The UK's New Medtech Strategy, Explained
Medical device businesses face a whirlwind of change covering the EU and UK. Commercialising medical devices in these regions means navigating multifaceted challenges, legal and beyond. Here's our overview of what you need to know.
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.
The Need for a Medtech Strategy
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.
Collaboration is Key
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.
Priority Areas of the Strategy
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):
- Making supply chains more robust.
- Transforming pathways to market so they are more coherent and co-ordinated.
- Introducing "enablers" into the system, supported by clear data, metrics, and engagement mechanisms.
- Identifying specific problems affecting key parts of the sector.
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.
Implications and Actions for Medical Device Businesses
The priority areas give a useful prompt to medical device businesses to:
- Review supply chain contracts. Whether you are looking upstream or downstream, there are contractual mechanisms and approaches that can help strengthen the supply chain.
- Collaborate to increase the chances and speed of access. Ensure in every collaboration that you protect the confidential nature of information being shared with and generated by collaborators and negotiate commercial rights or options covering any important outputs.
- Assess the source and required use of all relevant datasets, and identify any legal blocks to accessing, disclosing and exploiting them for your business purposes.