The Accelerated Access Review (AAR) interim report has helped focus our minds on the question of what processes need to be in place to prioritise innovations so that they can quickly be adopted across the NHS. If we are to pull the most promising, transformative innovations through a managed process, we need to be really clear about the key issues that innovators should be considering as their product moves down the development pathway.
Questions for innovators
I believe that innovators should be able to answer the following 6 questions at a very early stage of the process, if their product is to have any chance of being widely adopted in the NHS.
1. How will this innovation significantly change the patient’s clinical pathway and establish a new standard of care?
The answer to this question is vital to the success of a new medical technology, as it will usually entail a change in clinical practice. In answering it, the whole patient journey needs to be considered, from the absence of a clinical condition through identification of risk, pre-disposition, diagnosis and treatment, to cure, chronic disease management or end-of-life care. For example, the introduction of a novel surgical procedure in a prostate cancer patient’s journey might be much less relevant than a superior technology for assessing disease aggression and spread which can impact earlier in the patient journey and might affect the decision about surgery for some patients.
2. What will be the positive clinical, social and economic impacts from this changed pathway and new standard of care?
The gathering of evidence of clinical benefit can be less consistent in medical technology than in the development process for pharmaceuticals. But understanding the evidence of economic and clinical benefit is paramount if adoption is to be widespread. Social impact is equally important, given that med tech innovation is more likely to drive care away from traditional in-hospital settings, and assessing this impact requires a wider partnership with social care as well as with healthcare delivery agencies. A positive economic impact will provide the foundation for a convincing case for adoption.
3. How will these impacts be measured with sufficient precision to provide compelling evidence for the adoption of the innovation?
The scope of the product’s benefits, as defined by the innovator, has to include the whole patient pathway if the system is to capture the full potential of the proposition. This is particularly important in precision medicine and its enabling technologies, where completely new patient pathways may evolve. Med tech innovators will need to consider how they will gather evidence of and measure clinical, social and economic impact right through the patient’s journey.
4. What changes in workflow will be required to maximise the benefit of these impacts in a defined health and care system?
Impactful changes in clinical practice will almost inevitably lead to changes in workflow, both for health and social care providers. Understanding the changes in workflow is a particular challenge for innovators, particularly when current practices are inconsistent between practitioners. Often innovators make reasonable assumptions about the redeployment of labour, transfer of budgets and the benefits of efficiency without recognising the difficulty of moving away from the status quo. Innovators and providers, in partnership, need to define the desired future state and the best way of moving towards it. Working with those on the front-line to design the support for clinical change is essential.
5. How will the re-engineering of this workflow be resourced?
Any significant change in workflow will require process re-engineering and the deployment of change management processes. How can this be delivered in the NHS environment? When answering this question, innovators will need to understand the resources available and how they could be deployed and incentivised to drive the proposed changes. Incentives do not necessarily need to be financial but might include opportunities to improve patient outcomes or for publication.
6. How can these benefits be spread by disseminating the changes across and between healthcare systems?
Many new technologies find a willing early adopter but then struggle to replicate that uptake more widely in the system. Innovators often rely on a sales approach to individual providers; as well as being resource-intensive, these campaigns often fail to articulate an evidence-based argument for the necessary changes in clinical practice and workflow. The case for adoption needs to be made based on the clinical, social and economic impacts of the resulting new standard of care. The innovator needs to consider issues of pricing and reimbursement, and their case should reach beyond simply their device to encompass the whole service that might be associated with it.
Reaching detailed, qualitative answers to these questions might be an unrealistic objective for every new technology. But if no attempt is made to offer a logical response, albeit qualitative, to these challenges then the innovator can expect to face much greater obstacles to funding, product development, early application and commercialisation. If compelling answers can be provided, and a willing healthcare delivery partner engaged, the innovation might be considered to be sufficiently promising to move down an accelerated pathway with faster adoption as the aim. As always I’m grateful for any views you might have.