Regulatory specialist, Elaine Gemmell, speaks to BBH about what the Government’s new Medical Technology Strategy means for the future of regulation and bringing new innovations to the market
Elaine Gemmell is head of regulatory affairs at InnoScot Health
The UK government recently announced its first-ever Medical Technology Strategy to ensure the 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 the 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 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’.
Speaking to BBH, Elaine Gemmell, head of regulatory affairs at InnoScot Health, said: “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
“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.
“And 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.”
However, she said 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,” she adds.
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
“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.”
And she said collaboration would be central to the strategy’s long-term success.
“Regulation is an expansive area and building networks and successful collaborations across the sector is pivotal to this work,” she added.
“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 is 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.
Innovators have to 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
“An onus is therefore on the Government to help realise that.”
Offering advice to MedTech companies, she said 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 have to 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,” she said.
“In turn, the UK Government must follow through on its pledge to create better understanding and awareness of MedTech needs.
“As a formal partner of NHS Scotland, InnoScot Health believes we have a unique role to play in encouraging and developing new ideas from our staff and the more the Government can support healthcare innovation aims, the better for all.”