Prof Heneghans plenary and seminar discussed the key academic and clinical challenges in developing in vitro diagnostics.
The process of development, validation and adoption of new diagnostic technologies historically is recognised as being a lengthy process, and one that does not always meet the intended expectations. This experience contributes to the increasing focus on fast tracking the innovation process in healthcare, which is being developed in many healthcare systems.
It is also recognised that, on the one hand, investment in technology represents a significant proportion of healthcare spend, whilst on the other hand there is substantial evidence of emerging problems due to over requesting of investigations.
Innovation in healthcare results from a collaboration between clinicians, scientists, entrepreneurs and commercial organisations - as well as managers and policymakers in healthcare. Defining present standards of care and utilising new technology to redefine products and services will allow new best practices to be implemented and audited across healthcare systems.
To foster innovation there is a need to develop more effective ways of identifying diagnostic testing needs from different perspectives (patient/carer, clinicians, laboratory services, commissioners, industry) and develop an agreed set of evidence criteria, aimed at decision makers across Europe, whilst developing incentives for manufacturers to develop high quality evidence.