Concept Pathway

Concept

This is the “early idea” stage, where identification of unmet clinical needs and early clinical and patient engagement is key to shaping a successful product that will deliver patient and clinical benefits.

Considerations

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The main benefits of early dialogue for companies is to boost their understanding around requirements for approval and relevant evidence for the payer, allowing a company to make strategic decisions around product development

Relevance:Devices and DiagnosticsDigital

Feedback from stakeholders can be used to develop the best possible evidence for reimbursement and build the business case

Relevance:Devices and DiagnosticsDigital

At the earliest design stage it is important to consider whether the technology will address an unmet need in the NHS

Relevance:Devices and DiagnosticsDigital

Consider the NHS England Five Year Forward View for the national perspective or consult local CCG plans or Sustainability and Transformation Plans (STP) for regional perspectives

Relevance:Devices and DiagnosticsDigital

Patient views should be considered and patient groups and charities can provide this insight

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Consider whether the technology is going to be cost-effective for the NHS by carry out economic modelling early on

Relevance:Devices and DiagnosticsDigital

Consider the impact on the patient pathway and patient outcomes

Relevance:Devices and DiagnosticsDigital

Consider other requirements along the pathway, such as financial requirements of companies selling to the NHS (e.g. credit rating, published accounts)

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Consider involving patients in the specification stage to ensure relevance of the final product and will highlight any accessibility issues early (usability and human factors)

Relevance:Devices and Diagnostics

During the drug discovery process, scientists conduct basic research in order to discover new candidate medications. The aim of this stage is to demonstrate that there is a biological activity that has relevance for disease states and broadly test early safety

Relevance:Pharmaceutical

Interaction with external bodies is not required at this stage (unless filing a patent) but early conversations are possible around trial design for subsequent stages

Relevance:Pharmaceutical

A patent application protects the invention, whether it be for the active agent, medical use, method of manufacture, or formulation, behind any findings found during this stage and can be done at any time

Relevance:Pharmaceutical

Consider involving patients in the specification stage to ensure relevance of the final product and will highlight any accessibility issues early, especially if you are designing a patient facing app

Relevance:Digital
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