Informing the development of novel diagnostics & MedTech in the UK NHS
Research type
Research Study
Full title
Development of care pathways and expert elicitation to inform the development and deployment of novel diagnostics & MedTech devices in the UK NHS.
IRAS ID
344024
Contact name
Kile Green
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
The National Institute for Health Research (NIHR) HealthTech Research Centre (HRC) in Diagnostic and Technology Evaluation (DTE) is a member of the NIHR HealthTech Research Centre Network. The NIHR HRC DTE offers expertise in generating high quality evidence that demonstrates the potential value of medical technologies, with a particular focus on diagnostic tests. The HRC’s aim is to ensure that better diagnostics are delivered more quickly for the benefit of patients and the healthcare system.
Methodological work will focus around clinical themes with key unmet clinical need: (a) infection, (b) ageing and multiple long-term conditions, (c) precision medicine and rare diseases and (d) Mental Health, which the NIHR HRC DTE team are established as methodological leaders.
According to the British In Vitro Diagnostics Associated (BIVDA), diagnostic tests are used in approximately 70% of all clinical decisions, with diagnostic activities accounting for 85% of NHS clinical pathways. Diagnostic tests are essential for optimal patient care. As with new medicines, it is crucial that newly developed diagnostic tests are rigorously evaluated to ensure there is evidence that they are accurate, acceptable to patients and end users, cost-effective, manageable, and impactful in order to improve clinical outcomes.
This project will support early evidence generation within the NIHR HRC DTE’s clinical themes through stakeholder engagement with patients, clinicians, and NHS staff to better understand the patient care pathway, pinch-points and unmet needs in patient care, and the characteristics required of novel diagnostic tests and MedTech to improve patient care and management.
The elicitation process will capture the thoughts and opinions of patients, public, and care-givers to ensure new diagnostics are appropriate for use, acceptable to patients and clinical teams, and are developed with robust elicitation-based evidence at pace, for the benefit of patients and the NHS.REC name
Wales REC 6
REC reference
25/WA/0159
Date of REC Opinion
11 Jul 2025
REC opinion
Further Information Favourable Opinion