MedTech Global Insights

Ran Chen
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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.

  1. HACE 7 H

    Beyond FDA Approval: Pure Global's Playbook for Navigating the Global Regulatory Maze with Your Continuous Glucose Monitoring (CGM) Device

    The global market for Continuous Glucose Monitoring (CGM) devices is booming, offering incredible opportunities for MedTech innovators. However, the path to international success is littered with complex and varied regulatory hurdles. A device celebrated with FDA approval in the US can find itself grounded for years by the rigorous demands of the EU's MDR or China's NMPA. This episode of MedTech Global Insights dives deep into the real-world challenges of taking a CGM device global. We follow the journey of a MedTech company as they navigate the costly and time-consuming process of entering European and Asian markets, revealing the common pitfalls that can derail even the most promising innovations. We explore how a proactive, unified global strategy, powered by technology and local expertise, is the only way to win. A Real-World Scenario: Imagine your innovative, FDA-approved CGM device is ready to change lives in Europe. But you discover your clinical data is deemed insufficient by EU authorities, your chosen partner doesn’t have the right credentials, and you’re now facing a three-year delay and a budget overrun of millions. This is the reality for many, and this episode unpacks how to avoid it. In This Episode, We Unpack: 1. Why is the EU's MDR the "great filter" for so many MedTech devices coming from the US? 2. What are the specific, often-overlooked requirements of China's NMPA that can halt your market entry? 3. How can a single technical dossier be prepared to streamline submissions in over 30 countries simultaneously? 4. What is the true cost of a reactive, country-by-country regulatory strategy versus a unified global approach? 5. How can AI tools reduce your dossier preparation time from months to weeks? 6. What are the critical functions of a local, in-country representative that most companies get wrong? 7. How do you build a post-market surveillance plan that satisfies regulators in both Europe and North America? To learn more about navigating these challenges, contact us at info@pureglobal.com or visit https://pureglobal.com/.

    4 min

  2. HACE 1 DÍA

    The Global DTx Revolution: Cracking the Code on Digital Therapeutics Regulations with Pure Global

    In this episode of MedTech Global Insights, we explore the booming field of Digital Therapeutics (DTx). We uncover what sets these evidence-based software platforms apart from simple wellness apps and dive deep into the number one obstacle holding them back from global adoption: the complex and fragmented regulatory landscape. We discuss the unique challenges of gaining market access in key regions like the United States (FDA), the European Union (MDR), and Asia (PMDA, MFDS). We break down why a one-size-fits-all approach to regulatory submissions is destined to fail and how a strategic, technology-driven process is essential for success. Consider a startup with a proven DTx for treating insomnia. They want to launch in Germany and Japan, but are immediately stuck. How do they navigate the EU's complex MDR requirements, appoint a local representative, and secure a CE mark while simultaneously preparing a completely different, translated submission dossier for Japan's PMDA? Without a unified strategy, they face overwhelming costs, delays, and the risk of fatal compliance errors. Key Takeaways: - How is a regulated Digital Therapeutic (DTx) platform fundamentally different from a consumer wellness app? - What are the critical first steps to determine your software's regulatory classification in the EU versus the US? - Why do different data privacy laws like GDPR and local Asian regulations pose a major challenge for DTx platforms? - What common, avoidable pitfalls lead to the rejection of SaMD submissions by regulatory authorities? - How can AI-powered tools dramatically accelerate the creation and adaptation of technical files for multiple markets? - What is the mandatory role of a Local Representative, and why is it so critical for post-market surveillance? - How can a "single process, multiple markets" strategy help a startup access over 30 countries efficiently? - What are the unique challenges of securing reimbursement for DTx products in different healthcare systems? To learn more about building your global MedTech strategy, contact us at info@pureglobal.com or visit https://pureglobal.com/.

    4 min

  3. HACE 2 DÍAS

    Mastering the Maze: A Pure Global Guide to Global Market Access for Cardiovascular Drug-Eluting Stents

    In this episode of MedTech Global Insights, we explore the dynamic and challenging world of cardiovascular drug-eluting stents (DES). We uncover the technological evolution from early generation devices to today's advanced bioresorbable scaffolds and discuss the immense clinical impact they have had. While innovation is thriving, bringing a new DES to the global market is a formidable task. We delve into the complex, fragmented, and ever-changing regulatory landscapes in key regions like the European Union, Asia, and Latin America. This episode provides a strategic overview of how MedTech companies can overcome these hurdles to ensure their life-saving technology reaches patients worldwide. Consider this common scenario: A MedTech scaleup has developed a revolutionary new stent with stellar US clinical data. They are ready for global expansion but are immediately overwhelmed by the disparate regulatory demands of the EU, Japan, and Brazil. Their team is spending countless hours reformatting dossiers and searching for reliable local partners, causing launch delays that cost millions and postpone critical patient care. How can they turn this roadblock into a streamlined global launchpad? Key Takeaways: - What are the critical differences between first and second-generation drug-eluting stents? - Why does a successful FDA submission not guarantee a smooth path to CE marking in Europe? - How can you leverage a single technical dossier for submissions in over 30 different countries? - What is the role of an in-country representative, and why is it essential for market access? - How is AI transforming the process of regulatory intelligence and submission management? - What are the most common pitfalls to avoid when planning a multi-market product launch? - How do post-market surveillance requirements differ between major international markets? - What strategies can help you select the most promising new markets for your device? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/

    3 min

  4. HACE 3 DÍAS

    The Global IVD Maze: A Pure Global Deep Dive into Market Access Strategy, IVDR Hurdles, and Tech-Driven Solutions

    This episode of MedTech Global Insights explores the immense opportunities and hidden complexities of taking an In-Vitro Diagnostic (IVD) device to the global market. We move beyond a single-country approval and dive into the strategic challenges of navigating a fragmented international regulatory landscape, where success depends on more than just innovative technology. We break down why a celebrated FDA approval in the US can be just the beginning of a long and costly journey. The episode covers the specific, demanding hurdles presented by regulations like the European Union's IVDR and the unique requirements of key Asian markets, revealing how a lack of a cohesive global strategy can lead to critical delays and budget overruns. For example, imagine a US-based IVD startup with a revolutionary AI-powered cancer diagnostic test. They've secured FDA approval, but their plan to enter Europe hits a wall. The EU's IVDR classifies their device as high-risk, demanding entirely new clinical evidence that will take two years and millions of dollars to generate. How does a company pivot from this potentially fatal setback to build a scalable, multi-market expansion plan without starting from scratch in every new country? Key Takeaways: - What are the most significant differences between the US FDA and the EU IVDR for a high-risk diagnostic device? - How can you leverage your existing technical dossier for multiple market submissions without creating dozens of different versions? - Why is selecting your second international market the most critical strategic decision you will make? - What is the role of a local in-country representative beyond simple regulatory compliance? - How can AI and data analytics dramatically reduce the time and cost of global IVD registrations? - When is clinical data from one country accepted in another, and when is it not? - How do you manage post-market surveillance and vigilance reporting across more than 30 countries with different languages and rules? To learn more, contact us at info@pureglobal.com or visit https://pureglobal.com/

    3 min

  5. HACE 4 DÍAS

    Pure Global Presents: Mastering the MDSAP Audit (AU P0002.008) - Key Criteria for Global MedTech Market Access

    In this episode of MedTech Global Insights, we dissect the audit criteria of the Medical Device Single Audit Program (MDSAP), focusing on the specific requirements detailed in the influential AU P0002.008 audit model. We explore how this single audit program, crucial for market access in the US, Canada, Australia, Brazil, and Japan, has evolved and what it demands from your Quality Management System. We move beyond theory to discuss the practical implications of recent updates. We cover the increased scrutiny on manufacturer-sponsor agreements for Australian market entry and the critical importance of a "closed-loop" system that integrates post-market feedback directly into your risk management files. This episode is essential for any MedTech professional involved in quality, regulatory affairs, and global strategy. **Key Takeaways:** * What are the seven core chapters that structure every MDSAP audit? * How did the AU P0002.008 update change the audit focus for devices entering Australia? * Why is simply collecting post-market feedback no longer enough to satisfy MDSAP auditors? * What specific evidence do you need to present to demonstrate a closed-loop risk management process? * How can a deficiency in your purchasing process lead to a major non-conformance in design and development? * What are the most common pitfalls companies face when preparing for their first MDSAP audit? * How does the MDSAP model integrate ISO 13485 with specific country requirements from the FDA, TGA, and other bodies? To learn more about navigating global regulatory challenges, contact us at info@pureglobal.com or visit https://pureglobal.com/.

    4 min

  6. HACE 5 DÍAS

    From Device Malfunction to FDA Report: A Pure Global Guide to Mastering 21 CFR Part 803 Compliance

    Navigating the FDA's Medical Device Reporting (MDR) regulation, 21 CFR Part 803, is a high-stakes requirement for any MedTech company in the US market. A single misstep in reporting an adverse event can lead to warning letters, product recalls, and significant delays in future approvals. This episode provides a practical guide to understanding your obligations. We break down the essential questions: Who needs to report, what events are reportable, and what are the critical 5-day and 30-day deadlines. We explore the nuanced definitions of "serious injury" and "malfunction," which are common points of failure for many manufacturers, and discuss how to establish a bulletproof internal process for capturing and evaluating potential events from all sources. Consider this scenario: A startup's new monitoring device is implicated in an incident that leads to a patient's extended hospital stay. The internal team is unsure if it meets the FDA's definition of a "serious injury." The 30-day clock is ticking. A wrong decision could attract FDA scrutiny and jeopardize their next round of funding. This is the exact type of high-pressure situation we dissect in this episode. 本期干货 - What is the precise difference between a device 'malfunction' and a 'serious injury' in the FDA's eyes? - When does the 5-day reporting clock really start for your company after an event? - Are you required to report an incident if your device only *might* have contributed to it? - How can you avoid the most common documentation mistakes that lead to FDA Warning Letters? - What is the eMDR system, and are you using it correctly for all submissions? - Can a single reporting mistake in the US impact your market access in Europe or Asia? - How do you determine if a similar event that happened outside the US is reportable to the FDA? - What kind of training should your customer service and sales teams have to identify potential adverse events? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/

    4 min

  7. HACE 6 DÍAS

    Mastering Medical Device Safety: Pure Global's Expert Guide to the ISO 10993-1 Biological Evaluation Requirements

    In this episode of MedTech Global Insights, we dissect the essential requirements of ISO 10993-1 for the biological evaluation of medical devices. We explore the critical shift from a simple checklist to a comprehensive, risk-based approach, which is now the gold standard for regulatory bodies worldwide. We break down what this risk management process entails in practice. from material characterization and manufacturing considerations to the nature and duration of patient contact. This episode offers a clear guide on how to build a robust Biological Evaluation Plan (BEP) that can stand up to regulatory scrutiny and ensure patient safety. Consider this scenario. A startup develops a groundbreaking drug-eluting stent but faces a major setback. Their submission is rejected due to an inadequate biocompatibility evaluation. They followed a simple testing checklist but failed to create a comprehensive BEP that assessed the risks of the metal alloy, the polymer coating, and the active drug combined. This oversight leads to a nine-month delay and requires expensive, unplanned long-term studies, jeopardizing their funding and market entry. Key Takeaways: - Why is a risk management process now more critical than a simple testing checklist for ISO 10993-1 compliance? - How do you determine the correct biological endpoints for a device with long-term tissue and blood contact versus one with transient skin contact? - What are the essential components of a Biological Evaluation Plan (BEP) that will satisfy regulators? - When can chemical characterization data be used to reduce the need for extensive animal testing? - What are the most common pitfalls that lead to the rejection of a biocompatibility submission? - How does your manufacturing process impact the biological risk profile of your final device? - For complex devices like combination products, how do you separately evaluate the risks of each component? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/

    3 min

  8. 9 NOV

    Pure Global's Ultimate Guide to Structuring Your EU IVDR 2017/746 Technical File for Market Success

    This episode of MedTech Global Insights offers a deep dive into one of the most challenging aspects of European market access: structuring the technical file for the EU In Vitro Diagnostic Regulation (IVDR 2017/746). We break down the key requirements of Annex II, providing a clear roadmap for manufacturers to follow. We move beyond theory to discuss the practical application of each section, from defining your device and its manufacturing processes to demonstrating compliance with the General Safety and Performance Requirements (GSPRs). We place special emphasis on the Performance Evaluation Report (PER), detailing the three pillars of evidence required by notified bodies: scientific validity, analytical, and clinical performance. **Case Study:** A U.S.-based diagnostics innovator developed a groundbreaking liquid biopsy test for early cancer detection, a Class C device. They underestimated the IVDR’s demand for a standalone Performance Evaluation Report with robust clinical performance data. Their submission was rejected because they relied too heavily on existing literature instead of conducting a dedicated study on the European population. This resulted in a costly one-year delay, allowing a competitor to capture the market first. **Key Takeaways:** 1. Why is the IVDR Technical File considered a "living document" and not just a one-time submission? 2. How can you create a GSPR checklist that satisfies a notified body auditor? 3. What are the three essential pillars of the Performance Evaluation Report (PER) that can make or break your submission? 4. What is the single biggest mistake companies make when documenting their design and manufacturing information? 5. For a high-risk IVD, how do you generate sufficient clinical performance data to prove your claims? 6. How does your ISO 14971 risk management file directly influence your benefit-risk analysis? 7. How can AI-driven tools prevent critical errors and accelerate the compilation of your technical documentation? For more information or to discuss your regulatory strategy, contact us at info@pureglobal.com or visit https://pureglobal.com/.

    4 min
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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.

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  • Creador
    Ran Chen
  • Años de actividad
    2 k
  • Episodios
    90
  • Clasificación
    Apto
  • Copyright
    © Copyright 2025 Ran Chen
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    MedTech Global Insights