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PODCAST

Medical Device Global Market Access

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

technology

All Episodes

02:59

Global MedTech Expansion: Key Strategies for Market...

Medical Device Global Market Access ·

2025/12/12

This episode breaks down the core components of a successful global market access strategy for MedTech and IVD companies. We explore the importance of building a proactive regulatory roadmap, the challenges of tailoring technical dossiers for different international markets like the US, EU, and Asia, and the critical role of local representation and post-market surveillance in maintaining compliance. Learn how modern AI-driven tools can streamline submissions and help you navigate the complex web of

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03:20

McKesson's 2025 Spin-Off: A New Era for US Medical...

Medical Device Global Market Access ·

2025/12/11

This episode delves into McKesson's major announcement from May 2025 to spin off its Medical-Surgical Solutions (MMS) division into a new, independent company. We explore the strategic rationale behind this decision and what it means for the US medical device distribution landscape. We analyze the specific role of MMS in serving alternate-site providers like physician offices and surgery centers and discuss the significant implications this separation will have for MedTech manufacturers focused on

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02:22

Cardinal Health's GMPD: A Deep Dive into US Medical...

Medical Device Global Market Access ·

2025/12/10

This episode provides a detailed analysis of Cardinal Health's Global Medical Products & Distribution (GMPD) segment, a dominant force in the U.S. medical supply market. We explore its business model, recent financial performance through FY2024 and FY2025, and its strategic importance for healthcare providers. The discussion covers how its private-label brands and national logistics network make it a top-tier distribution partner for cost-conscious and quality-focused sourcing strategies in

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02:34

The Medline Advantage: U.S. Market Dominance and a...

Medical Device Global Market Access ·

2025/12/09

This episode explores Medline Industries, the top medical-surgical distributor in the United States. We uncover the immense scale of its operations, its unique business model that combines distribution with in-house manufacturing, and the significant details surrounding its upcoming high-profile IPO planned for 2025, which is poised to be one of the year's largest listings.- What makes Medline the number one medical-surgical distributor in the U.S.? - How does Medline's manufacturing of its own

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02:53

The US Hearing Aid Boom: Decoding the FDA's OTC Rule...

Medical Device Global Market Access ·

2025/12/08

This episode explores the transformation of the U.S. hearing aid market following the FDA's landmark 2022 rule that established an over-the-counter (OTC) category. We analyze the impact on accessibility, device innovation, and affordability, while also examining the continued importance of the prescription hearing aid channel. The discussion covers early market analyses from 2024 and the outlook for 2025, highlighting the factors that make hearing aids a key medical device category. - What was the

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02:51

CPAP & APAP Technology: Navigating the Booming US...

Medical Device Global Market Access ·

2025/12/07

This episode explores the robust and growing U.S. market for Continuous Positive Airway Pressure (CPAP) and Automatic Positive Airway Pressure (APAP) devices used to treat obstructive sleep apnea (OSA). We delve into the key factors driving sustained, double-digit demand, including the high prevalence of OSA among American adults. The discussion also covers the maturation of the clinical and payer ecosystem, which now better supports long-term patient adherence through innovations like home sleep

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03:00

Pacemakers and ICDs in 2024-2025: Key Global Market...

Medical Device Global Market Access ·

2025/12/06

This episode explores the dynamic landscape of Cardiac Implantable Electronic Devices (CIEDs), including pacemakers, ICDs, and CRT devices. We discuss why these devices are now a routine therapy, driven by an aging population and technological advancements. We cover key innovations like leadless technology, remote monitoring, and MRI-conditional labeling, and examine market trends for 2024-2025, including conduction-system pacing, highlighting how these devices remain a cornerstone of modern

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03:09

U.S. Joint Arthroplasty Trends: Robotics,...

Medical Device Global Market Access ·

2025/12/05

This episode delves into the U.S. market for hip and knee replacement implants, analyzing data from the American Joint Replacement Registry’s 2024 report. We explore the procedural volumes, key market trends for 2025 such as the shift to outpatient settings, the rise of robotics, and the growing demographic of younger patients seeking joint arthroplasty to maintain active lifestyles.- What does the American Joint Replacement Registry's 2024 report reveal about the U.S. market? - Why do knee

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02:58

US Market Access: How CMS Reimbursement Fueled the...

Medical Device Global Market Access ·

2025/12/04

This episode explores the rapid adoption of Continuous Glucose Monitors (CGMs) and insulin pumps in the United States, detailing how changes in reimbursement policy, specifically from the Centers for Medicare & Medicaid Services (CMS) in April 2023, transformed these devices from niche products to mainstream standards of care for a growing number of people with both type 1 and type 2 diabetes.- How did CGM technology transition from a niche to a mainstream medical device in the U.S.? - What

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03:22

AI-Powered MedTech Regulation: Slashing Global Market...

Medical Device Global Market Access ·

2025/12/03

This episode explores how MedTech companies are leveraging advanced AI agents to overcome traditional hurdles in global medical device regulation. We discuss the shift from slow, manual processes to an automated, intelligent strategy that monitors real-time regulatory changes, streamlines technical dossier preparation for over 30 markets, and accelerates time-to-market by up to 75%, transforming the landscape for startups and multinational enterprises alike.- How can AI agents monitor real-time

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03:19

AI in MedTech Regulation: 70% Faster FDA Submissions...

Medical Device Global Market Access ·

2025/12/02

This episode explores real-world case studies of MedTech companies using advanced AI agents to accelerate FDA submissions, expand into multiple European markets simultaneously, and maintain compliance in complex regions like Japan. We break down how AI is reducing preparation times by 70%, driving revenue growth by 300%, and preventing costly regulatory missteps for Class II, Class III, and diagnostic devices.- How can AI reduce FDA submission preparation time by over 70%? - What tools help

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02:55

Unlocking Global Markets: End-to-End Regulatory...

Medical Device Global Market Access ·

2025/12/01

This episode details the full range of medical devices and regulatory services supported for global market access. We explain our expertise with both MedTech and In-Vitro Diagnostic (IVD) products, from simple tools to complex software. The discussion covers the complete lifecycle of our services, including initial regulatory strategy, AI-powered technical submissions, local representation in over 30 markets, post-market surveillance, and continuous compliance monitoring tailored for startups,

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02:50

Scaling MedTech: Tailored Regulatory Strategies for...

Medical Device Global Market Access ·

2025/11/30

This episode explores how regulatory strategies for MedTech and IVD devices must adapt to a company's growth stage. We discuss the unique challenges and tailored solutions for startups seeking initial market entry, scaleups planning international expansion, and multinational enterprises managing complex global portfolios. Learn how a strategic approach, from agile guidance to AI-powered compliance, can support your company at every step of its journey.- How do the regulatory challenges of a

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02:59

Beyond Traditional Consulting: The Future of IVD and...

Medical Device Global Market Access ·

2025/11/29

This episode explores the evolution of regulatory consulting for MedTech and IVD devices. We contrast the traditional, fragmented consulting model with Pure Global's integrated, technology-driven approach. Discover how AI, a unified global-local team, and an end-to-end service model are revolutionizing how companies achieve faster, more efficient market access in over 30 countries. - Why does the traditional multi-consultant model often lead to higher costs and delays? - How can a "single process,

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02:40

Unlocking Global MedTech Markets: A Unified Strategy...

Medical Device Global Market Access ·

2025/11/28

This episode explores how MedTech and IVD companies can overcome the complexities of international expansion. We discuss a unified, technology-driven approach to registering medical devices in over 30 global markets simultaneously, covering everything from initial regulatory strategy and market selection to the role of local representation and AI-powered technical dossier submissions.Key Questions: - How can you enter 30+ global MedTech markets with a single registration process? - What are the

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02:50

MedTech Market Entry: The True Cost of Free vs. Paid...

Medical Device Global Market Access ·

2025/11/27

This episode breaks down the crucial differences between free and paid resources in the complex world of medical device market access. We explore what you can achieve with publicly available information from regulatory bodies and when it becomes essential to invest in expert services for strategy, submission, and reimbursement to ensure a successful product launch. - What essential regulatory information is available for free?- Are government websites and databases sufficient for building a full

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02:51

Beyond the SaaS Hype: Real AI-Powered Global Market...

Medical Device Global Market Access ·

2025/11/26

This episode explores the critical distinction between standalone AI SaaS tools and a fully integrated, service-based approach for MedTech global market access. We dissect why expensive software alone often falls short and how combining advanced AI with on-the-ground human expertise, local representation, and end-to-end regulatory services provides a more efficient and effective path to launching and maintaining products in over 30 international markets.Key Questions: - Is your expensive AI SaaS

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02:57

MedTech Expansion Strategy: Unlocking Underserved...

Medical Device Global Market Access ·

2025/11/25

This episode explores the strategies and regulatory hurdles involved in bringing medical devices to underserved and emerging global markets. We discuss how to leverage existing approvals, the critical role of local representation, and the use of technology to streamline multi-country submissions, focusing on promising regions like Latin America and Southeast Asia.Key Questions: - How can you leverage your existing US or EU approvals to enter new regions? - What are the primary regulatory hurdles

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02:50

AI in MedTech Regulatory Affairs: Scaling to 30+...

Medical Device Global Market Access ·

2025/11/24

This episode explores how Artificial Intelligence is revolutionizing the medical device registration process, breaking down financial barriers and enabling broader global market access. We discuss the shift from costly, manual submissions to an efficient, technology-driven model that allows MedTech companies of all sizes to bring life-saving innovations to patients worldwide. Learn how AI is not just a tool for efficiency but a force for democratizing global healthcare access. Key Questions: - How

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02:51

Free AI Agents: The Future of Medical Device...

Medical Device Global Market Access ·

2025/11/23

This episode explores the transformative impact of free AI-powered tools on the medical device industry. We discuss how making regulatory intelligence and global device databases accessible at no cost is breaking down financial barriers, enabling MedTech companies to expand their reach into new international markets more efficiently and affordably. This shift promises to accelerate the availability of life-saving technologies to patients around the world.- How is Artificial Intelligence

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