The clinical diagnostic market represents a unique opportunity for the
introduction of biosensors on a widespread commercial basis. To date,
however, very few successful biosensors have been launched in this fi
eld or any other, despite many promising ideas. The need for biosensor
s in this field must be analyzed more critically, to assess in which d
irection the developing biosensor technology can be most effectively a
imed and which areas need a more focused approach from basic research
in bioelectronics. The diagnostics market is already a highly competit
ive field; from an industrial perspective, some of the critical issues
that need to be taken into consideration when evaluating biosensor pr
ojects are: costs per test, regulatory requirements, quality control,
instrumentation design, and test parameter selection.