Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 87

5.3.1.9 Summary
It is important that you appreciate fully the value of a good PDS. While the above eight
sections have tried to demonstrate what a PDS contains, only the actual development of a full
PDS demonstrates the full beauty of its structure. We will produce one later in this chapter
as a case study; but before we do we need to look at where the information comes from. The
important thing to remember is that you should spend as much time as you think necessary
to produce a viable PDS, but also remember it is a living document and it can be modified as
your design develops.
5.4 Finding, Extracting, and Analyzing the Content
This section will look at the ways you can determine the content of the PDS. It is not split
into the PDS sections; each of the following items could supply information for any of them.
Also note it is applicable to any information sourcing throughout the whole design process.
Figure 5.4 illustrates a model that I call the data cloud and how it interacts with the procedure
for the development of a PDS. The concept of a data cloud is a good one: the sources are
numerous, they float around in the space around you, they are amorphous, and they are often
just out of reach. Your role, as the designer, is to attack all of these sources and determine
which aspects of each of the sources are relevant to your proposed design. Nearly all of them
will have some input, but some will be more direct than others. In the following sections I
will attempt to show you how to make sure that each of the individual voices in the cloud
influences your PDS.
5.4.1 Focus Groups
Focus groups are a collection of end-users or “stakeholders” 3 in a meeting place of suitable
standing. It is quite normal for your sales force to have identified end-users who are
sympathetic, free speakers and who do not bear grudges against specific disciplines. It is
also quite normal for you to have your own list. The basic premise of a focus group is to
bring a group of people together to discuss the issues around a topic of interest with a view
to determining the solution to a particular issue (or issues). You will almost certainly need
to consider the production of a non-disclosure agreement 4 to ensure that confidentiality is
ensured and maintained.
The basic goal of the focus group is to start the discussion concerning customer requirements.
Because the focus group is essentially a group of “friends,” they can be trusted to give you
3 Stakeholders are people directly concerned with your device who may not be end-users but who have defined
links to the discipline, use, purchase and, specification. They are not holders of shares in the company.
4 A non-disclosure agreement (NDA) is a legally binding document that is signed by all parties to ensure that
members of the focus group do not exploit what they have heard, nor share it with anyone else. If you do not
have an NDA you need one now!