Have you sought advice on clinical and non-clinical testing design such as usability testing, patient reported outcomes, and cost effectiveness?
Have you engaged with external stakeholders including MHRA, NICE, patient advocacy groups (e.g. charities) and providers?
Have you identified suitable laboratory space?
What class of device or diagnostic is your product?
Have you applied to MHRA for clinical trials authorisation, HRA for ethics approval and NHS trusts for R&D approval?
Have you set up early interactions with regulators for scientific advice that can include approaches to product development, trial design?
Have you had early interactions with health technology assessors for early dialogue on evidence and reimbursement requirements?
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?
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)
Have you confirmed the user requirements, test value proposition and the willingness to pay?
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
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?
Have you identified suitable office space?
Would your product be classed as a device or diagnostic?
Have you gained feedback on the type of evidence required to support your proposition?