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✨ Register for Day 2 of the UK MedTech to Market Programme: Ready to Supply! ✨🚀 The UK MedTech to Market Programme is a game changer for companies in the Medical Technology space. Join the programme and attend the ‘Day 2 - Ready to Supply’ event to prepare your MedTech company for market entry. If you are a MedTech company aiming for noteworthy market success, this programme is crafted with your aspirations in mind. Join this in-person event to delve into what it takes to not just enter the market, but to do so with confidence, efficiency and effectiveness. From navigating the UK’s diverse regulatory framework to mastering the art of protecting your intellectual property. Don’t miss out on this opportunity to equip your company with the knowledge and tools for sustained success. Whether you are at the beginning of your journey or preparing for market entry, this programme supports every step towards transformation. 📅 Thursday 10 October 2024 🕔 09:00-15:30 📍 In-person event, Central London Find out more and register now 👉🏻 https://buff.ly/3ZkC0gb #UKMedTech #MarketSuccess #Innovation #HealthTech #MedicalTechnology

🎉 Landmark Agreement Opens New Doors for UK MedTech Companies 🎉 Exciting news in the world of MedTech! Medilink UK has partnered with Medical Alley to support UK medical device companies in accessing the US market through their Market Access Programme (MAP). This collaboration provides valuable insights into regulatory, reimbursement, and commercial pathways, and is sure to be a game-changer for medical device firms in the UK. Dr Rashmi Raju, International Manager at Medilink, highlighted that this partnership aims to ease global market access complexities for participating companies. With the programme kicking off on February 17, 2025, companies will benefit from online sessions, a showcase pitch, and a market visit to Minnesota. The tailored U.S. Go-To-Market accelerator program will equip UK companies with the critical knowledge needed to succeed in the US market, offering direct access to Medical Alley's extensive network. This collaboration is a major step towards fostering innovation and improving patient outcomes on a global scale. Roberta Dressen, President and CEO of Medical Alley, expressed her excitement about supporting UK companies in bringing transformative technologies to patients worldwide. This initiative not only propels growth but also enriches the global healthcare ecosystem. #MedTech #HealthcareInnovation #GlobalExpansion

I was thrilled to attend the HEU-EFS annual Consortium Meeting in Geneva last week. HEU-EFS is a unique Public-Private Partnership co-funded by the EU and Co-led by Edwards Lifesciences Europe. This project will bring more Early Feasibility Studies (EFS) to Europe by setting a dedicated EU program. Early Feasibility studies are a critical step in the evidence generation cycle for medical devices.   This is important as Europe is losing out on innovation attractiveness. We need to work together and bring more clinical evidence to drive early access to innovation in Europe. By building a harmonized program for EFS in Europe, we will contribute to improving access to innovative technologies for patients with unmet needs, leading to significant benefits for patients, innovators, and the entire healthcare system. It’s time to put Europe at the forefront of medical innovation and the HEU-EFS program is a crucial step for establishing the EU as a global hub for innovative technologies. #innovation #Europe  

Our partner Clinical Accelerator is organizing a MedTech summit at The Biltmore Hotel Tbilisi, in Georgia. Scheduled to take place September 20-22nd, this event welcomes physicians interested in the latest developments in the world of medical devices, MedTech companies developing innovative devices and MedTech investors. The program will include latest advancements in the development of novel medical devices in cardiovascular and other important therapeutic areas. Another topic will be challenges faced by MedTech companies when dealing with clinical development and regulatory strategies. If you're interested in participating, register here: https://hubs.ly/Q02ydN7Y0 #medtech #medicaldevices #summit #georgia #greenlightguru #medtechsummit

Ireland's flagship #MedtechRising Conference and Annual Medtech Awards, takes place on the 05 December in Galway, jointly hosted by the Irish Medtech, Enterprise Ireland, and IDA Ireland for the past 17 years. 30+ Speakers across 9 sessions, this unmissable gathering of 500 medtech industry leaders in Galway. Reserve your conference place today at - www.medtechrising.ie Moderated by Anton Savage, Broadcaster & Journalist, our opening session (Session 2) will focus on 'Calculating & responding: charting the best path forward for Ireland'. Ireland’s medtech hub is over 100 years in the making and Irish-made medical technologies are used around the world to save and improve lives. However economic and political conditions at home and abroad, wider global uncertainty and volatility all have the potential to impact the medtech sector here – for better or worse. Bronwyn Brophy, CEO, Vitrolife Group, Fergal O'Brien, Executive Director, Lobbying & Influence, Ibec, William Corcoran, US East Coast manager Medical Technologies, IDA Ireland and Cepta Duffy, Manager High Potential Start Ups (Industrial & Life Sciences), Enterprise Ireland will reflect on some of the key inflection points in Ireland, Europe and further afield over the past 12 months, how Ireland is supporting & continuously developing our medtech ecosystem to respond and will discuss action Ireland and Europe can take in 2025 as we strive to further enhance and grow our medtech and life sciences hub.

📢 Calling All MedTech Innovators: Share Your Insights on Clinical Research! The HRB National Clinical Trials Office (NCTO) is conducting an anonymous survey to explore experiences with clinical investigations and performance studies for medical devices and IVDs. The input will help identify key challenges and opportunities for clinical research in Ireland, empowering the sector to: ✔️ Enhance support for innovative startups and multinational companies alike. ✔️ Address barriers to conducting impactful studies. ✔️ Foster an ecosystem that accelerates medtech advancements. This survey is open to commercial and research organizations, from small startups to global players, who are involved in clinical investigations and performance studies—both in Ireland and internationally. 📅 Survey Details: Closes: December 23 Link: https://lnkd.in/dZFpqibW Supported by: Enterprise Ireland, IDA Ireland, and Irish Medtech The data you provide will remain anonymous and will be used to drive critical improvements in the Medtech clinical research landscape. #MedTech #ClinicalResearch #Innovation #Ireland #MedicalDevices #IVDs #NCTO #HealthResearch #MDR #EU #ClinicalAffairs #RegulatoryAffairs

'Innovation, R&D, and new product development are going to be the key drivers of growth in the industry as Ireland looks to continue to diversify across the entire medical device value chain' 📢 Ireland's modern economy is powered by the research and development sector, which is essential to promoting innovation, accelerating economic growth, and boosting the nation's competitiveness internationally. As the world increasingly moves towards a knowledge-based economy, the significance of R&D in Ireland cannot be overstated.

🚨 Medical Technology Ireland Expo & Conference: A Hub for MedTech Innovation Attention #MedTech professionals! The upcoming Medical Technology Ireland Expo & Conference is set to be a major gathering of industry leaders, innovators, and experts in the #medicaldevice design and #manufacturing space. As one of Europe’s largest and fastest-growing events, it provides an unparalleled opportunity to explore the latest advancements and trends shaping the MedTech sector. #MedicalTechnology #IrelandInnovation #HealthcareTransformation Go check the post below 👇

Live from Rome: Catch the Replay of Yesterday's Webinar "Maximizing Structured Dialogue for MedTech." 👇👇 In case you missed yesterday’s expert webinar on Structured Dialogue for MedTech with Marta Carnielli, Bassil Akra, Alex Laan, Tom Patten, and Michelle Lott, RAC, here’s your chance to watch the replay. Event link: https://lnkd.in/exQ6yV-H Special thanks to these subject matter experts who generously donated their time! What You’ll Learn: ✅ What Structured Dialogue Is (and Isn’t): From its roots in MDCG 2022-14 to its practical application, the panel clarified the boundaries of what notified bodies can and cannot discuss. ✅ Bridging the Gap Between the EU and US Systems: A comparison of structured dialogue and FDA’s Q-Sub program, highlighting opportunities and challenges for manufacturers operating globally. ✅ How to Prepare Effectively: Insights on crafting the right questions, engaging with notified bodies early, and ensuring structured dialogue delivers value for your regulatory strategy. ✅ Key Best Practices: The importance of planning, submitting supporting documents in advance, and maintaining clear communication throughout the conformity assessment process. ✅ The Future of Structured Dialogue: Discussions on potential regulatory changes and how structured dialogue could evolve to better serve manufacturers, especially SMEs and startups. 💬 Audience Questions Answered: The panel tackled real-world questions, from product demos and device classification to how startups can leverage structured dialogue to gain clarity and confidence. This webinar was full of practical advice, candid discussions, and actionable takeaways to help you streamline your path to regulatory success. Whether you’re new to structured dialogue or looking for advanced strategies, this replay is a must-watch! 👉 Watch the replay now #eumdr #ivdr #notifiedbody #structureddialogue #mdcg MedTech Leading Voice, Team-NB, TÜV SÜD, BSI, GMED

🌟 What an incredible event we had yesterday on navigating "The Medical Device Road-to-Market"! 🌟 A huge thank you to our distinguished speakers from Lymphatica Medtech (Marco Pisano), Euresearch (Irina Sakharova Quitt), Swiss Medtech association (Daniel Delfosse), and F+R services (Mayella Favre) for sharing their invaluable insights! 👏 Here are some personal takeway from the event: 1. Financing Clinical Studies: It's essential to target a large addressable market (>500M USD/year) and gather support from clinical communities and strategic partners. Beyond venture capital, Horizon Europe funding can significantly aid in financing these studies. 2. Regulatory Challenges: The phrase "US innovates," "Asia manufactures," and "EU regulates" highlights the unique landscape. However, EU regulations introduce significant uncertainties regarding time and cost. EU regulators need to understand that patient safety is not just about product safety but encompasses product safety, availability, and innovation! 3. Achieving Reimbursement: Gaining CE certification is just the beginning. The next phase—securing reimbursement—requires navigating a complex process involving a different set of stakeholders. So bringing a medical device to market is a long and challenging journey that demands extensive planning and the engagement of a diverse range of stakeholders at various stages. The event truly underscored that the success of innovation extends well beyond mere technological advancements. Thank you to everyone who participated and made this event a success. Looking forward to more such enriching sessions in the future! #Medtech #Innovation #RoadtoMarket #MedicalDevices #VDtech Innovaud