Limited release for sale

July 12, 2017

When I was in industry, we would have a “release for sale” meeting in order to determine whether the product should be released or not. The person from regulatory affairs was always irksome because he always insisted the product was not ready for release. Yet, two hours or so later he signed the release for sale form. I think he behaved this way to show that 1) he was not some guy who would rubber stamp anything that was put in front of him and 2) if there were product problems he could say, he never wanted to release the product. But he nevertheless always looked bad because basically no new data had been put in front of him, yet he signed the release for sale form without someone putting a gun to his head. If he truly believed the product was not ready, he should have stuck to his guns.

But back to the title…, as a “concession” the marketing guy would say, ok let’s have a limited release for sale implying that fewer units would be delivered than possible. Of course, this was fiction – what the limited release really meant was marketing was limited to selling units as fast as they could, and because of startup issues, product sales usually took some time to get going.

On a more positive note, our release for sale meetings – as I recall – were always unanimous, and not every time was the decision to release – sometimes it was decided to not release the product.

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The concept of nano vacations

July 11, 2017

People go on vacation typically for a week or more. A mini vacation is perhaps two days. With our plane, we have been taking nano vacations. For example, the last one was leaving around 10 am, flying to Martha’s Vineyard, walking around Edgartown and having lunch, flying back, and home around 2:30.


A good vision / mission statement

July 11, 2017

I heard an advertisement from Alere which ended with the statement: knowing now matters. Unlike the vision and mission statements that I suffered through (and no longer remember) while I was in industry, the statement knowing now matters seems to be a perfect summation for a point of care company.


Transferring older posts – complete

July 7, 2017

All posts has been transferred. I deleted one post, which talked about my revised web site (which no longer exists). I also changed all links which referred to my now defunct web site. So with this post, there are 398 posts.

 


Overinterpretation of results – bad science

June 16, 2017

A recent article (subscription required) in Clinical Chemistry suggests that in many accuracy studies the results are overinterpreted. The authors go on to say that there is evidence of “spin” in the conclusions. All of this is a euphemistic way of saying the conclusions are not supported by the study that was conducted, which means the science is faulty.

As an aside, early in the article, the authors imply that overinterpretation can lead to false positives, which can cause potential overdiagnosis. I have commented that the word overdiagnosis makes no sense.

But otherwise, I can relate to what the authors are saying – I have many posts of a similar nature. For example…

I have commented that Westgard’s total error analysis while useful does not live up to his claims of being able to determine the quality of a measurement procedure.

I commented that a troponin assay was declared “a sensitive and precise assay for the measurement of cTnI” in spite of the fact that in the results section the assay failed the ESC- ACC (European Society of Cardiology – American College of Cardiology) guidelines for imprecision.

I published observations that most clinical trials conducted to gain regulatory approval for an assay are biased.

I suggested that a recommendation section should be part of Clinical Chemistry articles. There is something about the action verbs in a recommendation that make people think twice.

It would have been interesting if the authors determined how many of the studies were funded by industry, but on the other hand, you don’t have to be part of industry to state conclusions that are not supported by the results.

 


Blog Review

May 26, 2017

I started this blog 13 years ago in March 2004 – the first two articles are about six sigma, here and here. The blog entry being posted now is my 344th blog entry.

Although the blog has an eclectic range of topics, one unifying theme for many entries is specifications, how to set them and how to evaluate them.

A few years ago, I was working on a hematology analyzer, which has a multitude of reported parameters. The company was evaluating parameters with the usual means of precision studies and accuracy using regression. I asked them:

  1. a) what are the limits that, when differences from reference are contained within these limits, will ensure that no wrong medical decisions would be made based on the reported result (resulting in patient harm) and
  2. b) what are the (wider) limits that, when differences from reference are contained within these limits, will ensure that no wrong medical decisions would be made based on the reported result (resulting in severe patient harm)

This was a way of asking for an error grid for each parameter. I believe, then and now, that constructing an error grid is the best way to set specifications for any assay.

As an example about the importance of specifications there was a case for which I was an expert witness whereby the lab had produced an incorrect result that led to patent harm. The lab’s defense was that they had followed all procedures. Thus, as long as they as followed procedures, they were not to blame. But procedures, which contain specifications, are not always adequate. As an example, remember the CMS program “equivalent quality control”?


Transferring older posts

May 15, 2017

I have started the process of transferring older posts, which were in my now defunct website, to this blog. It will take a little while and additionally it will take some time for the search engines to catch up.