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What is a ' design freeze' in the context making a CO-VID antibody test?


Tally

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Forgive my lack of expertise or scientific knowledge what is a " design freeze" and what does it entail in terms of producing it?

 

Background: the government last week formed a consortium of 4 British bio-tech companies to create an antibody test for CO-VID 19. The statement from one of the companies was 

"Once the COVID-19 Rapid Test reaches design freeze, then the specification and standard operating procedures will be shared with each party of the consortium to enable manufacturing and/or assembly to be undertaken at each site".

Does that mean the test is in the final stage and something that will help get us of lock-down sooner?

Appreciate your thoughts.

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7 minutes ago, Tally said:

Does that mean the test is in the final stage and something that will help get us of lock-down sooner?

It doesn't mean it is, yet. They are talking about their future process. But design freeze sounds like it is end of the last stage before handing over to manufacturing.

During development (of almost anything) it is always possible to keep researching, tinkering, trying to make improvements, etc. So, in my industry (electronics and software) there will be several stages of development: specification (define exactly what the product is), design (work out how you are going to make it), implementation (actually create the first version of the product), test (make sure it works) etc.

Each of these needs to stop at some point before the next can start (in reality, they overlap and you move back and forth between them). So, at some point, the project manager will say that the specification or the code is "good enough" and it is time to move on the next stage. When writing software that is called a "code freeze"; there are no more changes allowed to the code unless major bugs are found.

So, the development of vaccines seems to have similar stages of development. "Design freeze" means (I assume, from the quote) that they have come up with something they think is good enough - further work will just take time and not add significant value - and at that point, the design will be shared with other companies to ramp up manufacturing. Then, I assume there will need to be further testing to ensure it is sufficiently reliable, etc. when manufactured in volume.

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1 hour ago, Strange said:

So, the development of vaccines seems to have similar stages of development. "Design freeze" means (I assume, from the quote) that they have come up with something they think is good enough - further work will just take time and not add significant value - and at that point, the design will be shared with other companies to ramp up manufacturing. Then, I assume there will need to be further testing to ensure it is sufficiently reliable, etc. when manufactured in volume.

Indeed, for medical devices this is usual the step when the overall parameters are set and the equivalent of a prototype emerges. Using that initial validation and testing will be conducted to see whether the desired parameters outlined in the previous stages have been met and so on.

Once that is all positive the next step is to go through actual trials and only after that we can implement them diagnostically.

That being said, research can be done even with poorly or untested systems. It is just important to document those limitations. There are already fully developed antibody tests around (with various sensitivity and specificity) and some may already be allowed in some countries to test for certain purposes.

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