A few years ago I worked for a smallish company where the repeated "why?" would consistently release untold nightmares. The turnover rate was high, but there were a few old-timers who would tolerate a historical/political inquiry, and a few more whose reactions revealed things about history and politics in a different sort of way. At a glance, the product designs and manufacturing procedures appeared to have been born from pure ether. (This company made medical devices.) Design decisions were undocumented; what documentation did exist was withheld out of general mistrust.
Problem: Applying the drug to the latest version of the device in the usual way gives a messy coating.
- Why is the coating messy on this design? Because the device's surface can't hold this much drug.
- Why are we applying so much drug? Because the previous products used the same dosage.
- Why was that dosage chosen? Because, in an animal study using sample size N=1-3 for each of three different dosages, this did slightly better than the other two. No further investigation was ever done. EOF
- Why can't this device cleanly carry as much drug as previous designs? Because the surface properties and geometries are different.
- Why did we change the design? What properties did the other design have that resulted in a clean coating?
Because a partner company wanted out of the biz, created a durability test no existing product could pass, and used that to torpedo our product. And, wait, that design had a problem with the coating, too.
- Why didn't we catch these coating problems in previous products? Because quality is fucked in this pilot facility, and our other manufacturing facility is still trying to get up to speed with the first product made with this manufacturing method, and unable to duplicate our allegedly flawless results from two years ago.
- Why are we unable/unwilling to do serious QC work here? Or even basic science? We think the CEO doesn't intend to pass regulatory requirements or even launch most of these newer products, so it doesn't matter. These projects are window-dressing for investors. Yes, of course we're all looking for new jobs on the side.
As it turned out, the real benefit to asking all of these whys was that I was able to abandon ship at just the right time. Shortly before I left for another job, having challenged the CTO about the scientific feasibility of his latest escapade during a meeting, a senior engineer showed me some years-old pictures of a device with exactly the same physical design as our flagship product. This young engineer was enlightened.
Problem: Applying the drug to the latest version of the device in the usual way gives a messy coating.
- Why is the coating messy on this design? Because the device's surface can't hold this much drug.
- Why are we applying so much drug? Because the previous products used the same dosage.
- Why was that dosage chosen? Because, in an animal study using sample size N=1-3 for each of three different dosages, this did slightly better than the other two. No further investigation was ever done. EOF
- Why can't this device cleanly carry as much drug as previous designs? Because the surface properties and geometries are different.
- Why did we change the design? What properties did the other design have that resulted in a clean coating? Because a partner company wanted out of the biz, created a durability test no existing product could pass, and used that to torpedo our product. And, wait, that design had a problem with the coating, too.
- Why didn't we catch these coating problems in previous products? Because quality is fucked in this pilot facility, and our other manufacturing facility is still trying to get up to speed with the first product made with this manufacturing method, and unable to duplicate our allegedly flawless results from two years ago.
- Why are we unable/unwilling to do serious QC work here? Or even basic science? We think the CEO doesn't intend to pass regulatory requirements or even launch most of these newer products, so it doesn't matter. These projects are window-dressing for investors. Yes, of course we're all looking for new jobs on the side.
As it turned out, the real benefit to asking all of these whys was that I was able to abandon ship at just the right time. Shortly before I left for another job, having challenged the CTO about the scientific feasibility of his latest escapade during a meeting, a senior engineer showed me some years-old pictures of a device with exactly the same physical design as our flagship product. This young engineer was enlightened.