How can the NHS be made more attractive for hosting commercial medical device studies? Insights from an NIHR industry engagement workshop
8 January 2018
Alex is a post-doctoral researcher in the Interdisciplinary Research in Health Sciences (IRIHS) group in Oxford University's Nuffield Department of Primary Care Health Sciences. He has a broad social science interest in medical innovation and health research policy. He tweets as @rushforthad
The recent NIHR industry event “Data, drugs, diagnostics and devices: promoting collaboration between industry and the NHS” brought together policy representatives, pharmaceutical and device company representatives, contract research organisations, administrators from NIHR support and funding programs, and clinical academics with a view to discussing how industry-NHS collaborations can be improved in the Oxfordshire and Thames Valley region and beyond.
The engagement day took place in Oxford and was a joint effort of two local components of the English health research policy landscape: NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Oxford and NIHR Clinical Research Network Thames Valley and South Midlands (CRN).
Whilst all could agree that supporting research in local NHS Trusts promises to improve health and wealth in the region, there was also recognition that the process of conducting clinical studies in primary and secondary care can often prove frustrating. Indeed, one of the most stimulating sessions of the day focussed on the obstacles faced in conducting medical device studies in the NHS.
The workshop enabled stakeholders from various contributing sectors to share experiences and troubleshoot for possible solutions, as well as generating feedback for Thames Valley CRN and CLAHRC Oxford on how they themselves could better support device studies in the local catchment area.
Attracting commercial device studies has been flagged as a key component in the new UK Life Science Industrial Strategy and NHS England’s Accelerated Access Review. According to one source, the global medical devices technology market was worth a whopping USD 483.65 billion in 2016 and is expected to reach USD 634.5 billion by 2021 (Market Data Forecast 2016).
Clearly one can see why hosting such studies is becoming an increasing priority for the NIHR, given their mission to improve the health and wealth of the nation by building-up the NHS’s research and development capacity.
So, what were the workshop’s main take home lessons about challenges of conducting commercially sponsored device research in the NHS and how might the NIHR research support infrastructure wish to respond?
The first task for participants was to consider why it might be considered desirable to conduct medical device research in the NHS in the first place.
Perhaps unsurprisingly, participants recognised that for patients to benefit from new medical technologies it is important to evaluate prospective products and ensure adequate quality and safety control. Furthermore, participants flagged the almost unique potential of the NHS in offering relevant populations on which to test devices. If devices are tested in the NHS and lead to strong evidence on effectiveness, this may also increase the chances of the self-same devices being adopted in the NHS down the line. Similarly, clinicians and GPs can learn about how to use devices in the course of participating in studies, thus potentially increasing “adopt-ability” of a product. Perhaps surprisingly, no groups mentioned wider economic arguments for promoting device studies in the UK.
Nonetheless, having reached broad agreements on many of the promises of using the NHS as a site for clinical research from both industry and NHS perspectives, the workshop participants were then challenged by the organisers to articulate major challenges in conducting device research in the NHS.
A device company representative stated that it was still common for studies to languish in the early stages – with contracts getting lost in the system, high turnover of Trust staff causing delays, and difficulties finding the right people to contact (especially in larger Trusts).
There may also be unintended consequences and unforeseen obstacles in efforts to promote the NHS as a hotbed of device studies, with the fear of commercial studies taking scarce resources away from other activities, for example, trials may require use of space or machines leading to delays in delivery of patient care (although some devices by contrast – like telemedicine – might free-up scarce clinical space).
Another potential challenge involves managing conflicts of interest, a logical consequence of policy calls to intensify clinicians’ involvement in device development, testing and use.
As well as focusing on NHS-specific problems, audience members also raised broader methodological challenges surrounding the evaluation of devices, as well as an increasingly stringent and complex regulatory environment (which may well be exacerbated further by Brexit).
The session ended with the organisers reminding the audience of the range of support and infrastructure services already offered by the NIHR (including free of charge checklists of questions to consider before commencing clinical studies in the NHS).
One of the ongoing challenges facing NIHR support services is to determine what problems it is possible to mitigate simply by making commercial actors more informed about requirements for conducting research in the NHS, and which problems by contrast are more intractable and cannot be mediated by the NIHR alone (for instance regulatory demands and lack of buy-in to research across the wider NHS). Thus, with budgets being increasingly stretched, extensive efforts must be made to ensure Trusts retain sufficient organisational slack and motivation to facilitate and attract research, prioritize areas of existing and potential research strength, and cultivate strong relationships with the NIHR and industry.
Finally, one clear and powerful message fed back from workshop participants to the organisers was the need to ensure effective signposting and advertising of the range of services the NIHR health research infrastructure currently provides. This is an obvious – but essential – step needed in order for the extensive health research infrastructure built-up by the NIHR over the last decade to deliver on its promise and make the UK an attractive place to carry-out commercial device research in the post-Brexit landscape.