Never underestimate the ineptitude e obtuseness of many (not all) third party auditors. It might surprise you, but it is possible this organization is given a clean bill of health.
Problem with organization
- Thread starter Tintypographer
- Start date
@Ed Panek is correct. In the startup phase the ‘rogue’ scientists are critical, but as the company transitions to commercial selling these scientists become a drag and a liability. Many brilliant scientists leave the large companies to start up company because they are free of regulations, I’ve seen this up close and personal. It is unfortunate that the brilliant founders can kill a mature company or keep it from becoming mature.
I've seen this myself: The prototype works (under some condition), but the design is marginal (narrow performance limits) and/or overly complicated... and the "rogue" scientist resents being shown tests where the protoype doesn't work as expected, and shrugs at fallout. There is a difference between tinkering a solution and engineering a solution. There is no shame in being a clever wizard that comes up with an idea to do something, but that doesn't mean the first idea is an engineered solution.
I remember my initiation into medical (early generation digital dental cameras) and complaining to a supplier about the low reliability of a sub-assembly, and hearing "that is a prototype design - they never spent the money and time to finish the project properly".
I used to explain it as “there is a difference between proving something will work and making a million a month for sale”
Too many (not all but many) of the R&D guys weren’t interested in anything beyond beyond proving their idea and would simply blame the operations guys for being too incompetent to make a million a month.
Too many (not all but many) of the R&D guys weren’t interested in anything beyond beyond proving their idea and would simply blame the operations guys for being too incompetent to make a million a month.
Tintypographer
Starting to get Involved
It's not that. The original inventor did a good job. The product is technically what is is. It's formed in a chemical reaction and that's the end. There isn't any secondary processing so even though it's a medical device the only difference is the size. Changes to it would be a different chemical structure.
The original inventor refused to map out transit studies for the post production as an example of the point when he quit. He got frustrated with risk analysis and I'll admit he had no guidance when he was forced to do it the first time. But HE left, honestly and with truth of intent. He went to a non medical device finance company and broke ties with this company. The problem is that the owners and subsequent owners kept expecting him to solve the problems. He was honest; he didn't want to do the regulatory work and was completely happy to leave. And to be honest I think that is ok.
At one point in between him leaving and my coming on board I realized that his original top risk could be someone "consuming the product." In the entire history no one consumed the product and it wasn't designed to be consumed. The original research person was from academia and was sort of browbeat into coming up with risks and not knowing what he was doing and not having guidance he just made them up. The problem then was that post market surveillance didn't show any consumption of the product ever and writing a plan to reduce this risk didn't make sense. I realized this but by that time there were multiple CAPAs and always the pressure for someone to come up with the potential risks from a group of lab techs who could make the product synthetically but not interpret clinical and consumer risks. But the focus was on calling the former inventor and asking him how he arrived at that risk when the truth was he didn't know what he was doing and by this time 10 years after he moved on to a hedge fund he didn't care. He was extremely annoyed when I called him and did not want to be associated with the product or company anymore having a completely different career in a different field.
I sort of took the same approach this time when the CEO called me. I can't help and I'm not longer involved.
I think we have to understand that for some people the work associated with regulatory and quality is not suitable to them and it's ok that they leave the field.
The original inventor refused to map out transit studies for the post production as an example of the point when he quit. He got frustrated with risk analysis and I'll admit he had no guidance when he was forced to do it the first time. But HE left, honestly and with truth of intent. He went to a non medical device finance company and broke ties with this company. The problem is that the owners and subsequent owners kept expecting him to solve the problems. He was honest; he didn't want to do the regulatory work and was completely happy to leave. And to be honest I think that is ok.
At one point in between him leaving and my coming on board I realized that his original top risk could be someone "consuming the product." In the entire history no one consumed the product and it wasn't designed to be consumed. The original research person was from academia and was sort of browbeat into coming up with risks and not knowing what he was doing and not having guidance he just made them up. The problem then was that post market surveillance didn't show any consumption of the product ever and writing a plan to reduce this risk didn't make sense. I realized this but by that time there were multiple CAPAs and always the pressure for someone to come up with the potential risks from a group of lab techs who could make the product synthetically but not interpret clinical and consumer risks. But the focus was on calling the former inventor and asking him how he arrived at that risk when the truth was he didn't know what he was doing and by this time 10 years after he moved on to a hedge fund he didn't care. He was extremely annoyed when I called him and did not want to be associated with the product or company anymore having a completely different career in a different field.
I sort of took the same approach this time when the CEO called me. I can't help and I'm not longer involved.
I think we have to understand that for some people the work associated with regulatory and quality is not suitable to them and it's ok that they leave the field.
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