Medtech Early Technical Assessment (META) Tool
The META tool is an affordable platform developed by NICE to help product developers understand what evidence is needed to make a convincing case to payers and commissioners for their technology.
What is the META tool?
The META Tool supports and informs a face to face discussion between you, the medical technology developer, and a trained adviser to identify the gaps in your product’s development and evidence generation plans. Completion of the online META Tool form and META process will help optimise your approach to addressing gaps in your development plans and in identifying the potential next steps to bring your product to market.
By using the META Tool you can develop an understanding of the level of evidence needed to show your product's value to the NHS. It can be used at any stage of development of your product.
It was developed by NICE in collaboration with Health Innovation Manchester, with their delivery partner TRUSTECH, and is also available through other relevant organisations under licence.
The META Tool process has 3 key steps:
Completion of an online form (synopsis)
The synopsis is a structured questionnaire that allows you to present information and data relevant to the development of your product. It also provides educational resources and links to other sources.
A meeting with a trained facilitator from your choice of organisation licensed to use the META Tool.
After reviewing your synopsis, the facilitator will meet with you to discuss any gaps identified in your product development plans.
Receipt of a META report.
The report will summarise the key issues identified by the facilitator during the meeting and the potential next steps that you should consider.
The process is flexible but usually takes about 6 weeks, depending on the facilitating organisation you choose and their availability.
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
- Create your META tool account or sign in through the home page to access the tool.
- 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.
- Complete a short online form which collects general and summary product information.
- Request a call back to discuss the META tool process with your chosen facilitating organisation
- Make your payment.
The payment process will be specific to the organisation you select as your facilitating organisation.
- 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
- 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.
- 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.
There are separate forms for medical devices and diagnostics. Both forms cover technologies that have digital elements.
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.
Email: info@deviceaccess.co.uk
Tel: 02380 118300
Since 2010, Device Access have successfully supported MedTech and Diagnostic companies through over 30 NICE evaluations, including Medtech Innovation Briefings (MIB), MedTech Guidance (MTG) Diagnostic Assessment (DAP) and interventional Procedures (IPG) guidance programmes.
Our services include:
Email: enquiries@healthtechenterprise.co.uk
Tel: +44 (0) 1223 422 422
Health Tech Enterprise is committed to supporting organisations working to improve people’s health through the development of technological and service innovations. Our healthtech consultancy services are designed to integrate seamlessly into our customers plan of work, no matter the stage of development, and are built upon twenty years of experience in delivering innovation support to industry, universities, and healthcare institutions in the UK and abroad.
As well as delivering the META-tool assessment on behalf of our clients we often work alongside them to fill the gaps in evidence the assessment may reveal; providing insights expertise and guidance to enable them to reduce the risks in reaching the market and take strategic decisions more effectively.
Specifically, we provide:
• Market Access support
• Market Insights
• Health Economic Analysis including NICE Health Technology Appraisal
• Carbon impact assessment
• Regulatory strategy road mapping and human factors analysis
• Advice on securing funding and investment
• IP and Commercialisation advice
• Real world evaluation assessment
• Training and Entrepreneurship workshops and mentoring
By combining this comprehensive range of services, with our collaborative approach we empower our clients with the tools and insights they need to bring their innovations to market while navigating the dynamic landscape of healthcare delivery, market needs, and competing technologies. With the aim of helping them to make an enduring impact on patients' lives and the healthcare industry.
Email: info@healthanalyticalsolutions.co.uk
Tel: 07957 295297
Health Analytical Solutions has over 5 years of experience supporting companies to understand & find solutions that improve their Market Access in the UK healthcare market.
This work has included:
Health Analytical Solutions has the expertise and experience to support your business advance access to the UK healthcare market.
Please feel free to get in touch to discuss how we might help you.
Email: lucie.burgess@helixdata.ai
Helix Data Innovation is a science impact accelerator, committed to helping innovators turn scientific breakthroughs into profitable ventures.
We provide expert advice to growth companies and research-intensive universities to launch, grow and scale early-stage ventures in health tech, med tech and deep tech. We’re a full-service boutique professional services firm, enabling our clients to develop and implement strategies for rapid and compliant market access, swift adoption and sustainable growth.
Email: scientificadvice@nice.org.uk
Tel: 0300 323 0140
Use of the META Tool with NICE Scientific Advice will help you:
Understand the evidence requirements for Health Technology Assessment; Develop an appropriate value proposition for your product; Identify the gaps in your evidence base for the claims being made for your product; Help identify next steps for the development of your product on the route to adoption into clinical practice
Email: eddie.tan@sehta.co.uk
South East Health Technologies Alliance (SEHTA) is a health technology network organisation, providing business support for the benefit of our members who represent health technology SMEs, health professionals, care providers and academia.
Founded in 2005 as an organisation to understand and meet the needs of small healthcare businesses, we are one of the largest networks of individuals from Academia, Business and Care/Clinicians (with over 1,400 members), with the purpose of improving the health and care of the citizens of the UK as well as increasing wealth. We do this by offering support on a one-to-one basis through our business support services and one-to-many through workshops, training and other events.
The SEHTA Team has carried out a number of bespoke work packages to our members to help develop:
• Market Understanding
• Value Proposition and Health Economics
• Market Access and Commercialisation Strategy
Through the use of the NICE META Tool, SEHTA can help companies that develop medical technologies or diagnostics to:
• Identify clinical and economic evidence gaps in their development of value proposition plans
• Explore different routes on how to generate evidence
• Assess the feasibility of further development
Email: MetaTool@AliraHealth.com
Tel: (+44) 7307 987136 or (+44) 7501 970 074
Alira Health provides a full spectrum of patient-centric data and tech-enabled services to accelerate innovation and deliver tomorrow’s standard of care. We have a global presence, including a London-based team with experience in Health Technology Assessment and Market Access at both the national and local level in the UK. Our experience in MedTech includes supporting assessments for NICE’s Medical Technologies Evaluation Programme and Diagnostics Assessment Programme.
Across our wide range of service offerings, we can support in every step of the product lifecycle. Building on the results of a META-tool assessment, we have capabilities to offer comprehensive support in:
- Regulatory Approvals
- Market Access and Reimbursement Support, from coding analysis to Health Technology Assessment submissions
- Health Economic Modelling and Outcomes Research
- Evidence Generation and Clinical Trial Design, including Real World Data collection and Statistical Analysis
- Value-Based Procurement and Sustainability Assessments
- Patient-Engagement
Email: info@healthtechnology.wales
Tel: +44 (0)29 2046 8947
Health Technology Wales (HTW) is a national body working to improve the quality of care in Wales through the identification, appraisal and adoption of non-medical technologies. One of HTW’s objectives is to support and nurture innovation and it aims to achieve this through its scientific advice function. Using the NICE META tool, HTW will:
- provide information and guidance to developers to increase awareness of health technology assessment processes,
- increase understanding of the clinical and economic evidence required to demonstrate that a new technology offers value to patients and healthcare systems,
- help to identify evidence gaps or other limitations in the product proposal.
Email: info@rtihs.org
Tel: +44 (0)161 447 6000
RTI Health Solutions is an independent, non-profit organisation whose UK-based team of medical device experts with previous experience at NICE are ready to guide you through the routes to market access in the NHS. Our primary objective is to provide the highest quality research and consulting throughout your product development lifecycle so that you—as well as regulators, payers, providers, and patients—can make informed decisions.
Our comprehensive approach to health economics and market access includes:
• NICE META assessment of the value proposition of your product
• Health economic modelling
• Health preference assessment studies
• Clinical trial design and real-world evidence generation
• Biostatistics
• Systematic literature reviews
• NICE health technology assessment preparation
Email: stuart@hecoanalytics.com
HecoAnalytics works with companies to develop a complete understanding of the disease area and pathway of interest with our team of highly experienced health economists and data scientists.
HecoAnalytics provides:
• web-based economic decision making tool that allows a company to make instant health economic assessment of their product portfolio and that allows for different scenario planning in response to new development, clinical or market data HecoAnalytics technology and approach is particularly relevant to the challenges of digital health.
• HecoNect that provides a secure interface for apps to upload behavioural or performance data onto the HecoAnalytics platform. Importantly, data are categorised without user identifiable reference for data security. The data itself is stored in semantically annotated NOSQL data stores that are then used by Web based economic modelling, machine learning and visualisation. Initially, app interventions can be monitored and evaluated against earlier economic assessment. Over time, data sets can be analysed to more accurately identify intervention opportunities as well as areas for additional app development.
• Initial assessments including facilitating the NICE META Tool.
Email: yhec@york.ac.uk
Tel: +44 (0)1904 323620
York Health Economics Consortium is a health economics consulting company owned by the University of York. It has around 60 members of staff and provides a range of services, including economic modelling, literature searching, systematic reviews, network meta-analyses, patient-reported outcomes, service review and applied research and training. YHEC’s clients include the NHS, NICE, local NHS Trusts, pharmaceutical and MedTech companies, digital health technology (DHT) companies as well as a range of organisations outside the health sector, including Local Authorities and the voluntary sector.
YHEC offers a range of national and international services to device and diagnostic companies, including DHTs, requiring health economic support for early detection, diagnosis or treatment interventions. Our expertise is of use to:
• Companies seeking national reimbursement via health technology assessment (HTA) agencies
• Those wanting to make an economic case to local decision makers
• Those aiming to demonstrate potential cost-effectiveness to in order to inform clinical study design, funding applications or price setting
YHEC is one of a group of Health Economics departments at York, which is the largest and most active group in the United Kingdom. It is the main consultancy provider of Health Economics expertise at York, combining rigorous research standards with efficient project delivery. As well as its own multidisciplinary staff, YHEC often draws on the specific expertise of staff in related academic departments.
Email: META@thenhsa.co.uk
Tel: +44 (0) 1524 944916
The Northern Health Science Alliance (NHSA) is the North of England’s health partnership, offering unparalleled access to the best of healthcare and life sciences in the region. The NHSA has delegated authority across 19 research-active NHS Trusts and universities, with Board approval to promote industry-research partnerships.
We are experts in understanding the health and life science landscape in the UK. Our Health Equity North (HEN) institute informs government health policy and publishes reports into the state of health in the region and our team has experience in delivering research, value proposition design, finding funding, and health technology assessments.
Using the META tool, we can assess your evidence base and value proposition for the NHS, preparing you for a potential NICE evaluation and to aid discussion with payers or commissioners.
With your final META report, the NHSA can offer additional support services and bespoke advice to help you formulate a plan to address any identified product or evidence development needs. We work closely with our member universities and NHS Trusts to match their needs and interests with emerging innovations, towards mutually beneficial referrals and prospective R&D partnerships with industry. This ranges from early scientific discovery, through translational clinical research and co-development, to partnering in real world evaluation studies, and supporting adoption and implementation. Our members and partners include multiple centres of excellence in R&D, NIHR infrastructure and other assets, including data and digital, horizon scanning, health economics, information services and more.
Email: info@mtechaccess.co.uk
Tel: +44 (0) 1869 222 490
We enable companies to bring healthcare interventions to patients, through successful partnerships in global market access and pricing, national reimbursement, and local value communication. With a highly experienced team, who have collectively supported over 170 UK and Ireland HTA submissions throughout their careers, we offer a full suite of HTA and medical technology commercialisation services, from strategy through to evidence generation, economic model development, dossier writing, and post-submission support, for medical technologies, diagnostics, and pharmaceuticals.
Through the META tool assessment, we will help you:
• Build a compelling narrative that presents the benefits that your product offers to patients and the healthcare system
• Identify gaps within the evidence package for your product, relevant to HTA evidence requirements
• Identify the next steps that are critical to the commercial success of your new product launch
Following the META tool assessment, our in-house experts are here to help with the next steps of your HTA journey. We can:
• Map out your route to market, by researching the market landscape, and then developing a bespoke launch strategy
• Develop a compelling value proposition that reflects the needs of payers, HTA agencies and other key decision makers
• Validate the principles and assumptions in your strategy with a global network of payers, clinicians and other affiliates, including over 100 contracted Associates working in the NHS
• Build robust (cost-effectiveness, cost-minimisation, cost-benefit, and budget impact) economic models that align with HTA standards and the latest technical methodologies, demonstrating the economic value of your product
• Synthesise the evidence you need to support your value proposition, with literature reviews (targeted or systematic) and statistical analyses
• Develop impactful dossiers for submission to the NICE Medical Technologies Evaluation Programme (MTEP) or Diagnostics Assessment Programme (DAP)
Frequently asked questions
The META tool has been designed to help all developers of medical technologies, both large and small. The META tool process helps Medtech companies and product developers understand the evidence requirements for NICE or other payers and the impact of the differences between regulatory and payer frameworks. This is intended to reduce the costs and risks associated with product development.
You can benefit from using the META tool at any stage of a product’s development. In the early stages it will help you understand the types of evidence that could be needed further down the development pathway, and guide efficient evidence collection. In the later stages it will act as a ‘gap analysis’ to sense check your readiness for a future health technology evaluation or to support discussions with payers and commissioners.
The service can be used on health technologies that have a CE or UKCA mark or are expected to obtain one in the foreseeable future. It is also suitable for advising on digital health technologies and interventions. It is generally not suitable for technologies that have no impact on patient care or health outcomes.
There is a description of the steps in the the META tool process on the ‘how the service works’ tab.
The online synopsis form has questions covering a broad range of topics so that the facilitator can fully understand your product and where it is in its development.
Areas covered include:
- information about your technology
- what it is indicated for (used to treat)
- what benefits it has for patients and for the wider healthcare system
- what clinical and economic data you have collected so far, and what evidence generation plans you have for the future.
This aims to help you to think about the issues that are important to payers and how their needs are different from the needs of regulators.
It can be filled in by one person, or by multiple users. It depends on the size of your company, the complexity of the clinical development pathway, and where you are in the stage of development of your product. The tool allows you to add additional people to your company's profile so that they can work on individual areas of expertise.
Yes. Once you have set up an account you can start multiple consultations either in parallel or in succession. However, each use of the META tool is for one product only. If you are developing more than one product, you will need to complete a separate synopsis for each product.
Yes. There is no restriction on how many times you can take the same product through the service. You may also benefit from using one or more of the other services offered by NICE Advice
Yes, you can go through the META tool process at any point in your product's development, either as an individual or through a company.
The process is flexible but usually takes about 4 weeks, depending on the facilitating organisation you choose and their availability.
The time it will take you to fill in the synopsis will also depend on where you are in the development process, how much evidence you have generated to date, and your level of understanding of the issues surrounding health technology assessment. It will also depend on whether you require external support to complete some sections (e.g. the section on economic evidence).
Your information can only be viewed by your chosen facilitating organisation and by NICE. Whilst the META tool is in the public beta phase of development, NICE will have access to your data for monitoring and development purposes only. Your information will be held on a secure server for a time period of 5 years after which time it will be deleted.
No - there is no obligation to act on any of the advice you receive.
No. The META Tool is designed to help you understand how robust your current and future development plans are. Going through the META tool process does not constitute a formal economic evaluation by NICE. While NICE has designed and maintains the tool, facilitating organisation licensees are not qualified to give advice on behalf of NICE and any products that go through a the facilitation process do not gain any form of accreditation as a result.
We are planning to update the META tool on an ongoing basis, throughout the beta phase and beyond. This is to ensure we provide companies with the most current resources and tools available, and to make sure that facilitating organisations have an up to date platform with which to work.
The fees charged by each facilitating organisation will vary. For example, they might offer the consultation as part of a bespoke service or within a larger package. We encourage you to explore options with them before choosing your facilitating organisation.
Please see the ‘Who provides the service?’ tab for the most up to date list of organisations who provide the META tool service.
NICE offers its own gap analysis service, underpinned by the META tool. The listed licensed organisations will offer their own version of this service until the end of 2024, from which point META tool consultations will be exclusively provided by NICE. The services provided by the different licensed organisations vary in cost and in areas of specialist expertise and so it is recommended that you explore available options to make the right choice for your particular needs.
It's important to note that if you use NICE as your facilitating organisation, the final report provided does not:
- give detailed step-by-step advice on exactly what to do to address the gaps in the evidence base for your technology
- assist you in drawing up an action plan
- provide traditional scientific advice on planned RCTs or other studies
- tell you how to price your product
- provide an evaluation of how good your technology is
- tell you whether the NHS will adopt your technology
If you are interested in scientific advice, please see our full range of services. Other facilitating organisations may provide some of the above services as part of their overall package.
If you experience any technical faults whilst using the META tool, please report any faults to the NICE enquiry handling team
Please note that this is for technical defaults within the META tool only. Please contact your facilitating organisation if you need support with clarifying any of the content or navigation through the tool.
- Contact us at niceadvice@nice.org.uk
META offers insights on evidence generation for Medtech products to support future engagement with:
NHS England
To support NHS commissioning decisions
NICE Health Technology Assessments
To inform Health Technology Assessment
Research organisations
To support interactioins with research organisations (E.g. NIHR, MRC)
Finance providers
To influence future development funding