Hardian Health Tech Summit: Lifting the veil on the realities of getting healthtech to market
It’s been a big year for us at Hardian! To celebrate four years of client service, we held our very first Hardian Health Tech Summit event at Havas HQ in King’s Cross. Joined by many of our clients changing the game in the healthtech industry as well as keynote speakers from MHRA and NICE (the big players in UK regulation and evidence standards) we brought together a community of healthtech leaders for everyone to connect, share and learn from the best in the industry.
We say this A LOT but getting healthtech to market doesn’t have to be difficult. If you’ve followed us for a while you’ll know that we’re all about breaking down complexity and making it simple.
So it was crucial for us that our Health Tech Summit Event really focused on bringing the practical realities of getting healthtech to market to life. An open and honest afternoon, sharing real and raw stories of progress within healthtech and first-hand accounts of the good and the sometimes rocky road of bringing digital solutions to market - we even heard about mental health app Koa’s first nail-biting encounter with the MHRA! Here are some of our highlights…
1) Straight from the source: NICE ESF
We were delighted to be joined by Farhan Ismail, Associate Director Office for Digital Health who explained the 2022 NICE ESF updates..
Currently, the most significant challenge for digital health technology (DHT) solution development, deployment and commissioning is generating high quality clinical evidence.
Healthcare is based on evidence, it's driven by standards, and digital should be no different - developers need to be able to look at and create the right kind of evidence for DHTs.
Why is this important? From a company perspective, good evidence helps to inform decision making, as well as giving a competitive edge. For patients, concrete evidence provides confidence in the solution, and ultimately as we move towards a more digital world this means the difference between a DHT being adopted or not.
Luckily for the industry NICE recognised this challenge early on and developed the NICE Evidence Standards Framework (ESF) for DHTs in 2018, with the ambition of encouraging a common language and introducing consistency in the way evidence is generated by DHTs, and evaluated by commissioners.
The NICE ESF is the evidence standards framework that we recommend to digital health manufacturers. Not only is it an important resource for DHT because it provides guidance on the evidence needed for a NICE health technology assessment (HTA), it can also be used by NHS health and care services to help commissioners evaluate and inform DHT commissioning and purchasing decisions.
What’s really brilliant to see is that the recent update aligns with recent regulatory updates (if you attended our Health Tech Summit you’ll have heard these from Johan Ordish, Software Group lead at MHRA). We recently summarised everything you need to know about the NICE ESF update and what it means for DHT - check it out if you still have unanswered questions.
Excitingly, Farhan confirmed that the NICE ESF will be developed as the sector evolves too. We’ll keep you up to speed with updates as they happen, so stay tuned…
2) Honesty and transparency: When the going gets tough
Our clients know that we’re always upfront about the journey ahead, even if it may not be what they expected. For our client Koa Health, this was exactly what they needed to get them back on track to launching their digital mental health app.
Dr Chuk Anyaegbuna, Clinical Service Lead at Koa Health told us all about their moonshot mission to give a billion people an extra five years of quality life by tackling the world's growing mental health crisis. The solution focuses on depression initially, providing app-based CBT to improve patient access to care and free up the time of therapists.
Initially, Koa had registered as a Class I medical device, the lowest risk classification, however when on submission of the clinical evaluation report, the MHRA disagreed with the proposed equivalent device - declaring the submission a “borderline case” and rejecting Koa’s equivalence justification.
Koa reached out to us in early 2022 to help guide their interactions with the MHRA. Our team conducted a thorough review of the solution and intended use to understand the progress made so far. Secondly, to better address MHRA’s concerns, we carried out a thorough systematic literature review of the target market and re-crafted the clinical evaluation report for a new submission.
As one of the most enlightening talks of the afternoon we appreciated Chuck’s openness in sharing Koa’s experience. We hope it showed the founders and developers in the room that with the right partner, bringing healthtech to market doesn’t have to be so complex. Now the Koa team feel confident to navigate the landscape to market and have the know-how to comfortably undertake this process in the future. We’re incredibly excited by Koa’s technology and we look forward to continuing to foster our partnership with them and seeing the impact their product will have on patients.
3) AI technology and health economics analysis: Evidence, evidence, evidence
There is currently very little health economic evidence for healthtech - especially those with AI systems. We’ve been working with AI imaging software company Aidence, to support the health economic analysis of their AI lung cancer nodule detection software.
David King, Project Manager at Aidence delivered a brilliant summary Aidence’s current evaluation programme for the technology, and how we’re helping shape their economic value proposition for the NHS.
Aidence’s AI software is currently regulated as a Class IIb medical device and is licensed for screening and routine practice. Recently they’ve received funding through the NHS Artificial Intelligence Award for Health and Social Care to develop an evaluation programme for their AI technology. With the support of the University of Edinburgh and Hardian, they wanted to drill down into the tangible impact for the NHS. Together we’re evaluating this in several different ways:
Clinical impact study - What difference does the technology make to clinical decision making?
Qualitative research - How do users perceive the technology?
Health economics analysis - What are the associated costs for the NHS?
So how do we answer this crucial question?
We’ve conducted several health economics projects with clients all around the world. How a digital health solution translates into benefits for healthcare services is a really important question. Fundamentally we approach these projects with the goal of providing evidence of the economic impact and financial value for healthcare services. In Aidence’s case, to effectively address this question, we are interrogating the hospital cost impact - is the technology cost-incurring or cost-saving for an NHS site? This is done using what is known as a Budget Impact Model (BIM). This will then allow us to plan out a full cost-effectiveness analysis once data from this and future clinical studies becomes available.
Ultimately, carrying out a health economic analysis will propel Aidence forward in gathering real world evidence to back their economic value proposition, and subsequently develop a business case for the NHS.
With updated frameworks like NICE ESF detailing the evidence required for DHT we do expect the volume of economic evidence for DHTs to grow over the next year. This is especially true for Budget Impact Modelling which is recommended by NICE for most DHTs - you know who to call if you’d like to learn more about our health economics service!
We’d also like to thank our other brilliant speakers; FiveLives who are building digital tools to track and improve cognitive health, Neuronostics who are developing BioEP, a digital biomarker for Epilepsy seizure risk, and Havas for sharing their insights into the the art of storytelling and brand building.
That’s a wrap…
A HUGE thank you to all of our speakers and attendees that attended our very first Health Tech Summit - it may be the first but certainly won’t be the last!
We hope that you were able to take away a deeper understanding of the market access hurdles for health and digital technologies, and you finally had some of your burning questions answered from our team, and our friends at MHRA and NICE.
A full gallery of pictures from the event taken by Jo Scott is available here:
We hope hearing our clients journey’s inspired you on yours - if you need any help on bringing your healthtech to market our inboxes are always open. See you next time…
Hardian Health is a clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
