MedTech Global Insights

Ran Chen
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  • علوم حياة

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. قبل ٥ ساعات

    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/

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  2. قبل يوم واحد

    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/.

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  3. قبل يومين

    MDSAP Explained: A Pure Global Guide to Participating Countries for MedTech & IVD Market Access

    In this episode of MedTech Global Insights, we explore the Medical Device Single Audit Program (MDSAP), a revolutionary framework allowing MedTech and IVD manufacturers to satisfy the quality management system requirements of multiple countries through a single audit. We break down how this program can dramatically reduce audit fatigue and accelerate time-to-market. We detail the five core member countries—Australia, Brazil, Canada, Japan, and the U.S.—and explain the unique role MDSAP plays in each jurisdiction, from being a mandatory requirement in Canada to a substitute for routine FDA inspections. We also uncover the program's growing global influence by discussing the key official observers like the EU and affiliate members like South Korea and Mexico, who leverage MDSAP reports for their own regulatory needs. Consider this scenario: you are a MedTech scale-up planning to launch your device in the U.S., Canada, and Brazil. You're facing the daunting and expensive task of preparing for three separate quality system audits, each with its own timeline and complexities. How can you consolidate this process, save critical resources, and streamline your entry into these key markets with a single, unified audit? Key Takeaways: * Which five regulatory authorities form the core of the MDSAP consortium? * Why is MDSAP certification a mandatory requirement for market access in Canada? * How does the U.S. FDA leverage MDSAP reports within its own inspection program? * What is the official role of the European Union and the World Health Organization in the MDSAP? * Which fast-growing markets in Asia and Latin America are now officially recognizing MDSAP audit reports? * Can a single audit truly satisfy the distinct regulatory requirements of Brazil's ANVISA and Japan's PMDA? * What are the primary strategic benefits that drive companies to invest in MDSAP certification? * How can an MDSAP audit accelerate your product launch timeline in multiple countries simultaneously? Contact us for more information at info@pureglobal.com or visit https://pureglobal.com/.

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  4. قبل ٣ أيام

    Unlocking US Market Access: A Pure Global Masterclass on Navigating the 510(k) Submission for AI-Powered Medical Devices (SaMD)

    As MedTech companies increasingly integrate artificial intelligence into Software as a Medical Device (SaMD), navigating the regulatory landscape becomes significantly more complex. The standard 510(k) pathway was not designed for adaptive algorithms, forcing the FDA and manufacturers to pioneer new approaches for ensuring safety and effectiveness throughout the product lifecycle. This episode delves into the specific challenges of securing 510(k) clearance for AI-enabled SaMD. We explore the FDA's thinking, the critical importance of a Predetermined Change Control Plan (PCCP), and the necessity of "explainable AI" to demystify algorithmic decision-making for regulators. **Featured Case:** A startup has developed a revolutionary AI algorithm that analyzes patient data to predict the likelihood of a specific cardiac event. Their technology learns and improves with each new data point, making it more accurate over time. However, this continuous learning is a major regulatory hurdle. How can they submit a 510(k) when their device is constantly changing? How do they prove substantial equivalence when their core technology is designed to evolve, and what happens if they need to push an urgent algorithm update to improve patient safety? **Key Takeaways:** * How does the FDA's "Total Product Lifecycle" approach change how you manage your AI SaMD post-market? * What is a Predetermined Change Control Plan (PCCP) and why is it essential for your submission? * How do you select a predicate device when your AI technology seems entirely new? * What are the biggest mistakes companies make when documenting their AI/ML models for the FDA? * How can you demonstrate your algorithm is free from bias? * What level of technical detail is required to achieve "explainable AI" in your submission? * When does an algorithm update require a new 510(k) submission versus a letter to file? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/.

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  5. قبل ٤ أيام

    Unlocking Global MedTech Markets: A Deep Dive into IEC 81001-5-1 Cybersecurity with Pure Global

    In this episode of MedTech Global Insights, we explore the new cornerstone of medical device security, the IEC 81001-5-1 standard. As healthcare technology becomes increasingly connected, the risk of cyber threats poses a significant danger to patient safety and can create major barriers to market entry. We break down what this standard means for manufacturers and why it's a critical component for regulatory approval in major markets like the U.S. and Europe. We discuss the standard's lifecycle approach, which integrates security into every phase of product development, from design and threat modeling to post-market surveillance. Learn how IEC 81001-5-1 aligns with the stringent expectations of the FDA and the EU MDR, and how compliance is no longer optional but essential for global success. Consider this scenario: a company's new AI-powered diagnostic software is rejected by the FDA during premarket submission. The reason? A vulnerability in an open-source component that could potentially expose patient data. This single oversight leads to a six-month delay, significant remediation costs, and loss of investor confidence. This episode explains how adopting IEC 81001-5-1 from day one would have prevented this, by mandating a secure software supply chain and robust vulnerability management plan. Key Takeaways: * Why are traditional IT security measures insufficient for protecting modern medical devices? * What is a Secure Product Development Framework and how does it change your development process? * How can threat modeling in the design phase prevent a costly product recall later? * What specific documentation does the FDA now require to avoid a "Refuse to Accept" decision on cybersecurity grounds? * How does IEC 81001-5-1 help you meet the EU MDR's requirements for IT security and data protection? * What is your responsibility for patching vulnerabilities after your device is already on the market? * How can you ensure third-party software components don't introduce critical security risks into your product? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/.

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  6. قبل ٥ أيام

    Cracking the Code: How Pure Global Helps SaMD Startups Navigate ISO 13485 Compliance

    SaMD developers operate in a fast-paced, agile world, but the medical device industry is governed by the structured ISO 13485 standard. This episode demystifies how to merge these two worlds, transforming compliance from a roadblock into an integrated part of your development lifecycle. We explore practical, real-world strategies to build a robust Quality Management System that satisfies regulators without sacrificing the speed and flexibility essential for innovation in digital health. Imagine a promising SaMD startup with a revolutionary diagnostic algorithm. They operate in two-week sprints, pushing updates constantly. But when they prepared for their first regulatory audit, they hit a wall. Their documentation was scattered, their design controls didn't align with their sprint-based workflow, and the auditor was questioning their risk management process. They faced significant delays and rework, threatening their market entry. This episode addresses exactly how to avoid this scenario. Key Takeaways This Episode: - How can the rigid structure of ISO 13485 design controls be adapted for an iterative agile backlog? - What does a "definition of done" look like in a regulated agile sprint? - How do you conduct continuous risk management (ISO 14971) within each development cycle? - Which tools can automate QMS documentation to prevent it from slowing down development? - When is the right time to perform software validation in a CI/CD pipeline? - How do you manage changes and document updates for a SaMD that is constantly evolving? - What are the key differences in applying ISO 13485 to a standalone SaMD versus software embedded in a physical device? - How can you prove to an auditor that your agile process is under control and compliant? Contact us at info@pureglobal.com or visit https://pureglobal.com/.

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  7. قبل ٦ أيام

    Unlocking MedTech Innovation: A Deep Dive into the FDA's AI Change Control Policy with Pure Global's Expertise

    In this episode of MedTech Global Insights, we dissect the FDA's groundbreaking final guidance on Predetermined Change Control Plans (PCCPs) for AI/ML-enabled medical devices. We explore how this new framework moves beyond the traditional, rigid regulatory submission process, creating a streamlined pathway for manufacturers to innovate and improve their smart devices safely and effectively. Discover how a PCCP can unlock the full potential of your adaptive medical software. We'll use the example of an AI-powered diagnostic imaging tool that continuously learns from new data. The pain point is clear: without a PCCP, every minor algorithm update could mean a new, costly submission to the FDA, stalling innovation. With a well-crafted PCCP, the company can deploy performance-enhancing updates swiftly, as long as they fall within the pre-approved plan, ensuring patients get the best technology faster. Key Takeaways: - What is an FDA Predetermined Change Control Plan and why is it a game-changer for AI/ML medical devices? - How do you define the scope of planned modifications without limiting future innovation? - What are the essential components of a "Modification Protocol" that will satisfy regulators? - How can you demonstrate that your device will remain safe and effective after multiple algorithm updates? - What are the best practices for documenting the verification and validation process for each change? - How does a PCCP impact the post-market surveillance and reporting requirements for your device? - What common pitfalls should manufacturers avoid when preparing their PCCP submission? - How can a strategic regulatory partner help you leverage the PCCP framework for faster global market access? Contact us at info@pureglobal.com or visit https://pureglobal.com/ for more information.

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  8. ٢٨ أكتوبر

    Cracking the Code: A Pure Global Deep Dive into Clinical Evaluation Requirements for SaMD under the EU MDR

    This episode of MedTech Global Insights delves into the rigorous clinical evaluation requirements for Software as a Medical Device (SaMD) under the European Union's Medical Device Regulation (MDR). We unpack the critical guidance from MDCG 2020-1, breaking down the three essential pillars of evidence required for your Clinical Evaluation Report: scientific validity, analytical validity, and clinical performance. We explore how the MDR elevates the burden of proof for software, moving it beyond simple verification and validation to demand robust clinical data. This shift presents a significant hurdle for manufacturers accustomed to the old directive, where clinical evidence requirements were often less stringent. Failing to meet these new standards can lead to costly delays and outright rejection by Notified Bodies, halting market access. **Case Study:** Imagine a US-based startup with a revolutionary AI tool for detecting early-stage skin cancer. They have stellar US clinical data and a flawless algorithm but face a complete standstill at the EU border. Their Notified Body rejects their technical file, citing insufficient clinical evidence for the diverse European population, forcing them back to the drawing board for a multi-million dollar prospective study. This is a common and costly mistake that can derail a product launch. **What You'll Learn:** - What are the three core pillars of a SaMD clinical evaluation? - Why is your software's scientific basis just as important as its code? - How is 'analytical validity' different from traditional software verification and validation? - What kind of clinical performance data will a Notified Body actually accept? - Why is US or single-country clinical data often not enough for an EU submission? - What are the key takeaways from the MDCG 2020-1 guidance document? - How can you generate sufficient evidence without conducting a full-blown new clinical trial? - What are the most common pitfalls that lead to the rejection of a SaMD CER? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/.

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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.

المعلومات

  • صناع العمل
    Ran Chen
  • سنوات النشاط
    ٢٠٢٥
  • الحلقات
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  • التقييم
    ملائم
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    © Copyright 2025 Ran Chen
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    MedTech Global Insights