20 YEARS IN HEALTH TECH
HealthTech: the changing landscape
How has the HealthTech sector evolved over the past 20 years – is the NHS still slow to adopt innovation, and how have events such as COVID and Brexit shaped the current landscape? Louise Frampton spoke to the Association for British HealthTech Industries to discover what has changed.
The Association for British HealthTech Industries (ABHI) works with industry and the healthcare system to improve the lives of patients and overcome barriers to people benefitting from medical technologies. Over the past 20 years, the organisation has witnessed some major changes in the sector, in terms of innovation and regulation, as well as across political, economic, and healthcare landscapes. So, how is the role of the ABHI changing to reflect these shifting priorities, challenges, and trends? Furthermore, how can we improve technology adoption, by removing barriers and bureaucracy, while addressing the changing demands of patients and the NHS? CSJ spoke to some of the ABHI’s leadership team to gain an insight…
Transformation
The ABHI was set up 34 years ago, initially with regulation in mind – including the need to demonstrate compliance with European directives. Regulation is still an important focus for the organisation, but its remit has become more ‘integrated’ and ‘holistic’ to reflect the increasing complexity of the issues facing the HealthTech sector. During this period, the organisation’s focus has widened to include: l Shaping how data and technology will transform healthcare and the lives of patients in the future.
l Working with the industry and the healthcare system to show the value of health technology.
l Informing regulation (as opposed to being reactive to regulation).
l Supporting sustainability. l Enabling a vision of an early and holistic diagnosis healthcare model.
l Creating a positive environment that encourages growth through international trade and SME support.
l Promoting equality, diversity and inclusion within the sector.
NOVEMBER 2022
“There are many issues that are interconnected; issues such as sustainability impinge on the supply of products, for example,” says Andrew Davies, ABHI’s digital health lead. “Everything is much more complex than it used to be…The only thing that hasn’t changed is that the NHS keeps changing.” However, he points out that COVID and Brexit have had the most significant impact on healthcare, over the past 20 years, and have fundamentally changed the political, economic and healthcare landscape. These two landmark events have also seen major changes to HealthTech regulation and the processes that surround it. Luella Trickett, ABHI’s director of value & access, explains that the whole industry went through major transformation in the lead up to the European Union Medical Device Regulation (MDR). “This transformation is now coming to an end, but we have the UK Conformity Assessed Mark (UKCA) that will also deliver
transformation from a regulatory perspective. It cuts across everything: what happens around sustainability; what you do with recycled materials and how you look at the circularity of medical equipment. But everything we do must have patient safety at the heart of it,” she comments. Phil Brown, ABHI’s director, regulatory and compliance, adds: “When the MDR first came out, you could tick box your way to regulatory compliance, but regulation has now become a business process. It is about keeping your product in the market because there is a need – regulation is just the facilitator. This is going to be increasingly the focus with the UKCA mark. “However, there needs to be urgent action on completing the necessary legislative processes such that we have a clear roadmap for the future, and align messages to potential investors. The current deadline of June 2023 for a fully operational UKCA process remains in legislation but the date is ever more unrealistic.”
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