What does it take to certify the UK’s first AI tool for predicting hospital-acquired infections? Sanome’s MEMORI has just become the first UK-built software to secure CE marking as a Class IIb device under MDR. For a startup, tackling such a high bar is no small feat, particularly when proving benefit in early-warning systems where harm is prevented before it happens. In our latest blog, we unpack how Sanome achieved this milestone, with Hardian’s regulatory team providing the strategic guidance to strengthen evidence, anticipate regulator pushback, and keep the process on track. Read the full blog here ➡️ https://lnkd.in/ehPm8Ndf Need support with complex regulatory submissions? Contact Hardian today ➡️ https://lnkd.in/ecUMAN9t
Hardian Health
Business Consulting and Services
Haywards Heath, England 4,560 followers
Software & AI as Medical Device consulting
About us
We've helped over 150 software and AI medical devices get to market. Harness regulatory and market access excellence through our consultancy services by experienced consultants and clinicians within the Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD) industry. We are a full stack consultancy: - Target Product Profiling and Value Propositions - Streamlined and agile FDA and CE/UKCA marking certification - Quality Management System design for software developers - Support against all ISO & IEC standards (13485, 14155, 14971, 62304, 82304, 27001, 42001 and more...) - Trained ISO auditors - mock audits and internal/external audit preparations - Notified Body and FDA engagement - Health economic modelling - budget impact and cost-effectiveness/cost-utility - Market access strategy and competitor analysis - Clinical evidence, clinical validation and post market clinical follow up - UKRP and PRRC functions - Intellectual property management - Investor due diligence Got a regulatory problem? We can fix it! Newsletter: https://www.hardianhealth.com/newsletter Contact us: https://www.hardianhealth.com/contact
- Website
-
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, scientific publication, due diligence, AIaMD, clinical investigations, ISO standards, UK DTAC, and quality management systems
Locations
-
Primary
Get directions
21 Perrymount Road
Haywards Heath, England RH16 3BA, GB
Employees at Hardian Health
-
Stephen Carter
Intellectual Property strategy & management for technology start-ups and scale-ups | 'Investment ready' IP strategy aligned with business goals |…
-
Mike Pogose
Director of Quality Assurance and Regulatory Affairs at Hardian Health — Innovation Management | Non-Executive Director | Quality Assurance |…
-
Ben Howes
Bridging Healthtech Software Engineering & Regulatory Excellence | SaMD/SiMD | ex-Founder, Advisor, CTO
-
Sarah Bell
Operations Manager at Hardian Health | She/Her/Hers
Updates
-
Hardian Health reposted this
Do you find yourself asking, 'Do procurement teams even see this as a priority worth their limited budget?' You know that getting that initial approval is just the start. Securing adoption is another. Regulators, clinicians, and payers want more than features. They want proof that your software delivers real value. That means showing how your product tackles a recognised priority by reducing clinical workload, cutting costs, improving capacity, or driving better patient outcomes. Framing your product around these priorities is what moves it from a nice-to-have to a must-have in procurement decisions. If you’re unsure how to build that value case, ask Hardian. We help define your product’s promise so it resonates with regulators, clinicians, and health systems. Need support with your Market Access strategy? Get in touch ➡️ https://lnkd.in/ecUMAN9t
-
Do you find yourself asking, 'Do procurement teams even see this as a priority worth their limited budget?' You know that getting that initial approval is just the start. Securing adoption is another. Regulators, clinicians, and payers want more than features. They want proof that your software delivers real value. That means showing how your product tackles a recognised priority by reducing clinical workload, cutting costs, improving capacity, or driving better patient outcomes. Framing your product around these priorities is what moves it from a nice-to-have to a must-have in procurement decisions. If you’re unsure how to build that value case, ask Hardian. We help define your product’s promise so it resonates with regulators, clinicians, and health systems. Need support with your Market Access strategy? Get in touch ➡️ https://lnkd.in/ecUMAN9t
-
Hardian Health reposted this
“How do I demonstrate that my SaMD solves a real NHS problem?” It’s a common challenge for health tech developers. Even with strong tech, adoption won’t happen unless procurement teams and clinicians see a clear unmet need. If you find yourself asking something similar, why not ask Hardian? We guide companies to align business cases with real clinical and economic needs, identifying the unmet need and helping you stand out to procurement teams and investors alike. In our latest blog, "How to ensure your product solves a real NHS problem," we explore why showing this alignment is the first step toward adoption. Read the blog here ➡️ https://lnkd.in/eNX7TKCZ Need support with your Market Access strategy? Get in touch ➡️ https://lnkd.in/ecUMAN9t Or reach out to our Strategy and Market Access team: Annemijn Eschauzier, Daniel R., and Marc Barlow
-
-
“How do I demonstrate that my SaMD solves a real NHS problem?” It’s a common challenge for health tech developers. Even with strong tech, adoption won’t happen unless procurement teams and clinicians see a clear unmet need. If you find yourself asking something similar, why not ask Hardian? We guide companies to align business cases with real clinical and economic needs, identifying the unmet need and helping you stand out to procurement teams and investors alike. In our latest blog, "How to ensure your product solves a real NHS problem," we explore why showing this alignment is the first step toward adoption. Read the blog here ➡️ https://lnkd.in/eNX7TKCZ Need support with your Market Access strategy? Get in touch ➡️ https://lnkd.in/ecUMAN9t Or reach out to our Strategy and Market Access team: Annemijn Eschauzier, Daniel R., and Marc Barlow
-
-
Are you going to the Economist Impact AI in Health Summit this week? Our Managing Director Dr Hugh Harvey, is! Hugh will be joined on a panel by Sandra L J Johnson from the University of Sydney, Jamie Cox from Scarlet, and David Novillo Ortiz, PhD, from the WHO, and moderated by Natasha Loder from The Economist to discuss how regulation can deliver both transparency and speed for Integrating AI systems into clinical practice. 📅 1 October, 16:40 BST 📍 London To gain expert insights into what effective governance looks like and how post-market surveillance will shape the future of AI in healthcare, be sure to join the session! Full programme: https://lnkd.in/eN7P4beT
-
-
Hardian Health reposted this
HEOR at Hardian Health are hiring! We are looking for a health economist who’s passionate about health tech and keen to help build a team. Fellow health economists - please spread the word! Full job description and application form: https://lnkd.in/eGw_nCve
We're growing our Health Economics and Outcomes Research (HEOR) team with an exciting new job opening for a Consultant Health Economist. One of the most important 'barriers' to AI adoption in health is not regulatory compliance or clinical evidence - it's proof of financial impact. Health economics is vitally important in helping provide evidence that AI can have positive financial effects, either cost-releasing or cost-saving. Time after time, hospitals get stuck with a business case that doesn't add up - and assessment bodies such as NICE reject or defer their recommendations of new technologies pending more robust evidence of financial benefit. Come join us and help get healthtech into healthcare! Apply here: https://lnkd.in/eqqQUj3i
-
Hardian Health reposted this
Often med tech companies tell regulators one thing about their product and then try and sell something different to customers because they haven't understood the two audiences. Aligning the intended use right from the start with a value proposition that truly resonates with customer is the proper way to do it - and you'd be surprised at how much more traction products get when they are truly serving an unmet need AND regulatory requirements. Not only does this streamline development and regulatory timelines, it aligns your company with customers from the start. Get in touch if you have any questions!
The market access questions you keep asking yourself, big or small, we’ve heard them all. Figuring it out alone can feel overwhelming. That’s where Hardian comes in. Ever wondered, "I have a great product, but how do I make sure my Intended Use and Value Proposition actually align? We know that a clear Intended Use Statement: 🔹 Prioritises safety and effectiveness 🔹 Guides your development plan 🔹 Shapes regulatory strategy, evidence, and market positioning When this is linked to an insight-driven value proposition, it ensures your product addresses a real unmet need better than any alternative, keeping customer value at the centre of every decision. This approach informs your evidence plan, development priorities, and market adoption strategy, giving you a clear path to success from day one. Stop guessing. Start knowing. Ask Hardian. Get in touch today ➡️ https://lnkd.in/ecUMAN9t
-
Hardian Health reposted this
When it comes to AI in medical imaging, few explain the stakes more clearly than Dr. Dr Hugh Harvey—radiologist-turned-regulatory expert and Managing Director at Hardian Health. In this video, he breaks down CADt, CADe, and CADe/x—and explains why CADe/x systems offer the most clinical value, but face the greatest regulatory hurdles (often taking up to two years for clearance). Most AI tools today are CADt or CADe - faster to clear, but limited in scope. Few reach CADe/x: delivering diagnostic outputs that radiologists can directly integrate into their decision-making. Reaching CADe/x requires more than strong detection algorithms. It demands: ▪️ Evidence & validation: It’s not enough to show detection accuracy. You must generate robust clinical trials, peer-reviewed publications, and real-world performance data to validate diagnostic claims. ▪️ Regulatory approval: Claims must be explicitly tied to intended use, and the evidence submitted needs to meet the stringent standards of regulators. ▪️ Integration into clinical workflow: To be useful, the system must slot seamlessly into existing PACS, reporting systems, and radiologist workflows without disruption. ▪️ Trust & transparency: Publishing scientific evidence, open methods, and validation results help institutions trust the system beyond just regulatory clearance. That’s the philosophy behind icometrix’s #icobrain platform. CE-marked, FDA-cleared, backed by extensive peer-reviewed research, and built to integrate smoothly into radiology workflows, #icobrain supports faster, more confident, clinically actionable decisions. As Dr. Dr Hugh Harvey emphasizes, the true benchmark is “diagnostic trust.” Very few #AI tools achieve it. icobrain already has. Hardian Health advises healthcare tech innovators on clinical strategy, regulatory clearance, health economics, IP, and more.
-
One of the biggest challenges we see is teams who know their software inside out, but lack a deep understanding of the regulatory requirements needed for approval. As our Director of Technology, Ben Howes explains, true success comes from working with experts who can bridge both worlds – combining engineering rigour with regulatory expertise – to deliver trusted, certified medical devices to market.