Highlights From The 2024 ABHI UK HealthTech Conference
The day after the annual ABHI UK HealthTech Conference is always one of those ‘phew’ moments. Organising such an event is quite the undertaking, but it is always worth it because of the superb insights our experts are able to provide.
This year, over the two days of regulatory and market access sessions, we had over 400 attendees, with more than 50% attending both days. This is testament to our ongoing commitment to integrating regulatory practices with business, ensuring that regulatory is an enabler rather than a barrier.
As with last year, the themes of the conference had a focus on recognition and reliance, innovation and capacity, but also ventured into discussions around national regulations and post-market surveillance, bringing a greater practical feel to proceedings. After opening remarks and provocations from the ABHI CEO, Peter Ellingworth and Sharon Lamb, a partner at McDermott, Will and Emery, as to the overall attractiveness of the UK market from both a regulatory and commercial perspective, Dame June Raine DBE of the MHRA provided an illustration of the current ‘state-of-play’.
Later in the day, Dr. Laura Squire OBE further outlined the status of the ‘Roadmap’ published in January, including the impact the general election had presented. Whilst the election has slowed some of the conversations, the MHRA are still committed to laying the post-market surveillance (PMS) Statutory Instrument (SI) by the end of the year, including the provision of another short consultation on the content and scope of international recognition.
With the new SI being slated for parliament by the end of the year, Mega Iyer (Thermo Fisher), Cait Gatt (Boston Scientific) and Mike King (IQVIA) provided some insights as to how PMS might be handled in the future from a manufacturer’s perspective. This additionally included discussions on the potential role of real-world evidence and the impact of software and AI to generate and interrogate world data.
Innovation was a big theme in 2023, with the start of the pilot for the Innovative Devices Access Pathway (IDAP). At this years’ conference, stakeholders from across this programme described their experiences so far, now that it is nearly 18 months since its inception. Dr. Iain Miller (Presymptom), as one of the eight companies included in the pilot, talked about the process and the value he has derived from it. Further regulator/government insight was provided by Heather Hobson (Office for Life Sciences), Dr Helen Compton (NIHR) and Rebecca Owens (NICE).
Continuing the theme of software and AI, Dr. Roberto Liddi (NuraLogix) and James Dewar (Scarlet) described how software and AI can be used safely within the bounds of the HealthTech regulations. Scarlet, as a conformity assessment body, specifically tasked with review and certification of software, juxtaposed the ambitions of industry, successfully describing how momentum and speed can be achieved in regulation of AI.
Moving on to an international theme, the conference was delighted to host discussions from Switzerland (Daniel Delfosse from Swiss Medtech) and the United States (Erin Cutts from the US FDA). Their input was extremely valuable, particularly as the FDA have been hosting the International Medical Device Forum (IMDRF) in 2024 and Switzerland have important programmes ongoing to develop international recognition processes. Tammy Steuerwald (Roche Diagnostics), added to the discussion by describing how her company has successfully used reliance mechanisms in the recent past, to streamline timeframes for placing products on the market.
As a final session, Sue Spence (Qserve), Adam Spink (8foldGovernance) and Diogo Geraldes (Veeva Systems), discussed the opportunities afforded regulatory professionals now and in the future. They agreed that the role of the regulatory professional is changing as a result of new processes, but that these changes ensure that regulatory affairs will be at the forefront of business for years to come.
Importantly, the conference had plenty of networking opportunities. The dinner and coffee-breaks were noisy affairs, which surely ensured that experiences were shared. Additionally, sponsorship by Compliance Solutions Life Sciences, Costello Medical, Element (RegNav), Kiwa, Revolve Healthcare, Solventum and McDermot Will and Emery, gave delegates that chance to speak to industry-wide experts, hopefully expanding knowledge and business relationships.
Another busy first day of the ABHI UK HealthTech Conference, which provided the perfect lead in for day two, covering market access and procurement. We heard from speakers across the health spectrum. The day was kicked off by an excellent keynote address from Alastair McLellan (HSJ) where we were privilege to his knowledge of the complexity of the NHS politically and practically. Steve McManus (Trust CEO) and Adam Doyle (ICB CEO) provided us insight into the NHS landscape as it is evolving, and the challenges system leaders are facing on a daily basis.
We then heard from Royal Colleges and clinicians (Professor Sarah Coupland, Professor Andy Metcalfe and Dr Stephen Harden) about the future of their specialties, digitisation, AI and robotics delivering productivity, efficiency and outcome improvements, and how to gather the evidence to assure and reassure these benefits.
Professor Bola Owolabi provided us with a sobering reminder of health inequalities and the financial case for change as well as the moral one, along with how industry could support this agenda, something ABHI is committed to as one of its priorities.
We concluded the morning with an overview from Mark Chapman at NICE as to how the Institute is evolving its programme of work when it comes to HealthTech Assessments. There is much going on here, some of which is proving very challenging. We continue to engage robustly on this.
The afternoon started with a very lively discussion about value-based healthcare and value-based procurement and what it means for medical devices, diagnostics and digital health solutions. We heard from both the NHS procurement professionals, Adriana Duree from NHS Supply Chain and Hamza Hussein, from SBS, along with colleagues from industry, Shona Macdonald form Convatec, Micheal Shenouda from Open Medical, Mike Cullen from BBraun and Jayne Bailey from Cepheid.
We could not hold a day about market access in the UK without specifically calling out innovation and what the system is doing to improve adoption and spread. David Lawson from the DHSC talked through some of the key initiatives of the MedTech Strategy aimed at addressing these issues. Stuart Monk from The Health Innovation Network highlighted how they are working with the NHS and suppliers on a practical level to support innovation.
The day drew to a close with presentations from Karen Mayor at DHSC on their Design for Life programme, that is all about moving to circular economy; watch this space for the publication of the Design for Life Roadmap. Our final speaker was Wendy Rayner, who had arguably travelled the furthest (sustainably by train) to share with us not only how Scotland and the other devolved nations are working closely to harmonise sustainability requirements, but also to highlight some of the specific work they are doing on plastics and their Civtech initiative.
All in all, a brilliant second day, with amazing speakers and audience participation.
As previously mentioned, over 50% of delegates attended both days, proving that the overlaps between regulatory and business are becoming increasingly blurred. Understanding how regulatory merges with the NHS, individual hospitals and the wider health and care ecosystem, is critical to today’s successful HealthTech manufacturer.
Preparations are already underway for the 2025 conference, but for now, ABHI is reflecting on the successful culmination of another impactful event.
Phil Brown, Steve Lee & Luella Trickett