Biomedical Engineering Reference
In-Depth Information
domestic/consumer market have more freedom; but it must be remembered that these are still
medical devices and hence you are still bound by medical device regulations.
Many of you will be designing and selling reusable devices (such as forceps). These are
amongst the greenest of medical devices as they get used over and over again. They are
not, strictly, recycled; they are reused. Again, even this is becoming cloudy as many online
articles now state things such as “reusing a medical device is like buying a secondhand
toothbrush.” We will never escape the hyperbole of the press and, even worse, the Internet.
In Europe it is now commonplace to be required to justify why your device is single use
(in order to stop companies from stopping items being reused to drive up income streams).
This clearly flies in the face of the previous public concerns. Another paradox is that many
hospitals now want single use items to be separately packaged and supplied sterile - this
obviously saves them sterilization and inventory costs but is a terrible waste of packaging
materials.
Hopefully you will begin to see that this subject (for medical devices) is a paradox. On the
one hand we have guidelines and legislation to force us to recycle, but on the other hand
we have legislations and guidelines that force us not to recycle. The only thing we can do
is “what is reasonably practicable.”
Table 8.12
is designed to help you do this. But do not
forget your device is part of a system; so you must look at the system as a whole.
As you should now see, if you develop your PDS well then most of these “seven wastes”
should have been covered from day one. But you should reexamine them in the light of
ever-increasing environmental legislation - especially those of you with electronics in your
devices.
One thing to remember: if you save material, energy, or transportation (i.e., any of the “green”
costs), then your main device is cheaper to manufacture and distribute. Hence you can reduce
sales cost or your margins will increase. So do not think that all “green” activities must “cost” -
they are more likely to “save.”
8.8 Design for Usability (DFU)
I have separated this from the other DFX partners, mainly because it is uniquely important
but also because I have invented it as a collection of three subdisciplines: ergonomics, man-
machine interface, and desirability. All three work together, as they highlight the fact that
your device is to be used by someone, and that someone has to be able to use it!
Some fundamentals to consider:
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Who is going to use the device?
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Who is going to install the device?
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How much training is required to assemble/use the device?
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