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

Medical Laboratory Observer, April, 2003 by Celia Stevens

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?