Development Pathway

Development

Further refinement of the product is carried out, as well as evidence gathering for any regulations that will apply. Clinical effectiveness and business case data should also be considered at this stage.

Questions

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Will the clinical testing design provide enough evidence for the value proposition?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Do patient reported outcomes show the product addresses the patient needs originally identified in the pathway?

Relevance:Devices and DiagnosticsDigital

Are you generating evidence for the business case and value proposition for all stakeholders (clinical and non-clinical e.g. procurement)?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you considered the likelihood of outcomes-based payments or whether further testing might be required e.g. Real World Evidence (evaluation of clinical and cost effectiveness data gathered when the product has been adopted)?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you confirmed the European directive requirements for the product?

Relevance:Devices and DiagnosticsDigital

Have you conducted a conformity assessment either for self-assessment or to be used as part of an assessment by a Notified Body?

Relevance:Devices and DiagnosticsDigital

Are relevant clinical trials authorisation (MHRA), ethics approval (HRA) and R&D approval (NHS Trusts) in place?

Relevance:Pharmaceutical

Have you continued to interact with regulators and HTAs for scientific and regulatory advice, especially in advance of preparing for regulatory submission?

Relevance:Pharmaceutical

Have you ensured that data required for regulatory submission is in the correct format (e.g. using MHRA marketing authorisation pre-submission checklist or EMA equivalent)

Relevance:Pharmaceutical

Have you considered contacting NIHR Clinical Research Network for free services and support tools to deliver high quality research?

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Have you ensured proactive safety management is used?

Relevance:Pharmaceutical

Have you confirmed the European directive requirements for the product as some digital health technologies may be classed as medical devices?

Relevance:Digital

Have you considered the health economic implications around the new product and established a process for gathering health economic data through clinical trial design

Relevance:PharmaceuticalDevices and DiagnosticsDigital

Is your product eligible for review and fast-tracking under the early access to medicines scheme

Relevance:Pharmaceutical
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