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. 9 GIỜ TRƯỚC

    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 phút

  2. 1 NGÀY TRƯỚC

    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 phút

  3. 2 NGÀY TRƯỚC

    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 phút

  4. 3 NGÀY TRƯỚC

    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 phút

  5. 4 NGÀY TRƯỚC

    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 phút

  6. 5 NGÀY TRƯỚC

    Beyond User-Friendly: Mastering IEC 62366-1 for Safer MedTech and Streamlining Global Market Access with Pure Global

    This episode of MedTech Global Insights demystifies the critical IEC 62366-1 standard for usability engineering. We move beyond theory to explore how a structured, safety-focused design process is essential for preventing use-related errors that can lead to patient harm. Learn about the key stages of the usability engineering process, from initial specifications to final validation, and understand why it is a non-negotiable requirement for securing market approval from global regulatory bodies like the FDA and in the EU. We examine a real-world scenario to highlight the stakes. Imagine a nurse in a hectic ICU attempting to program an infusion pump for a critical medication. A poorly designed user interface causes them to mistake 10.0 mg/hr for 100 mg/hr, resulting in a severe overdose. This episode breaks down how the rigorous process outlined in IEC 62366-1 is specifically designed to identify, mitigate, and test against such catastrophic use errors before a device ever reaches the hospital floor. Key Takeaways: - Why is "usability" in MedTech a critical safety feature and not just a matter of user preference? - What is the difference between a "use error" and a "user mistake," and why does it matter for your regulatory submission? - How can you identify potentially hazardous use scenarios before you even have a physical prototype? - What are the crucial differences between formative and summative usability evaluations? - How does the Usability Engineering File become a cornerstone of your FDA 510(k) or EU MDR technical documentation? - Can you leverage a single set of usability data to enter multiple global markets? - What common pitfalls lead to failed summative evaluations and costly project delays? - How does the user profile directly influence the risk analysis for your device? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/.

    4 phút

  7. 6 NGÀY TRƯỚC

    Navigating the Maze of IEC 62304: A Pure Global Masterclass on Medical Device Software Lifecycle and Global Compliance

    In this episode of MedTech Global Insights, we demystify IEC 62304, the international standard for medical device software lifecycle processes. We break down the essential requirements that every MedTech innovator needs to know, from initial planning and risk-based safety classification to rigorous testing and post-market maintenance. This is not just a theoretical overview. We provide practical insights and real-world examples to help you understand how to build a compliant and safe software product. Learn how to avoid common pitfalls that can lead to costly delays, regulatory rejections, and patient safety risks, ensuring a smoother path to global market access. A prominent startup developed a groundbreaking AI diagnostic tool. They focused heavily on the algorithm's performance but maintained minimal documentation for their software development process, viewing it as a formality. During their EU MDR audit, the Notified Body found their risk management file and verification records for their Class C software completely inadequate. The result was a major non-conformity, forcing a six-month project delay to retrospectively build the entire technical documentation, which jeopardized their funding and market entry. In This Episode, We Unpack: 1. What is the single most important factor in determining your software's safety class under IEC 62304? 2. How can a poorly written requirement at the start of your project lead to a complete regulatory rejection? 3. Why is your software architecture not just a technical issue, but a critical compliance checkpoint for auditors? 4. What is the crucial difference between software verification and validation, and why is this the most scrutinized part of a submission? 5. Does your responsibility under IEC 62304 end once your software is released to the market? 6. How can a flawed bug-fixing process trigger a full-scale product recall? 7. What are the key documentation mistakes that startups commonly make when first implementing IEC 62304? Contact us for more information at info@pureglobal.com or visit https://pureglobal.com/.

    4 phút

  8. 6 THG 11

    From Hazard to Market Approval: Pure Global Decodes the Practical Application of ISO 14971 for Medical Devices

    In this episode of MedTech Global Insights, we break down the practical application of ISO 14971:2019, the essential standard for medical device risk management. We move beyond theory to provide a clear, step-by-step framework for identifying, analyzing, and controlling risks throughout your product's lifecycle. This isn't just about ticking a compliance box. It's about building safer products, creating stronger regulatory submissions, and avoiding costly post-market surprises. We explore the common pitfalls companies face and provide actionable insights to ensure your risk management process is robust, effective, and aligned with regulator expectations globally. Consider this real-world scenario. A company launched an innovative infusion pump, but a seemingly minor software bug went undetected during a basic risk analysis. This bug caused intermittent dosage miscalculations, leading to several adverse events and a multi-million dollar product recall. A proper ISO 14971 process would have analyzed the full sequence of events from hazard to harm, forcing a design-level fix and preventing the disaster. In This Episode: * Why is a 'living' Risk Management Plan more than just a document? * How can you move beyond basic FMEA to identify the true sequence of events leading to patient harm? * What are the three critical levels of risk control, and which one do regulators prioritize? * When is a Benefit-Risk Analysis absolutely required, and what evidence must you provide? * How do you define an 'acceptable' risk without relying on subjective opinions? * What is the crucial difference between a hazard, a hazardous situation, and harm? * Why is planning for 'reasonably foreseeable misuse' essential for your product's safety profile? * How does post-market data create a continuous loop for your risk management file? For more information and expert regulatory guidance, contact us at info@pureglobal.com or visit https://pureglobal.com/

    4 phút
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Giới Thiệu

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.

Thông Tin

  • Nhà sáng tạo
    Ran Chen
  • Năm hoạt động
    2 N
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    87
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    © Copyright 2025 Ran Chen
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    MedTech Global Insights