Implementing Design Procedures - Medical Device Design: Innovation from Concept to Market - page 55

In reality, as Figure 4.1 illustrates, there are only three outcomes from an input: two outcomes
are a brand new device or a design modification/change. The third option, the trivial solution,
is that you decide not to follow up the need and abort the project. Hidden within this decision-
making process will be a risk analysis ; risk analysis is of paramount importance to the
medical devices designer and though it may not formally appear in a procedure it should be
assumed that it is undertaken .
It is important to see that the design process is input driven, as highlighted in Table 4.1 .
Where the inputs come from are up to you, but there are some that you have to cover. The
first is postmarket surveillance . Here your whole company is listening to your customers,
your specialist area, and scientists in your area. You will have a procedure in place that
enables your company to distill all of the information that comes in and will produce inputs
into your design process. The other main area you have to cover is vigilance (or complaints ).
Again, as a medical device manufacturer, you are required to have this procedure in place.
As a design input this is called preventative action and, again, it needs to be “procedurized,”
but it is one aspect that, hopefully, never gets utilized. The ultimate sanction is a product
recall - and we all can imagine the ramifications of that scenario! But on a positive note,
logging and analyzing complaints can result in design improvements and hence this will
almost always lead to a design change . One source of information you cannot afford to miss
is communication with the customer (the end-user); your links to your sales force are so
important. Do not fall into the trap of your sales team keeping information to themselves in a
“they are my contacts” way; you must use your sales team to get as much market intelligence
from the customer as possible. Often this will lead to design leads that you could never have
imagined. You should note that we have effectively covered the types of need we discussed in
previous chapters.
The next step is to develop a statement of need . This document should be approved and
signed off on the basis that it is a strategic decision. Do we want to go this way? Do we want
to make this change? Is it worth doing it? These are all the questions that you need to address.
Six Sigma uses the “ 5-Whys ” ( George et al., 2005 ): if you ask “Why?” five times you will,
nearly always, get to the answer you are looking for. In essence this is the opportunity for
the first risk assessment of your design. As stated earlier, once approved the design process
can only go two ways: it will either be a new product or it will be a design change. If it is not
approved it will come to a halt.
From here, you will see that two new procedures are required: a new product procedure and
a design modification procedure (we will explore these later). Both of these procedures will
incorporate the majority of the design process discussed in the previous chapter. Both will
result in an output: a design. However, the regulations state that output must be measured
against input. The two procedures will do this but it needs signing off. Hence there is a final
approval. Here we check that what should have been done has been done. Only then can
the device go into full production mode. If it fails there are two tracks: either the design