Invention Pathway

Invention

The creation stage of the pathway, where regulations need to be considered. Key stakeholders should also be identified, and engaged as early as possible to aid in product development.

Questions

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Have you sought advice on clinical and non-clinical testing design such as usability testing, patient reported outcomes, and cost effectiveness?

Relevance:Devices and Diagnostics

Have you engaged with external stakeholders including MHRA, NICE, patient advocacy groups (e.g. charities) and providers?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you identified suitable laboratory space?

Relevance:PharmaceuticalDevices and Diagnostics

What class of device or diagnostic is your product?

Relevance:Devices and Diagnostics

Have you applied to MHRA for clinical trials authorisation, HRA for ethics approval and NHS trusts for R&D approval?

Relevance:Pharmaceutical

Have you set up early interactions with regulators for scientific advice that can include approaches to product development, trial design?

Relevance:Pharmaceutical

Have you had early interactions with health technology assessors for early dialogue on evidence and reimbursement requirements?

Relevance:Pharmaceutical

Have you consulted with NOCRI (NIHR Office for Clinical Research Infrastructure) to ensure required evidence for key patient outcomes and clinical endpoints are embedded within trial design?

Relevance:Pharmaceutical

Have you considered early commercial considerations of full clinical development including formulation and presentation, frequency and patient outcomes (including funding options and sources for Phase III)

Relevance:Pharmaceutical

Have you confirmed the user requirements, test value proposition and the willingness to pay?

Relevance:Digital

Have you investigated whether the product will need to connect to personal health and care data in external databases? If so consult European Commission Policies

Relevance:Digital

Have you tested the product with any systems with which it might need to interact with and considered product security and protection of personal data?

Relevance:Digital

Have you identified suitable office space?

Relevance:Digital

Would your product be classed as a device or diagnostic?

Relevance:Digital

Have you gained feedback on the type of evidence required to support your proposition?

Relevance:Digital
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