DUNN

Another example of this is the issue of rule out diagnosis in pulmonary embolism. The tests are getting better, but sometimes it is hard to establish who is the target audience. There are multiple targets in the institution - there is the emergency room, the laboratory, perhaps the radiology department and payors, of course. Companies have to be careful how they market their products into the institution. We have certainly seen companies get burned by trying to take a product to a consumer audience and bypass the laboratory and the primary care physician. It may become more expensive to market some of these tests because they have to address diverse audiences.

BERNSTEIN

Playing off of what Kathy has said about maximizing the relationship with the customer, we have found that incorporating case studies into the marketing mix helps bolster the case for ROI. You take a one-on-one scenario with an early adopter and describe how a particular assay improves turn-around time on the clinician side, or addresses staffing issues or allows greater clinical utility. This allows companies to show a slice-of-life scenario and then follow up with hard, economic and quality of life analyses. This can help support a lot of the claims that our clients are hoping to share with the marketplace.

DIAGNOSTIC INSIGHT

Over the years as you have been consulting with companies, what are some of the surprises you have encountered?

CHOW

Something that we find with many of our clients is that when they go before the FDA or when they are planning their clinical trials, marketing has not been involved in planning these trials or their submissions. Therefore, the labeling claim that gets handed back to the marketing department is sometimes less than optimal. The surprise for me is that they do not incorporate market insight into their product development and regulatory submission process. This is important because the labeling claims, as we all know, can make a world of difference. To the extent that we can, we counsel them to do so, if we get involved with a company while the trials are still on going. We are very seldom involved in the study designs, but we are often involved before the claims have been submitted. Then we can encourage them to have marketing personnel participate in the submission process so that marketing and thus the customer has a voice in this.