General Considerations for the Development of Biomedical Devices - Advanced Design and Manufacturing Technologies for Biomedical Devices - page 23

adhere to the specifi c standards if end product safety is to be maximised. The
offi cial approval process for these devices also adds to the overall complexity of
their development.
• Human issues - These are linked to the particular complexity of the design pro-
cess for these products which require multidisciplinary teams with experts from
the different branches of science, particularly, medicine, engineering, biology,
chemistry and physics, among others, but which can lead to specifi c communica-
tion or coordination problems. On the other hand, it is important to point out that
developing a new device should emerge as a result of a real human need, a factor
that will be examined more closely further on.

The main additional issues to be taken into account when setting out to develop
a new medical device are explained in the following subsections. Reference will
also be made to the systematic methodology design stages explained previously,
together with refl ections on how the different issues infl uence these stages.

2.2.2 The Importance of a Relevant Medical Need

New developments and innovations in medicine and especially in the fi eld of medi-
cal device design usually stem from a problem-related need, and then, a technologi-
cal solution is found to solve the problem and satisfy the need (Kuklick 2006 ).
It is true that on some occasions a new technology or material can bring novel
diagnostic or therapeutic solutions to concrete problems, but these technologically
motivated products (instead of medically) only have an economic or social impact
on rare occasions.
Thus, most companies and technology centres given over to the design of medi-
cal devices, as well as more effective devices, are based on the application of effi -
cient technologies for resolving very specifi c clinical or surgical needs. The
approach of studying new technologies and examining any possible applications by
searching out medical needs is more linked to scientifi c research projects than with
product development, which means that the results are not materialised in the form
of commercial products.
However, both approaches have their own advantages and are perfectly valid
depending on what the objective is. So, when designing a product, it is usually more
effective to start out from a need and look for a technology to solve the problem.
Although, if it is wished to promote scientifi c progress the option of developing a
new technology and attempting to apply it to solve the needs of many varied sectors
probably makes more sense.
Therefore, this handbook looks to both approaches. It shows the development of
medical devices based on the use of novel technologies and materials, whose study
and subsequent development is motivated by real medical needs requiring a techno-
logical solution.