Our event brought together small and large companies, stakeholders from the UK government, the NHS, Innovate UK, academia, investors, and adjacent organisations to discuss how CPI can catalyse innovation in digital health.
On Tuesday, 28 March, CPI and Cambridge Design Partnership hosted a workshop at which key stakeholders met to work through the most important challenges facing digital health. Discussions at the meeting centred on creating actionable solutions to the hurdles and building a clear action plan to help the industry thrive.
These are topics CPI understands very well. Since February 2022, our Health Technology Regulatory and Innovation Programme (HealthTRIP), funded by Innovate UK, has supported small- and medium-sized health technology companies as they navigate the complex landscape of this sector.
One significant output from HealthTRIP has been our report on Challenges and Opportunities for the UK Healthtech Industry. Using data from 350 SMEs, this identified that the biggest obstacle to UK SMEs is understanding how to progress along the appropriate regulatory pathways – a task often attempted without detailed internal knowledge of the procedures involved. A particular block to progress is the difficulties of engaging with the relevant notified bodies and conformity assessment organisations. This process can take SMEs up to 18 months to accomplish before full assessment even begins.
The regulatory system available in the USA via the Food and Drug Administration is an increasingly attractive alternative route for faster access. Indeed, our report highlights that up to 24% of UK-based HealthTech SMEs currently aim to launch their innovations in the USA rather than in their home market. We also identified further challenges relating to the complexity of public funding schemes, insufficient support as innovations translate to market, and supply chain difficulties.
Our solution is laid out in the Challenges and Opportunities report and involves 45 individual recommendations across regulatory procedures, funding, sustainability, supply chains, IP, and skills, all geared towards developing and supporting SMEs in the UK. Without this support, our universities and innovators will continue to produce world-leading research that is then deployed overseas.
Lucrative opportunities during the next decade
We found a similar picture when we studied the in vitro diagnostics (IVD) field. The UK has a proud record of developing many foundational technologies in this sector, including paper chromatography that underpins lateral flow tests, and the genetic sequencing techniques used in around 80% of the world’s sequencing systems.
But while the UK excels at research, it lacks the infrastructure and funding for IVD companies to remain in the UK. Our HealthTRIP report, A Strategic Technology Roadmap for the UK IVD Industry, identifies seven major challenges relating to the UK’s lack of a suitable IVD ecosystem, the complexity of clinical studies, and financing models that do not favour the high-risk, high-impact, innovative tests that are needed.
Without a doubt, the UK has the potential to become a world leader in the high-growth IVD industry. Assuming the hurdles we have identified can be tackled, then it’s ideally placed to capitalise on nine potentially lucrative IVD opportunities that we foresee, all opening up within the next decade. Our report lays out the five-step strategic plan that will let this happen, a plan built in cooperation with the whole IVD industry and its partners – potentially the first time this collaborative effort has been possible.
A unique offer from CPI
At CPI, we specialise in supporting digital health SMEs with scale-up and commercialisation. And as an independent organisation, we’re especially well-placed to help companies access both local and global markets.
The UK’s existing strengths – its strong academic base, the NHS as a development partner, good early-stage funding offer and top-level support for digital health – set it up to be the future global leader in digital health. But the HealthTRIP reports and our March workshop stress that several barriers hold the UK back:
- Funding: How can we make it easier to obtain funding for mid- to late-stage development and early sales?
- Evidence: How can innovators better understand and make decisions based on regulatory approval, reimbursement and purchase needs?
- Developing with the NHS: How can we make collaboration easier in terms of running studies and trials?
- Accessing patient data: How can we make it easier for innovators to access high quality data?
- Business cases: How can we help innovators ensure they have a strong business case?
- Fragmented systems: How can we help innovators cope with their customers’ fragmented healthcare digital systems?
- Talent pool: How can we grow the digital health talent pool?
One of the recommendations in our Challenges and Opportunities report was that the UK needs to build capability in the HealthTech ecosystem by bringing together advice and expertise on development, scale-up, adoption, sustainability and regulatory matters.
Such an ecosystem would allow a broad provision of innovation and translational services to SMEs across standards development, rapid prototyping of software and hardware, and expedited access to vital clinical data.
Our HealthTRIP work provides evidence of these needs. As an innovation catalyst and social enterprise, we’re well-placed to convene the partners and capabilities required to get HealthTech products to market faster, where they can help improve people’s lives.
Growing our training offer is one of our organisational objectives for the next 5 years, and as we’ve demonstrated with our new RNA Centre of Excellence and RNA Training Academy, there’s also a valuable role for CPI to help address the skills shortages we’ve identified in areas such as regulatory affairs and quality assurance. At present, there are very few professionals in the UK with these skills, and those who do are more likely to work as consultants than take full-time positions within individual HealthTech companies – especially not in SMEs. There may be scope for us to offer training in regulatory issues, which would constitute a unique offer to the digital health industry.
The next pair of HealthTRIP studies are currently being prepared, with the first relating to the scale-up gaps that exist in digital health, due to be published in Summer 2023. A further report will focus on specific challenges to the HealthTech sector, where the development of medical equipment, machines and software has its own particular regulatory environment for SMEs to understand.
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