Biomedical Engineering Reference
In-Depth Information
have been identified and their role discussed. The results from a small survey on
this topic were presented and discussed, in order to provide a very preliminary
assessment of the different perspectives held by different professionals who have
participated in several medical device development projects.
Clearly, there are major challenges in today's development of medical devices
that are related to the interface between all the different individuals involved in the
process. The high complexity of products requires larger and more multidisciplinary
teams. Effectively coordinating these efforts and managing the overall development
project is not trivial, and can be a vital aspect in achieving a successful project. But
this becomes increasingly problematic in the user-centered development framework
that characterizes modern product development. In addition to researchers and
technicians, end users (doctors, nurses, and even patients) are involved in early
development stages, creating new challenges.
Vital aspects which could not be discussed here include medical device certifica-
tion, and the different paradigms of developing medical devices within companies
or in a university setting. These issues, and some aspects which could not be tackled
in great depth, should be further explored in future work. An obvious example is
expanding considerably the number of surveyed individuals for the discussion of
Sect.
14.5
.
Acknowledgments
Colleagues involved in the case-study, namely Jose A. Afonso, Higino
Correia, Adriano Moreira, Joaquim Mendes, and students Helena Fernandez-L opez, Ana Carolina
Matos, Duarte Pereira, and Bruno Fernandes. Clinical and financial support for the case-study has
been provided by Grupo AMI - Assistencia Medica Integral (Casa de Sa ude de Guimaraes, SA),
Portugal, under the partnership established between this healthcare company and the University
of Minho. Financial support was also provided by the MIT-Portugal program. The author also
acknowledges the Foundation for Science and Technology, Lisbon, through the 3
ı
Quadro
Comunitario de Apoio, the POCTI and FEDER programs, and Project PEst-C/CTM/LA0025/2011.
References
1. Zenios S et al (2009) Biodesign: the process of innovating new medical technologies.
Cambridge University Press, Cambridge
2. Alexander K, Clarkson J, Bishop D, Fox S (2002) Good design practice for medical devices
and equipment: requirements capture. Engineering Design Centre. Cambridge University,
Cambridge
3. Simoes R, Sampaio AM (2009) Exceeding problem solving expectations in industrial design
under severely restricted specifications, IRF - integrity, reliability and failure: challenges and
opportunities, INEGI Editions, Porto, p 445, ISBN 978-972-8826-22-2
4. Fernandez-Lopez H, Afonso JA, Correia JH, Sim oes R (2010) HM4All: a vital signs
monitoring system based in spatially distributed zigBee networks. In: Proceedings of pervasive
health 2010 - 4th international conference on pervasive computing technologies for healthcare,
Munich, 22-25 Mar 2010
5. Fernandez-Lopez H, Macedo P, Afonso JA, Correia JA, Simoes R (2009) Extended health
visibility in the hospital environment. In: Biodevices 2009 - Second International Conference
on Biomedical Electronics and Devices, Porto, Portugal, 14-17 Jan 2009, pp 422
