I have seen a well-known diagnostics company stumped as to why their shiny, new, commercially available diagnostic test has not been immediately lapped up by the NHS. It had proven clinical efficacy as well as health economics supporting the patient unmet need and potential cost savings. However, they had completely missed evaluating its clinical utility in its respective care pathway, as well as the reality of the actual patients it would impact.
Working with industry and the UK’s health research landscape for a decade has demonstrated to me that industry needs to consider clinical evaluation of new technology part of their market access strategy. By engaging with the NHS and the health research infrastructure in the UK to do this, they can guarantee the strongest case for adoption of technology by the UK and other international healthcare markets.
Post-Brexit the NHS remains the world’s largest single payer for healthcare and provides enormous potential for companies wanting to enter the global market. It also hosts organisations such as the National Institute for Care Excellence (NICE) which provides its desirable gold stamp of approval for new technology. As a result, the UK and the NHS is still prime territory for developing and validating new technology and a spring-board to markets further afield.
However, knowing exactly how to engage is hard and access points can be tricky to find, despite some core pieces of infrastructure in place to help bring innovation to the system. Companies will often approach me to support integrating new technology with the NHS too late in its development, where it is ready to ‘sell’ and consequently uptake is not as quick as first imagined.
The NHS is in desperate need of transformative technology, not just technology making up part of a clinical care pathway, but systems and processes which support service delivery and efficiency. Why are in-patient vital signs’ still taken down by nurses using pen and paper? It is a public sector organisation with limited resource and decisions around budget need to be rigorously appraised, but industry needs to support this as best it can. By including the healthcare system in the clinical validation process you are making the right connections early on, ensuring there is unmet need and so a route to procurement.
Clinical buy-in the essential precursor for integration of any new technology. With coordinated outreach across our member institutions, it is the first step the Northern Health Science Alliance (NHSA) takes in securing engagement with the healthcare system. The NHSA sits at the interface between the health research infrastructure in the North of England; supporting eight medical schools, eight large research active NHS Trusts and four AHSNs. As a single point of entry to this ecosystem, the NHSA is well placed to assist industry in finding the right institutions to evaluate their technology – and at various stages of its development.
With our large teaching hospitals bridged with their associated medical schools, they are able to provide translational research capabilities and are primed for partnering with industry. This is further supported by nationally recognised pieces of infrastructure funded by the Medical Research Council (MRC) and the National Institute for Health Research (NIHR), for example. Key opinion leaders and clinical investigators from our member institutions engage with industry partners through the NHSA and determine ways of evaluating the new technology in a meaningful way. This has often resulted in several institutions coming together as one and collaborating on a piece of technology with the industry partner, something the North of England is very content to do – perhaps more so than our Southern counterparts.
These multi-centre studies mean new technology is assessed in several intuitions at once, maximising the case for unmet need, as well as any outcomes being viewed as institutional preference. In this capacity, working with the NHSA and our 20 members can help establish inter-disciplinary consortiums to support the evaluation. This includes highly regarded health economic groups, NIHR infrastructure set-up to evaluate clinical validity and utility of new medical technology, and of course our four AHSNs who cover larger sub-regional footprints and can latterly support diffusion across their respective regions.
I have worked with large companies through to SMEs where this multi-centre approach has been valued and resulted in some interesting collaborations. One of the most developed is a Singaporean medical technology company, Biobot, who now have a multi-centre study about to begin with their automated prostate biopsy robot. This not only includes top urologists from two of our larger teaching hospitals, Leeds and Sheffield; but also robust economic modelling from a world-renowned health economics group based at the University of Sheffield, ScHARR. Supporting the collaboration is the Yorkshire & Humber Academic Health Science Network, who are able to ensure engagement with other regional centres post-evaluation. This strong consortium of centres and people mean the right type of evidence will be generated for eventual NICE approval, as well as NHS adoption.
There is a cost associated with this type of work, engagement with multiple institutions and pieces of infrastructure requires more resource. Although, where the financial investment is considered part of the development process and with the returns almost guaranteed to be fruitful, it is surely a smart way to look at establishing a technology in the healthcare market.
Having worked with industry, the NHS and academia for a number of years in this capacity, I urge companies to look at validation of technology and perhaps further iterative development within the NHS itself. As a result, the evaluation will include key components for NICE approval and adoption by healthcare systems worldwide. A win-win situation for everyone.