College of American Pathologists
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cap today

Back to basics—and beyond

March 2001

Earlier this year, CAPTODAY journeyed to Abbott Park, Ill., to engage in a roundtable interview with executives of Abbott Diagnostics. The discussion ranged from what’s in the Abbott pipeline to Abbott initiatives relating to the FDAconsent decree of 1999. William Check, PhD, a frequent feature contributor to CAPTODAY, joined publisher Bob McGonnagle in the questioning. Abbott’s representatives were Sue Widner, vice president of U.S. commercial operations; Mark Smits, vice president, marketing; Jim Walton, vice president, sales; and John Schueler, vice president, national accounts.

What is most important for laboratorians to understand about the consent decree, both in terms of what it has meant and the concrete things Abbott has done in the past year?
Mark Smits: It is important to understand that the FDA has never alleged a lack of safety or efficacy with respect to any of Abbott’s diagnostic products. The consent decree concerned Abbott’s conformance with the FDA’s Quality System Regulation. We have been working to rebuild our quality system under the new Quality System Regulation, and we have made substantial progress in working toward that goal. It is a project that has taken a considerable amount of resources, but we are proud of the work our people have done. We have devoted more than 1,000 people to the task of reinventing our quality system.

As a result of the consent decree, it’s our understanding that you are doing extensive product re-validations. Can you explain what you’re doing?
Sue Widner: Historically, we have always validated our products as we bring them to market. What changed as a result of the consent decree is the way we view validations. Instead of operating on a product-by-product basis, we moved to a common process approach, which meant we looked at all of the manufacturing processes that were common across our broad product line.

Some of those common processes are mixing, filling, lyophilization, sonic welding, and conjugations of our antibodies. We identified 14 of those processes that span our product portfolio and we are now validating each of those common processes. Those validations are being submitted on a time line to the FDA.

Concurrent with that are product-specific validations or remediations, which are taking place on a parallel path with the process validations. These two key activities must be completed before we re-launch products.

Mark Smits: We now have doubled our validation effort, because we are validating all the common processes, and we are still validating the products themselves. We do believe that we’ve learned a significant amount about how to improve quality processes as a result of this journey.

We also believe we are going to be in a great position from a quality perspective from this point forward. What’s important to us is that we are producing the best quality products we possibly can. That’s what our focus is on.

What would be some of the milestones that customers will want to look for as part of the re-validation of protocols and so on? Will the principal sign be the reentry of certain assays and tests into the marketplace?
Mark Smits: Yes. Throughout the course of 2001, you will see announcements of our achieving different milestones. Certainly one of those milestones will be the reintroduction of some of the assays that we removed from the market as part of the consent decree.

But it is important for our customers to understand that we look at the consent decree as the start of a completely new way of doing business. I’d like to emphasize this, because some people might think that once we reenter the market with the products, it will be back to business as usual. We don’t view it that way.

Instead, we view this as a continuous process. I believe that every month we will be a better company than the month before. We really do see this as a journey and as something that is going to continue from this point forward. So you’ll see milestones throughout the course of the year, but I think the most important message is simple: This is a new way of doing business.

We’ve heard a lot of stories in the past year from customers about how much Abbott employees have put themselves out to help customers, whether arranging for reference laboratory tests or even alternative suppliers. Based on what I know, you’ve done an exemplary job in trying to help customers get through this.
John Schueler: I appreciate your comment, and it certainly has been our objective from the beginning to do everything we can to help and to be as creative as we can. We offer our ideas, we listen to the customers’ ideas, and together we try to put together the best solution we can to minimize the inconvenience or the disruption to their service.

Jim Walton: I think for all of our customers, large and small, the one thing that has stood out is the dedication of our sales force in helping them meet their needs. Our people take it very personally when their customers are in trouble. They work extremely hard to ensure that they maintain their customers’ trust and loyalty. It is gratifying to me personally to hear customers talk about the dedication of our sales force in working with them through a difficult situation. Throughout the past year, our sales force shifted to an account maintenance role, making customer satisfaction our number one priority.

I believe communication is key to our success. For example, we must ensure that our customers are aware of any potential product shortages early on so that we can work together on the options available. We now have a person whose full-time responsibility is to help us work through allocation problems and communicate with and service our customers.

Mark Smits: During my first 10 weeks on the job, I tried to read as much as I could about what has happened over the last 24 months.

I received information from a wide variety of sources. Internal interviews that we’ve done, external articles that have been written. The one thing that is consistent—no matter what the source—is the extraordinarily high marks the sales organization has received from our customers. Their dedication, their commitment to solving the problems for the customers, their willingness to do whatever it takes to make sure we achieve the highest level of customer satisfaction possible.

Do you think your competitors might be somewhat surprised at the amount of loyalty laboratorians have been showing to Abbott throughout this?
Sue Widner: It’s not surprising to me, having been at Abbott as long as I have been, and having worked with our products and with the people in our organization. The foundation for this is the quality of the products we produce.

What are the key goals for Abbott Diagnostics in 2001?
Sue Widner: Above all, the division is working to complete our compliance initiatives and implement the enhanced quality systems that we’ve developed throughout our organization worldwide. In addition to that, another key goal is to build customer confidence and trust in Abbott’s Diagnostics Division. And we have a number of initiatives underway to do that. But fundamental to all this is our commitment to continue to do business openly and aboveboard with the customers we serve.

In terms of products, we feel very confident that we have the necessary strategies in place and the appropriate R&D investment to continue building our immunoassay franchise, to further enhance our hematology and chemistry products, and to continue to improve the reliability of our systems. We also intend to grow our franchise in molecular diagnostics. In addition, we will continue to be an innovator in the blood glucose arena, and will be introducing a number of new products to help people with diabetes better manage their disease. Equally important, we will continue to build system menu and reliability of all our platforms.

I realize you are talking about a new continuous quality systems approach and new things in that arena for 2001. Are there some other specifics that represent a shift, if any, for 2001?
Mark Smits: We don’t intend to make any major shifts. I noted that in CAP TODAY’s most recent benchmarking survey, your readers still rated Abbott highest in terms of quality of our immunoassay products as well as innovation.

As we focus on our communication activities for 2001 and beyond, one of the major areas we are going to emphasize is the quality of our immunoassay results. This is one of the chief reasons for the success we’ve enjoyed over the years. It is the foundation of our company. As we reintroduce products to the market this year, it puts us in a position to make assay quality the centerpiece of the communication we have with our customers. We can start by helping decision-makers understand how quality of results can translate into cost-effectiveness.

Jim Walton: One of the things we are going to do is to ask more questions about the challenges the laboratorian has, as we look for ways we can better help them meet those challenges.

For example, let’s say someone obtains falsely elevated PSA results, more so than normal, and we have a PSA test that gives the correct result. We are going to compete for that business, and we are going to help our customer solve whatever problems they may have by understanding their true needs better than our competitors.

That’s a mission we are on this year: to better understand how the lab operation works, what the goals are of the laboratory, and to partner with them to meet those goals. I think we can do a better job of this, so we are re-dedicating ourselves to this mission.

You’re speaking, then, about a return to the clinical quality of the assay itself-as opposed to selling a platform and all the peripherals that essentially run the clinical assay.
Mark Smits: The feedback we get from our customers tells us the clinical quality of the test still is a very important part of their decision-making. We all want to make sure that we provide our sales organization with the information they need to discuss the clinical utility of our assays with customers.

Jim Walton:We’ve learned throughout the past 12 to 24 months that our customers want to be as informed as possible about our products. As part of our marketing plan for 2001, we are going to make a major investment in educating our customers about our products.

We have some products that have been on the market for a while now, like the AxSym and the Cell-Dyn 4000. There are definitely benefits to having well-known, reliable products that have a big menu. One of the downsides is that as lab employees move from location to location, you lose some of the expertise you may have had on the system when you just acquired it.

So, throughout the course of 2001, we are going to go from city to city in the United States to conduct workshops for AxSym and some of our hematology instruments.

Mark Smits: At the same time we are doing those workshops, we are going to be asking our customers to give us feedback. We are going to be setting up user groups, and we are going to really try to have a straight dialog with our customers where we listen to what they’ve got to say to us. As we ask more questions about the challenges the laboratorian has, we can find ways to help them meet those challenges. That’s a big part of our marketing plan for 2001.

When we talk about returning to the assays, is it the case that the customers themselves have missed some of this interaction in the recent past? In other words, are they still concerned with the clinical quality of the assays?
Jim Walton: Early on in my career, which has been 22 years, the criteria were closely scrutinized in terms of assay performance-CVs and linearity, things of that nature. What I’ve seen over time is a lot of that has been taken for granted. There has been more focus on automation because the demands on the laboratory have not lowered; they’ve gone up, and yet head count has gone down. But we know our assays have advantages technically, and we feel that that will also save labor costs.

We have a legacy, particularly in immunoassays. We’ve taken assays that were very manual procedures to full automation through a three-step process. First we went from RIA to EIA with the Quantum. Then further automation with FPIA on the TDx and large molecules on the IMx, and then combined multiple methodologies with continuous access on the AxSym, and now the Architect. No one else in this industry has that track record.

We’ve grown our business to where we are one of the largest companies in diagnostics. We have been meeting customers’ needs for over 20 years. We haven’t relied on mega-mergers to grow. Our focus has been on investing in research and development and external opportunities to supplement our capabilities to meet customer needs. So I think that for us to continue to be successful, we have to point out, in more detail, the advantages of our technologies.

We’ve talked about an evolving strategic direction for ADD. What specific things are in the pipeline over the next year or two from Abbott?
Sue Widner: In the immunoassay area, we are continuing to focus on the expansion of our Architect menu as well as integrating immunoassay with clinical chemistry. On our AxSym platform, we are focusing on developing a larger menu.

One highlight we are looking forward to is the launch of a single automated platform for full hepatitis panels.

In hematology, our key investment will be in improving reliability for our customers, as well as incorporating new technology into next-generation platforms. In clinical chemistry, our focus will be on increasing the menu on our existing platforms, as well as looking at introducing an integrated chemistry and immunoassay platform for the mid-volume market.

From a molecular diagnostic standpoint, there are a couple key things. One is expanding the menu we currently have available on our LCx system and looking at next-generation assay development as well as automation, particularly in the area of sample preparation.

In the point-of-care arena, we’ve looked at integrating the traditional point-of-care blood gases with glucose monitoring, launching one platform that does an entire menu of POC testing.

Finally, we will continue to make investments in our consumer blood glucose monitoring business with innovations in new meters, looking at virtually painless testing and innovative strip technology.

If you saw an ideal DNA extraction and automation process, do you think that would make a huge difference in driving incremental volume in molecular testing?
Mark Smits: Yes, let me give you an example. If we can solve the labor component, and we’ve got some nice ideas and technologies we are looking at, it could be similar to what you saw in the early 1980s when we introduced the TDx.

Therapeutic drug testing at that time was so laborious that it had to be done in large reference labs and large hospitals. With the introduction of the TDx, you were able to decentralize that important testing down to even the smallest clinic. We see that same kind of future with probe technology once we solve the labor component.

On a closing note, is there something about Abbott Diagnostics that should be more widely known, something beyond what we talked about today?
Jim Walton: The one thing that’s exciting for all of us is that many of us have spent our entire business life with Abbott. Even out in the field, you have representatives with five, 10, 15, even 20 years of experience. That’s a nice feeling to watch people grow up in business, to work together in different positions, and feel such a passion about the business and the company. If I were a customer, that would tell me a lot about the culture here, and we are real proud of that. A lot of us are friends, and we are determined to maintain our standing as one of the best companies in American industry.

Sue Widner: My closing thought is just that I want our customers to know that we are grateful for them. We are very thankful for the support they’ve given us, and we are going to work extremely hard to maintain their loyalty. We will continue to make the investment necessary to maintain our leadership in innovation and quality, and we will continue to do business in an open, straightforward way.