Hardian Health

Looking for the secret formula when developing medical devices? It's all about ICER! Incremental Cost-Effectiveness Ratios (ICER) is a metric used to assess the value of healthcare interventions. It compares the cost difference between two treatments (Cost A - Cost B) to the difference in their health outcomes (Outcome A - Outcome B). Why is this important? ICER helps healthcare providers and policymakers determine which treatments offer the best value for money. For instance, if Treatment A costs more but significantly improves patient outcomes compared to Treatment B, the ICER helps justify the additional expense. Understanding ICER is essential for making informed decisions about resource allocation in healthcare, ensuring that funds are spent on interventions that provide the most benefit to patients. Find out more ➡️ https://lnkd.in/eG2qJE5N #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

We can all agree that the rise of generative AI has generated considerable excitement within healthcare… However, despite the enthusiasm, there is still a lack of sufficient scientific evidence to ensure these technologies can be safely implemented in healthcare settings. In our latest blog, our MD Dr Hugh Harvey explores the significant potential of generative AI to transform various aspects of medical practice, such as clinical note-taking and documentation. He also addresses the challenges and realities of integrating AI into healthcare, including: 🔹The current evidence on AI performance in healthcare 🔹The regulatory landscape for AI in medicine 🔹What the future of generative AI and LLM in medicine will look like Read the full blog ➡️ https://lnkd.in/eY_FYeha To learn more about the regulatory landscape of AI in healthcare, contact the Hardian team today ➡️ https://lnkd.in/ecUMAN9t #hardianhealth #regulation #startups #healthtech #digitalhealth

Now, as boring as paperwork can be, here's the files you need to pay attention to ⬇️ The Technical Documentation (TD - AKA the Medical Device Technical File or Medical Device File) is your passport to getting your medical device approved in the EU and UK. It’s the ultimate document that proves your device is safe and effective. What’s in it? Everything from design details and manufacturing processes to risk management and clinical evaluations. This stack of evidence proves to regulators that you’ve covered all of your bases. Submitting a detailed and accurate TD is not just a regulatory requirement—it’s a testament to your commitment to delivering safe and effective healthcare solutions. Ensuring your TD is comprehensive helps streamline the approval process and reinforces your product's credibility in the market. So, make sure that paperwork is in check! Check out our website to learn more about regulation ➡️ https://lnkd.in/ehrRuaa6 #hardianhealth #regulation #startups #healthtech #digitalhealth

What does the #AI industry need to make AI #implementation happen in #medical #imaging and #radiotherapy? You name it, or rather, UN-AIMIT! Are you an employee at an industry that creates or sells AI tools in medical imaging or radiotherapy? We need your views from #everywhere in the world, we would like to hear from different stakeholders within the same company too, so please circulate widely! This is an #anonymous 15-minute survey! https://lnkd.in/eiYNb2KU Thanks for taking part! On behalf of the research team Kicky van Leeuwen Prof. Susan Shelmerdine Nikolaos Stogiannos Dr Christina Malamateniou, Reader/Associate Professor City, University of London for any info or enquiries please contact: nikos.stogiannos@city.ac.uk REC approval: School of Health and Psychological Sciences, City, University of London Research Ethics Committee [ETH2324-2242]. Society and College of Radiographers (SCoR) EFRS European Federation of Radiographer Societies The Royal College of Radiologists AXREM Jan Beger Annalise.ai Qure.ai Charbel Saade, PhD, MBA Juan Gutiérrez Alliende Christina Triantafyllou Ben Huard Radiobotics Ultromics Andrea B. Perspectum Ltd ThinkSono Guerbet Bayer Louise Hillier Jonathan Coupland Philips GE HealthCare Siemens Healthineers Canon Medical Systems Corporation Canon Medical Systems Europe Graham King Shamie Kumar Chad McClennan Catherine Jones Mark Phillips EuSoMII - European Society of Medical Imaging Informatics Hardian Health The British Institute of Radiology European Society of Radiology Lunit Cancer Screening icometrix

Hardian Health x MIAC AG; a collaboration you didn't know you needed! We have partnered with MIAC, a leading EU digital CRO, to help bring clinically evidenced imaging-based devices to market. With knowledge across medical imaging, SaMD validation, and a skilled in-house reader team, MIAC specialises in designing and conducting validation studies for SaMDs. Together we will work on mutual projects, with Hardian providing regulatory, HEOR and go-to-market support for companies that use MIAC for their clinical studies. Want to know more about our collaboration with MAIC and be the first to hear about exciting Hardian news? Sign up to our newsletter ➡️ https://lnkd.in/eaF6MMWs #hardianhealth #regulation #startups #healthtech #healtheconomics

Interested in the cutting edge of regulatory science for AI medical devices? Want to better understand NICE EVA, or NHS procurement? Or just fancy networking with people passionate about healthtech? The Hardian Health Tech Summit is coming soon. Tickets will only be available to our newsletter subscribers, out on the 1st of each month. Details to follow. https://lnkd.in/eaF6MMWs

Big changes are on the way for the UK medical device industry… The Medicines and Healthcare products Regulatory Agency (MHRA) has rolled out new guidance for the regulation of AI as medical devices (AIaMD). The draft policy uses existing international regulations in collaboration with guidance authorities in Australia, Canada, the EU, and the USA to accelerate patient access. However, manufacturers can still opt for the UKCA marking for the UK market. While leveraging trusted international approvals helps reduce the number of redundant assessments, it’s essential that the unique risks and key aspects of AIaMD are thoroughly evaluated, and policies continue to prioritise patient safety. Read more ⬇️ https://lnkd.in/d4nWf3QP To stay up to date with the medical device regulation space, subscribe to the Hardian Health newsletter ➡️ https://lnkd.in/eaF6MMWs #hardianhealth #regulation #startups #healthtech #digitalhealth

How can you protect your ideas in a competitive market? Navigating the world of Intellectual Property (IP) can be tricky, with competitor patents often being a primary concern for developers of SaMD. While that is an important area of IP to consider, Stephen Carter, our Senior Consultant on Intellectual Property, highlights an often overlooked but crucial aspect: IP ownership. IP ownership is vital for preventing potential disputes and ensuring your business's long-term success and so when working with clients, this is the first thing we dive into to ensure clear agreements with all parties involved for the best business outcomes. If you need support conducting comprehensive searches, identifying potential patent blocks, and establishing clear ownership agreements, contact our team today ➡️ https://lnkd.in/ecUMAN9t Listen to Stephen explain further ⬇️ #hardianhealth #intellectualproperty #startups #healthtech #digitalhealth

For companies in digital health, understanding Software as a Medical Device (SaMD) is important. SaMD generally refers to software that performs medical purposes independently of any hardware. It is used in healthcare to diagnose, treat, and monitor patients. Take it from us, obtaining regulatory approval for SaMD requires thorough research and strict adherence to standards. To avoid legal issues and ensure patient safety, it is essential to establish clear regulatory pathways and engage with authorities early to ensure your software meets all safety and efficacy standards. To find out more about SaMD's, contact the team today ➡️ https://lnkd.in/ecUMAN9t #hardianhealth #regulation #startups #healthtech #digitalhealth

If you think the FDA won't remove your product from the market after approval, think again... The FDA has issued a Class I recall for Tandem’s t:connect iOS mobile app, which is used in conjunction with the company's insulin pump. This recall follows 224 reported injuries and affects over 85,000 devices. A Class I recall is the FDA's most urgent type, indicating that using the device could lead to serious injury or death. A critical software flaw in the app caused it to crash and restart repeatedly. This constant cycle led to excessive Bluetooth communication, rapidly draining the pump's battery and causing unexpected shutdowns. As a result, insulin delivery was interrupted, potentially leading to dangerously high blood sugar levels. All developers and manufacturers of Software as a Medical Device (SaMD) should be aware that the FDA can and will remove unsafe devices from the market as a measure to protect patient safety. Read the full story ⬇️ https://lnkd.in/eSmjs6vD Sign up for the Hardian Health newsletter to stay up to date with all things SaMD ➡️ https://lnkd.in/eaF6MMWs #hardianhealth #regulation #startups #healthtech #digitalhealth