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.

Questions

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Have you consulted NHS-wide and CCG priorities to see whether your device addresses an unmet need?

Relevance:Devices and DiagnosticsDigital

Have you identified the potential end user and buyer?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you determined the potential demand?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you identified competitive devices?

Relevance:Devices and DiagnosticsDigital

Have you consulted NHS healthcare practitioners to understand the current care pathway and how your device might impact this?

Relevance:Devices and DiagnosticsDigital

Have you identified patient needs through patient advocacy groups, charities and patient online platforms?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you considered data and privacy regulations?

Relevance:Devices and DiagnosticsDigital

Have you identified what type of patent is required and which locations could be covered (e.g. UK or international)?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you identified possible future clinical champions to involve in development and uptake of your product?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you considered the business requirements for companies selling to the NHS?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you considered funding and commercialisation routes?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you identified competitive products?

Relevance:Pharmaceutical

Have you consulted NHS healthcare practitioners to understand the current care pathway?

Relevance:Pharmaceutical

How do the system and patient needs align to the product mechanism of action?

Relevance:Pharmaceutical

Are you using Good Laboratory Practice (GLP)?

Relevance:Pharmaceutical

Do you have a target product profile that sets out the objectives of the R&D programme?

Relevance:Pharmaceutical

Have you conducted freedom to operate searches to establish around your invention and whether there is any intellectual property that could impact on your ability to commercialise the product?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you considered the opportunities around the Patent Box and tax benefits for the commercialisation of intellectual property in the UK?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you conducted freedom to operate searches to establish around your invention and whether there is any intellectual property that could impact on your ability to commercialise the product? Have you considered possible research exemptions around the Bolar provision and the clinical studies on new technologies?

Relevance:Pharmaceutical
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