Come and listen to Julian Hitchcock talking regulation next Wednesday 17th July!

Julian Hitchcock, ably assisted by Zac Fargher, has kindly agreed to spend an evening updating people on the regulation of medical and in vitro devices at a joint DHACA/Heath Technology Forum London meeting on Wednesday 17th July.

This comes at a time of huge uncertainty so Julian and Zac’s advice will be especially important for members: in addition to Brexit, the Notified Body capacity crisis is imperiling the implementation dates of both the MDR in 2020, and the IVDR after that.

Anyone following this editor’s recommendations will already be aware of Julian’s presentational clarity and depth, and his very humourous style.

Booking is here. Please try to arrive at 6.15 pm on 17th July so we can get started promptly at 6.30 pm. Julian and Zac will speak until 8pm, after which there will be time for networking drinks, kindly sponsored by Bristows, who are also generously hosting us for the evening.

Do come and join us!

Next DHACA Day 9th July, London – seeking new members (psst–it’s free)

DHACA, the Digital Health and Care Alliance, with some 850 members currently, is having a new membership drive among SMEs working in the UK’s digital health & care space, following the kind offering of new sponsorship by Kent Surrey and Sussex AHSN and UCL Partners. 

The organisation’s objective is to help members develop their innovative products and services commercially, to achieve successful sales to the NHS. DHACA works right across the UK.

If you aren’t a member, you can sign up here to ensure you are kept aware of important news and of DHACA events. Membership is entirely free and members’ details will of course never be passed on to any other organisation.

Whether or not you are currently a member, booking is now open for the next DHACA Day. This event is primarily aimed at informing members working in the digital health & care sector of the major recent changes they need to be aware of, and how best to navigate them to make greater sales to the NHS and other health & care organisations. There is a small charge of £30+VAT to provide lunch, otherwise all other costs will kindly be covered by the event Sponsors, Baker Botts, in whose premises at 41 Lothbury (the opposite side of the Bank of England to the Bank Tube) it will be held.

The draft agenda includes talks by Luke Pratsides, Clinical Lead, Digital Development, NHS England about NHSX, Sam Shah, Director of Digital Development at NHS England and James Maguire, Clinical Advisor in Digital Innovation & AI at NHSX on NHS England’s digital development strategy, Mark Salmon, Programme Director, NICE on their HealthTech Connect and Evidence Standards, Neil Foster, Partner, Baker Botts on Finance for digital health start-ups, Neil Coulson, Partner, Baker Botts, on IP protection and the GDPR, Rob Berry, Commercial Director, UCL Partners on how the AHSNs can help SMEs and much more. Neil McGuire, Clinical Director of Devices, MHRA, has also been invited to update attendees on MDR implementation – a most important topic.

DHACA is keen to get members’ views on how they’d like it to be organised and governed in order to deliver what members want, so there will be time in the middle of the day for this too.

Should be a great day!

(Disclosure: this Editor is also DHACA CEO) 

 

A selection of short digital health items of potential interest

Editor Charles has taken time off recently from assessing mHealth apps to give us a selection of short news items and event notifications.

CE and FDA certification

This editor recently stumbled over the first list he’s ever seen of approved digital health medical devices. As of today there are some 151 products on there which is hugely impressive. One of the reasons for the relatively poor showing of CE certifications on the list is that there is no official list yet: latest forecasts for Eudamed, which will provide this, are Spring 2020 amid much uncertainty about whether enough Notified Bodies will be approved to certify to the MDR in time. Immediately spotted as a CE certification missing is Walk with Path’s Path Finder device for helping people with Parkinson’s to avoid a freezing of their gait (though CE certification is well hidden on their website) and doubtless there are others. Clearly the list points up potential benefits were it ever possible to harmonise the approval process across the Pond.

Longevity 

The first Longevity Leaders event took place on Monday, perhaps the first large event in the UK on that topic. Based on the enthusiasm of attendees, clearly it won’t be the last. Doubtless in due course it will fragment into a myriad of specialist topics though currently it is a fascinating combination of almost every medical/pharmaceutical and digital discipline, plus housing and a range of other considerations. Timescales varied widely too – for example I talked about the immediate benefits of digital health including keeping people in their own homes, thus minimising sarcopenia from being confined to a hospital bed and avoiding exacerbating dementia by a change of environment, whereas others spoke of how best to make DNA immortal and whether the first person destined to live to 1000 had already been born.

Clinical  Homecare

From the sublime (last item) to the The National Clinical Homecare Association‘s conference on 31st January, where this Editor also spoke on how digital health could help people to be treated in their own homes. Notable was the absence of any Twitter handle for the Association, no hashtag for the conference and just two people it seemed out of 250 using social media. Clearly there are huge opportunities here for digital health suppliers, particularly as so much of what was said by other speakers, and what was being shown in the exhibition was very much manually-intensive stuff: join the NCHA and start a revolution in clinical homecare! 

Recent developments in AI

Since this editor stopped active involvement in conference organisation for the Royal Society of Medicine it is encouraging to see that the younger generation has picked up the baton and is running even harder, such that the above event, on 26th February, has proved so popular that it has been moved to the largest (300 seater) lecture theatre at the Society, and on current sign-up rate will sell out.  Speakers from Babylon, Ada Health, DeepMind, Kheiron Medical, BenevolentAI, UCL Life Sciences & Alan Turing AI partnership, and many more will ensure that delegates gain a comprehensive understanding of how AI is being used across healthcare. Book here to experience the delights of the new RSM all-new website which makes signing up for an event so much easier than in the past. Fear not though: the RSM’s legendary low ticket costs are maintained!

Wayra and Novartis

A most exciting event this week was the announcement of the joint Wayra and Novartis health call now looking for their next cohort of remarkable start-ups to join their new programme called The Health Hub. This is built together with their new partner Novartis, one of the leading pharma companies. Their focus is on how healthtech can be used drastically to innovate long-term disease management. Apply here, by February 17th. Hat tip to Professor Mike Short for this item and other observations in this post .

Rewired Pitchfest

Early health tech entrepreneurs should consider taking part in the Rewired Pitchfest at the Digital Health Rewired Conference and Exhibition, Olympia London on 26 March. Sponsored by Silver Buck, this provides the opportunity for early stage digital health start-ups to showcase their disruptive ideas and prototypes to NHS IT leaders. Applicants will compete before a judging panel featuring investors and successful start-up founders. It’s a great way to gain significant exposure and make connections with a diverse range of UK digital health leaders…and the winner will be announced, and congratulated, by Matt Hancock himself! There is also the chance of winning a mentoring programme with the experts on the judging panel and PR features in Digital Health News. (Disclosure: this editor is on the Programme Committee of Rewired, as well as being a Pitch judge)

Punning headlines

It’s rare that a single item is worthy of its own paragraph on TTA these days however an exception must surely be made for one of the few punning headlines to be found in digital health, especially as it’s for such an old – and until now undelivered – idea: “Smart toilet seat is flush with possibilities to monitor patients’ health”

Regulation, safety and sustainable development: three short important updates

Erik Vollebregt has just released a blog that should be read by anyone with a medical device or whose technology is likely to be classified as a medical device under the new Medical Devices Regulation (MDR – Regulation 2017/745/EU) which replaces the MDD in early 2020. It makes scary reading as to what will need doing to comply with the new regulations as approval under the MDD will no longer apply (no ‘grandfathering’). MedTech Europe has helpfully produced a flowchart describing the necessary steps. Advice from official sources given to this editor is that, as the MDR already applies in the EU, its continued application in the UK after Brexit is not in serious doubt, so UK companies should not delay.

The Digital Health & Care Alliance (disclosure; that this editor manages) and DigitalHealth.London are jointly running a digital health safety conference on 7th November. Key players in the UK are on the agenda (including the CQC, MHRA, HSIB, NHS Digital/England, Datix, Vitalpac etc.). This is a topic that requires the attention of all developers and providers of digital health, as new technology, being unfamiliar, is inherently risky. It is therefore really key for everyone involved to share experiences, understand the risks and carefully plan avoidance and mitigation.  The draft agenda and booking details are here (there is a small charge for lunch).

For those who have doubts about the benefits that mobile communications can bring at times, a read of the GSMA’s 2017 report on mobile’s contribution to the UN’s sustainable development goals will fill you full of optimism of what technology can do, for health and many other aspects of life. Beautifully presented and full of interesting facts: recommended! (If you’ve not enough time, the summary is here.) Hat tip to Prof Mike Short.