References 167
in product designation. The successful completion of design, development, and
testing stages mentioned above set the tone for the remainder of the process.
Table 7.5 summarizes some important aspects of biocompatibility and biofunction-
ality within the pre-FDA submission process which should be addressed.
MEMS technological advances rooted within the semiconductor industry have
opened the road to the development of BioMEMS for drug delivery applications
which target critical clinical needs such as diabetes, vascular disease, and cancer.
Indeed, the desire of developing a treatment solution which would restore the life
of patients suffering of diabetes or vascular disease, as well as those battling cancer,
has motivated engineers, biologists, and physicians to put forth a concerted effort
through advancing purely industrial technologies to clinical viability.
The development of many materials intended for clinical applications has
found its origin in the industrial field, materials created without a biological
application in mind. As these materials enter the realm of intended clinical
application, selected for their flexibility of processing, mechanical properties or
mechano-active/electro-chemical aspect, the questions of impact on the host re-
sponse (biocompatibility) and of in situ functionality (biofunctionality) become
The emergence of the bionanotechnology, at which level fundamental biology
is defined, advances the micro-scale to a nano-level. The nano-world relates to that
of the extracellular matrix and its components, which defines the realm of tissue
engineering and advances the concept of tissue regeneration. The natural progres-
sion from BioMEMS to BioNEMS (Bio-Nano-ElectroMechanical Systems) is taking
place today. The bionanotechnology brings together multiple approaches, materi-
als, and systems all directed towards the understanding, control, and construction
of molecular structures exhibiting new useful properties and functions. It is the
hope of the interdisciplinary scientific community that bionanotechnology will
integrate these properties and functions within the local biological environment
leading the effort towards advanced regenerative therapies.
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Santini J. T., Jr, Richards A. C., Scheidt R. A., Cima M. J., and Langer R. S., Microchip
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