Τα καλύτερα Medical Device podcast (2025)

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Pacemakers and ICDs in 2024-2025: Key Global Market and Technology Shifts 3:00

18h ago3:00

3:00

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 la…

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The #1 Lesson After Helping 2,500 People Break Into Medical Device Sales 26:09

1d ago26:09

26:09

Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you’re new to my channel, my name is Jacob McLaughlin. I’m the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a…

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Wie ROCHE die EU Digital-Regulierung bewältigt 33:21

5d ago33:21

33:21

Vom EU-HDS über den Data Act bis zum AI Act Der "Head of Legal Digital & IT" bei ROCHE berichtet, wie ein Konzern mit der EU-Digitalregulierung umgeht, wie er auf Augenhöhe bleibt, auf was es bei der Implementierung ankommt und welche Kritik und welche Hoffnung an bezüglich dieser Vorgaben hat. Christian Johner beleuchtet die gleichen Fragestellung…

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The REPS Who Play Chess Not Checkers 27:31

5d ago27:31

27:31

Send us a text What separates top reps from the rest? It’s not just skill, it's how they think. In this episode, Lisa and Cindy break down why critical thinking is the ultimate competitive edge in medical device sales. They share how this mindset helps you navigate complex decisions, read the room, and deliver value beyond the pitch. Tune in for re…

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#435: ICYMI (In Case You Missed It!) Becoming a Regulatory Affairs Professional 44:35

6d ago44:35

44:35

In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the …

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U.S. Joint Arthroplasty Trends: Robotics, Demographics, and the 2025 Implant Market 3:09

1d ago3:09

3:09

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 arthrop…

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US Market Access: How CMS Reimbursement Fueled the CGM and Insulin Pump Boom 2:58

3d ago2:58

2:58

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 o…

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AI-Powered MedTech Regulation: Slashing Global Market Access Time by 75% 3:22

4d ago3:22

3:22

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 accel…

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AI in MedTech Regulation: 70% Faster FDA Submissions & Japan Compliance Case Studies 3:19

5d ago3:19

3:19

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 regul…

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Unlocking Global Markets: End-to-End Regulatory Services for MedTech and IVD Devices 2:55

6d ago2:55

2:55

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 t…

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Scaling MedTech: Tailored Regulatory Strategies for Startups, Scaleups, and Global Enterprises 2:50

7d ago2:50

2:50

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 appr…

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Beyond Traditional Consulting: The Future of IVD and MedTech Market Access 2:59

8d ago2:59

2:59

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 m…

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Making the Leap: How One Mom Built a Career in Medical Device Sales 40:20

9d ago40:20

40:20

Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you’re new to my channel, my name is Jacob McLaughlin. I’m the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a…

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Unlocking Global MedTech Markets: A Unified Strategy for Registration in the US, EU, and Asia 2:40

9d ago2:40

2:40

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-p…

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MedTech Market Entry: The True Cost of Free vs. Paid Regulatory Resources 2:50

10d ago2:50

2:50

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 successfu…

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Beyond the SaaS Hype: Real AI-Powered Global Market Access for MedTech 2:51

11d ago2:51

2:51

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…

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MedTech Expansion Strategy: Unlocking Underserved Global Markets in LATAM and APAC 2:57

12d ago2:57

2:57

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…

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The Best Thanksgiving Recipe: A Dash of Gratitude, A Heavy Scoop of GRIT 24:35

12d ago24:35

24:35

Send us a text Happy Thanksgiving from the Girls of Grit! Lisa and Cindy flip the script in this Thanksgiving episode of The Girls Of Grit. They share five things every medical device rep should be grateful for, yes, even the tiny wins that often go unnoticed. From the people who make your cases possible to the territories that feel like a second h…

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AI in MedTech Regulatory Affairs: Scaling to 30+ Global Markets 2:50

13d ago2:50

2:50

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 innova…

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#434: ICYMI (In Case You Missed It!) Project Management In Medtech 1:02:20

13d ago1:02:20

1:02:20

This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile pract…

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Free AI Agents: The Future of Medical Device Registration in the US, EU, and Beyond 2:51

14d ago2:51

2:51

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.…

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Colombia Medical Device Registration: Unpacking Decree 4725 of 2005 3:16

15d ago3:16

3:16

This episode provides a detailed overview of Colombia's foundational medical device regulation, Decree 4725 of 2005. We explore the critical role of INVIMA, the risk-based classification system, key submission requirements for market approval, and post-market surveillance obligations for MedTech and IVD manufacturers looking to enter the Colombian …

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Stop Doubting Yourself—Breaking Into Medical Device Sales IS Possible 15:36

16d ago15:36

15:36

Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you’re new to my channel, my name is Jacob McLaughlin. I’m the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a…

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Mexico's Technovigilance: Mastering COFEPRIS NOM-240 for Post-Market Success 3:12

16d ago3:12

3:12

This episode provides a detailed overview of Mexico's Technovigilance requirements for medical devices under COFEPRIS regulation NOM-240-SSA1-2012. We explore the mandatory post-market surveillance system, including the roles of the Sanitary Registration Holder, adverse event reporting timelines, and the documentation required for registration rene…

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Mexico's New Medical Device Labeling Standard: A Deep Dive into NOM-137-SSA1-2024 3:07

17d ago3:07

3:07

This episode provides a critical update on Mexico's new mandatory standard for medical device labeling, NOM-137-SSA1-2024. The host breaks down the key changes from the previous 2008 version, including the strict Spanish language requirement, new provisions for electronic labeling and Software as a Medical Device (SaMD), and updated rules for symbo…

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Navigating NOM-241-SSA1-2021: Medical Device GMP Compliance in Mexico 3:15

18d ago3:15

3:15

This episode provides a detailed overview of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. The host breaks down the key requirements for medical device manufacturers, including the implementation of a Quality Management System, risk management protocols, and alignment with ISO 13485. We discuss the standard's sc…

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Navigating COFEPRIS: A Deep Dive into Mexico's 'Reglamento de Insumos para la Salud' for Medical Devices 3:24

19d ago3:24

3:24

This episode provides a detailed overview of Mexico's medical device regulations, focusing on the Reglamento de Insumos para la Salud. We explore the role of the regulatory authority, COFEPRIS, the risk-based device classification system, and the available registration pathways, including the Standard and Equivalency routes. The host also covers th…

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The Unseen Habit of High Performers 34:00

19d ago34:00

34:00

Send us a text Ever wonder why some reps crush their goals and then struggle to repeat their success? In this episode, Lisa and Cindy reveal the secret ingredient that separates high performers from the rest: consistency. They break down how showing up, following through, and building trust with physicians and staff creates momentum that drives lon…

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Mexico's COFEPRIS Framework: A Deep Dive into the Ley General de Salud for Medical Devices 2:54

20d ago2:54

2:54

This episode provides a comprehensive overview of Mexico's foundational health regulation, the Ley General de Salud, and its impact on medical device market access. We explore the role and authority of the regulatory body, COFEPRIS, and break down the key requirements manufacturers must meet, from pre-market registration and GMP compliance to post-…

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#433: ICYMI (In Case You Missed It!) Climbing the Medtech Ladder - How to Get to the Top 1:10:28

20d ago1:10:28

1:10:28

In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, levera…

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Brazil GMP Certification: A Deep Dive into RDC 687/2022 for Class III/IV Devices 3:16

21d ago3:16

3:16

This episode provides a detailed analysis of Brazil's RDC 687/2022, a critical regulation from ANVISA governing Good Manufacturing Practices (GMP) certification for Class III and IV medical device manufacturers. We explore the key requirements, audit procedures, and documentation needed to secure the mandatory CBPF certificate, highlighting the cha…

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Navigating Brazil's ANVISA Technovigilance: A Deep Dive into RDC 67/2009 Reporting Timelines 3:13

22d ago3:13

3:13

This episode provides a detailed overview of Brazil's key technovigilance regulations for medical devices, RDC 67/2009 and RDC 551/2021. We explore the mandatory requirements for post-market surveillance, the critical role of the Brazilian Registration Holder (BRH), and the specific, strict timelines set by ANVISA for reporting adverse events, malf…

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A Veteran Rep’s Take on How the Industry Has Changed and How Her Son Just Landed His Dream Job 53:43

23d ago53:43

53:43

Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you’re new to my channel, my name is Jacob McLaughlin. I’m the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a…

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Brazil's BGMP Overhaul: Navigating ANVISA RDC 665/2022 and MDSAP Compliance 3:07

23d ago3:07

3:07

This episode explores Brazil's key regulation for medical device and IVD manufacturers, ANVISA RDC 665/2022. We break down the Brazilian Good Manufacturing Practices (BGMP) requirements, its alignment with international standards like ISO 13485, its replacement of the former RDC 16/2013, and its crucial integration with the Medical Device Single Au…

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Brazil's IVD Shake-up: ANVISA RDC 830/2023 and New Risk Classifications 3:10

24d ago3:10

3:10

This episode provides a detailed analysis of Brazil's new IVD regulation, ANVISA RDC 830/2023, which was implemented in June 2024. We explore the critical changes to risk classification systems, which align with international standards and result in the up-classification of many devices. The discussion covers the impact on regulatory pathways, tech…

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ANVISA RDC 751/2022: A Manufacturer's Guide to Brazilian Device Registration 3:36

25d ago3:36

3:36

This episode provides a detailed overview of Brazil's pivotal medical device regulation, ANVISA RDC 751/2022, which became effective in March 2023. We explore its comprehensive framework, including the four-tier risk classification system, the distinct pathways for notification and registration, and its alignment with international standards like t…

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Singapore MedTech: How to Break Free from Distributor Lock-In 3:44

26d ago3:44

3:44

This episode delves into the critical process for medical device manufacturers to regain control of their Singapore market access by transitioning from a distributor-held registration to an independent registrant. We explain why tying your regulatory license to a commercial partner creates business risks and outline the strategic advantages and pro…

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From Stuck to Unstoppable: Becoming Procrastination Proof 26:40

26d ago26:40

26:40

Send us a text Are you ready to be unstuck and unstoppable? In this episode, Lisa and Cindy expose the hidden illusion that’s quietly stealing your sales success. The one that keeps you “busy” but never bold enough to move forward. They break down the psychology behind why we delay the very things that could change our careers and how fear often di…

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Unlocking Your MedTech in Vietnam: The Registration Holder Dilemma 2:51

27d ago2:51

2:51

This episode delves into the critical process of changing a medical device registration holder in Vietnam. We clarify a common misconception: a direct license transfer between holders is not permitted by the Ministry of Health. Instead, manufacturers must navigate a full re-registration process. We outline the steps involved and highlight the signi…

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#432: China MedTech Compliance: Regulatory Risks, Rewards, & Strategy with Elaine Tan 40:20

27d ago40:20

40:20

This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation’s stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting th…

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Japan's D-MAH System: Regaining Control of Your Medical Device 3:09

28d ago3:09

3:09

This episode explores the critical strategic choice between appointing a distributor versus an independent Designated Marketing Authorization Holder (D-MAH) for medical device registration in Japan. We break down how using an independent D-MAH allows foreign manufacturers to retain ownership of their marketing approvals, providing essential flexibi…

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Australia TGA Sponsor: How to Take Control of Your Medical Device Registration 2:43

29d ago2:43

2:43

This episode delves into the strategic process of changing a TGA Sponsor for medical devices in Australia. We explore the critical differences between using a distributor as a sponsor versus an independent sponsor, outlining the risks of the former and the long-term benefits of the latter. Learn about the official transfer process, the importance o…

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Landing a 6-Figure Med Device Job in 2 Weeks — Here’s How 42:08

29d ago42:08

42:08

Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you’re new to my channel, my name is Jacob McLaughlin. I’m the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a…

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Unlocking India: The Strategic Advantage of an Independent Authorized Agent 3:23

30d ago3:23

3:23

This episode explores the critical process of switching your Indian Authorized Agent (IAA) with the CDSCO, moving from a commercially-tied distributor to an independent regulatory partner. We detail the significant business risks of using a distributor as your agent and provide a step-by-step guide for making the change, including the crucial role …

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Regain Control: Transferring Your ANMAT Registration in Argentina 3:06

1M ago3:06

3:06

This episode delves into the critical process of transferring ANMAT medical device registration in Argentina from a distributor to an independent holder. We explore the strategic risks of distributor-held registrations, such as commercial lock-in, and provide a clear overview of the transfer process, including the role of the Argentina Authorized R…

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Unlock Chile: Why Your Distributor Shouldn't Own Your Medical Device Registration 3:02

1M ago3:02

3:02

This episode explores a crucial, often overlooked aspect of entering the Chilean medical device market: the selection of an in-country registration holder. We detail the significant risks of appointing a distributor as your registration holder with the Instituto de Salud Pública (ISP), including loss of market control and conflicts of interest. The…

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