The main benefits of early dialogue for companies is to boost their understanding around requirements for approval and relevant evidence for the payer, allowing a company to make strategic decisions around product development
Feedback from stakeholders can be used to develop the best possible evidence for reimbursement and build the business case
At the earliest design stage it is important to consider whether the technology will address an unmet need in the NHS
Consider the NHS England Five Year Forward View for the national perspective or consult local CCG plans or Sustainability and Transformation Plans (STP) for regional perspectives
Patient views should be considered and patient groups and charities can provide this insight
Consider whether the technology is going to be cost-effective for the NHS by carry out economic modelling early on
Consider the impact on the patient pathway and patient outcomes
Consider other requirements along the pathway, such as financial requirements of companies selling to the NHS (e.g. credit rating, published accounts)
Consider involving patients in the specification stage to ensure relevance of the final product and will highlight any accessibility issues early (usability and human factors)
During the drug discovery process, scientists conduct basic research in order to discover new candidate medications. The aim of this stage is to demonstrate that there is a biological activity that has relevance for disease states and broadly test early safety
Interaction with external bodies is not required at this stage (unless filing a patent) but early conversations are possible around trial design for subsequent stages
A patent application protects the invention, whether it be for the active agent, medical use, method of manufacture, or formulation, behind any findings found during this stage and can be done at any time
Consider involving patients in the specification stage to ensure relevance of the final product and will highlight any accessibility issues early, especially if you are designing a patient facing app
Comments are closed.