There are few industries that can lay claim to touching the lives of everyone, yet healthtech is one of them.
With more than half a million different products, we will all interact with healthtech, within our own home, GP surgeries, hospitals or care facilities.
The products, technologies and services are both varied and dynamic; from medical devices, including pacemakers, surgical instruments and infusion pumps, and diagnostic tools, such as tests for infectious disease and MRI scanners, to emerging digitally enabled technologies, robotics and artificial intelligence (AI).
Healthtech is integral to the delivery of modern healthcare, enabling clinicians to provide improved patient outcomes in a safe and effective manner for the NHS.
As the largest employer within UK life sciences, this diverse industry is made up of 127,400 people working across 3,860 businesses, who collectively generate a turnover of £24 billion.
Careful regulation of healthtech is crucial
Healthtech products are highly regulated. To enter the market, they must demonstrate robust quality, safety and performance attributes that clearly prove their benefit outweighs the risk involved in their use. They are then continually monitored during their life cycle to ensure their long-term safety.
The iterative nature of the way such products are developed, and their potential to be truly disruptive to care pathways, means that a unique, nimble approach to approval and introduction into the NHS is needed.
Regulation has balanced risk and benefit and has led to the introduction of technologies that many of us now take for granted, such as joint replacements. The collection of high-quality data has been crucial in monitoring their safety performance, with initiatives like the National Joint Registry demonstrating how useful data collection systems can be.
Registries enable both industry and the clinical community to collaborate positively via an agreed framework, monitoring and assessing the performance of devices in a real-world setting.
In ensuring the continued safety of all healthtech products, registries are likely to be a prominent feature of future healthcare discussions and the healthtech industry looks forward to supporting such efforts.
How Brexit will impact healthtech
How this work fits into the wider regulatory framework is also important. The UK currently belongs to a European-wide system, which will end when the post-Brexit transition period concludes on December 31, 2020.
In line with the government’s desire to develop a more sovereign regulatory regime, there are opportunities to consider other potential processes in the long term.
Data compatibility with the European system would make sense, as a wider population pool significantly helps to monitor safety trends. That said, a more bespoke system could also enable greater consistency with international requirements, mirroring a trend towards global harmonisation of regulations.
Interactive, patient-focused regulations can also support emerging technologies such as AI, where systems continue to learn and refine once they are in clinical use and collecting new data. This is an opportunity for the UK to work towards and excel in.
Well-crafted regulations can ensure both continued patient safety and the demands of future technology-led healthcare delivery. The UK has the chance to be a global leader in this vital work.
For us to succeed, it is important to continue this public discourse about the balance of risk and benefits associated with the medical treatments from which so many of us benefit.
