders is a source of higher customer satisfaction and will assist lab managers in dealing with the labor challenge.Stevens: Which areas of the market do you believe will offer prime growth prospects for your company in the next five years?Kozy: Safety products in the United States and the remaining highly developed healthcare markets will be a large opportunity. Canada, several countries in Western Europe and to a large degree, Japan, are all looking closely at healthcare worker safety, as well as patient safety. We hope to bring educational capability, affordable products and hands-on training to each of these markets.Infectious disease testing will continue to be expanded. The BD ProbeTec and BD Phoenix systems, as well as improved capabilities of the BD BACTEC system offered globally will be a foundation for this growth. Next-generation instruments, leveraging many of the new technologies we mentioned, will appear in the five-year time frame, as well. Where timely diagnosis can impact the patient outcome, rapid method platforms will be developed and/or extended.Information management especially those areas associated with patient safety will be an opportunity to provide customers with new solutions. These improved systems will also provide notable cost benefits.