On Monday, 3 July 2017, the scientific advice service within the National Institute for health and Care Excellence (NICE) launched its Medtech Early Technology Assessment (META) Tool.
The META Tool is an online service that provides developers of medical devices, diagnostics, digital health interventions, and medical apps with a framework to help them identify potential gaps in the available evidence, and prepare for discussions with investors, health technology assessment organisations (including NICE itself), and payers.
META allows a developer to sign up for the service online and, after paying a fee, to complete a structured questionnaire (the synopsis) providing information and data relevant to the development of the product. The questionnaire includes details about the product, the evidence collected to date, and the current and future development plans. It will also include health technology assessment questions with the aim of generating the evidence needed to show the product is clinically and cost effective. Following submission of the questionnaire, the product will be allocated to a trained “facilitator” from an organisation of the company’s choice, which is licensed to use the META Tool. The facilitator will meet with the developer and discuss any gaps identified in the product development plans and recommended steps to get the product to market. The steps may include advice as to clinical studies, partnering with regulatory consultants, advice on the information required to pitch to investors, and knowledge of commissioning within the health service. Finally, a concise META report will be produced summarising the issues identified by the facilitator during the meeting, and possible steps to be considered in order to address these. The process usually takes around four weeks.
This process is aimed at helping small- and mid-sized developer companies to understand the level of evidence needed to show a product’s value to payers, and ultimately to speed up time to access to market. The advantage for NICE is an awareness and understanding of upcoming Medtech products.
The META Tool can be used once or more, at any stage of development—including very early concept, post-regulatory approval, or even once the product is placed on the market—in order to obtain assistance in understanding which purchasers may require the product and how they may use it.
NICE’s initial user testing of the META Tool has been positive. The advice received by manufacturers has assisted them to prepare effectively for consideration of their products by payers by ensuring that the value proposition has been appropriately defined and allowing them to direct limited resources so that the relevant evidence is available.