Biomedical Engineering Reference
In-Depth Information
Laboratory development
Development team
Biomedical
engineering
Materials
engineering
Electronic
engineering
Design
Social sciences
Computer
science
Project Leader
(technical & scientific
coordination)
Decision
makers
Technicians
Medical doctors
Market analyist
Communication
and media
advisor
Patients
Nurses
Marketing
End-users
Fig. 2
Typical actors involved in the laboratory-stage product development cycle of novel medical
devices
On the other side, we have end-users (various healthcare professionals and
patients), marketing professionals, and decision makers (e.g. health provider facili-
ties administrators):
•
Medical doctors. They are the key interface between scientific research and field
practice. Thus, they must be an integral part of the development, from concept
development and selection, setting PDS (including technical and non-technical
requirements), and product validation (including field trials). Their opinions
will be collected by decision makers and thus they must find added value in
the new products compared to previous solutions (if they exist). Their level of
involvement and contribution to the project will naturally affect their opinion of
the product.
•
Nurses. Very often they will be the ones using the device. Even if not, they
will be responsible for one of the following: setting it up, making it available to
doctors, or giving it to patients. Their role is pivotal and their opinions should be
collected from early development stages. It is important for them to validate the
device.
