Will the clinical testing design provide enough evidence for the value proposition?
Do patient reported outcomes show the product addresses the patient needs originally identified in the pathway?
Are you generating evidence for the business case and value proposition for all stakeholders (clinical and non-clinical e.g. procurement)?
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)?
Have you confirmed the European directive requirements for the product?
Have you conducted a conformity assessment either for self-assessment or to be used as part of an assessment by a Notified Body?
Are relevant clinical trials authorisation (MHRA), ethics approval (HRA) and R&D approval (NHS Trusts) in place?
Have you continued to interact with regulators and HTAs for scientific and regulatory advice, especially in advance of preparing for regulatory submission?
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)
Have you considered contacting NIHR Clinical Research Network for free services and support tools to deliver high quality research?
Have you ensured proactive safety management is used?
Have you confirmed the European directive requirements for the product as some digital health technologies may be classed as medical devices?
Have you considered the health economic implications around the new product and established a process for gathering health economic data through clinical trial design
Is your product eligible for review and fast-tracking under the early access to medicines scheme