Biomedical Engineering Reference
In-Depth Information
competences listed for each of the fields of expertise above. It is thus not surprising
to find teams will be based on the above listed competences, in some cases
complemented by others with specific expertise.
One should notice that the only reason the development team roster above does
not include clinical staff and medical doctors is because this discussion assumes
the team is working cooperatively in close collaboration with those professionals,
following the development approaches listed in §3.1.
3.3
Understanding Wants and Needs
On the earlier stages of the development process, methods such as Ethnographic
Research and Voice of the Costumer can be employed to assess and understand user
wants and user needs. These methods can help translating the 'needs and wants'
of the user into product requirements and features. If the project is planned and
implemented following a user-centered approach, identifying the best methods to
be used for this purpose should not be a problem.
3.4
Product Design Specifications (PDS)
Pugh is one of the key authors dealing with this issue in depth [
9
]. He compiled
a comprehensive list of types of specifications, in a wide range of aspects of the
product development process. In this work, namely in §4, we analyze and classify
the PDS, based on Pugh's list, which we believe helps in selecting specifications for
a particular project. A better understanding of specifications and their role on the
product development process is required, particularly in the current trend of faster
obsolescence and increasing complexity of products [
10
].
The team will have to define a set of PDS at the early laboratory development
stage. However, this will only be a partial PDS, since: (a) the team does not have
sufficient understanding of the problem and sufficient definition of the solution to
set some of the specifications at this stage, and (b) there is no need to establish
specifications that will not affect the final output of the laboratory development
process.
During the laboratory development stage, the key PDS to set are those that have
a direct impact on the selection of concepts and solutions, selection of technologies
(such as a communication standard), or usability. This is shown schematically in
Fig.
3
.
In Fig.
3
, PDS are represented with respect to when they are set along the
development process, considering two large stages: laboratory development and
industrial productification. A bold PDS border implies a primary PDS, whereas
dashed lines imply secondary PDS. Also, some PDS are shown stretching between
