Last month we hosted our third Health Tech Summit, bringing together our healthtech community at the London Institute for Healthcare Engineering for an afternoon filled with engaging discussions, expert insights, and canapés with a view!

This year’s summit was focused on key themes including the role of venture capital in healthtech, regulatory challenges for AI in medical devices, and the UK's innovative approaches to integrating digital health solutions into the NHS.

At Hardian, we see first-hand how difficult juggling, acquiring funding, gaining regulatory compliance and staying on track with commercial goals can be for startups. It is our hope that with our Health Tech Summits, having the opportunity to hear from leading healthtech innovators and NHS leaders to investors and academic researchers, everyone leaves with practical, actionable insights that can support on the journey.

Where is the money?

Over the past 12 months, funding, particularly venture capital funding, has been a sensitive topic in the healthtech community. Partially because many people have not been able to acquire the funding they need for various reasons. We were lucky enough to have Vishal Gulati of Recode Ventures provide a comprehensive overview of the VC landscape in healthtech.

We know that venture funding plays an important role in the progression of the healthtech industry, particularly by funding high-risk, high-reward companies. Investors often look for companies that exhibit exponential growth, not necessarily those with the highest likelihood of success. In fact, the ideas that seem “crazy enough” are often the ones that attract venture capital, as these companies have the potential for significant returns, even if they carry a high risk of failure.

Vishal introduced the concept of data flywheels – companies that harness data to drive continuous innovation. The cyclical nature of data generation enables rapid scaling, making such businesses particularly attractive to venture capitalists.

If you want some insights into where, globally, your best chances of getting funding are, the United States far outpaces Europe in both the number of healthtech companies and money available. Moreover, due to the complex regulatory landscape in the UK and Europe, particularly around AI and medical devices, it is becoming increasingly challenging for companies to acquire the necessary regulatory requirements, deterring some investors.

Despite these hurdles, healthcare startups, especially those integrating AI solutions, continue to be a major focus for healthtech investors so all is not lost!

Everything you need to know about the EU AI Act

Launched in August 2024, the EU AI Act is the first comprehensive law aimed at regulating AI. Inma Perez Ruiz from BSI offered an in-depth look at the EU AI Act and its implications for AI-enabled medical devices. The AI Act introduces a range of obligations for developers that go above and beyond compliance with the Medical Device Regulation (MDR), ensuring robust data governance and risk management.

A key element of the new EU AI Act is the risk management requirements under Article 9. Risk management is continuous and must be conducted throughout the AI system’s lifecycle, focusing on potential risks to health, safety, and fundamental rights. AI systems also need to undergo real-world testing to ensure safety and effectiveness.

Data governance practices are another critical element. Developers must ensure that their data is representative, accurate, and complete. High-risk AI systems that process sensitive data , such as genetic or biometric data, must implement additional safeguards. We have broken down the Act in this blog so that developers can ensure they are compliant with these new regulations and aligned with these standards now.

Wrestling with risk in AI medical devices

Hannah Richardson from Microsoft Research gave us a fascinating look at the evolving role of generative AI (GAI) in healthcare. While GAI models open the door to exciting possibilities - like generating synthetic content for medical devices - they also come with new risks.

One major issue is that traditional regulations, like the EU MDR, weren’t designed for the constantly changing nature of GAI. These frameworks were built around static code and fixed datasets, but GAI systems keep learning and adapting, making risk management far more complicated.

Some of the risks include inaccurate content generation, automation bias, and cybersecurity threats like data poisoning. To tackle this, risk management needs to be transparent, with human oversight and strong ethical considerations. Red teaming (where developers simulate system failures or misuse) and early impact assessments are critical steps to catch potential issues before they escalate.

On top of that, integrating ISO and NIST standards is key to keeping these systems safe and compliant as they evolve.

IDAP’s fast lane

David Grainger from the MHRA introduced the Innovative Devices Access Pathway (IDAP), a pilot programme designed to make patient access to cutting-edge medical devices quicker and easier. Launched in 2023, IDAP brings together key players like MHRA, NICE, NHS England, and others to focus on unmet clinical needs within the NHS.

Eight devices have already been selected for the pilot, including a blood-based biomarker for Alzheimer’s and an AI-powered tool for predicting COPD. The goal is to fine-tune these tools and build a comprehensive pathway for medical devices across the UK.

One of the programme’s key elements is the Target Development Profile (TDP) tool, which helps developers align with IDAP partners and map out evidence generation. There’s also Joint Scientific Advice (JSA) for regulatory feedback, and the Access Forum, a platform where stakeholders collaborate on strategies for clinical integration and market access.

For UK medtech innovators, IDAP is a real opportunity – a clearer path to market and more collaboration with developers, regulators, and healthcare providers.

Moving with the times

In the past two years, the National Institute for Health and Care Excellence (NICE) has significantly advanced its digital health efforts, led by the newly established Office for Digital Health. NICE’s Farhan Ismail shared some of the key projects and frameworks that have been launched to support the adoption of digital health technologies and to position NICE at the forefront of healthcare innovation.

They have created the Evidence Standards Framework, a global initiative designed to standardise evidence generation for digital health technologies. NICE employs the ESF across multiple programs and there is ongoing work to keep it updated, notably generative AI has been considered as a potential addition to the ESF.

As well as this, NICE has introduced the AI and Digital Regulations Service (AIDRS), a comprehensive platform that offers regulatory guidance for AI and digital health technologies. AIDRS aims to provide accessible advice on compliance, transparency, and trust-building, all of which are vital for the successful integration of AI into healthcare.

With AI ever evolving and having a growing influence in healthcare, NICE has published a position statement on AI for evidence generation, marking its increasing role in healthcare delivery. Efforts are underway to develop a specific framework for AI evaluation, with a focus on real-world evidence.

As we all know, there are many challenges that come with the implementation of AI within healthcare settings, but with NICE's expanding initiatives to lay the groundwork for these technologies, we can ensure clear regulatory classifications, robust clinical evidence, and a well-articulated value proposition for each product.

Frameworks with a future

Hamza Hussain from NHS Shared Business Services shared a sharp look at how AI procurement frameworks are helping the NHS integrate new technologies. At the forefront is the framework for stroke AI solutions, which has seen swift adoption across the UK. Companies like Brainomics and Rapid AI are already making an impact, with their diagnostic tools now in use at NHS stroke centres.

Rather than simply meeting compliance, these frameworks are shaping a clearer, more practical path for small and medium enterprises (SMEs) to navigate the often-complicated NHS procurement system, offering them a chance to get their innovations in front of the right people.

The due diligence process ensures suppliers meet critical standards like Cyber Essentials Plus and ISO certifications. While it can be an investment for SMEs, the assurance of safety and reliability in AI products is important - there’s no room for compromise in patient safety.

Looking ahead, the potential for expanding AI frameworks into specialties like cardiology, radiology, and ophthalmology is significant. And it’s not just about technology, there’s a growing focus on social value metrics, aimed at improving the well-being of both NHS staff and patients.

And that’s all from us… for now!

A huge thank you to all our speakers and guests who made our third Hardian Health Tech Summit such a fantastic day.

We hope you came away with some valuable insights into the challenges that digital health companies face on their way to market – and that you left feeling confident that, while the road may be tough, it’s one you can navigate with the right support. And if you ever need that extra bit of guidance, you know where to find us.

If you would like to attend our event next year - only our newsletter subscribers can get tickets, so sign up now. Until 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.

View event photos

Big challenges meet bright solutions at the Hardian Health Tech Summit