Hardian Health

🛠️ The FDA has issued a major update for developers of AI-enabled medical devices... The new draft guidance offers practical recommendations to cover every stage of the device lifecycle, from design and testing to postmarket monitoring. It’s the most comprehensive guidance yet, addressing key areas like transparency, bias mitigation, and performance monitoring. The key points for developers are: 🔵 Vendors are being encouraged to prioritise clear and transparent communication about their products, especially for unapproved uses. This includes outlining limitations, providing evidence-based messaging, and highlighting safety considerations. 🔵 The FDA is calling for early and frequent collaboration with sponsors to ensure that development and regulatory submissions align. We’re keen to see how this raises the bar for AI in healthcare. Let’s keep pushing for transparency and patient safety. Read the full guidance here ⬇️ https://lnkd.in/gvSBYQEm

Thank you Marc Lamoureux for publicising the IMDRF "Characterization Considerations for Medical Device Software and Software-Specific Risk", and Johan Ordish for bringing it to my attention today! I had a good look through it, to see how it fits in with our existing practice of constructing intended use statements and software device descriptions, particularly for AIaMD. I'm all for the emphasis on intended purpose/ intended use, but I'm still struck by the various definitions of the foundational information that is "intended use" or "intended purpose" across the EU MDR (and IVDR), the US FDA's different regulations and guidance documents, the ISO standards particularly 14971, and the IMDRF and others' publications. I'm also keen to keep our Hardian Health templates up to the concrete requirements of EU Notified Bodies, UK Approved Bodies, the US FDA (via the eSTAR template), and others' requirements such as Health Canada's and the Australian TGA's. So whilst it's a grey Saturday afternoon here in the English Midlands, a mapping exercise...

Do you know how many AI-enabled medical devices are approved for use in the UK? It’s a simple question but the answer is far from straightforward... That’s why, at Hardian, we’re building HaRi: Hardian’s regulatory intelligence. Still in beta, HaRi is designed to collate publicly available data, creating a clearer view of approved medical devices across jurisdictions. Unlike the FDA’s regularly updated list or the EU’s forthcoming EUDAMED database, the UK’s Public Access Registration Database (PARD) lacks the transparency needed to track AI-enabled devices effectively. Without specific identifiers or clear public records, understanding what’s approved – and for what use – remains a challenge. In our latest blog, we explore: 🔵 Why tracking AI-enabled devices in the UK is so challenging 🔵 How other jurisdictions are setting the bar higher 🔵 What needs to change to make UK regulations fit for purpose Read the blog here ⬇️  https://lnkd.in/e7XDfbW9

We're still riding the wave of Guilford Street Laboratories' (GSL)FDA Breakthrough Designation success! For the GSL team, securing Breakthrough Designation for their proteomic Parkinson’s diagnostic, PD Predict, wasn’t the finish line – it was the starting point. With help from Hardian, GSL's newfound access to FDA resources is helping them map their path to pre-market approval and accelerate product development. This designation has offered them the opportunity to refine their strategies, ensuring PD Predict aligns with the highest regulatory standards. This has led to a sharpened focus on optimising timelines and building a strong foundation for success. Need a partner for your FDA submission? Get in touch ➡️ https://lnkd.in/ecUMAN9t

Attention medical device developers in the EU! The EU's new Health Technology Assessment Regulation (HTAR), which took effect on January 12th, brings significant changes for high-risk medical devices. Designed to improve patient access to innovative health technologies, the HTAR creates a unified framework for evaluating these devices and other health technologies. So, what does this mean for developers? High-risk devices will now undergo Joint Clinical Assessments, evaluating their safety and effectiveness against existing technologies. This process reduces duplication and provides a clearer pathway to market. Developers will also be able to engage early with regulators to align evidence generation with requirements, streamlining approvals and minimising delays. By unifying assessments and fostering collaboration between regulators and HTA bodies, the HTAR aims to accelerate innovative devices while supporting healthcare sustainability. Learn more about what this regulation means for medical device developers ➡️ https://lnkd.in/eAznQ347 

Did you catch our MD Dr Hugh Harvey on the Future Medicine AI podcast? Navigating the complex regulations required to bring AI medical devices to market can be daunting for founders. In this interview, Hugh shares his expert perspective on the challenges and opportunities in healthcare AI and provides invaluable insights on what it takes to bring AI medical devices to market. As well as delving into how best to navigate the regulatory approval process for AI medical devices, Hugh discusses: 🔹 The unique challenges of different AI systems, including generative AI 🔹 What it takes to successfully implement AI in healthcare systems like the NHS 🔹 The future of AI in healthcare and its potential impact 🎧 Listen to the full episode to gain a deeper understanding of how to bring AI solutions to market while prioritising safety and compliance ➡️ https://lnkd.in/dfiuZBWK 

Innovators – do you want to earn the trust of patients, clinicians or commissioners for your #XR product in healthcare? Check out our free #elearning module, created with Institute of Psychiatry, Psychology & Neuroscience, on the research process including design, ethics and data collection. These #elearning modules, part of Innovate UK's Mindset-XR programme, are just one way we are supporting innovators to increase the adoption of XR in the health sector. Start learning: https://buff.ly/41rlTyt The Mindset XR programme works in partnership with Hardian Health, The XR Health Alliance, MQ Mental Health Research, Health Innovation Research Alliance Northern Ireland (HIRANI), Hill Dickinson LLP, Health Innovation South West, Health Innovation North East and North Cumbria, Life Sciences Hub Wales, Digital Health & Care Innovation Centre

💡 What’s the reality of AI adoption in radiography? Members of the Hardian team have co-authored a paper in the Journal of Medical Imaging and Radiation Sciences (JMIRS), exploring how radiographers are using AI tools in practice. Here are our key takeaways: 1️⃣ While AI adoption is growing, there’s still a significant knowledge gap. Clear guidance, education, and training are urgently needed to prepare for more widespread use. 2️⃣ Radiographers emphasised that patient care and safety must remain central to successful AI implementation.  3️⃣ Multidisciplinary teamwork and leadership are essential to integrating AI seamlessly into workflows. At Hardian, our clinically driven, multidisciplinary expertise helps ensure your medical device successfully navigates clinical investigations, has a robust health economic model, and a market strategy that showcases genuine value in real-world healthcare settings. Read the full paper ➡️ https://lnkd.in/ehHT_HvY Need support tackling your regulatory challenges? Get in touch ➡️ https://lnkd.in/ecUMAN9t

How do you navigate the FDA Breakthrough Designation Pathway process with confidence? Guilford Street Laboratories (GSL) did just that with their groundbreaking proteomic blood test, PD Predict - the first of its kind for Parkinson’s disease - by partnering with Hardian. With the regulatory expertise of our team, GSL was able to refine its process to align seamlessly with the FDA’s rigorous standards. Through collaborative sprint sessions and meticulous data planning, the team achieved a submission process so robust that they cleared FDA review without a single non-conformity. This significant milestone not only secured Breakthrough Designation but also reinforced PD Predict – and Guilford Street Laboratories – as leaders in advancing Parkinson’s diagnostics. Need a partner for your FDA submission? Get in touch ➡️ https://lnkd.in/ecUMAN9t

📋 Ready to elevate your QMS game? The final part of our Quality Management System (QMS) blog series dives into the practicalities of implementing and managing a QMS effectively. In part one, we covered the essentials – what a QMS is, why it’s crucial, and how to set one up. Now, it’s time to roll up our sleeves and explore the how-to’s of embedding a QMS into your organisation: 🔵 Learn who your key stakeholders are and their roles 🔵 Understand the timeline for setting up and certifying your QMS 🔵 Discover how to store and manage documented information Whether you’re just starting out or optimising your existing system, this is your go-to guide for navigating the process with confidence. Read part two here ⬇️ https://lnkd.in/e5smhMYJ #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth