Biomedical Engineering Reference
In-Depth Information
human tissue derived therapies that do not fit pre-existing categories
(Faulkner et al., 2003).
For adult stem cell therapies, the most pertinent issues are new
biological devices regulations that have been developed in some
places to regulate human cell and tissue derived products. As
marketable products not subject to the usual transplantation
protocols that might apply to whole organs, stem cell derived
therapies represent a challenge for regulators. In the EU, for instance,
concerns were raised as to whether human tissue and cell based
therapies could be regulated under the existing rules regarding
medical products and devices (Faulkner et al., 2003). Given that
human tissue and cell based therapies are, strictly speaking, neither
products nor devices but something in between, new sets of
regulations have been or are being put into place to address this new
class of products in the EU, the US and Australia.
3.2.3 Workforceandeducation
Adequate human resources are another key factor for developing
innovation systems that are able to generate quality scientific and
translational outcomes. Shaped by the strength of the knowledge
base on which it draws, successful innovation requires a highly
skilled workforce (Patel and Pavitt, 1994). The concept of 'human
capital' has been applied to measuring the effect of human resources
on innovative activity, where human capital here refers to an
'… individual's knowledge and abilities that allow for changes in
action and economic growth' (Coleman, 1988, cited in Dakhli and
De Clercq, 2004). There are different types of human capital,
including expertise at the firm, industry and individual level
(Dakhli and De Clercq, 2004). Overall though, higher numbers of
individuals with higher education and training in a community will
translate into a range of benefits for the community, including
economic growth (Dakhli and De Clercq, 2004).
Focus on the quality of education and training leading to economic
growth is arguably not a recent phenomenon, but dates back to the
Industrial Revolution in Britain and the birth of modern economics
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