Postmarket Surveillance - Medical Device Design: Innovation from Concept to Market - page 295

1

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0

0 1 2 3 4 5 6 7

Ranked position

Figure 12.9
Example plot from data in Table 12.2 .

However, their real benefit comes as the first tranche of users when your device is released.
Rather than rushing headlong into a full launch, letting your KOLs and EAs have “first use”
can reveal end-user issues while they are in your control.

They also have a further use for you - they can provide the information required to produce
the key documents discussed in the previous chapter. Furthermore they are able to tell the
clinical community how to use your device in a clinical environment: it is highly unlikely
they would listen to you! Another of their uses is as leaders of your focus groups.

12.4.2 Focus Groups
We discussed focus groups when we discussed ideas generation. However they have further
benefits and that is to provide key developmental information for your products.

Many companies use focus groups to bring new products to the end-user community before
they are released. It is a good idea to do this in an environment that is as close to a clinical
environment as possible (or as close as possible to the real environment in which the
device is to be used). Hence if your device is to be used on a ward, try and do your initial
demonstration in an environment as close to a ward as possible. Then you should get your
end-users to use your device; and let them be as rough as they like. Make sure your device
doesn't let you down (as it could be embarrassing) - but also don't expect them to perform
somersaults; they will always find something!