Biomedical Engineering Reference
In-Depth Information
1
Introduction
As products are becoming increasingly complex, the product design and
development (PDD) processes are also evolving into collaborative multidisciplinary
team processes. This creates new challenges, both for product development, but also
in project management. In the case of medical devices, this is further complicated
by rigorous specifications and regulatory requirements [ 1 ], as well as the fact that
the development process requires strong interaction with multiple individuals, with
the concept of end-user depending on the specific device. It is this important to
understand how the PDD process can be planned for and managed in the case
of medical devices, whether they are a single biometric device or a complex
information coordination system [ 2 ]. This chapter follows previous studies on
product design specifications [ 3 ], wireless networks for health monitoring [ 4 ],
evaluation of vital signs monitoring systems [ 5 ], communication platforms for
medical data [ 6 ], embedded microelectronics [ 7 ], and performance evaluation of
ZigBee networks [ 8 ].
The first section describes the life cycle of novel medical devices in the current
context of increased complexity and performance demands.
The second section focuses on the laboratory development stage, with the goal of
obtaining a fully functional product, although typically not optimized for production
and not sufficiently competitive for the market. The actors and their respective roles
are described, namely in the framework of user-centered design, with emphasis on
the development team. In fact, for a successful outcome, a plethora of different
people have to become involved in the project.
It is also important to establish how to get from user wants and needs to partial
product design specifications (PDS). These need to be understood by people from
different areas, requiring agile and effective communication among team members.
The PDS are partial due to the fact that many specifications only need to be defined
(and in fact, can only be defined due to insufficient knowledge) at the industrial
productification stage.
Some specifications must even be jointly specified by team members of different
expertise. Thus, an analysis is provided in the third section on the multidisciplinary
integration within the development team and communication between this team and
the different other actors that are essential for a successful product development
process.
In large projects, and particularly when multidisciplinary teams are involved, the
role of coordination becomes pivotal, and it is very important to understand some
of the characteristics of how that can be effectively achieved. This is the goal of
Sect. 14.4 .
Section 14.5 describes a survey conducted with several people involved in
medical devices development projects. These individuals were selected in order
to cover the different profiles that are established in Sect. 14.3 (researchers,
practitioners, managers). Although the number of surveyed professionals is small,
the survey provides some interesting information on their different perspectives.
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