Biomedical Engineering Reference
In-Depth Information
Planning and laboratory development
Industrial productification and production
Competition
Processes
Packing
Political &
social implic.
Time scale
Quality and
reliability
Manufacturing
facility
Shelf life
(storage)
Weight
Maintenance
Shipping
Size
Customer
Company
constraints
Performance
Aesthetics,
appearance &
finish
Target
product cost
Market
constraints
Life in service
Installation
Product life span
Materials
Standards &
specifications
Quantity
Ergonomics
Testing
Safety
Documentation
Environment
Legal
Disposal
Patents
Fig. 3
Setting product design specifications at different development process stages. See text for
interpretation and discussion
phases, which implies they are either: (1) set in the first stage and revised in the
second, or (2) preliminarily considered in the first stage, but only fully defined in
the second stage.
As an example, while ergonomics is important at an early stage, since it will come
into play in concept selection and in the validation of the conceptual solution with
end-users, aesthetics and finish can only be specified when materials, manufacturing
processes, and cost are being defined.
Note that although the assessment in Fig.
3
categorizes PDS as being of primary
or secondary importance in the specific framework of medical devices, this is
quite subjective and dependent on the specific product. It also does not mean
the secondary PDS do not require considerable attention. The assessment was
essentially based on personal interpretation of current trends in development of
medical devices from the analysis of multiple recent and ongoing projects in the
area [
11
].
From the analysis of Fig.
3
, one can state that the majority of what were labeled
the most important PDS are set during the first stage of development, even though
a little over half of them have to be revised in the second stage. Conversely,
only a couple of the most important PDS are set in the second stage. It is also
