Abstract
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.
Highlights
The results showed that 78% of the companies did indicate they would have staff available, where necessary, to produce a submission to the NICE Evaluation Pathway (EP) Programme for Medical Technologies
Due to the multinational market for medical devices and the significant presence and contribution of small and medium enterprises (SMEs) within this innovation landscape, it is imperative that NICE engage constructively with SMEs to ensure their active involvement in the new EP programme
NICE need to acknowledge and address, where possible, the actual and perceived barriers observed by manufacturers to ensure manufacturers see submission to the EP programme as a viable and beneficial exercise
Summary
Competing interests The authors have no competing interests to declare. All articles were originally commissioned by NICE from independent. External Assessment Centres (EACs) to address areas of interest to the Medical Technologies. Evaluation Programme (MTEP, originally known as Evaluation Pathways EP). The EACs were engaged under a contract to NICE
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