Biomedical Engineering Reference
In-Depth Information
Table 5.5: An Example of the Sales Section in a PDS
Section 5: Sales
Number
Comment
Source
5.1
Selling price:
Sales report
Not to exceed £50 with a gain
margin of 60%.
5.2
Color:
Sales report: Market trend report
Purple is going to be the “in color”
at the time of sale.
5.3
Operating system:
Sales report
Apart from mains electricity the
use of “solar power” would give
a USP.
5.4
Color:
Sales report
Could any knobs be individually
colored for ease of training?
5.5
Sales:
Sales report
Estimated demand is 400 per year.
manufacturers only like to use one grade of material on a particular machine to avoid
cross-contamination from tools.
2
Do not assume “6.2 - Animal products” is a simple item (
Table 5.6
). You really need to
ensure that you have no animal products in your manufacturing chain - they can creep
in anywhere, especially with plastics. It may not be universally known, but the lubricants
used in plastic production, machining, and extrusion can be of animal origin. You
must
get
confirmation from your suppliers that this is not the case.
5.3.1.7 Packaging and Transportation
This is simple but often overlooked. Too many times I have heard “If only it were 12 mm
shorter it would have it in our standard box.” There is so much to the final packaging of
a device that it must not be ignored (
Table 5.7
). What packaging is required: sterile or
nonsterile? What labeling is required? What is to go into the package - full instructions or
single instructions for use sheets? What size box should it go into?
Does the packaging have to be specially designed to meet the rigors of transportation?
You will be amazed at the vibration a device has to withstand just in the boot (trunk) of a
2
When you machine a material some of the machined material resides on the tool itself. Hence if you machine
titanium one morning and then stainless steel in the afternoon you may impart some titanium on the workpiece -
hence contamination is possible.
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