Make every penny count with Cost-Effectiveness Analysis (CEA)! CEA is an economic evaluation that assesses the financial impact and health benefits of an intervention compared to alternatives on the market. When a new intervention is clinically superior but more costly, NICE recommends using CEA (as stated in Standard 18 of the Evidence Standards Framework for Digital Health Technologies). CEA showcases value for money by including clinical measures like life years, QALYs, or DALYs. It often uses patient lifetime horizons to capture full outcomes. Developing a CEA involves reviewing the literature, defining the decision problem, gathering real-world data, building the model, analysing results, and testing for uncertainty with sensitivity analysis. Learn more about CEA ➡️ https://lnkd.in/dk8MsXbb #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
Hardian Health
Business Consulting and Services
Haywards Heath, England 3,052 followers
Clinical | Digital | Consulting
About us
We help researchers, industry and investors bring digital solutions to healthcare.
- Website
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http://www.hardianhealth.com
External link for Hardian Health
- Industry
- Business Consulting and Services
- Company size
- 11-50 employees
- Headquarters
- Haywards Heath, England
- Type
- Privately Held
- Founded
- 2018
- Specialties
- medical devices, SaMD, regulation, health economics, intellectual property, clinical trials, scientific publication, due diligence, and AIaMD
Locations
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Primary
21 Perrymount Road
Haywards Heath, England RH16 3BA, GB
Employees at Hardian Health
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Stephen Carter
Intellectual Property strategy & management for technology start-ups and scale-ups | 'Investment ready' IP strategy aligned with business goals |…
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Mike Pogose
Director of Quality Assurance and Regulatory Affairs at Hardian Health — Innovation Management | Non-Executive Director | Quality Assurance |…
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Sarah Bell
Operations Manager at Hardian Health | She/Her/Hers
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Shirley Bonta
Operations and Projects Lead
Updates
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Navigating regulatory compliance is complex, but it doesn’t have to be! Our collaboration with Envisionit Deep AI® demonstrates how our technical and clinical expertise can help to streamline and strengthen regulatory applications, including US FDA. With our guidance, Envisionit successfully established a strong regulatory framework and Quality Management System, crucial for meeting compliance standards. This support refined their evaluation process and market strategy, ensuring their product approval success. We are dedicated to working collaboratively with our clients to navigate regulatory complexities and achieve market readiness. Need support tackling your regulatory challenges? Get in touch ➡️ https://lnkd.in/ecUMAN9t #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth
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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
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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
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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
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Hardian Health reposted this
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
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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
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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
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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
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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