Medical Device Global Market Access Podcast Por Pure Global arte de portada

Medical Device Global Market Access

Medical Device Global Market Access

De: Pure Global
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 Navigate every market. Accelerate every launch. Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut. Why listen? • Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other regimes, showing exactly how long each milestone really takes and where companies get stuck. • First-hand war stories – Hear candid interviews with regulatory veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale. • Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve. • Actionable templates – From clinical evaluation checklists to technical-file skeletons, we break down the documents you’ll need and the pitfalls reviewers love to flag. • AI-powered insights – Because Pure Global mines millions of public filings, tenders, and recalls, we surface data-backed best practices you won’t hear at conferences—or from competitors. What you’ll hear • Launching SaMD under multiple risk classes in parallel • Surviving an unannounced ISO 13485 audit • Building a “reg-first” QMS that scales • Mastering Latin-American registrations without endless language cycles • Leveraging real-world evidence to shorten clinical timelines • Aligning cybersecurity, privacy, and post-market surveillance rules across regions Whether you’re plotting first entry, managing lifecycle expansions, or rescuing a delayed submission, subscribing could shave months—and millions—off your path to revenue. ⸻ Brought to you by Pure Global – the AI-native consultancy that already guides MedTech innovators through regulatory and market-access hurdles in 30 + countries. Ready for expert help on your next submission? Visit https://pureglobal.com or email info@pureglobal.com to start accelerating today.Copyright 2025 Pure Global
Episodios
  • Unlock Global MedTech Markets: Finding Your Ideal Distributors

    Unlock Global MedTech Markets: Finding Your Ideal Distributors
    Jun 11 2025
    This episode delves into proven strategies for medical device companies to identify, vet, and secure local importers and distributors worldwide. We explore a multifaceted approach, combining digital tools, key industry events, professional networks, and crucial due diligence steps to help you effectively expand your product's global reach and navigate market entry complexities. Key Questions: • How can specialized online databases supercharge your distributor search? • What is the unique value of attending major medical device trade shows? • Why are industry associations a goldmine for finding vetted partners? • How can B2B marketplaces and professional social media expand your outreach? • What are the advantages of collaborating with local representatives or logistics firms? • How can analyzing competitor strategies reveal hidden distributor opportunities? • What critical aspects must you evaluate when performing due diligence on potential partners? • Why are geographic targeting and regulatory compliance non-negotiable before engaging distributors? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    5 m
  • The Multi-Billion Dollar Diagnosis: Unpacking MedTech's Top Revenue Generator

    The Multi-Billion Dollar Diagnosis: Unpacking MedTech's Top Revenue Generator
    Jun 10 2025
    This episode delves into the dominant force in medical device revenue: In Vitro Diagnostics (IVDs). We uncover why IVDs consistently lead the global market, highlighting key drivers like early disease detection and the rise of chronic illnesses. We also explore the geographical strongholds, with a focus on the U.S. market's supremacy, and identify the leading corporations such as Abbott, Roche, and Siemens Healthineers shaping this lucrative sector. Key Questions: • Which medical device category earns the most worldwide? • What exactly are In Vitro Diagnostics and why are they so crucial? • How does the United States maintain its lead in the global medical device market? • Which companies are pioneering the IVD space? • What impact does the increasing prevalence of chronic diseases have on IVD revenues? • How is point-of-care testing changing the diagnostics landscape? • Is the Asia Pacific region poised to challenge North America's dominance? • What are some examples of high-revenue IVD devices? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 m
  • Beyond EU Bottlenecks: MedTech's New Global Market Hotspots

    Beyond EU Bottlenecks: MedTech's New Global Market Hotspots
    Jun 9 2025
    This episode explores the evolving global market entry strategies for medical devices. We discuss the significant regulatory hurdles in the EU due to MDR/IVDR, leading manufacturers to increasingly prioritize the U.S. market. We also delve into the burgeoning opportunities in high-growth emerging markets across Asia-Pacific and Latin America, offering insights into strategic planning for today's complex MedTech landscape. Key Questions: • Why is the EU becoming a less attractive first-launch market for medical devices? • What makes the U.S. market increasingly appealing for MedTech manufacturers? • How are new EU regulations (MDR/IVDR) impacting device approval timelines and costs? • Which Asia-Pacific countries offer the most promising growth for medical devices by 2025? • What are the key drivers behind Latin America's expanding medical device market, projected to reach $71 billion by 2032? • How should manufacturers adapt their regulatory strategies in this shifting global environment? • What role do local partnerships play in accessing emerging markets? • Are there benefits to pursuing simultaneous submissions in multiple regions? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 m
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