BIVDA attended a roundtable event earlier this week which focused on developing the definitions of innovation and proposed classification levels.
The roundtable examined a drafted definition for innovation which was good and specific in most areas but was determined to be too broad when referring to “system” and the value of a glossary was noted. The definition should not give advantage to any first to market technologies and needs to be strong for innovation and emphasis the impact for patients. The definition should also include process as well as product.
It was recognised that the current system has bias for first to market, and consumers would expect something innovative to be something that wasn’t actually available in some form.
Unmet need currently focuses on the NHS. The addition of consumers could help determine the prevention policies.
The Innovation Service has a looser definition for innovation, and there was a lot of discussion on how the definition would be applied across the system in practice. It will rely heavily on self-selection by innovators.
Continuous improvement is a key theme, and it was argued that it didn’t need to be a classification and could be woven into the overall other classification categories. There is a fine line between radical and transformative classification, the NHS does continuous improvement better than it does adoption of radical or transformative technology and process.
It was emphasised that no innovation type is to be prioritised over another.
Within the innovation landscape, it is likely that companies will be talking closely with academics and the difficulty lies in defining scientific innovation and practical innovation. There is a difference between scientific innovation and addressing an unmet need. This is where it is envisaged that Value Based Procurement will be applied and will be critically important.
How to introduce innovations into a mature health system was discussed in detail.
The terminology presented were accepted as clear and concise, but there was still a need to understand how they will be applied. The circumstances in which they apply needs to be clearer.
The lens in which the classifications are being viewed also matters. Radical and Transformative will have more patient safety considerations than Continual Improvement which will likely have more cost-efficiency considerations.
It was noted that NICE were currently looking at how to prioritise technologies into the NHS, and they are finding classification difficult. Particularly with state-of-the-art technology and science such as AI.
By defining innovation across the system, this should help the process. Instead of defining the assessment by technology, it can put innovators’ products through the right technology assessment. If the language and definition can be adopted across the system, this will help companies and stakeholders.
There isn’t enough mention currently of adoption and spread and with the AHSN’s soon to become Health Innovation Networks, there is a need for policy, drivers and capacity to adapt.
Concentrating on the core 20+5 categories would make a massive difference, and there is a need to recognise the wider impacts and how to feed back into the initial funnel of how successful the assessment and classification model is.
A top down and real-world experience approach would be beneficial.
The intended users of the classification were assessed, and if the classifications were given to industry, there is a high likelihood that it would be different from a clinician. It is intended that everyone in the sector would be users due to alignment of language and terminology. The integration of the nomenclature into the system will be key.
Complexity needs to be avoided as the current system is complex and results in localised innovation and adoption by going through alternative mechanisms. This soft introduction outside the current system increases the risk of the technology being seen as iterative as it won’t be considered “new”.
The NHS will still potentially “game” the system.
The classification proposals will be re-looked at based on feedback from the roundtable attendees and ensure that they are risk based, with traceability and ease for the market and there will likely be multiple streams.
Overall, the increase in control and requirements will assume that everyone participates fully across the healthcare system with everyone doing the same thing which will be a challenge.
Further updates will be shared with members when available. If anyone would like to discuss this, please contact Helen