Biomedical Engineering Reference
In-Depth Information
5.3.1.1 Customer
All devices will have a customer; in modern parlance the end-user . It is often very difficult
to find the actual end-user as the person that initiates the need may not actually be an
end-user. Equally, the person who actually buys the device may not be an end-user (but is
certainly a customer). This is where things such as workshops, focus groups, and talking at
conferences really help. The voice of the customer has been overlooked on many occasions,
and often to the detriment of the company concerned. However, this is the easiest section to
complete as all the thinking is done by others - you act as a filter. All of the other sections
in the PDS are wholly yours. Hence there is no reason why this section should be devoid of
content. Furthermore, as the voice of the end-user becomes more prevalent in the regulatory
framework (which it is), this section needs to be demonstrably visible.
Please, please, please do not think that just by talking to a surgeon you have discussed items with
an end-user. They are often the last link in the chain; an important last link, but still the last link.
Before them come purchasing: What is it they want to see? Has it got to be blue? Has it got to
be cheaper or within 10% of an original price? What do the sterilization and cleaning staff want?
Does it need cleaning trials before it can be accepted? Do they need holes in places for washing
that you never thought of? What does the nursing staff want? (They will be fetching it and
unpacking it.) Does it need to be below a certain size for the shelves? Does it need to be below
a certain weight for them to carry? Would they like it to be a special color to stand out from the
other items? It is important that with the comment you include the source of the comment. This
is useful for “backtracking” (i.e., going back to the source to confirm) and for cross-referencing.
All of the above is concerned with finding out what the customer “actually” wants. As stated
earlier, often they do not know what they want - you have to tease it from them.
I cannot stress enough the importance of the voice of the customer. It is only by getting
them on board that you will really fully understand the problem you are trying to solve.
Furthermore this section will be of great importance when we address the House of Quality .
Table 5.1 illustrates how different sections of the customer base see simple things like color
differently. It is your job to filter these down to some form of consensus to enable a sensible
PDS to be written.
5.3.1.2 Regulatory and Statutory
This is basically common sense. We are bound by rules set down by the FDA and by the
European Commission - we have to meet those so make sure they are stated. The obvious one is:
It must meet the essential requirements as detailed in
However there are many more standards and regulatory requirements that your device will have
to meet, some of which you may not have even thought of (those of you who have powered
devices may come under numerous regulations from noise limitation to electromagnetic
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