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PODCAST

MedTech Global Insights

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.

science life sciences

All Episodes

02:18

USA Digital Health: Navigating FDA's New...

MedTech Global Insights ·

2025/12/09

Last week, the US FDA's new digital health pilot program sent ripples through the MedTech industry. This is more than a simple regulatory update; it's a pivotal shift that moves cybersecurity from a compliance task to a major commercial and contractual battleground, fundamentally changing the rules for market access. This episode breaks down how the convergence of new FDA initiatives and proactive industry standards is creating unforeseen hurdles. The burden of proof for cybersecurity has

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01:55

Brazil's MedTech Maze: Pure Global's AI Escape from...

MedTech Global Insights ·

2025/12/08

Traditional MedTech global expansion is broken, defined by premium consulting fees, opaque processes, and frustrating delays. This episode of MedTech Global Insights unpacks the new playbook for international market access, revealing how companies are finally breaking free from the old model. We explore how the strategic fusion of advanced AI and on-the-ground regulatory experts is revolutionizing the industry. Discover how Pure Global's proven approach helps companies slash timelines, reduce

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02:17

Germany to FDA: Pure Global's AI Crushes Doc Bottlenecks

MedTech Global Insights ·

2025/12/07

In this episode of MedTech Global Insights, we tackle the silent killer of speed-to-market: regulatory documentation bottlenecks. As companies expand globally, the sheer volume and complexity of preparing submissions for different health authorities can lead to costly delays and divert expert teams to low-value administrative work.We explore how cutting-edge AI is transforming this landscape. Discover how AI agents automate everything from device classification to technical file generation and

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01:56

Pure Global: Brazil's MedTech AI & Decoding...

MedTech Global Insights ·

2025/12/06

In the fast-paced world of MedTech, falling behind on regulatory changes isn't just a risk; it's a guarantee of costly delays and missed opportunities. The sheer volume of updates from global health authorities has made manual tracking an impossible task, leaving even the most diligent teams vulnerable to compliance gaps. This episode of MedTech Global Insights dives into the AI revolution in regulatory affairs. We explore how Pure Global's real-time intelligence platform transforms the chaotic

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01:55

Pure Global: Brazil MedTech AI - Unlocking 75% Faster...

MedTech Global Insights ·

2025/12/05

Are you ready to accelerate your MedTech or IVD product's global launch by 75%? In this episode of MedTech Global Insights, we explore how Pure Global's advanced AI platform is dismantling the traditional barriers to international market access, transforming a multi-year ordeal into a matter of months.We dive into how this technology provides real-time regulatory intelligence and automated compliance pathways, achieving a 95% approval success rate across 30+ major markets, including the FDA, EU,

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02:22

EU MedTech's Unfair Advantage: Pure Global's...

MedTech Global Insights ·

2025/12/04

In an industry where regulatory costs and complexities can stifle innovation, Pure Global's AI platform emerges as a game-changer. This episode of MedTech Global Insights delves into the five strategic advantages of leveraging their free, powerful AI agents to navigate the intricate world of global medical device registration. We explore how this technology isn't just an incremental improvement but a fundamental disruption to the old models of market access.We uncover how companies can drastically

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02:13

Cracking the Code of Global MedTech Expansion: How...

MedTech Global Insights ·

2025/12/03

In this episode of MedTech Global Insights, we explore the number one hurdle for ambitious medical device and IVD companies: navigating the fragmented and complex world of international regulations. We unpack why the traditional, country-by-country approach to market entry is inefficient and costly in today's fast-paced environment.We then break down a modern, integrated strategy for global expansion. This involves leveraging a core technical dossier across multiple markets simultaneously, powered

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02:26

Unlocking MedTech Success in China: Why a...

MedTech Global Insights ·

2025/12/02

In this episode of MedTech Global Insights, we explore the paradigm shift in global market access strategy. We move beyond the traditional, fragmented approach of managing regulatory hurdles country by country and dive into the rise of integrated, technology-driven consulting firms. These firms are not just advisors; they are end-to-end partners with a clear mission to streamline global expansion. We discuss how leveraging a single, centralized process combined with in-country expertise and

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02:25

Unlocking APAC MedTech Markets: How Pure Global...

MedTech Global Insights ·

2025/12/01

Navigating the complex, ever-changing web of global MedTech regulations is a primary barrier to market entry. The traditional, manual approach is notoriously slow, costly, and fraught with risks of rejection, delaying access to critical innovations for patients worldwide. This episode of MedTech Global Insights explores a new, technology-driven paradigm. We dive into how embedding advanced AI and a massive global database directly into regulatory services is transforming the industry. Learn how

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02:09

From Chaos to Clarity: Navigating MedTech Regulations...

MedTech Global Insights ·

2025/11/30

The global MedTech regulatory landscape is a maze of constantly changing rules and fragmented information. Relying on static guides or old webinars leads to costly delays and rejected submissions. This episode explores a modern solution: a "living library" of expert global insights that converts complex knowledge into simple, actionable checklists for your specific products and target markets.We break down how this dynamic approach transforms your regulatory strategy from reactive to proactive

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01:57

Unlocking Global MedTech Markets: Pure Global’s...

MedTech Global Insights ·

2025/11/29

Navigating the complex world of global MedTech regulations can be a major challenge. Many companies find themselves juggling multiple local consultants, leading to duplicated work, inconsistent strategies, and costly delays. This episode of MedTech Global Insights dives into the powerful alternative: partnering with a single, end-to-end provider for global market access. We explore how an integrated approach streamlines the entire product lifecycle, from initial classification and dossier

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02:08

Global MedTech Delays: How Pure Global’s 24-Hour...

MedTech Global Insights ·

2025/11/28

In the race for global market access, the biggest hurdle isn't always the regulations themselves, but the 24-hour clock. When your teams are spread across continents, progress can grind to a halt while one part of the world is asleep, turning simple questions into 48-hour delays. This episode dives into the hidden operational drag of time zone differences in MedTech regulatory affairs. We explore why the traditional model of hiring separate local consultants is no longer sufficient in a

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02:18

Cracking the Code: Pure Global's Expert Guide to...

MedTech Global Insights ·

2025/11/27

This episode of MedTech Global Insights dives deep into the strategic imperatives for entering China's complex medical device market. We demystify the NMPA's regulatory landscape, focusing on the three pillars of a successful market entry strategy: precise pathway planning, navigating stringent clinical evidence requirements, and the critical role of the legally mandated NMPA Local Agent.We explore how to avoid common pitfalls that can delay your launch by years and add millions in costs. Learn

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02:03

The Hidden Risk in the United States MedTech Market:...

MedTech Global Insights ·

2025/11/26

Entering the US MedTech market is a major achievement, but maintaining that access requires navigating critical annual compliance tasks. This episode explores the often-underestimated risks of the FDA establishment registration and device listing renewal process, a simple task that can lead to severe consequences if missed. We discuss how a simple administrative oversight can halt multimillion-dollar shipments at the border and freeze your US sales.We unpack a real-world case where a successful

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03:00

Pure Global's Guide to U.S. Market Entry: Mastering...

MedTech Global Insights ·

2025/11/25

In this episode of MedTech Global Insights, we tackle a critical and often misunderstood requirement for non-US medical device manufacturers entering the United States: the distinct roles of the FDA US Agent and the Official Correspondent. Getting this crucial step wrong can lead to costly delays, import holds, and significant compliance risks that can jeopardize your entire US market strategy. We break down the specific responsibilities of each role, explain why they are not interchangeable, and

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02:13

Beyond the CE Mark: Pure Global's Guide to EUDAMED...

MedTech Global Insights ·

2025/11/24

In this episode of MedTech Global Insights, we explore the critical challenges and strategic solutions surrounding the EU's EUDAMED database. We move beyond the basics of compliance to discuss why deep data literacy and expert-level management of your EU technical dossier are essential for maintaining market access and ensuring full traceability. We'll break down how EUDAMED is more than just a submission portal; it's a complex ecosystem that reflects the quality and integrity of your entire

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02:06

Unlocking the EU Market: Why Pure Global Advocates...

MedTech Global Insights ·

2025/11/23

This episode of MedTech Global Insights delves into the critical role of the EU Authorized Representative (AR) under the stringent MDR and IVDR. We explore why the AR is no longer a passive administrative contact but a legally liable partner crucial for your market success. Choosing the right AR is a strategic decision that directly impacts your compliance, risk management, and ability to remain on the European market.We uncover the significant dangers of partnering with 'mailbox' AR services and

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04:11

Navigating the Global Maze of Telemedicine & RPM: How...

MedTech Global Insights ·

2025/11/22

The telemedicine and remote patient monitoring (RPM) revolution is here, promising a new era of accessible and personalized healthcare. But for innovators in this space, global expansion presents a daunting maze of fragmented regulations, data privacy laws, and market entry barriers. This episode of MedTech Global Insights dives deep into the real-world challenges of taking a telemedicine or RPM platform global. We explore the complex regulatory landscapes of key markets like the EU and Brazil,

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03:57

Beyond the Scan: How Pure Global Navigates the AI and...

MedTech Global Insights ·

2025/11/21

In this episode of MedTech Global Insights, we delve into the technological revolution transforming Computed Tomography (CT) scanners. We explore the two seismic shifts pushing the boundaries of medical imaging: the introduction of high-resolution photon-counting detectors and the integration of sophisticated Artificial Intelligence.We discuss how these advancements lead to clearer images, more accurate diagnoses, and enhanced patient safety by reducing radiation exposure. But beyond the

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03:02

From Local Success to Global Leader: Pure Global's...

MedTech Global Insights ·

2025/11/20

In this episode of MedTech Global Insights, we delve into the complex world of orthopedic joint replacement implants. While an aging global population creates unprecedented demand, manufacturers face a labyrinth of regulatory hurdles that can stall expansion and keep vital technology from patients. We explore the key challenges, from the stringent EU MDR to the unique requirements of emerging markets.We break down why a traditional, country-by-country approach to regulatory submissions is no

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133 results

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