Hardian Health

The Hardian Health Tech Summit is now SOLD OUT. If you'd like to get on the waitlist, simply leave your email at the registration page, and we will let you know if a ticket becomes available. Don't want to miss out next time? Sign up to our newsletter: https://lnkd.in/eaF6MMWs https://lnkd.in/eQ2_-zGu

Want to outshine your competitors? Well, you need a robust pre-market competitive analysis! By evaluating your competitors' products, services, and go-to-market strategies, you can identify their strengths and weaknesses relative to your own. This is essential for your product development and launch strategy, helping you articulate your competitive advantage, shape your value proposition, and refine your pricing strategy. Start by gathering comprehensive information on current and potential competitors, including product profiles, performance, and pricing strategies and then use these insights to differentiate yourself. Not sure where to start? Contact the Hardian team today to leverage our deep knowledge and tested strategies! ➡️ https://lnkd.in/ecUMAN9t Learn more about pre-market competitive analysis ➡️ https://lnkd.in/e4Q7VGTX #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

The Hardian Health Tech Summit is now SOLD OUT. If you'd like to get on the waitlist, simply leave your email at the registration page, and we will let you know if a ticket becomes available. Don't want to miss out next time? Sign up to our newsletter: https://lnkd.in/eaF6MMWs https://lnkd.in/eQ2_-zGu

How can you secure value in your business through intellectual property? Understanding your company’s current position and ownership assets is essential. Stephen Carter, our Senior Consultant on Intellectual Property underlines that the first important step is an IP audit. This can be a light touch or an in-depth analysis, depending on your needs. By evaluating your existing IP assets, ownership status, and related agreements, we ensure everything is in place for your business's growth. We also forecast future asset creation to capture and protect new IP effectively. If you need support with your IP strategy, contact Hardian today to safeguard your business's future. ➡️ https://lnkd.in/ecUMAN9t Listen to Stephen explain further ⬇️ #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

Keep calm, and don't forget to carry out your post-market clinical follow-up… Post-market clinical follow-up (PMCF) is a systematic, proactive, and documented process where medical device manufacturers collect clinical data based on the intended use of their devices. The goal is to confirm the clinical performance and safety of the device throughout its lifecycle while it is on the market. PMCF also helps determine the acceptability of identified risks and detect emerging risks based on factual evidence. This continuous monitoring is crucial for ensuring ongoing patient safety and regulatory compliance. By gathering and analysing real-world data, manufacturers can address any potential issues early and maintain the high standards required for medical devices. Find out more ➡️ https://lnkd.in/eqSjhTaw #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

It goes without saying that strategic planning is crucial for both regulatory approval and market success. We cannot underestimate the key role that both a Minimally Viable Product (MVP) and a Minimally Marketable Product (MMP) play in achieving market success. Believe it or not, understanding your target market should happen before you begin your regulatory journey. An MVP ensures essential regulatory certification by focusing on safety and effectiveness, while an MMP builds on the MVP by adding market-specific features, making your product attractive to buyers and valuable to users. In our latest blog, our Director of Quality Assurance and Regulatory Affairs, Mike Pogose, delves into: 🔹 The importance of MVP and MMP 🔹 The right time to start MVP and MMP evaluations 🔹 How to make a successful transition from MVP to MMP While it’s easy to focus solely on gaining regulatory approval, failing to consider market fundamentals at the same time can lead to issues down the line. Want to know more? Read the full blog ⬇️ https://lnkd.in/eaetNZ8W For expert guidance on MVP and MMP strategies, contact the Hardian team today ➡️ https://lnkd.in/ecUMAN9t #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

It's time for machine learning-enabled medical devices to provide a little more clarity... The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guiding principles for transparency in machine learning-enabled medical devices (MLMDs). These principles are designed to ensure safety, effectiveness, and clarity by providing essential information on device use, performance, and decision-making logic through: 🔹Emphasising clear communication with healthcare professionals and patients 🔹Focusing on transparency throughout the device lifecycle 🔹Improving trust and informed decision-making in using AI While addressing the significant concerns around the opaque nature of AI systems, it's essential that safety and effectiveness are not compromised by undisclosed risks or biases. Transparency is key to fostering trust and confidence in AI healthcare technologies, which should remain under critical examination. Read more ⬇️ https://lnkd.in/dzUFxKaR 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 help address uncertainties in health economic models? Uncertainty in health economic models will always be a concern as they aim to simplify real-world scenarios and can stem from various parameters, methodologies, and model structures. To manage this, it’s important to use sensitivity analyses as recommended by NICE. There are two types of sensitivity analyses: ➡️ Deterministic: this varies the inputs of individual parameters (one-way or multi-way) and uses tornado plots for results. ➡️ Probabilistic: this assigns distributions to individual parameters and runs the model multiple times to capture variation. At Hardian, we ensure our models are robust and aligned with best practices, giving you confidence in your economic value proposition. Want to ensure your health economic model accounts for all uncertainties? Contact our team today ➡️ https://lnkd.in/ecUMAN9t Learn more➡️ https://lnkd.in/ewedTsnD #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

Missed out on HLTH Europe? You’re in the right place! After Europe’s largest health innovation event discussing the industry's future, the Hardian team were left with a lot of food for thought... Here are some of our key takeaways from the event: ➡️ The role of large language models was a big topic, with discussions weighing up the potential of (or lack of) AI in healthcare and concerns around their regulation. ➡️ Clinical evidence seemed to fly under the radar this year. Whilst new technology is always fun to talk about, it’s the evidence that ensures devices do what they claim and keep patients safe. ➡️ Last but not least, our favourite: regulations. They might not be glamorous, but regulations are essential. At Hardian, we don’t stop talking about them, and we would have enjoyed hearing more discussions about them this year. Keen to hear more? Read the full blog here ⬇️ https://lnkd.in/eRtAUaYj #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth

What keeps medical devices safe and effective? Regulatory requirements and quality management systems (QMS) are important parts of ensuring the quality of medical devices we see on the market. It goes without saying that rigorous testing and evidence-based validation are crucial in healthcare, given that healthcare directly impacts people's health, their ability to live fuller lives and disease prevention.". QMS provides a regulatory framework that ensures products are evidence-based and safe before hitting the market. Beyond quality and safety, it's important to understand how these solutions will impact clinical practice and patient outcomes. With these clear expectations, patients receive the most effective care. Listen to our Consultant in GTM, Strategy, and Pricing, Annemijn Eschauzier explain further ⬇️ #HardianHealth #Regulation #Startups #HealthTech #DigitalHealth