In Silico ,In Vitro and In Vivo Testing of Biodevices - Advanced Design and Manufacturing Technologies for Biomedical Devices - page 282

As already explained, systematic validations throughout the whole development
process, by using simulations and computer-aided engineering resources for in
silico testing, rapid prototypes with increasing level of detail for in vitro trials and
(only when working principles and safety have been verifi ed) in vivo trials with
animal models, are essential for reaching the preproduction stage.
In this chapter, we have introduced the different kinds of procedures used for
testing biodevices, providing examples of in silico, in vitro and in vivo testing and
trying to detail some novel resources for more adequate validations, from work-
benches and automated test systems to physical biomimetic models and virtual real-
ity (VR) haptic devices.
Some commercial systems from relevant enterprises in their respective sectors
have been described, as a help for researchers seeking novel, improved and secure
ways of probing their biodevices and medical appliances, without directly resorting
to the use of animal models.
Again it is important to highlight that before carrying out any in vivo trials, as
working with animals is a privilege and should be taken very seriously, exhaustive
in silico and in vitro testing is necessary and, if adequately performed, leads to
fewer in vivo trials needed. In addition, biocompatibility of the biodevice has to be
adequately assessed, not only with the in vivo trials in animal models in perspective,
but as it will provide also necessary information required for the clinical trials and
fi nal production. Of course evaluating the biocompatibility of a device is aimed at
protecting patient safety.
Important advices can also be obtained by consulting the most relevant related
standards, which have been also discussed. It is necessary to highlight again the
importance of multidisciplinary teams in projects linked to the development of
novel biodevices as, also for the different kinds of trials, abilities from physicians,
surgeons, engineers and scientists are needed.
This chapter is directly linked to the proposal for structured development meth-
odology treated in Chap. 17 , which incorporates some of the knowledge acquired
along the handbook, in order to modify the systematic development methodologies
used in conventional product development, so as to adapt them to the special require-
ments linked to biodevices.

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