Have you consulted NHS-wide and CCG priorities to see whether your device addresses an unmet need?
Have you identified the potential end user and buyer?
Have you determined the potential demand?
Have you identified competitive devices?
Have you consulted NHS healthcare practitioners to understand the current care pathway and how your device might impact this?
Have you identified patient needs through patient advocacy groups, charities and patient online platforms?
Have you considered data and privacy regulations?
Have you identified what type of patent is required and which locations could be covered (e.g. UK or international)?
Have you identified possible future clinical champions to involve in development and uptake of your product?
Have you considered the business requirements for companies selling to the NHS?
Have you considered funding and commercialisation routes?
Have you identified competitive products?
Have you consulted NHS healthcare practitioners to understand the current care pathway?
How do the system and patient needs align to the product mechanism of action?
Are you using Good Laboratory Practice (GLP)?
Do you have a target product profile that sets out the objectives of the R&D programme?
Have you conducted freedom to operate searches to establish around your invention and whether there is any intellectual property that could impact on your ability to commercialise the product?
Have you considered the opportunities around the Patent Box and tax benefits for the commercialisation of intellectual property in the UK?
Have you conducted freedom to operate searches to establish around your invention and whether there is any intellectual property that could impact on your ability to commercialise the product? Have you considered possible research exemptions around the Bolar provision and the clinical studies on new technologies?
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