Working in the medical instrumentation sector there was an FDA policy that I saw as horrific. It was the requirement that all obstacles in development be identified up front so that performance is accurately predicted in the marketing submittals to the FDA, long before the core development takes place. If the device performance is not as good as stated in those early marketing docs, then the device does not get FDA approval. Or this was my impression of how it works.
Such a policy ignores important truths in development. Engineering is about doing very quickly things you have done before. It is about using your training and experience. R&D is not just engineering. It usually has a scientific element which is more about speculation on how things that have not been done before are likely to work. The best of scientists do not do a perfect job predicting such things. To have to toss a project and start over because it did not meet the original marketing goals just doesn't make any sense. This begs for scientists to lie about data. And I am sure it goes on all the time.
It seemed to me that under-performance relative to marketing goals, in some aspect of a device, is likely common. And my experience is that it is very common.
After getting scrwd at that MRI company (that I talk about all the time) I was cast out into the temporary workforce. A common job available to temporaries with Validation and Verification background is the testing of devices that don't quite make the marketing requirements in some way. It is the job of the temporary to make the device pass. If you don't, they can get another temporary. And if you make waves, they can ruin you. Blackballing is very real.
How do they just get a new temporary. You can do V&V testing on a device at one of the companies and there will be no record of you working there. If things go badly, you worked for the temporary agency (who typically knows nothing about the work you perform for the client). If things go well you worked for the client.
The point is that the rigidity of the FDA in this regard creates horrible situations in industry. It should be fairly standard to simply modify the original marketing requirement. The FDA review of those changes should be reasonable and take a reasonable amount of time.
Here, it appears the FDA has finally taken that attitude. While LP's connections may have helped, there has been a great deal of pressure for the FDA to be a cooperative body rather than a competitive body in the development and approval of new drugs, such as cures for cancer. In this case it is not a change to the marketing requirements, but it is a similar change in attitude by the FDA that is required.
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