MedTech Global Insights copertina

MedTech Global Insights

MedTech Global Insights

Di: Ran Chen
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A proposito di questo titolo

 What's next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you're an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.Copyright 2026 Ran Chen Economia Scienza Scienze biologiche
Episodi
  • UK AI Diagnostics: Pure Global on MHRA's Risky New Pathway.

    UK AI Diagnostics: Pure Global on MHRA's Risky New Pathway.
    Jan 22 2026
    This week on MedTech Global Insights, we dissect the UK MHRA's groundbreaking new accelerated approval pathway for AI-powered medical devices. This policy shift aims to make post-Brexit Britain a hub for digital health innovation, but what does it really mean for manufacturers on the ground? We explore the real-world implications through the lens of the first company to navigate this new process. Discover the potential pitfalls and strategic adjustments you must consider to capitalize on this opportunity without getting caught in unforeseen regulatory traps. A case in point is a startup with a revolutionary AI diagnostic tool. They saw the UK's new pathway as a golden ticket for rapid market entry, but they were unprepared for the vague requirements around real-world performance data and the intense scrutiny of their algorithm. Their dream of a quick launch is now bogged down by unexpected data demands and costly delays, highlighting a critical gap between policy and practice. Key Takeaways: - Is the MHRA's new AI pathway truly 'accelerated,' or just a different kind of bottleneck? - What are the top hidden data requirements that can derail your UK submission? - How does the UK's new framework compare to the FDA's De Novo and the EU's MDR for software devices? - Why might your existing clinical evidence not be sufficient for the MHRA's new standards? - What is the biggest cybersecurity risk you must address for a UK SaMD submission? - How can you leverage a single technical dossier for the UK, EU, and US markets simultaneously? - What are the post-market surveillance demands unique to this new UK pathway? Contact us at info@pureglobal.com or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and a free medical device database.
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    2 min
  • EU's MDR Relief & Notified Body Rift: A Pure Global Brief

    EU's MDR Relief & Notified Body Rift: A Pure Global Brief
    Jan 21 2026
    The European Union's notoriously complex MDR and IVDR regulations have been a major challenge for the MedTech industry. Last week, the European Commission unveiled a proposal to simplify the rules, offering a glimmer of hope for manufacturers. However, the situation is complicated by a new position paper from the Notified Bodies (Team-NB), who are raising concerns about the proposed changes. This episode of MedTech Global Insights dives into this critical regulatory development. We explore the potential benefits of the Commission's proposal for companies trying to enter the EU market and dissect the crucial counterarguments from the Notified Bodies. This isn't just a regulatory update; it's a look into the dynamic and often conflicting forces shaping global market access. **Key Takeaways:** * What specific changes is the European Commission proposing for the MDR and IVDR? * Why are Notified Bodies expressing concerns about these proposed simplifications? * How could these changes impact the timeline and cost for getting a device to the EU market? * What are the potential risks for manufacturers if they misinterpret these evolving regulations? * For non-EU companies, does this proposal make the European market more or less attractive? * How should your company's regulatory strategy adapt to this period of uncertainty? * What does the tension between the Commission and Notified Bodies signal about the future of EU regulation? Contact us at info@pureglobal.com or visit https://pureglobal.com/. You can also visit https://pureglobal.ai/ for FREE AI tools and a free medical device database.
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    2 min
  • Pure Global: Europe's MedTech & The Post-Market Surprise

    Pure Global: Europe's MedTech & The Post-Market Surprise
    Jan 20 2026
    Many MedTech companies breathe a sigh of relief after achieving their European CE mark, believing the hardest part is over. But a recent guidance document from the EU's Medical Device Coordination Group (MDCG) on post-market surveillance is proving that the finish line has moved. This new interpretation demands a more dynamic and data-intensive approach to monitoring devices, catching many manufacturers off-guard. In this episode, we break down what this enhanced scrutiny really means for your business. We go beyond the regulatory jargon to reveal the hidden operational and financial burdens of these updated expectations, and discuss how proactive compliance is the only way to safeguard your hard-won market access in the EU. Imagine this: Your company's innovative cardiovascular device has been successful in the EU for two years. Suddenly, a routine audit flags your post-market data collection as non-compliant with the new MDCG guidance. You now have 90 days to implement a costly new patient follow-up study and overhaul your reporting system, or face the risk of having your CE certificate suspended right as you're planning your expansion. What You'll Learn: - What is the single biggest mistake companies make in their post-market surveillance plans? - How does the new MDCG guidance change the requirements for your Periodic Safety Update Report (PSUR)? - Why might your current clinical data be insufficient for the new Post-Market Clinical Follow-up (PMCF) standards? - What are the early warning signs that your PMS system is falling behind the new expectations? - How can you turn mandatory surveillance activities into a source of competitive advantage? - Is your designated Person Responsible for Regulatory Compliance (PRRC) truly prepared for these new demands? - What technology can help automate the intensified data collection and reporting? Contact us at info@pureglobal.com or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and free medical device database.
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    2 min
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