Early technology review during prototype development and at proof of concept: the case for developing a sequential versus a single-stage approach to early evidence development for health technologies.

The effect of Early Technology Review (ETR) through early engagement with multiple stakeholders on strategic development for technologies at prototype development and proof of concept was examined through two generic case studies of relevant outcomes. In both examples, advice to companies could have significantly changed strategic direction to become more relevant to payers and clinical experts. In one instance, the advice was followed and resulted in an expedited first-in-human study and was considered for a second ETR to inform the proof-of-concept study. In the second example, it was reported that changes in strategic direction were being considered.These reports provide descriptive accounts of very early applications of the ETR process that now spans the entire preclinical trajectory. Had the second case study at proof of concept been able to benefit from this approach at the point of prototype development, it could have avoided the costs and research through earlier advice. This begs the question whether a sequential iterative approach to evidentiary multiple stakeholder advice across the technology life cycle may reduce risk and cost while benefitting from efficiencies of applying adaptive design.