Biomedical Engineering Reference
In-Depth Information
Maintained sales profile
v1
v2
v3
birth
rebirth
time
Figure 1.2
Sequential “bathtubs” maintaining the sales profile.
1.3 Medical Devices Definitions
As discussed earlier it is important to be embedded in the discipline in which you practice
design. Hence car designers are embedded within the automotive industry: they probably
play with their own car at night and on weekends; almost certainly watch or take part in
motorsport; and will read every car magazine under the sun. So it is with medical device
designers: we must tinker, read, observe and play … but it is unlikely that we will ever be
able to use our designs. Hence we operate (excuse the pun) remotely, but we also know
that one day our design may just come and save us too. The lesson here is that we need to
know as much about the
end use
as the end-user themselves. In fact we need to know more
than the
individual
end-user; we need to consider
all
end-users. I can promise you that if
you understand your discipline well then your designs will be good and you will get great
satisfaction in knowing that you have saved someone's leg, eye, or life.
However, the corollary is that you can also contribute to the loss of someone's leg, eye,
or life. To this end medical devices is one of the most highly regulated arenas to work in.
Because of this the first staging post is to fully understand what a
medical device
is. Believe
me when I say that this is one of the hardest battles you will have with your end-users. Each
one will think they are a special case and are, somehow, excluded - they are not and neither
are you. More importantly, you are the one who will end up in court.
The European Union (EU) and FDA have tidy definitions of a medical device. Within Europe
this is laid down in law under the Medical Devices Directive 93/42/EEC as amended (most
recently) by 2007/47/EC. It is by no means concise, but it is neat.
(a) “medical device” means any instrument, apparatus, appliance, material or other article,
whether used alone or in combination, including the software necessary for its proper
application intended by the manufacturer to be used for human beings for the purpose of:
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