Market access for drugs is a relatively well-established pathway, from pre-clinical drug discovery and development, through first-in-human studies, Phase II or III randomised control trials, submission to regulatory bodies, reimbursement processes and finally post-launch marketing activities. On the other hand, market access for devices, diagnostics, digital technologies and all of the many variations and permutations therein is much more opaque. There are no clearly defined pathways for market access, beyond the regulatory requirements, which can be as limited as self-certification. On top of that, there is asymmetry of information for many developers, who do not recognise the need for a market access strategy because they are not familiar with health technology assessment (HTA). Trying to help companies to navigate this landscape can be difficult, as some may be resistant even to the idea that regulation will not automatically grant market access.
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