Biomedical Engineering Reference
In-Depth Information
Fig. 7
Results regarding the suggested timing for involvement of the different profiles in the
laboratory-stage product development process for medical devices
However, the results follow expectations, namely that doctors, nurses, and health-
care facilities managers/administrators are those whose opinion will be critical when
a decision is made regarding taking the project to the next level.
Finally, people were asked to indicate when along the development process
(still considering only laboratory-stage development), each of the identified profiles
should be involved in the project. The results are shown in Fig.
7
.
Based on the individual input from all those inquired, the average timing and
the respective standard deviation were calculated, for each of the profiles previously
identified. Those values are represented in Fig.
7
. In this figure, the bottom line of
the plot corresponds to people being involved in the project from its very beginning.
Conversely, the line at the top indicates a profile that should be involved in the
project only after some preliminary development, typically after a first prototype
is built or, at least, after a conceptual solution has been designed but not yet
implemented. Thus, the higher we move on the vertical scale, the later should be
the involvement.
It is important to emphasize again that these results have no statistical signifi-
cance, nor do they attempt to be representative of all medical device development
processes, which can vary tremendously in terms of complexity, technical level,
scope, and goals.
The opinions of those inquired were relatively consensual in that highly technical
researchers must become involved at the earliest possible time, and that doctors and
nurses should become involved earlier than patients. However, it was suggested that
some basic grinding be done before they are involved. Also, decision makers, such
as hospital administrators, should be involved only after some preliminary work has
been done.
