Biomedical Engineering Reference
In-Depth Information
The extent of communication between the teams intervening in those two
stages;
•
Agility of the transfer process;
•
Ability to retain members of the first stage team in the second stage team.
•
After the industrial productification stage, come all other stages of a product life
cycle, such as distribution, end-of-life handling, etc., undoubtedly important, but
outside the scope of this chapter. Obviously, these later stages may have a large
impact into decisions made for the development of subsequent versions of the
product or future related products.
2.2
Focus of This Study
This work focuses on the first development stage, conducted by a research team, in
cooperation with different clinical professionals, pursuing a fully functional, albeit
laboratory-state, prototype.
3
The Laboratory Development Process
Only within the scope of laboratory development, there is much to understand
regarding the different actors involved and what their role is in the process of going
from the market needs to product concepts and subsequently product specifications.
3.1
Actors and Roles
One of the key features of current development practices in the field of medical
devices is the involvement of health professionals from the start. This type of
collaborative development, following widespread approaches such as living labs,
translational research, or the most traditional sub-contracting the advice of expert
healthcare professionals, is currently regarded as most effective and followed by the
major companies in the field.
Independently of the degree of interaction between the development team and
the end-users, these two main groups are vital elements of the process, as shown in
Fig.
2
.
Thus, on one side, we have the development team, responsible for the scientific
development and technical implementation of the prototype solution.
For most medical devices, development teams have to incorporate researchers
from a variety of fields, such as electronic engineering, computer science, biomed-
ical engineering, materials engineering, design, and social sciences. The formation
and inner working of these teams is further explored in §3.2.
