Biomedical Engineering Reference
In-Depth Information
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Can we afford not to do it?
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Who wants it?
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How many want it?
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For how much?
…but not necessarily in that order. The design brief is also the start of the formal design
process and hence needs formal approval. The best way to achieve this is to formulate a
simple document, or pro forma, to complete. We are in a quality process so this document
cannot be ad hoc: it needs to be developed, written, and approved before it can go ahead.
Figure 5.1
is an example of an approved statement of need pro forma. As with all other
example documents in this text it is by no means an exemplar for direct copying, but is a basis
from which to develop your own.
It is so simple to produce a pro forma on modern computers that there is little excuse not to
have one. Note that this is a controlled document hence it has a unique name, a version, and
formal approval. It should be housed in your company's quality manual.
It is worthwhile giving each new statement of need a unique project number - this makes
cross-referencing so much easier. Hence it is worth keeping a log/track record of all
statements of need and their outcome. The product title need not be the name the product will
keep forever but can be a good secrecy ploy. In the First World War, when a new armored
vehicle was being developed, the military didn't want its secrets to get out; hence it had lots
of different companies making lots of different bits that when put together made this new
vehicle. When the companies asked what they were making they were told it was a new
vehicle for carrying much needed water to the troops, which was quite logical since it was a
big metal box on wheels; hence everyone called it
a tank
…and this name has stuck ever since.
If you are working on something brand new and secret don't give your project a name that
gives it away. You don't want your competitors knowing what you are working on, so call it
something that people can recall but that means nothing outside of a closed circle of friends.
We have covered the description of the need earlier. But this section must contain all the
information required to make a reasoned commercial decision on whether or not to go ahead.
The minimum should be the overall aim of the product (the one thing), where the demand
has come from, potential market size, and potential sale price. It is also worth stating whether
this is totally new to your company or not (e.g., a cardiology specialist going into diabetes
management) and whether you have the expertise to do this. An accurate indication of Cost to
Market (R&D) is essential.
The next section details the evidence submitted. These could be written demands from
customers, copies of market research reports, or transcripts from focus groups. This section
enables you to put all of that evidence in one place.
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