『Medical Device Global Market Access』のカバーアート

Medical Device Global Market Access

Medical Device Global Market Access

著者： 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
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  • From Lab to Life: The Rise of Bioactive 3D-Printed Spinal Implants

    From Lab to Life: The Rise of Bioactive 3D-Printed Spinal Implants
    2025/07/20
    This episode delves into the revolutionary world of personalized 3D-printed spinal implants, highlighting Xenco Medical's TrabeculeX Continuum. We explore how its bioactive matrix eliminates the need for painful bone grafts, significantly reducing surgery time, and how its integrated recovery app is transforming postoperative care through remote monitoring and high patient engagement. Key Questions: • How can 3D printing revolutionize spinal implant surgery? • What are bioactive materials and how do they eliminate the need for bone grafting? • Can a medical device really reduce spinal surgery time by over 30 minutes? • How is digital health being integrated directly with surgical implants for better outcomes? • What does the future of postoperative recovery look like with remote monitoring apps? • Why was Xenco Medical named one of the world's most innovative companies in 2023? • How can high patient engagement with a recovery app transform the rehabilitation journey? 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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    3 分
  • The Remote Revolution: How At-Home Devices Are Solving the Physical Therapy Crisis

    The Remote Revolution: How At-Home Devices Are Solving the Physical Therapy Crisis
    2025/07/19
    This episode explores the rise of remote physical therapy devices like ROMTech's PortableConnect as a direct response to the significant shortage of physical therapists in the United States. We analyze the market drivers, patient benefits, and the critical market access hurdles, including payer reimbursement, that innovative MedTech companies face when introducing disruptive technologies. Key Questions: • What does the latest data from October 2024 reveal about the physical therapist shortage in the U.S.? • How does tele-rehabilitation technology aim to bridge the gap in patient care? • What is the ROMTech PortableConnect, and how does it function? • Can at-home devices truly deliver outcomes comparable to traditional, in-person physical therapy? • What are the reported cost savings for patients using remote therapy devices? • Why has prescription growth for these devices increased by 36% year-over-year? • What is the current stance of major insurance payers on reimbursing for this technology? • What regulatory and market access challenges do innovators in this space encounter? 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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    3 分
  • From Niche to Mainstream: The AI Revolution in Wearable Health Tech

    From Niche to Mainstream: The AI Revolution in Wearable Health Tech
    2025/07/19
    This episode explores the rapid expansion of AI-integrated wearables, focusing on how continuous glucose monitors (CGMs) are transitioning from clinical devices to mainstream wellness tools. We delve into the technological drivers, such as advanced sensors and on-device AI, and the market catalysts, including the 2024 Medicare coverage expansion, that are fueling a 25.53% CAGR in the wearable medtech market. • How are wearables evolving from simple trackers to predictive health monitors? • Why are continuous glucose monitors (CGMs) no longer just for people with diabetes? • What role does Artificial Intelligence (AI) play in real-time health analytics? • Which new over-the-counter devices from companies like Abbott and Dexcom are leading this trend in 2024? • How is the expansion of Medicare coverage accelerating the adoption of wearable medtech? • What does a 25.53% CAGR mean for the future of the wearable medical technology market? • Can these devices truly predict health events before they happen? • What do manufacturers need to know about the regulatory landscape for these new wellness 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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    3 分

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