Thread by @pmdfoster

🚨🚨🇬🇧🇪🇺💉🦼🩺🏥😷🇪🇺🇬🇧🚨🚨Medical devices industry tests UK plans for post-Brexit divergence via @FT …this is the real front line of post #brexit U.K. Theoretical upsides, but practical obstacles. Stay with me. /1
on.ft.com/3kuD5xz

@FT So what are we talking about? Medical devices - stents, implants, urine testers etc etc. Can the UK have it's own post-#Brexit regulatory regime? (Sure) Can that regime pay a dividend that makes UK hub for innovation, development, growth (Trickier). /2

The background is the EU introduced new Medical Devices Regulation in May after load of scandals (breast implants failing etc) ...but UK isn't following MDR, but is starting consultation on new UK regs designed to grasp "opportunity" of #Brexit /3

futurecarecapital.org.uk/latest/mhra-la…

But as @MedilinkUK boss Kevin Kiely and Prof James Moore of @imperialcollege and Prof Derek Hill @ucl tell me,
the industry is worried that UK (3pc of global medical spend) isn't big enough to have a really separate regime, coz EU (22pc) and US (43pc) dominate the market/4

@MedilinkUK @imperialcollege @ucl So 'size matters', per James Moore, because investors who acquire new tech and bring tech to market will jump through the hoops for the biggest market, or the adjacent on (the EU historically)...although there IS a theoretical upside. /5

@MedilinkUK @imperialcollege @ucl Because the MDR (new EU rules) is time-consuming, bureaucratic and is giving headaches to the so-called 'notified bodies' that certify devices as compliant -- and with MDR the hurdles are higher to prove devices are not just safe, but provide improvement/savings. /6

@MedilinkUK @imperialcollege @ucl So in theory, the UK could* be nimbler than this, streamlining applications, recognising datasets from trials done for EU & US market and then stealing a march on other stuff, like software regulation, low-risk stuff, early stage companies /7

@MedilinkUK @imperialcollege @ucl In theory, again, the NHS should be a perfect testbed for new products, encouraging early stage companies to come to UK to trial their new ideas...delivering benefits to patients, and cutting costs. In theory.....but there's a but, you knew that, right? /8

@MedilinkUK @imperialcollege @ucl Firstly the NHS is a nightmare for procurement, it's fragmented and difficult to deal with.... the trade body the @UK_ABHI is working with govt to improve this but the reality says the boss of Forte Medical @Giovanna_Forte is very different. /9

@MedilinkUK @imperialcollege @ucl @UK_ABHI @Giovanna_Forte Their clever device @peezymidstream could save NHS time and money, and patients anxiety of bad/false tests (urine sampling is fascinating btw, all depends when u take the sample, see vid)...but getting this stuff trialled is hard. /10

@MedilinkUK @imperialcollege @ucl @UK_ABHI @Giovanna_Forte @peezymidstream Secondly, the EU MDR is a mess, but so TOO is the UK's own approvals system...there is a chronic lack of 'notified bodies' (in fact only three in UK) so it can take 18 months to get approval sorted...even when you've got your data, per Kiely. /11

gov.uk/government/pub…

@MedilinkUK @imperialcollege @ucl @UK_ABHI @Giovanna_Forte @peezymidstream So it turns out that the notified bodies + NHS fragmentation + uncertainty over new rules (not expected til Spring 2022 after consultation) adds up to a system that is in danger of being not so nimble after all /12

@MedilinkUK @imperialcollege @ucl @UK_ABHI @Giovanna_Forte @peezymidstream And as Daniel Green of @YaqritLtd observes it's a **global** competition:

“If we have to invest in regulatory approval in the US, the EU and the UK, each will have a different return on capital, and the one with the best return will attract the capital." /13

@MedilinkUK @imperialcollege @ucl @UK_ABHI @Giovanna_Forte @peezymidstream @YaqritLtd So as @Neelam_P1 of MedCity, a life sciences cluster organisation for Londontells me, the trick will be to find the "sweetspot" for the UK -- leveraging, NHS and @MHRAgovuk know-how as a world class regulator.

Lots to play for. Watch this space. ENDS