AI, Innovation and Regulation: Solving Healthtech Puzzles at the Hardian Healthtech Summit
Time has certainly flown by since our last Healthtech Summit in September 2022!
A few weeks ago we gathered again at the Havas HQ in King's Cross for our second annual Hardian Healthtech Summit. We brought together a diverse community of healthtech leaders across academia, the NHS, investors, and industry titans, as well as many of our valued clients to share their stories and learn from each other.
At Hardian, we know that healthtech is hard - just like solving a Rubik’s cube. There’s no denying it’s complex and often trying to get your healthtech solution to market can feel like a long, difficult journey. Yet, just like a Rubik's cube, it's not an impossible puzzle. Many have cracked the code and all you need are the right tools in your arsenal to navigate the various obstacles to reach your goals.
It was crucial for us that our Healthtech Summit focused on some of the challenges that many startups face on their path to market and the ways in which they can overcome them. It was an afternoon of candid conversations, sharing real and raw stories of progress within healthtech and offering firsthand accounts of the highs and lows encountered while bringing digital solutions to the market.
If you weren’t able to make it to the summit, here are some of our highlights…
Bring out the big players - MHRA
We were pleased to kickstart the afternoon with our keynote speaker Dr. Paul Campbell, Head of Software and AI at Medicines & Healthcare products Regulatory Agency (MHRA) who broke down some of the key questions everybody wants answers to regarding the regulation of AI in healthcare.
AI is a huge buzzword in the healthcare world and people either love it or are apprehensive about it. Dr Campbell highlighted the importance of evaluating and regulating even the most seemingly basic of software and AI. The MHRA is on top of this as they ensure software updates and changes are thoroughly evaluated, especially in areas like cybersecurity and AI.
However, the challenges associated with AI do not stop once it’s been regulated. MHRA places a high priority on addressing ongoing concerns like the bias, drift and the quality of input data in AI applications. Without guarantee of high-quality input data, the safety and efficacy of AI-driven healthcare solutions cannot be ensured in the wild.
All in all, the MHRA acknowledges both the challenges and opportunities and evolving nature of the regulatory landscape. They stress the critical importance of collaboration and adherence to global standards to ensure the safe and effective utilisation of AI in healthcare. The MHRA remains committed to collaborating with the industry to confront these challenges, ensuring that we harness the full potential of AI in healthcare. Which is great to hear!
“Sometimes you have to kiss some frogs before you find your Prince” - Hardian Client showcase
Who is Hardian without our valued clients? We were lucky enough to have multiple Hardian clients come on stage to share their remarkable journeys, the challenges they faced during various stages of their regulatory, clinical and commercialisation pathways, and how they have worked to overcome them.
First up was MyCardium AI, whose software is delivering better diagnosis through precision AI for Cardiac Magnetic Resonance Images. The MyCardium team shared a similar problem to many companies in the space – overcoming skill gaps within the founding team. General Manager Michael Walker noted that the company was founded by visionary academics with limited regulatory experience. This led MyCardium to seek assistance from outside sources, and at Hardian we were able to conduct a comprehensive gap analysis to support them in evaluating their journey so far and the steps they needed to take to help them achieve their regulatory goals.
Anthony Williamson, CEO of Alphabiomics, also candidly addressed this issue on stage. We recently supported the team in building a robust go-to-market strategy to get their first product, RxSelex™, a microbiome-based predictive diagnostic tool for patients with inflammatory bowel disease (IBD), to market. Read all about how we did this in our case study blog.
When searching for companies to support you on your journey to market, it is important that they are doing exactly that. Supporting you. Finding a company that seamlessly aligns with your goals and has the expertise to get you there can be difficult, it can take some trial and error - kissing some frogs - before you find a company that works best for you - your prince!
We are firm believers that our clients are developing some truly remarkable healthcare solutions. From IESO Health, who connects patients with therapists through text-based communication to address mental health conditions, to Spotlab who are creating a platform for health data capture through images and data analysis to enhance healthcare accessibility globally. Or even, Okko Health who are tackling macular degeneration, the leading cause of blindness, with a game-based application facilitating ongoing monitoring of visual acuity.
We were lucky enough to have Andrew Welchman from IESO Health, Miguel Luengo-Oroz from Spotlab, and Lucy Rogers from Okko Health share insights into their products and the challenges they've faced and are overcoming. While their solutions differ significantly, all companies share similarities in some of the milestones they aim to hit.
Both Okko Health and Spotlab found themselves in a similar position, transitioning to the new Medical Device Regulation (MDR) and requiring guidance on how to get there. Between the mountains of paperwork and documentation, our clients shared that working with Hardian provided a “human-touch” to the entire process. Simplifying the complex regulatory language, bridging the gap between technical jargon and actionable steps. A process which enabled IESO Health to develop clinical-grade products while maintaining a patient-centric approach and aided Spotlab to obtain FDA 510(K) clearance.
The “Standing Together” project
Finally we had the privilege of hearing from Professor Alastair Denniston and Dr. Xiao Liu, leaders of the National Health Research and Policy Group at the University of Birmingham. They shared some of their latest research findings, shed light on the importance of responsible innovation in AI and healthcare as well as delved into their “Standing Together” project.
Professor Denniston shared the three fundamental pillars that underpin their work: safety, equity, and effectiveness. These pillars ensure that not only is the use of AI in healthcare positively impacting the lives of both patients and healthcare professionals, but also, working to address algorithmic bias while promoting fairness to prevent the exacerbation of health inequalities.
Dr. Xiao Liu delves into the issue of algorithmic bias in AI systems used in healthcare a little more. Biases in AI can lead to harm and worsen the health disparities that the technology was created to solve. Whilst this bias can infiltrate AI systems at the various stages of development, the team at the University of Birmingham are focusing on data as a primary source of bias.
The Standing Together project aims to tackle algorithmic bias through the development of standards that ensure AI technologies are supported by diverse, inclusive and generalisable data. This initiative aligns seamlessly with established regulatory guidelines and aims to set standards for transparently documenting and mitigating bias. This includes consultations with stakeholders from over 58 countries and close collaboration with organisations like the MHRA to systematically evaluate and assess safety throughout the lifecycle of AI technologies.
And, that's a wrap…
We want to extend a massive thank you to all of our speakers and guests who attended our second annual Healthtech Summit!
We hope we were able to answer some of your questions surrounding the different hurdles digital health companies face when trying to get their products and solutions to market, and we also hope you were able to see that whilst it is hard, it’s not impossible! All you need is the right help, and for that our inboxes are always open. See you next year!
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.
