Performance vs. Utility
In the increasingly challenging environment of healthcare marketing, diagnostic marketers need to take a page from the pharmaceutical industry—no, not to learn from their excesses and extravagances, but for insights into how they work to understand the way doctors make decisions and adopt new technology. It may seem obvious, but I have watched too many clinical diagnostic marketers fail to realize the market potential of their offerings by not putting into practice what they need to do if they expect their innovations to move more quickly into clinics. I have long been intrigued by the low value assigned to diagnostics by the healthcare system, and I have been looking for tangible, actionable ideas I can give to my clients in the diagnostics space. Here is the beginning of a short list, which I hope to build with the help of colleagues and visitors to our website.
I was in the audience at the Burrill Personalized Medicine Meeting recently when Alberto Gutierrez, PhD, an official from the FDA’s Office of In Vitro Diagnostics, was interviewed. Dr. Gutierrez must have said at least three times that the FDA “doesn’t look at clinical utility” when it comes to IVD clearance. This fact is well known by regulatory specialists and embraced in their filing strategies. Yet many marketers do not seem to realize that marketing’s work begins, not ends, with FDA clearance, unless the product is truly a me-too version with a well-established place in clinical practice. Most diagnostic marketers I know can produce a respectably thick binder of published studies demonstrating the analytical performance of their products, including studies comparing their products with traditional methods and showcasing superior results. Then, months to years after launch, the same marketers are surprised to learn that doctors continue to use these other methods even though they take longer and provide incomplete and/or inaccurate results, and even though reimbursement is available for the new and improved test.
So, rule number one: Don’t equate performance with utility. Proving that the performance of a new diagnostic test has been demonstrated through properly designed, robust trials, and getting FDA clearance must be paralleled by an equally arduous effort to work with clinicians in understanding and demonstrating clinical utility—what is the relevance of the test results in the clinical setting, how will it influence patient care (e.g., where in the clinical pathway does the test fit, what action should be taken based on the result) and how all of this will improve outcome. Working with clinicians, conducting the studies, publishing the findings and communicating them to the target market are just a few of the necessary steps toward adoption.