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Medical Device Insights

Prof. Dr. Christian Johner

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Der Podcast "Medical Device Insights" des Johner Instituts wendet sich an Medizinproduktehersteller, Behörden und Benannte Stellen. Er liefert Praxistipps, um sichere und wirksame Medizinprodukte mit minimalem Aufwand zu entwickeln, zu prüfen, zuzulassen und im Markt zu überwachen. Damit hilft er Herstellern, Audits sicher zu bestehen und mit ihren Produkten im Markt erfolgreich zu sein. Mit diesem Podcast sind die Hörerinnen oder Hörer bestens informiert und diskutieren mit Behörden, Benann ...
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Grounded in GRIT, our mission is to be ambassadors for professional women in the medical device sales industry, helping them tap into their potential, magnify their mindset & escalate their careers by providing real world every day scenarios, struggles and solutions.
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The Podcast That Will Dive Into The Exciting and Ever Changing World Of Medical Device Sales. Join Founder And Host, Gyda Loveres, Who Has Been In The Space For Over 13 Years, And Listen As She Explores The Ins And Outs Of This Fascinating Industry. Gyda Together With Her Guest, Will Uncover The Secrets, Challenges, And Triumphs That Come With Selling Medical Devices. You Will Hear First-Hand Stories From Industry Professionals, Gain Insights From Experts, And Navigate This Ever-Evolving Wor ...
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We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.
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The Medical Devices Group is the medical device industry hub that connects you with experts cherry-picked among our 350,000 members. • MedicalDevicesGroup.net – 1,000+ archived discussions + resources • medgroup.biz/premium – direct access to medical device experts • medgroup.biz/10x – in-person events • medgroup.biz/linkedin – legacy group • medgroup.biz/podcast – this podcast • medgroup.biz/eavesdrop – sister podcast Medical device work saves and transform lives, so we make our recordings, ...
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In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturer…
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Have you ever wondered why some sales reps consistently close deals while others fall short? The answer might be simpler than you think. In this episode, The Girls of Grit wrap up their three-part series on what it takes to succeed in medical device sales by revealing the crucial role of follow-up. They dive into the power of thoughtful, personaliz…
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Anthony Munoz shares his journey from medical device sales to real estate investing. Learn about breaking into med device sales, building trust with surgeons, and scaling income streams. Hear insights on transitioning careers, starting a real estate business, and achieving financial freedom—all while balancing personal goals and challenges. Perfect…
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Adnan Ashfaq, a seasoned quality, regulatory, and validation specialist, to explore the critical role of developing a regulatory roadmap for medical device companies. Adnan breaks down the differences between a regulatory strategy and a regulatory roadmap, highligh…
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Erfolgsfaktoren für Personen und Unternehmen Die Gesellschafter des Johner Instituts, Stefan Gössel und Christian Johner, offenbaren erstmals die Geheimnisse, die dem Institut über 20 Jahre zu einem stabilen Wachstum verholfen und es zu einer Institution für das Medizinprodukte-Ökosystem gemacht haben. Eine Institution an dem Top-Expertinnen und Ex…
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Send us a text In this episode, Chris McAuliffe, CEO of Theragen, shares his extensive journey in the medical device industry with a focus on non-invasive spine fusion. He recounts his personal experience as a patient undergoing spinal fusion surgery and how it has influenced his work and product design. The discussion covers the challenges of spin…
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In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree. Who is Rod Beuzeval? ​Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS s…
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What does it truly mean to bring value to medical device sales? In part two of our three-part series, The Girls of Grit dive into Patricia Choquette’s next essential principle for success: Bringing Value. They discuss what it takes to become the rep clients trust and return to time after time. This episode explores how intentionality and preparatio…
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Learn why many don't earn $100K in medical device sales and how mindset, avoiding self-sabotage, and pushing through discomfort can make the difference. Break into Medical Device Sales Online Course:https://courses.newtomedicaldevicesales.comhttps://www.linkedin.com/in/jacob-mclaughlinhttps://www.linkedin.com/company/new-to-medical-device-sales…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS). Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, cult…
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In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice. Who is Stefan Bolleininger? ​ Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH …
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How do you go from just another face in the room to the indispensable expert everyone relies on? In this latest episode of Secrets in Medical Device Sales, the Girls of Grit dive into the mindset and strategies that set-top reps apart. Kicking off their new series on what it takes to stand out, they explore the first key principle: being the hardes…
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In Today's Episode, We Talk About What It Takes To Take Your Career To The Next Level. My Guest Today Is The One And The Only Kat Hurd. She Started With A Clinical Background, Then Broke Into Medical Device Sales, Then Into Leadership, And Now Into Entrepreneurship As A Mentor Helping Those Needing Guidance To Grown Their Careers Not Just As A Sale…
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I sit with my old friend Jim Hunt, a medical device sales veteran as he shares invaluable tips on breaking into and thriving in the industry during his 20 years with MedtronicBreak into Medical Device Sales Online Course:https://courses.newtomedicaldevicesales.comhttps://www.linkedin.com/in/jacob-mclaughlinhttps://www.linkedin.com/company/new-to-me…
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In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices. Originally developed for AI-based devices, the PCCP framework is now available for all types of medical devices…
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Medboard https://www.medboard.com/ EU Urgent update needed – EU MDR and IVDR: https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf HMA communication: https://www.hma.eu/fileadmin/dateien/Medical_Devices/CGMD/241018_Letter.pdf EU Commission Newsletter – What are the hot news: https://ec.europa.eu/newsroom/sante/newsletter-archives/56…
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Could the secret to long-term sales success really be this simple? The answer is YES. In this episode, The Girls of Grit reveals one of the most powerful yet underestimated secrets in medical device sales: showing up. It’s not just about physically being there; it’s about consistently positioning yourself in front of your clients, being present whe…
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Welcome To Another Episode Of The Device Diaries. In today's Episode, We Will Explore What A Value Proposition Truly Is, How It Shapes Customer Perception, And Its Impact On Brand Loyalty And Market Positioning. From Understanding Customer Needs To Differentiating Your Offering In A Crowded Marketplace, We'll Cover It All. Tune In And Discover How …
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In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions…
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In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So, let’s review that together. Who is Adam Isaacs Rar? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsm…
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What if a single misstep today could close doors on your career tomorrow? In this episode of Secrets in Medical Device Sales, The Girls of Grit delve into a crucial topic that can make or break careers: burning bridges. They discuss the long-lasting impact of our actions and how seemingly small decisions can have a ripple effect in the close-knit w…
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In Today's Fast-Paced Society, Achieving Work-Life Balance Is Often Seen As An Elusive Goal. With The Demands Of Work, Family, And Personal Interests, Many Find Themselves Overwhelmed And Struggling To Find The Right Equilibrium. However, Prioritizing Work-Life Balance Is Essential For Overall Well-Being And Productivity. So Let's Talk About It... …
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In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation. Simon breaks down NEST's critical role in catalyzing the use of RWE to stre…
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in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team. Who is Georg Digel? I’ve reviewed too many Medical Device CAPAs over the last 10 years. I think I’ve seen almos…
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What if every "no" you hear in sales isn’t a dead end but a hidden opportunity? In this episode of Secrets in Medical Device Sales, The Girls of Grit, dive into one of the toughest topics in sales—rejection. They share personal stories that highlight how rejection doesn't have to be a stumbling block but can instead be a stepping stone to greater s…
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As A Medical Device Representative, You Know That We Travel A lot. We Also Have A Pretty Hectic Schedule From Emails, Going Out On The Field, To Checking In With Our Customers And Not To Mention, The Big Installs, Day/Night Shift Education, Keeping Up To Date On Vendor Credentialing, While Trying To Crush Our Quota All At The Same Time. But How Do …
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In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these …
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Medboard: https://www.medboard.com/ EUROPE TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf MDCG…
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Aufgaben, Herausforderungen und Wünsche eines Regulatory-Affairs-Experten Alexander Beck ist ein leitender Regulatory Affairs Manager bei Richard Wolff in Knittlingen. Im Gespräch mit Prof. Johner schildert er, wie er zu diesem Beruf (dieser Berufung?) kam, worin seine Aufgaben bestehen, wann die Vorgesetzten zufrieden sind und welche Herausforderu…
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What’s the real reason you didn’t hit that goal—too busy, or just too many excuses? In this Secrets in Medical Device Sales episode, The Girls of Grit tackles the fine line between taking a much-needed break and letting excuses derail your progress. Whether missing quotas, balancing work and life, or letting fear get in the way, excuses are often o…
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An Old Adage Says, " Fake It Until You Make It." In Today's Episode, I Am Going To Challenge This Adage. I Don't Believe In Faking It Until You Make It. Listen As Our Guests Today Will Reveal How Being Real Has Transformed His Life And Career. My Goal In Releasing This Episode Is To Encourage You To Redefine Success On Your Terms. Be Sure To Like, …
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In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings. They explore how home use devices, su…
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In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this. Who is Lucas Pianegonda? Lucas Pianegonda is an expert for medical grade plastics, material testing and materi…
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How can you stand out in a male-dominated industry? With over 16 years in sales and a remarkable track record in the medical device industry, Patricia Choquette’s story is one of grit, resilience, and determination. From selling cars to becoming a four-time Rep of the Year in medical devices, Patricia’s journey is a testament to the power of persis…
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In This Episode, We Talk About The Importance Of Being Authentic To Who You Truly Are. Let's Define Authenticity, It Is The Quality Of Being Genuine Or Real. Join Me Today As I Dig Deeper Into The Importance Of Staying True To Who You Are, And Being Loved And Accepted Because Of It. Support the show Device Diaries Founder/Host: Gyda Loveres.…
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In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality …
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