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MedTech Global Insights

MedTech Global Insights

Written by: 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.Copyright 2026 Ran Chen Biological Sciences Economics Science
Episodes
  • US FDA Quality System Overhaul: Pure Global on Life Beyond ISO 13485

    US FDA Quality System Overhaul: Pure Global on Life Beyond ISO 13485
    Feb 8 2026
    In a landmark decision, the US FDA has finalized its rule to replace the decades-old Quality System Regulation with the new Quality Management System Regulation (QMSR). This historic move aligns US medical device standards with the international ISO 13485, marking a significant step towards global harmonization. But this is not a simple copy-and-paste of the global standard. This episode breaks down the critical details of this regulatory shift. We explore why being ISO 13485 certified is not enough to guarantee compliance. We uncover the specific US requirements the FDA has retained, creating a unique hybrid model that manufacturers worldwide must now navigate before the February 2026 deadline. A prime example is a mid-sized American device maker, fully compliant with the old FDA system. They now face a two-year deadline to completely restructure their quality management system, retrain their entire staff, and renegotiate supplier agreements to meet the new risk-centric approach. This is not just new paperwork; it is a fundamental culture shift where one mistake could halt all US sales. Key Takeaways: - The FDA's QMSR is more than just ISO 13485; what key US-specific requirements remain? - If your company is already ISO 13485 certified, are you automatically compliant? - What are the top three priorities for your gap analysis before the 2026 deadline? - How will this change affect your relationships with suppliers and contract manufacturers? - What specific record-keeping practices need to be updated to align with the new rule? - How is the FDA's inspection process expected to change under the new QMSR? - What are the hidden risks of ignoring the subtle differences between the old and new systems? To learn more or for a free consultation, contact us at info@pureglobal.com, visit https://pureglobal.com/, or access our FREE AI tools and medical device database at https://pureglobal.ai/.
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    3 mins
  • Pure Global: US LDTs, the FDA's Regulatory Wake-Up Call

    Pure Global: US LDTs, the FDA's Regulatory Wake-Up Call
    Feb 7 2026
    The U.S. FDA has just upended the diagnostics world. After decades of operating in a regulatory gray area, laboratory-developed tests (LDTs) will now be regulated as medical devices. This episode of MedTech Global Insights dives deep into what this massive policy shift means for labs, patients, and the entire MedTech industry. We explore the end of the FDA's "enforcement discretion" policy and the beginning of a new era of compliance. We unpack the immense operational and financial challenges facing academic medical centers and specialized labs, who must now navigate the same stringent requirements as major IVD manufacturers. A Real-World Dilemma: Imagine a university lab that developed a groundbreaking genomic test for a rare pediatric cancer. Now, they are considered a medical device manufacturer by the FDA, facing a multi-million dollar compliance burden without the staff or budget. Will their vital test disappear, leaving patients with no options? This is the reality many labs now face. Key Takeaways From This Episode: - Why did the FDA decide to regulate LDTs as devices after decades? - What is the four-year transition timeline, and what are the key compliance deadlines? - How will pre-market review requirements impact innovation in personalized medicine? - What are the strategic options for labs: build, partner, or discontinue tests? - Will this new rule create more opportunities for large IVD companies? - How can labs with limited resources begin building a compliant Quality Management System? - What happens to niche tests for rare diseases that may not be commercially viable under this new rule? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/. You can also explore our FREE AI tools and medical device database at https://pureglobal.ai/.
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    2 mins
  • USA SaMD & The RWE Paradox: A Pure Global Briefing

    USA SaMD & The RWE Paradox: A Pure Global Briefing
    Feb 6 2026
    This week, we dissect the FDA's sudden and impactful new guidance on Real-World Evidence (RWE) that just sent ripples through the US digital health sector. This isn't just another update; it's a fundamental shift in how data from wearables and EHRs will be scrutinized, potentially derailing existing regulatory strategies for countless SaMD and AI-driven medical devices. We explore the new, stricter demands for data integrity and what it means for companies that have banked their futures on the promise of RWE. We break down the strategic pivots innovators must now consider to stay compliant and competitive, transforming a potential regulatory crisis into a strategic advantage. **Case Study:** A leading digital health firm has spent two years and millions of dollars building a product roadmap based on leveraging real-world data for rapid market expansion. Last week, the new FDA guidance rendered their entire evidence portfolio questionable, putting their next funding round and product launches in jeopardy. Their data asset has suddenly become a massive liability. **What You'll Learn:** 1. What are the critical new data integrity rules in the FDA's RWE guidance? 2. Is your current Real-World Evidence strategy now obsolete? 3. Why did a past failure of a cardiac monitoring app trigger this FDA crackdown? 4. What specific validation steps are now required for data from wearables? 5. How does this shift impact the valuation of digital health startups? 6. What is the new cost of bringing an RWE-supported device to market? 7. How can you turn this regulatory hurdle into a competitive advantage? 8. Will the EU and other markets follow the FDA's lead? For a deeper dive into crafting a resilient global regulatory strategy, contact us at info@pureglobal.com, visit https://pureglobal.com/, or explore our FREE AI tools and medical device database at https://pureglobal.ai/.
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    2 mins
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