The NICE Medical Technologies Evaluation Programme (MTEP): manufacturer submission challenges

The purpose of this report was to explore and describe the challenges that healthcare sector manufacturers face when producing a submission to the NICE Evaluation Pathway (EP) Programme for medical technologies. The EP Programme was developed to evaluate new and innovative medical technologies to inform adoption of efficient and cost effective devices and diagnostics in the NHS. The premise was to produce recommendations based on a similar process currently used for pharmaceutical products. A submission requires manufacturers to complete a data capture template collating high quality clinical and cost effectiveness evidence for their device. This includes indicating how the device integrates into current NHS clinical pathways and how it performs in relation to current best practice. The time scale for completion of a submission is an approximated 6 weeks. Particular consideration was given to small and medium enterprises (SMEs), and availability and access to resources and skills. A consultation process was undertaken to ascertain the opinion of small, medium and large manufacturers in the healthcare sector who could potentially submit an application to the EP programme. The results of this process would highlight any real or perceived barriers identified by manufacturers that could prevent them from submitting to the new EP programme. The EP programme was renamed after preparation of this report to the Medical Technologies Evaluation Programme (MTEP), and details are available here: http://www.nice.org.uk/mt. Methods