A new insights report from CPI has revealed that 24% of UK-based HealthTech SMEs aim to launch their innovations in the US rather than the UK.

The study, which worked with over 350 SMEs, shows that the UK may be losing out on its early-stage investment in medical device and HealthTech innovation. 

Combining data from clinicians, publications and patents, the roadmap corroborates that the UK has excellent research in diagnostics and identifies the top nine trends that will transform UK diagnostics and so should be invested in over the next 10 years.

While the study found that the UK excels at research, it suggests ecosystem and infrastructure for commercialisation needs to be improved upon, meaning that many UK inventions are commercialised by companies from other countries. 

The survey reveals that about one in five companies now target the US for launch, thanks to its large market potential and more favourable regulatory environment. 

Further, 70% of surveyed SMEs find the recent changes in medical device regulations a challenge, especially post-Brexit with UKCA still not finalised. 

As most SMEs do not have in-house regulatory expertise, they cited challenges including the struggle to navigate the complex system and difficulties with rapidly progressing technologies to commercialisation.

90% of SMEs therefore rely on external consultants for advice and support, but are still finding it difficult to identify consulats with the right expertise. 

The report recommended that SMEs be offered more support in adapting to ever-changing regulation frameworks, but first stipulates that the UK needs a comprehensive regulatory roadmap for HealthTech products. 

SMEs also felt undersupported in terms of public funding schemes, which they felt were too complex and took focus away from product development. The UK is therefore losing out on the realisation of ideas and tech that was developed in UK universities and institutions, that then have to look globally for further funding and development. 

Similarly, healthtech SMEs are also struggling in commercialising their research, and as supply chain issues continue to hit the UK, many start-ups are forced to look elsewhere for both support and materials. 

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The report follows news from the European Commission announcing a proposal to give more time for manufacturers to transition to the new requirements of the Medical Devices Regulation to avoid device shortages. 

Manufacturers with medical devices on the EU market are struggling to transition to the new requirements of the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) due to the capacity limits of conformity assessment and notified bodies. 

In addition, many manufacturers lack the internal resources to meet the more robust requirements of the regulation by the end of the current transition period. 

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