Changing demands and market needs drive Doug Harris, Greiner Bio-One's VP of sales and marketing. (Expert Opinion).

Interview by Celia Stevens

Celia Stevens: What do you see as the key trends that will most affect the future of the clinical diagnostics industry over the next few years?

Doug Harris: Key trends I see include:

* further automation of the laboratory and less human handling of samples,

* reduced individual sample volume,

* increased sensitivity of instrumentation,

* increased TDM testing,

* increased molecular diagnostic testing,

* continued challenges of collection due to decentralization of collection process in large institutions, and

* the need for sample and transport product improvements to be coordinated with instrument and diagnostic manufacturers.

Stevens: How will those trends most affect your company?

Harris: All products in the market were designed for manual manipulation. As robotics take over the tasks and more closed sampling occurs, we must work closely with instrumentation manufacturers to anticipate the necessary product improvements required to make products that fit the varied approaches the instrument manufacturers use to access the sample. We must continue to understand and work closely with the instrument manufacturers to provide the easiest target and, once access is made, to be able to locate sample and access sufficient sample quantity;

As the diagnostic tests become more and more sensitive and specific, we must work harder to understand the influences that may occur during the collection process and then work with the diagnostic manufacturers to minimize the influence and effects. For example, within the last year, the entire marketplace was forced to shift from [K.sub.3] (liquid) EDTA to [K.sub.2] EDTA. This shift seemed to catch many instrument manufacturers and customers by surprise, and there are still instruments in the market that are not validated for use of [K.sub.2] EDTA blood samples. Many labs had [K.sub.2] EDTA substituted for [K.sub.3] EDTA by purchasing departments, and no product validation occurred. The clinical effect may not be great; however, we are aware of several labs that have suffered through instrument performance issues. Greiner works to understand these issues, and we developed the technology to manufacture a EDTA product and will continue to offer [K.sub.3] EDTA.

Many large institutions have a multiple collection points for blood-sample collection. Each phlebotomy individual possesses different skill levels and understanding relating to blood-specimen collection and management. As a result, blood-collection tubes must be designed to require a minimum of attention in order to provide an optimal sample. Additionally, nonlaboratory people are presented with multiple collection paths--such as IV, central line or PIC lines--for collecting specimens from critically ill patients. These situations present special challenges. The challenges range from the

* risk to the phlebotomist of injury during transfer of sample to the tube,

* to the challenges of the collection process itself,

* the process of getting the sample into a tube,

* to the possibility of sample contamination by medical personnel present at the site of the collection.

We listen hard to be able to respond to these challenges and to help provide the appropriate solutions.

As products evolve or improve, the challenge is to make sure one improvement does not lead to another issue along the path that leads from sample to diagnostic result. This challenge is shared equally between the sample-collection device manufacturers, the diagnostic-kit manufacturers and the instrumentation manufacturers. In the past, the communication between these various companies was nonexistent. As a major supplier of pre-analytical devices, we believe it is critical to build communication with as many of these companies as possible, but this can be a daunting task. The array of systems and kits, and the variability of one system from the next, is huge. The changes can be easily developed as technology drives the improvements and each company strives to maintain confidentiality. At the core of Greiner Bio-One's business is a culture that nurtures collaboration and alliance with many of the market leaders. We have several people around the world who are responsible for keeping up with the changes and col laborating with these key diagnostic players.

Stevens: How important is online communication with your customers, and do you expect that interaction to expand in the future?

Harris: At Greiner Bio-One, we see this as a critical way for our many valued customers and potential customers to access important information about our products. It provides them with a rapid, simple way of solving problems, and enhances their ability to perform critical tasks. We have seen this communication method grow over recent years; and, as laboratory professionals gain more access to the Internet, they may rely on it more and more as the preferred method of accessing critical information.

Stevens: What impact has the OSHA Bloodborne Pathogens Standard had on Greiner Bio-One's planning for future product development?

Harris: The Bloodborne Pathogen Act, in a way, is the reason for our existence. Greiner Blo-One is directly focused upon providing products that facilitate safe sample collection from safety-needle devices to our VACUETTE line of plastic tubes. We were the first to develop the technology to manufacture plastic tubes, and this provided us with the opportunity to become one of the top two suppliers of blood-collection tubes in the world.

Stevens: Will your company continue to focus on the two main categories of pre-analytics and bioscience, or do you plan to branch into other categories in the future? Harris: Currently, the two parts of our company, BioScience and Pre-Analytical, allow us to better focus on the customer needs that are specific to those separate markets. The key point is that Greiner Bio-One is successful because we actively listen to the needs and challenges presented by customers, and rely on our ability to interpret and respond with a product solution. Where we go from here depends entirely upon the changing demands and needs of the markets we currently serve. If our technology presents the opportunity to move into other categories, we will certainly investigate the opportunities. For now, these two markets are in transition to our technology, and we have more than enough to keep us occupied for the near term and to continue our success.

Stevens: Safety products are an important part of your product line. Do you anticipate further developments in this line in the next few years?

Harris: Yes Greiner Bio-One will continue to listen and work with the marketplace to make safety products easier to use. Vie have several projects in place that will provide next generation products.

Stevens: What are the most significant challenges facing clinical laboratories in the next five years, and how will Greiner Bio-One help labs meet those challenges?

Harris: Over the next five years there will be continued decrease in the number of qualified laboratory technologists. Our products will be able to help in a minor way by adjusting to accommodate the automation that laboratories will use to make up for the deficit of qualified technologists

Stevens: What effect has the lagging economy had on your business, and, in your opinion, on the clinical diagnostics industry as a whole?

Harris: Unfortunately, we are all getting older and requiring more healthcare, even as the economy slows. Greiner Bio-One has been fortunate not to show any signs of a slowdown in the demand for our products.

Stevens: Since emerging on the U.S. market in the 1990s, Greiner has made a significant splash in the blood-collection tube market. To what do you attribute your company's success?

Harris: Our success is attributed to the great people we have working at Greiner and to the exceptional products the marketplace has helped us design and market.

Stevens: Many new companies have difficulties building inroads into the laboratory market because of group purchasing organizations. How have GPOs affected Greiner's penetration of the market?

Harris: GPO'S have certainly slowed and limited the penetration into the laboratory market. In most cases, they have forced customers to use just a single choice of product, often one that the laboratory would not have chosen. They also prevent the laboratories from utilizing a full line of safety products and finding solutions to everyday problems.

Stevens: Greiner seems to dedicate resources toward educating the phlebotomy community on blood specimen collection. To what extent is education a part of Greiner's marketing plan?

Harris: Most laboratories today are challenged to provide a sufficient budget to train their employees. The phlebotomy area often loses out to other more critical education needs. Greiner has worked with Dennis Ernst to develop an online (Internet-based) phlebotomy continuing education program. We want to make sure we provide the best product and believe supporting it with education programs is necessary in order to make sure the very best patient results come from our solution.

RELATED ARTICLE: Doug Harris, Vice President of Marketing end Sales for North America, has spent 20 years in various sales and marketing positions in the healthcare industry. He joined Greiner Bio-One in 1997, with the responsibility of building the North American program. After three years, Harris was given the opportunity to build Greiner's American manufacturing plant, with more than 55 employees. He lives with his wife and daughter in Waxhaw, NC, where he is active with the local PTA, and serves as Vice Chair for the Chamber of Commerce, member of the Steering Committee for Vision 2020, and on the Economic Development Board for the City of Monroe.