Biomedical Engineering Reference
In-Depth Information
Finally, in Sect. 14.6 , a case-study is succinctly described, where several different
areas of expertise were brought together in a multidisciplinary team, working close
together with different healthcare professionals, resulting in a health support system
that includes biometric devices, communication networks, and information systems
technology.
2
Life Cycle of Novel Products
Developing new products is a complex process, and multiple methodologies have
been proposed over the years by different authors on how to approach this sys-
tematically. However, a major obstacle is the highly variable nature of the process.
In the specific case of medical devices, new products usually take considerable
time before reaching the market, not only due to the development stage, but also
certification, setting up distribution channels, and many other necessary steps.
Despite the wide range of possibilities, in most cases there are two main phases
within the development process.
2.1
Main Phases
Medical devices are typically developed either by:
Companies within the scope of their business plan;
Research teams at Universities or R&D Centers within the scope of their ongoing
research activities on healthcare or a specific research project.
These two cases may appear very different at first sight. However, in both cases
there are, almost inevitably, two different development stages; see Fig. 1 .Thefirst
stage results in a fully functional device but not optimized to be market competitive.
A second stage is required, where many specifications and product features are
revised, and several aspects which could (or had to) be left open are defined.
The difference between these two stages being conducted wholly within a single
company or the first stage in a research unit and the second in a company (either
through patenting or through a spin-off or a start-up) pertains essentially to:
Fig. 1
Stages in the life cycle of novel medical devices
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