Biomedical Engineering Reference
Your sales force will always have an input. They know the marketplace, they know
the buyers, and they know the problems associated with selling the devices. Get them
on board straight away and ask them what it is that will help them to sell your device.
This may be the one chance you get to plan tests that are not just for meeting regulatory
requirements but are actually there to produce marketing collateral before the device goes
out for sale.
Your sales force will tend to bring things into the design with the intention of making the
device “sellable” ( Table 5.5 ). They will, as with customers, pose questions rather than
requirements. For example, can this be done? Can this be achieved? One of the most
important facts is the selling price (with, of course, profit margin)…this tells you what
your budget is!
This section has two aspects. Manufacturing can set limitations, for example you may be
unable to manufacture in composites; there can also be requirements for production, for
example you may have to make this device in a clean room .
More importantly, this is your chance to get input from the personnel who will actually
make the “thing.” Too often things get to the shop floor only to be returned labeled
“unmakable.” The manufacturing team at your disposal is a great asset; bring them in at
the start to look at how manufacturing capability not only limits your design but also to
possibly open your eyes to something you never thought of (by and large it is the latter
which is the most invigorating).
You may have to look at installation too. Will your device have to be installed (this is a part
of the manufacturing process)? Will it require calibration, setting, or adjustment in situ? Who
will do this? What is required to do this? Will your device need assembly - does it arrive like
flat packed furniture?
One of the main reasons for estimating the classification is for this section. The higher the
classification the greater the level of importance laid on your manufacturing facilities. It
is quite apparent that the cleanliness of a manufacturing facility for a syringe is far more
rigorous compared with that for a chair for a hospital waiting room. The classification of your
device gives you an indication of the rigor required.
Quite often a company will have internal rules, sometimes to minimize stock on the
shelves and sometimes just from a bad experience with a previous product. Sometimes
they should be adhered to, sometimes they can be questioned - but they should not be
ignored. You may also find that your suppliers do not like to mix materials. Many implant