Regulatory inefficiencies and “unworkable” NHS tendering requirements are causing delays in innovation, according to the Association of British HealthTech Industries’ annual business survey.
The ABHI highlights that, for the third year in a row, challenges for health technology companies have grown.
Challenges
These challenges centre around regulatory uncertainty for half of the industry – something which the UK Government will hope can be addressed by the recently announced Regulatory Innovation Office which Steve Lee, diagnostics and digital regulation director at the ABHI described as a “key step” towards reform.
The ABHI wants the office, along with the Medicines and Healthcare products Regulatory Agency, to conduct a rapid review of the system.
Also in the report, more than a third (35%) of companies estimate that the time taken from idea conception to regulatory approval is three-to-five years – the highest proportion. A similar amount (31%) believe it also takes around three-to-five years from regulatory approval to full adoption in the UK.
"UK HealthTech is at a crossroads. Regulatory uncertainties and NHS challenges are repeated hurdles that are driving companies, and consequently their technologies, to more receptive markets abroad,” said CEO at the ABHI, Peter Ellingworth.
Three in 10 companies are also not bidding on NHS tenders due to requirements that they deem are singularly focused on unit price, rather than the total value achieved across the clinical pathway.
The ABHI also highlights the NHS’s carbon reduction requirements not having clear guidance and support measures, as well as rising costs (including the proposed MHRA hike) as having a compounding impact on this.
Reasons for optimism
Despite the ongoing challenges, more than three in 10 organisations are planning on expanding their R&D and manufacturing footprint in the UK, implying confidence in future opportunities.
Organisations are also enthused about the proposed solutions to challenges, such as the MHRA’s international recognition framework which is favoured by four times as many companies than any other initiative.
Ellingworth continued: “There is immense potential if we navigate these challenges wisely, and it is in the interest of the NHS and the patients that our industry serves to correct these trends. Immediate and prompt action is needed.
“The Government's renewed focus is promising, and with strategic investments and clear policies, we can cement the UK's position as a global hub for HealthTech."
Rahul Kapoor, director of HealthTech at the Centre for Process Innovation, which collaborated with the ABHI on the report, added: “To ensure the sector remains dynamic and exciting, we must provide further support and focus on key areas such as regulatory improvements, NHS procurement processes, and sustainability initiatives.
“Furthermore, better communication across the industry facilitated through leadership groups to drill down into specific challenges that can be solved through public-private partnerships would be highly beneficial. This is especially linked to the critical need for more funding to accelerate innovation, which will help grow the UK HealthTech ecosystem as a global hub.”
Image credit: iStock
