So your product manager asks you to “improve” your latest diagnostic assay. “It needs to be faster. Ease of use will be a problem for most of our customers. Also the sensitivity and specificity could be better, 99.5% is good but we really need 99.9% at a minimum. We also will need AOAC, AFNOR, and health Canada validation. Not AOAC-PTM but official methods status.” “So you are saying we can’t sell the test without all of this stuff?” you ask naively. “Maybe to a few early adopters but the bulk of our market will need everything. How long will it take and what will it cost?” Your mind reels. Of course you have heard all of this before but always thought the test you have dedicated the last three years of your life to developing could at least launch and make some sort of impact before all the boxes were checked. Maybe sell in China or South America or someplace where the standards for new methods weren’t quite as rigorous. “Well the sensitivity can not get any better. Unless we are willing to implement some sort of analyte concentration step up front. Since this would make ease of use even more of an issue we ruled any such technique out from day 1. To improve specificity any further would require a total reboot of the bioinformatics process. In silico and in vivo development and testing of new targets would essentially put us back in early phase research again. Even if we could identify better targets in a few weeks, reoptimization of the assay would take at least three months. Most likely more. Any improvements in speed would be directly tied to theoretical gains in sensitivity. Again we run into the ease of use problem. The validation requirements you need will cost tens of thousands of dollars and take from 1–2 years to complete.” All of this was clearly spelled out in the project proposal you think to yourself. The project manager and sales team signed off on it. They made specific revenue projections based on what R&D had told them. Suddenly the test is ready and it turns out those projections were wildly overstated. Without all of things your intrepid project manager is now badgering you about it will be impossible to meet those targets. Upper management is ticked, the sales force is disappointed, and your PM blames you. So you rally your team and head back into the lab the very next day. Two years later everything you were told was so critical has been delivered. Unfortunately the market has changed a lot in that time. Five years have now passed, you have a couple patents from the technology you invented to make the test, yet it sits on the shelf unsold and unused. Oh well there is always the next test in the pipeline.

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Research scientist (Ph.D. micro/mol biology), Thought middle manager, Everyday junglist, Selecta (Ret.), Boulderer, Cat lover, Fish hater

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