| What to consider | Why is it important? |
|---|---|
| Value proposition structure | This will really help your audience (including buyers and decision-makers) to understand the opportunity you are bringing to them. |
| Intellectual property | Through every stage of your innovation’s development, you will need to consider protecting your idea with intellectual property (IP). |
Your guide to innovation in the NHS
This guide has been created to make it easier and faster for you to bring high-impact innovations into the NHS.
It is for people who need support with a health innovation and want to have it adopted into the NHS. You could be at the very early stages of development or may have already started developing your health innovation idea and want to have it adopted by NHS services.
This guide contains detailed information on:
- developing your innovation
- protecting your innovation
- regulations you will need to know and comply with
We hope that this information will save you time, money and help you focus on the right approach for your innovation.
The guide has been developed by the Accelerated Access Collaborative. This is a collaboration between patient groups, government bodies, industry and NHS bodies. We’ve also asked experienced innovators.
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| What to consider | Why is it important? |
|---|---|
| Identify a need and market value | Before investing significant time and effort in developing an innovation for healthcare, you should first ask yourself the question: Is my innovation really needed? |
| Market research | You should do market research to determine the demand and need for your innovation. You should budget for this stage, as it is an integral part of your strategy to succeed. |
| Finding patients and users for testing and development | Patient and Public Involvement (PPI) is the process of involving patients and public to help inform the design and improvement of an innovation or service. |
| Further information on patient and public involvement | Further information on patient and public involvement |
| Budget impact model | From your market research you can create a budget impact model. This tells both buyers and sellers what finance or other resources will be needed to bridge the gap between current and future steady-state, and what the impact of using the innovation will be on the services and an organisation's budget. |
| Integrating with NHS digital services and APIs | There are many existing NHS digital services and APIs available that can be integrated into your innovations. |
| What to consider | Why is it important? |
|---|---|
| Outcome measures | You will need to make a case for your innovation. This includes showcasing the outcomes from a variety of perspectives. |
| Quantitative experimental studies | Randomised control trials (RCTs) are the most rigorous approach to generating evidence. RCTs are experiments which show an outcome has occurred as a result of the innovation that has been implemented. |
| Quantitative observational studies | There are instances where an experimental study design is inappropriate, so observational studies are used instead. Observational studies do not have an experimental intervention. They rely on the observation of people without full randomisation. These types of studies can inform cause and effect associations and can be applied to existing data sets. |
| Qualitative studies | These types of study do not collect numerical data. They gather information on participants experiences, perceptions and behaviours. |
| Economic studies | Health economic studies investigate the cost of care. |
| Real world evidence | Real world data (RWD) is used to generate real world evidence (RWE). |
| Presenting evidence | When you are preparing to present your evidence, you will need to think about what is most important to each of your user groups. |
| Population, intervention, comparator and outcomes framework | The population, intervention, comparator and outcomes (PICO) framework helps the formulation and answering of clinical questions. It can also be used to help you structure and present your evidence. |
| Support services | Support services that can help you with evidence collection. |
| What to consider | Why is it important? |
|---|---|
| Medical devices | This guidance is specific to the provisions in Great Britain (England, Wales and Scotland). For information on how to comply with the legal requirements in Northern Ireland, please see the MHRA guidance for Northern Ireland. |
| General medical device and active implantable medical devices | If your product is a general medical device, or an active implantable device, you need to determine which class your device is in. Guidance is available from the MHRA. |
| In vitro diagnostic medical devices | In vitro diagnostic (IVD) medical devices are usually a reagent, calibrator, apparatus, equipment or system used in vitro to examine specimens such as blood, tissue and urine for a clinical purpose. |
| Registering your medical device with MHRA | Medical devices, including IVDs and custom-made devices, need to be registered with the MHRA after they have been certified by an UK approved body, an EU notified body, or where they have been self-certified, and prior to being put onto the UK market |
| Medicinal product | Get in touch with the MHRA as soon as possible if your innovation is a medicinal product. You can access support from MHRA through the NHS Innovation Service. You should also register new medicines with UK Pharmascan. This supports the uptake of new medicines into the NHS. They will help you understand what is required from the marketing authorisation process and how to comply with the Human Medicines Regulations 2012. |
| Surgical or invasive procedure | This applies to a new surgical technique or interventional procedure. |
| Digital healthcare technologies | Digital healthcare technologies (DHTs) are apps, software, artificial intelligence (AI) and digital platforms or services used for health or social care. Some DHTs are considered to be medical devices. |
| If you are unsure about your innovation category | If you are unsure which category your innovation falls under, read more regarding MHRA guidance. |
Commissioning and adoption
What you should know about the commissioning and adoption process in the NHS.| What to consider | Why is it important? |
|---|---|
| Health technology evaluation | Assessments of health technologies are carried out by regulatory organisations in England, Scotland and Wales. The evaluations carried out by these organisations are considered equivalent. |
| Delivering a net zero, sustainable, health service | The NHS in England is aiming to become a net zero carbon national health service in response to the profound and growing threat to health posed by climate change. This was embedded into the NHS through the Health and Care Act 2022. |
| Understanding the NHS | To understand more about the NHS and its ongoing development, read about the NHS Long Term Plan. Find out more about how the NHS works from The Kings Fund charity which works to improve health and care in England. |
| Commissioning in the NHS | The commissioning of services in the NHS changed with the introduction of integrated care systems (ICSs). ICSs are formed of an integrated care board (ICB) and an integrated care partnership (ICP). |
| Specialised commissioning | Specialised commissioning supports technologies and treatments for patients with rare and complex healthcare needs. |
| The Drug Tariff Part IX | The Drug Tariff is a monthly publication issued by NHS Prescription Services of the NHS Business Services Authority (NHSBSA). |
| Supporting the adoption of new innovations into the NHS | Innovators need to consider how their innovation will be made available and adopted and by NHS organisations and any support which healthcare providers might value when implementing a new technology. |
| Procurement frameworks | Procurement frameworks are agreements that enable NHS organisations to buy services and goods from one or more suppliers. |
| NHS Supply Chain | NHS Supply Chain’s role is to source, deliver and supply healthcare products, services and food for NHS trusts and healthcare organisations across England and Wales. |