Developing Your Product Design Specification - Medical Device Design: Innovation from Concept to Market - page 79

Table 5.1: An Example of the Customer Section in a PDS

Section 1: Customer

Number Comment Source

1.1 Color: OR theater staff

Theater staff requested it not to be
black as this is common and causes
confusion between components of
various companies.

1.2 Color: Central cleaning and sterilization

staff

Central sterilization requested that the
color be resilient enough to cope with
the latest washing regime. Lots of “older”
devices tend to lose surface color using
newer washing machines.

1.3 Color: OR surgical staff

Surgical staff really like the plain surfaces
to be shiny, but not so shiny as to cause
reflections from the OR theater lighting.

compatibility). The important thing is that you conduct a thorough review to find out which
regulations, standards, and guidelines your device must adhere to. Don't forget that there are
different standards for the same thing in certain countries so just doing something to a British
Standard does not mean automatic correlation to an American ASTM standard. Standards may
well be expensive items but, as we will see later, you have little excuse not to refer to them.

This is also the section where you may wish to include any requirements for instructions for
use and languages. You will also need to include labeling requirements.

You should have made an estimate of the classification of your device; this may well
change as your design progresses but the higher the classification the more rigorous the
design process. Hence it is better to start at the right level than to try and increase your
rigor part way through!

In Table 5.2 you will notice a comment called the standards review. It is worthwhile to conduct
a review of standards to find which are applicable (and those that are not) and to write a brief
document so that the specification can be brief but also supported by a report of depth.

5.3.1.3 Technical
As you learn more about the problem you will start to think of your own criteria - these are
classed as “technical” (some people call this functional requirements but it matters not). For
example, will the device's power supply be 110V or 240V? You will also start to understand
any loading the device may be subjected to. This is your opportunity to use your experience
to start to lay down the technical boundaries to the design space.