Many technology companies have changed their focus to help during the current crisis, so does this mean long-term changes to healthcare are on the horizon?
Since the coronavirus crisis (COVID-19) hit, the health technology sector has responded to a call from the UK government to help the effort to stop its spread.
As a result, one of the long-term effects of the pandemic could be that the healthcare system takes a new approach to how it approves new products, balancing speed of approval, resource allocation and safety considerations more effectively.
Over the past decade, the idea of early health technology assessment (HTA) has gained traction. This aims to consider the impact of a new product alongside its technical viability during development, rather than after the product has been fully developed. By capturing and incorporating clinical needs, acceptance and end-user preferences at an early stage, product design and development can be transformed. Better insight into the question of “how to make it work for users” helps ensure that the technology becomes a better fit with the clinical environment.
Over the past decade, the idea of early health technology assessment (HTA) has gained traction
There are many challenges in shifting HTA from a tool for resource allocation in healthcare – the prevailing use today – to one which supports development and commercialisation. Evidence for the impact of a novel product is usually scarce at the early stage of development, while uncertainties abound. Smaller technology developers are frequently unaware of HTA processes and lack resources to conduct them. Paradoxically, foregoing early assessment renders these vulnerable companies more prone to product failure.
Addressing the challenge
How to help innovative medical devices and diagnostic companies address this challenge has long exercised academics, policy makers and industry stakeholders.
Small health technology developers usually lack economic sophistication and do not understand the multi-dimensional and cross disciplinary evidence needs that reflect the complexity of healthcare systems and their innovation processes. Innovations often impact on a range of healthcare stakeholders, playing different roles in different organisations. They have diverse objectives, and so too are their evidence needs for decision-making about innovation adoption.
Small health technology developers usually lack economic sophistication
Supporting design and manufacturing decision-making at an early stage therefore requires tools that are far more dynamic and multi-faceted than those typical of mainstream HTAs. One approach is the Lean and Agile Multi-dimensional Process (LAMP), developed by researchers at Imperial College London.
This is designed to enable rapid cycles of evidence generation and synthesis at different stages in the product development journey, enabling incremental changes in product design, while simultaneously developing robust commercialisation and implementation strategies. It involves a multi-disciplinary approach to evidence generation, with a greater emphasis on qualitative tools (e.g. stakeholder analysis) and expert knowledge than found in more conventional quantitative modelling approaches. This helps to merge perspectives from the supply-side (the technology developer) and the demand-side (the healthcare adopter) in a way that is both transparent and actionable to both.
Since their inception over a decade ago, early HTAs have been used to gain insights into market uptake and technology design. Their popularity continues to rise among researchers and methodologists, yet early HTAs are frequently not implemented in practice. Technology developers lack awareness of them and the diverse range of tools and expertise required can be overwhelming even for methodologists.
LAMP offers a solution by providing tool for synthesising evidence, harmonising perspectives from key stakeholders and taking into account local contexts, in a way that is “lean” in its activities while “agile” in its operation. A freely available online version of LAMP will help improve access.
Creating and implementing innovative solutions to the short- and longer-term challenges healthcare systems are facing has never been more important. The need to tackle to the spread of COVID-19 should not only generate new medical technologies and new ways of organising health services. It should also stimulate new approaches to evidence gathering and regulation that help innovators in their struggles to bring their new ideas to market.
In the first part of this article we looked at whether the healthcare system can stomach the level of innovation now demanded of it.