De-risking innovation: it’s not just about the evidence
Evidence is just one of a number of elements that helps to ‘de-risk’ an innovation and accelerate its adoption and spread. But as Dr Amanda Begley, National Director for the NHS Innovation Accelerator explains, there are a range of assurances and mitigations which can support and speed up successful implementation.
At the NHS Innovation Accelerator (NIA), we are frequently asked by potential applicants, assessors and NHS sites: ‘what evidence is needed to get on the NIA?’ To help with this, we now provide evidence summaries for every NIA innovation on our website. However, a focus primarily on evidence tends to provoke diverse opinions, often resulting in a debate that can stall rather than accelerate adoption. So, the question of whether an innovation is ‘ready’ or ‘right’ for the NIA is much broader than simply assessing the evidence base.NIA assessors are purposely drawn from a broad range of experts to ensure that we capture the views of those using and implementing the innovation. This includes patients, clinicians, commissioners, commercial experts, and academics. Sometimes assessors agree unanimously on the value and readiness of an innovation; other times views vary.
NIA shortlisting and selection – aka de-risking an innovation
The role of the NIA shortlisting and decision-making panels is to review assessor scores and comments against selection criteria (including, but not limited to, evidence) to determine the best applicants and the most impactful innovations.
For each innovation, an informed decision is taken on ‘risk’. For example, are there any clinical, financial, regulatory or reputational risks? If so, can these be mitigated? Finally, these panels determine if we can – via the support available on the NIA – help to de-risk the innovation for its users and accelerate uptake.
Why do we include a focus on risk in NIA selection and delivery? Risk management is a widely used and well-established practice within the NHS, which staff use within any new project. It is not used to prevent delivery. It is used to provide assurance that projects (including adoption of an innovation) are being robustly and safely implemented within an agreed governance structure.
So, what does de-risking involve? How can we make the adoption of innovations ‘SAFER’ for patients, carers, clinicians, managers and/or commissioners?
Are there opportunities to Share risk?
If patients and the NHS are not the sole bearers of the risk, an innovation can become more attractive. Sharing risk can include a range of mechanisms; from patients making informed consent, through to a business model where buyers only pay for the innovation at agreed milestones and/or when outcomes are delivered.
How can the innovation be Adopted and Adapted?
If users have concerns about adopting an innovation, there are tried and tested methods like co-design and quality improvement, which can help de-risk its implementation. Robustly identifying opportunities for users to adopt and adapt an innovation to their local context. An NHS site may, for example, want to use the innovation with one patient and one clinician and then review – using ‘Plan Study Do Act’ cycles – before adapting and expanding its use. NIA Fellows are open to this adaption, and also share practical insights (like Care City’s Blueprint for AliveCor’s Kardia) across sites, facilitating knowledge transfer for time constrained NHS staff.
Who are the Followers?
It is hard to be the first person to use an innovation. Risk is reduced if, for example, patients and NHS staff have been involved in its development; the innovation is already in use in the NHS; there are credible advocates and champions; awards have been won; the innovation has been selected onto well-respected national (e.g. NIA, SBRI) or regional innovation programmes (e.g. AHSN digital accelerators, like the DigitalHealth.London Accelerator)
Within the NIA, we share the view of Steve Woolgar who said that innovation is: “the art of interesting an increasing number of allies who will make you stronger and stronger.”
What is the Evidence base?
Evidence is critical, albeit not a necessary or sufficient condition for innovation use. The level of evidence needed depends on, for example, how the innovation is to be used (e.g. diagnostic, invasive), its cost, its theory of change, the extent of its promise, etc. Evidence can reduce risk for the user by answering pertinent questions on safety, clinical effectiveness, patient or user-centredness, timeliness, efficiency, equitability. Helpful guides (e.g. Evidence Guide for App Developers) provide frameworks for us to assess an innovation’s evidence. However, evidence gaps aren’t a reason not to use an innovation. Many NHS sites choose to participate in strengthening the evidence base – e.g. firming up the economic case, trialling the innovation in a new pathway – if they see the value of an innovation, and can manage any risks to its use.
Does the innovation adhere to Regulatory requirements?
Within an understandably heavily regulated sector like healthcare, it is essential that innovations meet regulatory standards and legal requirements specific to the nature of the innovation and its use. Adherence needs to be openly and robustly demonstrated to alleviate any concerns for the user. It is also a key part of the NIA selection process.
When thinking about an innovation’s readiness for the NIA, the primary focus is the intended user. Evidence base is, of course, an important consideration within this. First, we determine whether an innovation is ready to address a significant problem that the intended user needs help with. And if it does, we consider any concerns that the user might have in using the innovation. Within the NIA, ‘risks’ (including limitations within the evidence base) are not something that should be used to prevent the uptake of innovations for the benefit of patients and the NHS. Risks become something to be openly discussed and mitigated, helping to make adoption of the innovation SAFER for the user – who, ultimately, is the courageous risk-taker.
This comment piece by Dr Amanda Begley was first published by the HSJ on 15th June 2018.