Translational research is a core pillar of the ChromaDose i4i project. The consortium is fortunate to have expert in translational methodologies in the form of the NIHR London IVD MIC (Imperial College London). Across 5 intense days of collaboration, the ChromaDose technology development and translational research personnel set out to plan a series of work packages to tackle during the project, to aid the performance of the technology in a future health technology assessment, thereby expediting its translation into clinical and commercial settings.
The core goal of this activity is to define key evidence requirements needed for innovation market adoption and to understand a working framework in how such evidence can be shared by both translational and technical teams to develop a product that is truly fit for purpose. Initial familiarisation of the technology vision and information to date highlighted areas of missing evidence. Understanding resource availability both in terms of expert time and budget helped outline reasonable timelines over which the work could be conducted. The evidence requirements were assessed alongside best practice (POCKET criteria) and the general inclusions of a health tech assessment.
Identified work packages were classified as sprints (deliverables achievable across short and intense working) or phases (deliverables achieved over a longer period time through ad-hoc interaction). The core areas of evidence gathering identified include:
A usability engineering process.
Conducting stakeholder engagement (end-users, beneficiaries, regulators, methodologists and payers).
Analyse user scenarios, conduct hierarchical task analysis and evaluate associated risks.
Assess human factor and environmental considerations in technology implementation.
Health economic analysis to understand the cost effectiveness and budget impact of the innovation.
Gather complementary clinical evidence alongside for demonstration of clinical benefit.
Establish a market access strategy, including a pricing model and an appropriate route to market.
This exercise has delivered huge value to the ChromaDose project, as it has laid out a comprehensive map of research activities that once completed, shall support rapid adoption by both payer and end-user.