If you are attempting to sell medical devices and health technology in the EU or the UK, you will have a tough time getting to grips with the changing laws and regulations. But the difficulties go significantly beyond the legal, which is just one piece of the puzzle.
According to the UK Government, the COVID-19 pandemic "highlighted the value and need to have a targeted, stand-alone medtech strategy". In the UK, we now have a strategy (published in February 2023). It's new, but at least we have one. In the opening section, it admits that "…[d]espite the importance of medtech to the health and care system, there has not, to date, been a central governmental approach" and then announces the bold ambition to "bring clarity to this complex landscape". Also, while commending the innovative nature of the sector, the strategy confirms what many businesses have been saying; in particular, that "the innovation frameworks can be difficult to navigate, with the majority supporting only one of the many steps in the route to market". In other words, there is some work to do to smooth the path to market.
The strategy also suggests that the solution to the long-term challenge requires an incremental collaborative approach. A call for collaboration is a common thread in life sciences strategy publications, and the reference to increments is a recognition that the significant changes required can't happen overnight.
The strategy compliments the UK regulatory and guidance bodies and points out, based on COVID-19 experience, that the route to market can be relatively fast. Then, bearing in mind the many existing initiatives in this area (such as the reform of UK regulation, the Accelerated Access Collaborative, and the hard work demanded by the Cumberlege report), the strategy focuses on four other priority areas, including (my summary):
Each of the four priority areas of the strategy is broken down into actions, and all of it is intended to move the UK towards the vision of the right product, at the right price, and in the right place.
The priority areas give a useful prompt to medical device businesses to: