Elaine Gemmell, head of regulatory affairs at InnoScot Health, discusses what the new strategy means for the future of regulation and bringing new innovations to the market.
Martin Shields
Elaine Gemmell from InnoScot Health © Martin Shields
The UK government recently announced its first-ever medical technology strategy to ensure that our healthcare system can reliably access safe, effective, and innovative medical technologies, helping to deliver the best possible outcomes for the NHS and its patients.
The key aims of the strategy will be to boost the supply of modern equipment and technologies to the UK, in turn better equipping our NHS in a range of areas including faster diagnosis and treatment, while helping to tackle growing demand and mounting pressures on its workforce.
It is expected that the MedTech strategy will align specifically with wider government priorities such as maximising post-EU exit opportunities by, in its own words, “building our own regulatory regime for medical devices to improve patient safety, increase transparency, and promote innovation.”
The UK’s current regulatory framework is based on legacy European legislation that does not fully address the advances in technology, so the ambitions published in the new strategy are to be welcomed, particularly if they succeed in their further aims of encouraging innovative research, attracting investment to the UK economy, and creating fresh jobs.
To see that regulation is now acknowledged and recognised by the UK government as an integral part of bringing innovative medical technologies to the market is certainly positive.
It is progressive also that, in formalising the UK’s MedTech strategy, the government has laid the groundwork for reacting faster to required changes in regulation. Technology is changing very quickly, and regulation will be required to keep up.
Nevertheless, it must be acknowledged that the strategy represents more of a tentative step in the right direction, rather than the significant leap forward that many were hoping for.
It could have, for instance, gone further in addressing areas such as funding for SMEs and the wider industry at this crucial time and should have provided further clarity on identifying solutions to Brexit-related barriers.
At the same time, its publication must still of course be welcomed, and it cannot be understated just how important it is that the government recognises the importance of accelerating the adoption of proven innovation for a wide spectrum of benefits.
The new strategy is also timely. Regulation is an expansive area and building networks and successful collaborations across the sector is pivotal to this work. With key collaborations between the NHS, the National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare products Regulatory Agency (MHRA), there’s a clear opportunity to build on the Life Sciences Vision and create better services for patients across the UK.
The medical device industry saw unprecedented growth over the course of the pandemic and regulators were required to become far more flexible against the backdrop of fast-changing collaboration-led advances in science and technology.
That momentum must now be maintained during the post-pandemic recovery period and extended beyond it too. An onus is therefore on the government to help realise that.
From my own innovation-focused point of view, I believe that a strong understanding of regulatory compliance must be closely intertwined in the early development process when attempting to harness the true potential of new ideas.
Innovators must be supported in their grassroots understanding of what is required of them from a compliance point of view to ensure that good practice is inherent in product development strategies. In turn, the UK government must follow through on its pledge to create better understanding and awareness of medtech needs.
InnoScot Health continues to closely monitor developments in medical device regulation, ensuring awareness and compliance with legal responsibilities, and supporting the design and development of products under an accredited regulatory framework.
As a formal partner of NHS Scotland, we believe that we have a unique role to play in encouraging and developing new ideas from its staff. The more the government can support healthcare innovation aims, the better for all.
