The Design Process - Medical Device Design: Innovation from Concept to Market - page 29

Figure 3.3
The design iceberg.
underneath - all that lies under the water. Eventually your project will be that Ferrari, but you
must not forget all that lies under the water. Forget this simple fact and, just like the Titanic,
your whole design process, and your project, will sink - out of sight.
This chapter, and the subsequent chapters, will present design models and processes that
enable you to develop your own design process. It is important for you not to just copy from
the text; this will not help you or your company. You should use the following chapters as
guides to help you develop your own. Your processes need to fit your company, your discipline,
and your aspirations - if they do not then they are as useful to you as a “ chocolate fireguard.”3 .” 3
3.2 Design Models
There are several models of the design process. We shall address them here and put them
into the medical devices context. You must remember models change with the wind and,
unfortunately, with fashion. So what is an acceptable model today is out of favor tomorrow.
However, the fundamental design process is constant. We will examine these models to
ascertain the constants and then assimilate these into something we can shape and model to
suit our own interests and aspirations.
There are two main models for design in the texts. The first was developed by Pahl and
Beitz, the second by Pugh. They are both configured around engineering design. As we are
dealing with medical devices this is the most appropriate design philosophy to use. You may
ask why. Medical devices are products in their own right, be they software or hardware. At
the end of the day they have to be made; they have to be engineered - hence an engineering
design philosophy is the most appropriate. Later we shall see that it fits the requirements
3 Old English saying describing anything that is useless - other similar phrases include “like a fish needs a
bicycle.”