In conversation with Tim Clover, CEO, Rayner and HBI 2022 panellist 

Few healthcare services sectors are as tech focused as ophthalmology – but where there are devices there is regulation. HBI catches up with Tim Clover, CEO of UK-based ophthalmic medical products specialist Rayner and HBI 2022 panellist, and hears why new rules are set to push up prices.

Clover explains: “The European Medical Device Regulations (MDR) have just come into force (along with parallel UK provisions). It puts medical technology in Europe on a path towards the US style FDA regulation approach. It’s more stringent, requiring more clinical evidence and follow up, the cost of which is significant.

This is the European Union response to the PiP (breast implant) scandal, and it is substantially strengthening regulations – in error in Clover’s opinion: “I never saw a single safety target set.” He believes Europe is now moving up on a par with the US and China in terms of its regulatory burden.

“The one thing defining the UK market is it has the lowest prices globally – we’re around 40% of China or USA (two of the highest regulated markets). I’d be surprised if UK prices don’t double over the near to medium term – and I don’t mean just in ophtha.

“Regulators can’t impose ever more burdens without considering the impact. This will lead to fewer choices. If you have smaller selling SKUs (stock keeping units) or product lines it won’t justify the enormous clinical filing.”

“I hope that there is a period of substantial inflation in the market. We increased prices 8.5% this year. I suspect there will be several years of those kinds of increases. 

Notified bodies – the organisations enacting these new regulations and working with companies on this new paperwork, are struggling, he adds, with some having packed up, while others have stopped taking on new work. “Small products fulfilling a clinical need could be lost”, he explains.

“Every surgeon in the US laments they get products five years behind everyone else. Europe is voluntarily heading on the same path. This will have a knock-on effect for service providers as the pace of innovation will slow. Choices will shrink. Cost of products will increase significantly.”

The UK is imposing its own regulatory regime, the UKCA mark – the same as the European regulation in essence. Clover says: “I don’t understand the rationale for setting up the UK separately if you don’t intend to diverge.”

Tim Clover is a panellist at HBI 2022 alongside Peter Byloos, Optegra, Ulla Napankangas, Coronaria Eye Health, and Tobias Koesters, L.E.K. Consulting. HBI members with Deals+Insights access and above can click here to read the full interview, including Clover’s thoughts on enhanced mono-focal lenses, pricing, RnD developments, and market trends.