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12th Feb 2021- Workshop report

Workshop on the Future of Innovation in Diagnostics

 

  1. Foreword

On Friday 12th February, we hosted a workshop on the future scenario for diagnostics jointly organised by London In-Vitro Diagnostics Co-operative (London IVD) and Prof James Barlow (LIVD methodology lead and Professor of Innovation at the Imperial business school), and Dr Richard Broyd (Blenheim Chalcot). The session was chaired by Dr. Broyd and facilitated by Prof. Barlow. It was attended by a range of experts and stakeholders in diagnostics innovation, including healthcare start-ups/ventures, investors, industries (diagnostics/pharmaceuticals/pharmacies), clinicians, health technology assessment experts, and academics.

 

  1. Aim of the Workshop

The workshop aimed to identify existing/future barriers to the innovation of diagnostic technologies during/after the pandemic and discuss (and potentially reach a consensus on) actions to progress the innovation in diagnostics.

 

  • Scope/definition of diagnostic technologies

The boundaries between technologies used for diagnostics, monitoring, wellbeing are blurring. Diagnostics are conventionally defined as in-vitro/lab-based technologies, not necessarily imaging equipment. However, there are grey areas such as wearable consumer wellbeing devices. The definition/scope of diagnostics is increasingly going beyond ‘sickness’. For example, wearables are moving towards the ‘wellness’ away from the ‘sickness’. Meanwhile, imaging will play more important roles in the future, but while more information is being captured in clinics, we are not making good use of it.

 

  1. Barriers to the innovation of diagnostics

IV.1. Consumer acceptance and demand

With the advent of Covid-19 pandemic, individuals are taking more responsibilities for their own health and well-being, leading to a greater acceptance of self-testing. The examples of Letsgetchecked.com and healthy.io were cited an example.  This trend is likely to continue and may change the future roles of pharmacies. Greater acceptance is also seen in home testing and point of care testing (POCTs). Consumers are more willing to adopt/utilise the self-testing technologies and expecting to get the testing results quickly. The Covid-19 pandemic is driving the revolution in this trend, particularly with POCTs, and more developments will continue to be seen. Public acceptance of testing at home and the infrastructure to manage this within the healthcare system is emerging.

 

IV.2. Data collection, evidence generation

The public are using at home and wearable devices to monitor their health but the data generated is not yet fully integrated into their healthcare provision.  Electronic health records are useful; however, such electronic database is not harmonised among community/primary settings, although great strides are being made in this area.

Proving the technical performance of diagnostics is straightforward, but there are challenges around evidence generation and use. For example, responsibilities for the generation of evidence needs to be established in contexts where multiple organizations across health services are involved. Better evidence generation, especially through longer-term clinical trials, is needed both to support investment cases for adoption by NHS etc and help innovators/developers create sustainable business models.

Stakeholders are more likely to accept evidence generated from large-randomised controlled trials (RCTs). One participant’s start-up company could only gain traction after all data on clinical and health economic evidence were sufficiently established. Data gathering is a key to unlock innovation, and academic-commercial collaboration is of paramount importance for that.

 

IV.3. Adoption

 

Translating science into value for health systems or stakeholders to pay for the innovation is challenging. The path for diagnostics to get approved by NICE is not straightforward in the UK.

 

Those parts of the health system that bear costs of diagnostics are often not those who get the benefits, it is therefore challenging to provide health economic arguments and value propositions. This slows adoption. Other barriers to adoption are the resistance of incumbent providers of centralised systems to more distributed technologies. We observe more innovation in cancer because it is deemed ‘easier’ to make the case for cancer related innovations/health technologies.

 

IV.4. Funding

 

Funding is a challenge, especially when POCTs do not have a range of evidence generated, and the uncertainty over the adoption curve deters funding and decreases investment in innovation. Also, benefits brought by the technology are not clearly linked across different health systems. The diagnostic technology is there but the funding mechanism supporting its implementation/ or integration is not aligned between different health systems (for example, between different trusts or primary care settings) and costs and benefits are unevenly distributed.

 

The UK is in a better position regarding the data gathering, given its relatively centralised health system, than the USA with its fragmented healthcare systems. However, diagnostics companies also experience the fragmentation of systems in relation to NHS trust’s with different procedures and expectations. Streamlining the case-to-case replicability of real-world system value of diagnostics is one of the biggest challenges to the adoption/scale-up of diagnostics.

 

IV.5. Regulation

 

Currently, regulation is not aligned with the speed for diagnostic innovations, despite calls from innovators/developers and market forces. The UK regulator, the MHRA, is willing to improve the regulatory pathway by creating a better environment for research and development of diagnostics and manufacturing. There is a lack of regulation in ‘wellness’ diagnostics/digitals.

 

  1. Actions to progress innovation

The key is to bridge the path from proving that the technology is technically working at lab settings to getting adopted in the UK NHS. Establishing a systematic framework for accelerating this path, taking diagnostics from technical validation to the adoption in the NHS is the key. For example, a regulatory ‘sandbox’ analogous to that of the Financial Conduct Authority (FCA) could be created.  T Another action is that public money should go into de-risking the adoption curve after regulatory approval, as has been seen in the development of covid vaccines. This would have a positive multiplier on the amount of investment into innovation in diagnostics.

 

All participants provided keywords for actions to the progress of the innovation for diagnostics through Mentimeter. The most frequently mentioned keyword was Sandbox. Other action keywords included regulatory speed, integrate NHS pull, clear adoption pathway, investors who understand, self-care and prevention, clinician acceptance, return on investment, investment into systems, appropriate regulation, centralised approval, build sandbox, better integration, early-stage support, more agile evidence, early authorisation, NHS adoption framework, mandated funding, adoption challenge.

 

A follow up workshop on the design of a regulatory sandbox is planned.