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. 19시간 전

    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/

    3분

  2. 1일 전

    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/.

    4분

  3. 2일 전

    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/.

    4분

  4. 3일 전

    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/.

    4분

  5. 4일 전

    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/

    4분

  6. 5일 전

    From 21 CFR Part 820 to the QMSR: Pure Global's Deep Dive into the FDA's New Quality System for MedTech Innovators

    In this episode of MedTech Global Insights, we explore the monumental shift in the U.S. FDA's approach to quality systems for medical devices. We break down the transition from the long-standing 21 CFR Part 820 regulation to the new Quality Management System Regulation (QMSR), which harmonizes with the global standard ISO 13485. This isn't just a regulatory update; it's a fundamental change in how MedTech companies must approach their global compliance strategy. We move beyond the theory and dive into the practical realities, discussing the core pillars of a successful quality system, from management responsibility and design controls to the critical role of a robust CAPA system. Learn about the common pitfalls that can lead to costly submission delays and warning letters, and understand why the new QMSR is more than just a copy-and-paste of ISO 13485. This episode provides actionable insights for startups and established enterprises alike on how to turn regulatory compliance into a powerful competitive advantage. A real-world example: A European startup with a groundbreaking diagnostic device planned a rapid U.S. launch. They believed their ISO 13485 certification made them "FDA ready." However, their submission was put on hold because their Design History File, while compliant with ISO, lacked the specific traceability and risk analysis documentation the FDA expects under its Design Control requirements. This mismatch in expectations cost them an extra year and significant capital to remediate their documentation, allowing a competitor to capture early market share. Key Takeaways: - Why is the FDA aligning 21 CFR Part 820 with ISO 13485, and what does this mean for your global strategy? - Is your management team just signing documents, or are they truly prepared to defend your quality culture during an FDA inspection? - How can a gap in your Design Controls documentation derail your product launch, even with a revolutionary device? - What is the critical difference between a good CAPA system and a great one that prevents future recalls? - Are you prepared for the specific FDA requirements that go *beyond* ISO 13485 in the new QMSR? - How does a robust Quality Management System shift from being a regulatory cost center to a strategic business asset? - What are the three most common, yet avoidable, mistakes companies make when facing an FDA quality system inspection? For questions or support with your global regulatory strategy, contact us at info@pureglobal.com or visit https://pureglobal.com/.

    4분

  7. 6일 전

    Mastering the MedTech Clinical Evaluation Report (CER): A Deep Dive with Pure Global on MEDDEV 2.7/1 rev 4 Compliance and Avoiding Common Pitfalls

    In this episode of MedTech Global Insights, we demystify one of the most critical documents for European market access: the Clinical Evaluation Report (CER). Navigating the stringent requirements of MEDDEV 2.7/1 revision 4 is a major challenge for many MedTech companies, often leading to costly delays and rejections from Notified Bodies. We move beyond theory to provide actionable advice. This episode breaks down the four most common and critical failure points in CER writing: conducting a superficial "state-of-the-art" analysis, failing to rigorously justify equivalence, performing a non-systematic literature search, and inadequately appraising clinical data. We provide concrete examples of what Notified Bodies expect and how to build a robust, defensible clinical argument for your device. A common pain point we explore: Imagine your company has developed an innovative bone graft substitute. You've spent months compiling a CER, claiming equivalence to a market leader to avoid a costly clinical trial. However, the Notified Body rejects it, stating your data on the material's resorption rate and biomechanical properties is insufficient to prove equivalence. Your market launch is now delayed by at least a year, and you're facing an unplanned, multi-million dollar clinical study. This episode teaches you how to avoid that scenario. Key Takeaways: - Is my "State-of-the-Art" section a true clinical analysis or just a list of competitors? - How can I prove technical, biological, and clinical equivalence so rigorously that I can avoid a new clinical trial? - What specific elements must be included in a literature search protocol to make it "systematic" and audit-proof? - How do I properly weigh and appraise different levels of clinical evidence? - What is the direct link between my risk management file and the data presented in my CER? - Why is a large volume of data not always a good thing in a clinical evaluation? - What are the most common gaps that Notified Bodies find in CER submissions today? Contact us for a consultation at info@pureglobal.com or visit https://pureglobal.com/

    4분

  8. 11월 3일

    The Ultimate Guide to EU MDR GSPR Compliance: How Pure Global Helps You Avoid Critical Notified Body Findings

    This episode of MedTech Global Insights provides a deep dive into the General Safety and Performance Requirements (GSPR) of the EU MDR 2017/745, Annex I. We move beyond the checklist and explore the real-world challenges and regulatory expectations associated with these critical requirements. We uncover the most common pitfalls that can lead to Notified Body rejections, from inadequate justifications to insufficient clinical evidence. Learn how to build a GSPR compliance strategy that is robust, evidence-based, and aligned with the highest standards of safety and performance for your medical device. A specific example we explore involves a company with an innovative AI-powered diagnostic software. Despite having strong data on technical accuracy, their submission was challenged because their clinical evaluation failed to prove a tangible benefit to patient outcomes, a key demand of GSPR 1 and 8. This misstep resulted in costly delays and the need for a new prospective clinical study, a pain point that could have been avoided with a more robust regulatory strategy. Key Takeaways: - Why is simply marking a GSPR as "Not Applicable" a major red flag for auditors? - How can you definitively prove clinical benefit beyond just technical performance data? - What specific evidence is required to justify the chemical and biological safety of your materials? - Have you fully assessed the risks associated with your device's user interface and labeling? - Is your risk management file a truly living document that aligns with all GSPRs? - How do you bridge the gap between the old Essential Requirements and the more demanding GSPRs? - What are the most common weaknesses found in technical documentation related to GSPR Chapter II on design and manufacturing? - Are your post-market surveillance activities adequately designed to confirm ongoing GSPR compliance? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/.

    4분
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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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    Ran Chen
  • 방송 연도
    2025년
  • 에피소드
    84
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    © Copyright 2025 Ran Chen
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