Medtech Early Technical Assessment (META) Tool

Benefits of using the META Tool

Using the META Tool will help you:

• understand the evidence that payers, commissioners and investors need
• understand what demonstrates value for patients and the healthcare system
• increase your understanding of the implications of any gaps in your current evidence base or the evidence you are planning to collect
• prioritise investment in your product's development strategy
• develop value claims for a health technology assessment (HTA), for example, at NICE
• understand evidence requirements through a selection of educational resources
• find out about local, regional or national support that is available to help you generate the necessary evidence to support your product's claims.

Is the META Tool right for me?

• The tool is designed to support the developers of medical devices, diagnostics and digital health technologies (DHT) or apps.
• It can be used at any stage of development, from early stage ideas through to sense checking whether you have all the evidence you need to demonstrate the value of your product to NICE or another HTA body/payer.
• The META Tool can be used by small companies, large companies, or an individual developer.
• You can go through the process as many times as you need, either with the same product or different products.
• If you have already engaged with NICE, going through the process can help you understand the evidence required for a successful NICE evaluation.

How the service works

1. Create your META tool account or sign in through the home page to access the tool.
2. Select the organisation you believe will most appropriately facilitate your META consultation

   You can choose from a range of facilitating organisations with different areas of expertise, so you can select the one that best meets your needs. The organisations currently listed here have a licence to use the META tool and all the facilitators have been fully trained by NICE.

3. Complete a short online form which collects general and summary product information.
4. Request a call back to discuss the META tool process with your chosen facilitating organisation
5. Make your payment.

   The payment process will be specific to the organisation you select as your facilitating organisation.

6. Complete and submit a secure online synopsis form for your product

   You will need to submit details about your product, the evidence for the product you have collected to date and your current and future development plans. The sections in the form cover a wide range of topics relevant to product development including:

   • Health Technology Assessment requirements
   • defining and understanding healthcare system benefits
   • clinical and economic evidence generation relevant to HTA organisations and payers

There are separate forms for medical devices and diagnostics. Both forms cover technologies that have digital elements.

7. The Facilitation

   Your facilitator will review your submission. This will be followed by a meeting to discuss the different sections of the tool together and the key issues that have arisen in your development plans. The consultation can be done in person, by video link or on the telephone.

   The length and depth of this facilitation session will depend on the organisation you have chosen to work with.

8. The META Report

   Your facilitator will send you a report which will:

   • summarise potential additional evidence requirements needed to support your product's value claims
   • provide options for any potential next steps
   • highlight areas where you should consider doing further work to generate evidence in order to demonstrate the product's value to the healthcare system.

   Some facilitating organisations may offer further services to assist you with obtaining the additional evidence needed. Please discuss the options available with your facilitating organisation.

Who provides the service?

NICE currently licenses the tool to the organisations listed below. Each of these organisations has received training from NICE on how to use the META Tool to support an evidence gap analysis. Each organisation has different areas of expertise and you can select any of them to work with you, facilitate your session and write the report for your product. For an initial discussion about whether the META tool is right for you or to find out more about a particular organisation, please use the contact details below to get in touch with a licensed organisation.

Frequently asked questions