Case Study: Wearable Systems - Developing Biomedical Devices: Design, Innovation and Protection - page 65

In fact, the next component of the system is electronics, which can be divided
into the analogue front-end for signal sensing and pre-processing, or for the con-
ditioning circuits of the micro-actuators, and the digital part for control and data
pre-processing.
Finally the last element is related to output signal/information and this is
done through two integrated layers: the first one is the second physical Human-
Machine-Interface, i.e. buttons, display, LEDs, icons and any other kind of inter-
face commands; the second layer is related in particular to the communication
facilities which the electronics is equipped with, which include the firmware to
pre-process data and the communication transceiver, where several options could
be adopted: from mobile GSM/UMTS device, to satellite modules, from stand-
ard or dedicated ISM radio chipset, to commercial Bluetooth/WiFi embedded or
integrated radio, up to ZigBee (particularly interesting to build up distributed body
sensors networks) or Wireless USB options.
Therefore it is easy to understand that for continuity of care in a social-oriented
and no more hospital-centered service, WBS can become strategic and offer clini-
cal tools such as market development. Hence the research and industrial interest in
WBS is huge.
This opened an enormous rush to strategic IPR in this field. In the last decade,
about 600 patent applications were issued worldwide [ 4 ].
4.2 Research in Wearable Biomedical Systems
Human health is one of the issues that has always driven research and innova-
tion, but this process is often done in single sectors, and only after some time and
efforts the real integration between disciplines was started [ 1 ]. The same biomedi-
cal technologies are a paradigmatic example and in these ones it is particularly
true that there are devices with high technological content but whose usability is
often critical even for very experienced users and poorly studied from the point of
view of the comfort of the patient. This means to adopt the most common technol-
ogy-driven approach for innovation.
Today, ergonomics in healthcare cannot be delayed any longer: high qual-
ity new devices are needed to provide care and a safe and effective treatment to
patients, as well as to ensure comfort, health and safety for any user (clinical or
not, such as relatives).
Thus we must turn to a user-driven innovation approach: it is mandatory (and
also the law is going to introduce this requirement for the quality certification
of new devices in the next two years) to correctly identify user needs and trans-
late them/incorporate them into the design of the product/environment/interface/
service as an essential element of this success. In fact, these health systems are
almost always used by many different actors, such as health professionals, phy-
sicians, patients and their families. This leads to great difficulties in the design,