Talking with Rudy Mareel of BD Biosciences Immunocytometry Systems

May 1, 2002

Medical laboratory industry Interview by C. Anne Pontius MBA, CMPE, MT (ASCP)

Welcome to the fifth installment in our yearlong series of interviews with executives in the clinical laboratory industry. Our plan is to give you a birds eye view of where these key players see the industry going in the next five years.

MLO editorial board member Anne Pontius, president of Laboratory Compliance Consultants in Raleigh, NC, is conducting the interviews.

The executives interviewed in the first six installments, or other executives from their companies, will also participate in a panel discussion, which will be co-sponsored by MLO and CLMA at the CLMA annual meeting. The panel discussion has been set for Breakout Session I on Thursday, June 27 from 3:15 p.m. to 4:15 p.m. 

Our May interview is with Mr. Rudy Mareel, General Manager, BD Biosciences Immunocytometry Systems.

Celia Stevens, Editor

Anne Pontius:
What one factor will have the most impact on the laboratory industrys five-year future?

Rudy Mareel: Its difficult to pinpoint one factor. In our opinion, several factors will influence the laboratory industrys future. Those factors include cost and labor constraints, which will produce a need for productivity and drive automation. Another factor is the discovery of new diagnostic markers and technologies as a result of research in the areas of genomics and

The laboratory professional associations claim the industry is facing a personnel shortage that has recently started and may not peak for several years. Based on BDs future product development, do you envision a decline or growth of the use of the professional

Mareel: Our products are primarily targeted to the immunology and cellular analysis market. This is a specialized field in which current tests tend to be scientifically complex. In addition, future products may be derived from new technologies and from combining multiple technologies to produce an answer. Therefore, we envision these tests will remain scientifically complex, but we will bring them to market in an easy-to-use format. This will help laboratories deal with the potential shortage of professional

Over the next five years, do you foresee more or less consolidation of industry manufacturers or laboratories (i.e., hospital and independent labs, and hospitals purchasing physicians offices)? 

Mareel: In regard to laboratory consolidation, the pendulum is always swinging. Weve seen consolidation in the past driven by financial and regulatory considerations; however, with a move toward easier to use formats, we are likely to see some tests going back into point-of-care testing either at the bedside or physicians office laboratories. We believe that the rapid pace of laboratory consolidation will slow down considerably. With respect to industry, consolidation will be driven by one of two things a need to access new technology, or a need to supplement product offerings to offer a more complete portfolio.

Pontius: Becton Dickinson recently announced an affiliation with Harvard Institute of
Proteomics. Where is that going to lead BD in the future? What types of technologies do you see for your consumers as a result of this affiliation?

Mareel: The Harvard Institute for Proteomics (HIP) is a significant NIH project. The goal of the project (MGC or Mammalian Gene Collection) is to have a complete collection of human full-length genes in a vector backbone that will allow researchers (without any barriers) to study human proteins. Since the vector backbone is based on BD Creator technology, it allows researchers to use a variety of BD Proteomics Products such as protein expression systems (BD Tet/On and BD Tet/Off Retroviral Adenoviral Expression Systems, BD Baculogold System, BD TALON Protein Purification Systems). 

What other new testing technology do you foresee for laboratories, and where is it applicable? 

Mareel: Testing for assessment of immune function, molecular diagnostics, and multiplex assays are new technologies that will be applicable to laboratory testing. Immune function assays may be applicable in the area of vaccine efficacy, monitoring for infectious diseases such as HIV, and for cancer. 

Is the new technology dependent or independent of automation? How big a factor will automation be over the next five years? 

Mareel: Automation will be a large factor in the successful adoption of new technologies. We see the ability to automate what may be a complex testing process as a requirement for bringing the product to market. Reducing new technologies to practice in an easy-to- use format will be essential.

Pontius: Do you think point-of-care testing in the hospital and physicians offices over the next five years will be used more or less than it is today? 

Mareel: The physicians office lab and point-of-care testing markets have been in a state of flux over the last several years. The diagnostic industry, including some divisions of BD, are very interested in these markets because of the potential to tap into a new source of revenue. Many have shown their interest by introducing products that serve the needs of these types of customers. The challenges for our technology are in the areas of regulatory labeling of the complexity of the tests and reimbursement associated with the tests.

Based on CLIA data, physicians offices are currently the fastest growing sector of laboratories. Does this have an effect on BDs strategies over the next five years? 

Mareel: Because physicians offices are currently the fastest growing section of laboratories, there is a need to simplify tests. The cost to provide complex tests in a simplified format can be high. Reimbursement commensurate with the cost of the test is critical.

Will growth in the direct access testing market affect BD? Do you foresee BD affiliating with laboratories to directly market to consumers?

Mareel: BD has always marketed its products to physicians, not consumers. This is unlikely to change in the foreseeable future.

What role will computerization and/or the Internet play in customer/consumer relations for your business?

Mareel: Computerization will play a large role in the future of our business. The need for easy-to-use products and the need to lower costs will be addressed, in large part, with computational solutions. In regard to the Internet, the Internet is and will continue to be a highly sought-out place for consumers and customers to get information.

As new technology and procedures emerge, do you believe reimbursement will cover costs? 

Mareel: No, this will remain a big challenge.

Pontius: Regulatory agencies are cracking down on quality issues within the industry. Do you see the implementation of regulatory requirements making business of the future simpler or more complex, and cheaper or more costly?

Mareel: BD has always adhered very closely to regulations throughout the world, so our business has always taken regulations into account in terms of product development and costs. As a result, implementation of regulatory requirements is very unlikely to affect BD.

Today, and for everyones foreseeable future, we have to focus on concerns of
bioterrorism. How did Sept. 11, 2001, impact BD, and will it play a part in BDs future?

Mareel: In a research mode, our technology is applied in many ways. Some of our customers are likely to be using our flow cytometry systems for pathogen detection; however, these customers are very early adopters of our technology for this purpose. Currently, our technology is not specifically designed to address this application. 

C. Anne Pontius, MBA, CMPE, MT (ASCP), a member of MLOs editorial advisory board, is president of Laboratory Compliance Consultants in Raleigh, NC.

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