Những podcast Medical Device hay nhất (2025)

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China's 2025 MedTech Surge: NMPA's New Fast-Track for Innovative Devices 5:07

5h ago5:07

5:07

This episode delves into China's transformative 2025 NMPA Roadmap, detailing how the "NMPA regulation 2025" aims to accelerate approvals for innovative medical devices. We explore the new Special Review Pathway, shortened clinical trial timelines, priority review categories, and expanded domestic production opportunities, offering insights for manu…

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Diagnosed but Not Defeated: The Power of Women Who Rise 24:47

13h ago24:47

24:47

Send us a text What if your greatest challenge became your greatest calling? In this unforgettable 100th episode of Secrets in Medical Device Sales™, Cindy and Lisa sit down with two powerhouse women who turned fear into purpose—Tina Valbh and Jessica Krauser. These warriors didn’t just survive a life-altering diagnosis; they chose to rise, speak o…

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Episode 39: Titled "The Real Rep Playbook- From The Surgeon's Point Of View." 58:23

1d ago58:23

58:23

Welcome back to another episode of the Device Diaries Podcast where we navigate the world of Medical Sales. In this powerful episode, we’re joined by Dr. Andrew Chung—an elite, double-fellowship trained orthopedic spine surgeon who’s seen it all in the operating room. Board-certified by the American Board of Orthopedic Surgeons and trained at world…

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#409: How Iterative Management Transforms MedTech Teams: Faster Execution, Smarter Decisions 23:15

1d ago23:15

23:15

In this episode recorded live at LSI Dana Point, Etienne Nichols sits down with Ed Muzio, author of Iterate, to explore how iterative management helps MedTech companies move faster as they scale. Muzio breaks down the pitfalls of traditional management—including siloed execution and backward-looking metrics—and offers a proven alternative grounded …

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2025-09: TÜV Rheinland & der Structured Dialogue 38:10

4d ago38:10

38:10

Effektive und gesetzeskonforme Kommunikation mit einer Benannten Stelle Der Arzt Christoph Ziskoven und der Jurist Marc Engelhardt beschreiben aus der Sicht ihrer Benannten Stellen die regulatorischen Anforderungen und den Ablauf des Structured Dialogues. Dabei erläutern sie auch die Ziele, die Einschränkungen und die Best Practices bei der gesetze…

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Saudi MedTech Breakthrough: Understanding the SFDA's MDS-G002 Pathway 3:55

1d ago3:55

3:55

This episode delves into the Saudi Food and Drug Authority’s (SFDA) Innovative Medical Devices Pathway (MDS-G002), a strategic initiative designed to significantly accelerate market entry for novel medical technologies in Saudi Arabia. We explore the key features, eligibility criteria, and the profound impact this pathway has on reducing time-to-ma…

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Brazil's RDC 751/2022: Your 2025 MedTech Compliance Guide 3:21

2d ago3:21

3:21

This episode unpacks Brazil's transformative RDC 751/2022 medical device regulation, effective since March 1, 2023. We cover the updated four-tier risk classification system, the 22 detailed classification rules (including those for SaMD and nanomaterials) aligning with EU MDR, and the distinct Notification (Class I/II) versus Registration (Class I…

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FDA's Landmark QMSR Rule: ISO 13485 Harmonization for 2026 3:31

3d ago3:31

3:31

This episode delves into the U.S. FDA's significant 2024 Quality Management System Regulation (QMSR) final rule. We explore how this rule, effective February 2, 2026, aligns 21 CFR Part 820 with the international standard ISO 13485:2016, discuss key changes, FDA-specific additions, and the crucial steps medical device manufacturers must take to pre…

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EU MDR's New Timetable: Are You Ready for 2025, 2027, and 2028? 4:50

4d ago4:50

4:50

This episode delves into the crucial extended transition deadlines for the EU Medical Device Regulation (EU MDR), now set for 2027 and 2028. We explore what these extensions mean for manufacturers of legacy medical devices, emphasizing the critical actions that should have been completed by May and September 2024 to benefit from this extra time. Th…

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EU IVDR: Strengthening Your MedTech Supply Chain Controls 4:43

5d ago4:43

4:43

This episode delves into the critical supply chain requirements for Economic Operators under the EU's In Vitro Diagnostic Regulation (IVDR), referencing insights from April 14, 2025. We explore common pitfalls leading to Notified Body non-conformities, the specific obligations for manufacturers, importers, distributors, and authorized representativ…

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Unlocking Worldwide IVD Access with Europe's IVDR 4:03

6d ago4:03

4:03

This episode explores how the European Union's stringent In Vitro Diagnostic Devices Regulation (IVDR) can strategically benefit IVD manufacturers seeking market access beyond the EU. We discuss leveraging IVDR CE Marking for easier entry into global markets, the role of harmonized quality management systems like ISO 13485, and the importance of a …

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Leveraging Real-World Data: MHRA's Blueprint for Clinical Trials 4:33

7d ago4:33

4:33

This episode delves into the UK's Medicines and Healthcare products Regulatory Agency (MHRA) guidance, updated 20 May 2025, on utilizing Real-World Data (RWD) in randomised controlled trials for regulatory decisions. We explore the scope, design considerations, safety monitoring, and regulatory acceptability of RWD-based trials, highlighting their …

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Burnout Is Real. So Is Your Power. 30:13

8d ago30:13

30:13

Send us a text Ever felt like you’re giving everything to your career and wondering if it’s giving enough back? In this candid and uplifting episode, Lisa and Cindy sit down with powerhouse sales leader and founder Kirsten Haight to talk about what it really looks like behind the scenes in medical device sales. From overwhelming schedules and misse…

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Navigating MHRA's 2025 Real-World Data Guidance for UK Clinical Trials 4:03

8d ago4:03

4:03

This episode unpacks the UK MHRA's updated May 20, 2025, guidance on employing Real-World Data (RWD) in clinical studies for regulatory approval. We discuss the scope, the critical emphasis on data quality, essential considerations for sponsors using RWD sources like EHRs and wearables, and how the MHRA is shaping the future of evidence generation …

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#408: What MedTech Startups Miss: Design Mistakes, Risk Testing & the Myth of the Quick Exit 9:27

8d ago9:27

9:27

In this live episode from the LSI conference, Etienne Nichols sits down with Justin Bushko—known as the "MedTech Man" and author of Medical Device Fireside Chats—to dive into what separates thriving medical device companies from those that fail. From costly engineering missteps like ignoring tolerance stack-ups to the human factors issues that dera…

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Wireless MedTech: Navigating Global RF Compliance 5:19

9d ago5:19

5:19

This episode offers medical device manufacturers an essential overview of navigating global wireless compliance when integrating radio frequency (RF) modules. We explore crucial considerations from selecting RF module suppliers and understanding international certification pathways—like modular versus system-level approvals—to compiling necessary d…

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Brazil's MedTech Pulse: Fresh Registration Insights for 2025 Q2 5:10

11d ago5:10

5:10

This episode delves into the latest medical device registration data from Brazil, focusing on trends observed in March and April 2025. We explore the prevalence of Class I and II devices, particularly in diagnostics, the types of higher-risk Class IV devices gaining approval, and the manufacturing landscape, highlighting both strong domestic produc…

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Don’t Let the Whale Swim Away: How to Retain Your Biggest Clients 26:41

15d ago26:41

26:41

Send us a text You finally landed the whale… now what? After months—maybe years—of chasing down the biggest account of your career, this episode is your blueprint for keeping it. Lisa and Cindy break down the exact playbook they’ve used to turn high-stakes KOLs and massive hospital systems into career-long allies. Discover the secret to retention, …

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#407: Cybersecurity in MedTech: FDA Compliance, Patient Safety & the Hidden Risks You’re Missing 42:21

15d ago42:21

42:21

Christian Espinosa, founder of Blue Goat Cyber and leading voice in medical device cybersecurity, joins Etienne Nichols to unpack the urgent and often misunderstood topic of cybersecurity in MedTech. From FDA’s 2023 regulatory overhaul to real-world hacking scenarios that could harm patients, Christian provides practical advice for innovators, RA/Q…

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Hooking the Whale: How to Land Game-Changing Clients 28:49

22d ago28:49

28:49

Send us a text Ever wonder how some reps manage to land massive hospital systems or superstar surgeons while others struggle for small wins? In this episode, Lisa and Cindy break down the art and strategy behind “landing a whale”—those game-changing customers who can transform your entire territory and career. They share real stories, key mindset s…

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#406: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 2 51:51

22d ago51:51

51:51

In part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC). This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and th…

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2025-08: MDR-Zertifizierungen bei BSI 19:17

26d ago19:17

19:17

Benannte Stelle BSI: Was die Zulassung beschleunigt und was es Neues gibt Dr. Axinja Wolf arbeitet bei der Benannten Stelle BSI. Sie teilt in dieser Podcast-Episode ihre Erfahrungen, wie lange die Zulassungsverfahren dauern, was Hersteller tun können, um diese Dauer zu minimieren und welche Services BSI rund um das Thema KI anbietet. Wenden Sie sic…

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Unspoken Rules of Conferences Every Woman in Med Device Needs to Know 25:51

29d ago25:51

25:51

Send us a text What’s the cost of one bad decision at a professional meeting? In this episode of Secrets in Medical Device Sales™, Lisa and Cindy get real about what it takes to show up like a true high performer in male-dominated spaces. From avoiding after-hours pitfalls to mastering your presence at conferences, the Girls of Grit™ serve up hard …

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2025-07: AI Act – Ein Praxisbericht 28:26

29d ago28:26

28:26

Von der Umsetzung bei einem Startup lernen Die Direktorin "Global Regulatory Affairs", Carmen Bellebna, berichtet darüber, wie sie und ihr Unternehmen DeepEye die Anforderungen des AI Act erfüllen. Keine Theorie, sondern Praxiserfahrungen aus erster Hand. Vom Schreiben von SOPs über Aufwandsschätzungen bis zum Umgang mit Benannten Stellen. Sie find…

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#405: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 1 40:04

29d ago40:04

40:04

In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world example…

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#404: MedTech 101: What You Need to Know About the Medical Device Industry 58:08

1M ago58:08

58:08

Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass. They unpack the roles, regulations, and realities of medical device development in a heavi…

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Use these 3 Tips to Maximize Your ROI on Customer Engagements 28:31

1M ago28:31

28:31

Send us a text Are your physician dinners falling flat instead of closing deals? In this high-impact episode, Lisa and Cindy share the 3 essential steps to execute a standout physician dinner — from strategic planning to unforgettable execution and the one crucial follow-up tactic most reps miss. Learn how to avoid the anxiety and start maximizing …

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#403: Global Perspective on Medical Device Reimbursement 37:04

1M ago37:04

37:04

In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets. From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep…

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The Triple Threat: 3 Secrets to Transform Your Sales Game 27:42

1M ago27:42

27:42

Send us a text Are you showing up as the most powerful version of yourself or just playing a role? In this deeply honest and energizing finale to their 10-part high performer series, Lisa and Cindy pull back the curtain on the secret sauce that separates top sellers from the rest: authenticity. From real-life stories to tactical action steps, this …

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#402: How to Attract Real Talent in the Medical Device Industry 41:06

2M ago41:06

41:06

Episode Summary: In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kirk Petyo, Managing Partner at Talent Factory Recruiting, to explore the art and science of hiring in MedTech. Kirk shares strategies for building magnetic employer brands, explains the difference between competencies and capabilities in cand…

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Linked by Fate: Unlocking the Doors of Opportunity 31:10

2M ago31:10

31:10

Send us a text How often do we find ourselves sitting at an event, wondering if we’re truly making the most of our networking opportunities? Whether you’re trying to advance in your career or make valuable connections, the power of networking can open doors you never thought possible. In this episode, Cindy and Lisa dive deep into the importance of…

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#401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity 48:34

2M ago48:34

48:34

In this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development. They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The …

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The ONE Shift That Gives You Hours Back—Without Working Harder 30:14

2M ago30:14

30:14

Send us a text What if the secret to getting more done wasn’t working harder? In this episode, The Girls of Grit™ reveal a game-changing shift that will help medical sales reps take back control of their time—without sacrificing performance. Lisa and Cindy break down the most common time-wasting habits that keep reps stuck in a cycle of burnout and…

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Episode 38 Titled " Give To Give: The Power Of Reciprocity In Sales 29:16

2M ago29:16

29:16

Welcome Back To Another Episode Of The Device Diaries Podcast, Where We Navigate The Daily Grind Of A Medical Device Sales Rep. In Today's Episode, We Explore How The Principle Of Reciprocity Can Transform Your Career And Lead You To More Success. Be Sure To Take Notes As I Drop 3 Tips On How To Get Started. Thank You For All Your Support. Don't Fo…

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2025-06: Neues aus Dänemark 23:21

2M ago23:21

23:21

Was der TÜV SÜD mit seiner neuen Benannten Stelle plant und zu klinischen Bewertungen empfiehlt Der TÜV SÜD hat eine neue Benannte Stelle in Dänemark aufgebaut und bereits erste Zertifkate vergeben. Der Arzt und Global Director des Clinical Centers of Excellence, Dr. Nitsche, verrät im Gespräch mit Christian Johner, was die Motivation für diesen Sc…

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#400: The State of the Medical Device Industry 53:55

2M ago53:55

53:55

In our 400th episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Greenlight Guru’s Sara Adams to unpack the findings of the 2025 Medical Device Industry Benchmark Report. From the rise of family office investments to QMS upgrades and the impact of regulatory uncertainty, this episode delivers a candid and comprehensive l…

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Warrior Within: How Battling Cancer Fueled a Mission for Change with Tina Valbh 34:37

2M ago34:37

34:37

Send us a text What does it take to turn life’s greatest challenges into a force for change? In this powerful episode, The Girls of Grit™ sit down with Tina Valbh, a pharmacist, entrepreneur, and breast cancer survivor who transformed her personal journey into a mission to reshape healthcare. From launching her consulting business to founding Tina’…

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2025-05: Auswirkung der Ökodesign-Richtlinie auf Medizinprodukte und IVD 21:19

2M ago21:19

21:19

Eine temporäre Entwarnung beim Digital Product Passport Die Ökodesign-Verordnung fordert einen "Digital Product Passport". Diese Verordnung schließt Medizinprodukte im Gegensatz zu Arzneimitteln explizit nicht(!) aus. Doch was müssen Hersteller jetzt tun? Dr. Harald Oehlmann gewährt in dieser Podcast-Episode einen Blick hinter die Kulissen und gibt…

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The ESSENTIAL Element to Advancing Sales… Are You Missing It? 27:25

2M ago27:25

27:25

Send us a text What does it take to truly lead yourself to success in sales? In this episode, Cynthia and Anneliese dive into the essential qualities of leadership and why mastering self-leadership is the first step toward becoming a high performer. From creating a clear vision to taking full ownership of your territory, they unpack what it means t…

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Episode 37: Titled " The Power Of Preparation Part 2!!" 1:01:31

2M ago1:01:31

1:01:31

Welcome Back To Another Episode Of The Device Diaries Podcast. In Today's Episode, I Welcome Back Jarrett Mitchell, A Seasoned Pharma Rep Who Is Killing It In His Space. Today We Will Dive Deeper Into How To Prepare Effectively For Every Sales Call, Meeting, And Pitch. We'll Cover Everything From Understanding Your Prospect's Needs, Crafting Your P…

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