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Looking to break into medical device sales? I share my experiences of breaking into the industry and what it’s like during the process and as a rep
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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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Global Medical Device Podcast powered by Greenlight Guru
Greenlight Guru + Medical Device Entrepreneurs
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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Listen Medical Device Regulation and Standards
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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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The AI Act or Artificial Intelligence Act is now a reality. But what does it mean for the Medical Device industry and what should you do within your Quality or Regulatory affairs activities. Erik Vollebregt, from Axon Lawyers will tell us what we should understand with this new legislation and what are the consequences for the Medical Device commun…
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In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. The discussion unveils the complexities and common misconceptions surrounding QMS, drawing an intriguing analogy between building a QMS and crafting sourdough bread. Sara shares he…
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22 year old Breaks In Medical Device Sales in 2 Weeks with Joe Dobbs
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May 4th Scottsdale Arizona Meetup: https://www.newtomedicaldevicesales.com/event Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medic…
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2024-06: Rechtliche Anforderungen an Cloud-Lösungen (mit Prof. Strittmatter)
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Was Medizinproduktehersteller (nicht nur) bei der Vertragsgestaltung beachten sollten Medizinproduktehersteller nutzen die Cloud für ihre internen IT-Systeme, zum Beispiel um ein ERP zu betreiben oder sogar mit einem cloudbasierten ERP zu arbeiten. Gleichzeitig nutzen einige Hersteller die Cloud, um selbst Dienstleistungen anzubieten, wie das beisp…
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If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the life to the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant. Who is …
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Who You Listen To Matters with Jason Elmore
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Web Page To Meetup: https://www.newtomedicaldevicesales.com/event Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales…
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#359: Project Management in MedTech
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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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Sponsor: Medboard: https://www.medboard.com/ EU MDR and IVDR national languages update – France accepts English MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_s…
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Software Sales VS Medical Device Sales with Will Padilla
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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Since EU MDR and IVDR launched, there is a phenomenon that raised which is the use of surveys to gather clinical data. So we wanted to share with you how to do this right and what you should be careful on. So listen to Cesare Magri from 4BetterDevices who will tell us more about surveys in the Medical Device field. Who is Cesare Magri? Cesare has a…
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2024-05: Was der EU AI Act für Medizinproduktehersteller bedeutet
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Eine erste Einordnung der neuen EU-Verordnung mit Dr. Till Klein Anfang März 2024 hat die EU den AI Act, die Verordnung zu Produkten mit künstlicher Intelligenz, veröffentlicht. In dieser Podcast-Episode geht der AI-Act-Experte Dr. Till Klein im Gespräch mit Prof. Johner Fragen nach wie: Was ist das Ziel des AI Acts? Welche konkreten Anforderungen …
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Being a Woman in Medical Device Sales with Roxy Tirado
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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#358: FDAs Voluntary Improvement Program
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In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss the pivotal Voluntary Improvement Program (VIP). This conversation sheds light on how the program, stemming from FDA’s Case for Quality initiative, utilizes the Capability Mat…
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The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified. Who is Steve Curran? Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and le…
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2024-04: Mit Medizinprodukten schnell im großen US-Markt Umsätze erzielen
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Hilfestellung für die FDA-Zulassung von Medizinprodukten Der US-Markt wird für europäische Hersteller immer attraktiver. Denn zum einen gelingt es den Herstellern, schneller und einfacher die regulatorischen Anforderungen zu erfüllen und ihre Produkte in den Markt zu bringen. Zum anderen ist der US-Markt sehr groß und teilweise homogener als der eu…
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Medical Device Sales Rep At 22 Years Old with Garrett Wilson
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution? Naveen Agarwal from Exceed will answer this question. So don’t miss this episode to know more about QMSR. Wh…
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GEO Scientist to Medical Device Sales in 8 Weeks
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This week's episode features Darren Adams. Darren joined the course as a GEO Scientist and has been hired medical device sales. Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevice…
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#357: The State of UDI Across the World
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In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and regulatory compliance. They embark on a comprehensive exploration of the ever-evolving landscape of UDI requirements, shedding light on crucial deadlines, common pitfalls, and…
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EU EU proposal to prevent shortage – And other things: https://www.consilium.europa.eu/en/press/press-releases/2024/02/21/medical-devices-council-endorses-new-measures-to-help-prevent-shortages/ Notified Body Survey – Interesting statistics: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_…
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Informing Parents About New To Medical Sales
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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In January 29th, 2024, the EU Commission issued a Proposal that discuss mainly the shortage of Medical Devices, the EUDAMED availability and the IVDR transition periods. So apparently this is urgent and needed to avoid shortage. Let’s ask Erik Vollebregt what he thinks about it. Will this really help and when will this become a law as it is only a …
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2024-03: Produkthaftung: Was auf Hersteller zukommt
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Wer wann wofür bei Medizinprodukten haftet Die EU bereitet eine neue Produkthaftungsrichtlinie vor, die insbesondere Medizinproduktehersteller betrifft, explizit auch solche, deren Produkte Verfahren der künstlichen Intelligenz (KI) verwenden. Prof. Johner klärt im Gespräch mit dem auf Medizinprodukte und Produkthaftung spezialisierten Rechtsanwalt…
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From Enterprise To Medical Device Sales with Wynrick Smothers
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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#356: Quality Myths & Lessons Learned Part II
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In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. They explore the nuanced challenges of ethical decision-making in the MedTech industry, the complexities of accelerated testing, and the continuous quest for quality improvement. …
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When you are willing to sterilise your Medical Devices, you maybe think of EtO or Ethylene Oxyd as the method. So if you are on that case, there is a potential change that will happen and we want to alert you about that. Christina Ziegenberg from BVMed is answering my questions and will explain to us the situation. So don’t miss this episode. Who i…
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2024-02: Keine Angst vor FDA Inspections
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Was Sie vor, während und nach FDA-Inspektionen tun sollten, um einen FDA-Warning-Letter möglichst zu vermeiden Wenn sich die FDA zu einer Inspektion ankündigt, steigt der Blutdruck in den Unternehmen. Falls die Inspektion nicht erfolgreich verläuft, ist der Stress sogar noch höher. Der FDA-Experte Luca Salvatore gibt im Gespräch mit Prof. Johner Ti…
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How To Move On In The Medical Sales Interview Process
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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#355: Mastering the Pitch: MedTech Innovations from Concept to Market
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In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Blythe shares her wealth of experience, from her early days as a marketer to leading significant product launches and achieving FDA breakthrough designations. The conversation …
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You are maybe about to take a new job and you find out this episode of the podcast on how to prepare for an interview. I must say that we have invited the expert in recruitment for Medical Devices Elena Kyria from Elemed. She will give you all the hints, tips to make your interview a success. So don’t miss this episode and don’t forget to raise you…
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From Bottle Service To Medical Device Sales with Katie Beck
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Website: https://www.newtomedicaldevicesales.com Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com Guide for Breaking into Medical Device Sales Ebook: https://www.newtomedicaldevicesales.com/product/guide-for-breaking-into-medical-device-sales First Year in Ebook: https://www.newtomedicaldevicesales.com/prod…
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EU Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/…
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#354: Advice for MedTech Regulatory Affairs Professionals
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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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2024-01: Data Act relevant für Medizinproduktehersteller? Ein Gespräch mit Prof. Dr. Marc Strittmatter
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Was die EU beschlossen hat und welche Chancen es gibt, sich "herauszuwinden" Der EU Data Act ist in Kraft getreten. Ab September 2025 müssen Organisationen seine Anforderungen erfüllen. Doch welche Organisationen betrifft der Data Act? Müssen Medizinproduktehersteller dessen Anforderungen einhalten? Oder gibt es Argumente und Konstellationen, die v…
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5 Common Interview Mistakes In Medical Device Sales
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Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com/yt/ Guide For Breaking into Medical Device Sales Ebook: https://newtomedicaldevicesales.squarespace.com/ New to Medical Device Sales Podcast: https://podcasts.apple.com/us/podcast/new-to-medical-device-sales/id1522512043 New to Medical Device Sales YouTube: h…
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#353: How Artificial Intelligence is Impacting the MedTech Industry
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In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare. The discussion also touches on the challenges and opportunities i…
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We always have a problem to contact regulators to ask them if our strategy is correct. In Europe, you cannot do that with a Notified Body unless you apply with one first and they cannot provide you with advice but just agree or disagree on your plan. Is it the same with the FDA. They have a specific pathway called Q-sub or Pre-Submission and you’ll…
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Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com/yt/ Guide For Breaking into Medical Device Sales Ebook: https://newtomedicaldevicesales.squarespace.com/ New to Medical Device Sales Podcast: https://podcasts.apple.com/us/podcast/new-to-medical-device-sales/id1522512043 New to Medical Device Sales YouTube: h…
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Who is Adam Isaacs Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stre…
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In this episode, I discuss a common question I get all the time: "Do I need an internships to break into medical device sales?" I talk on my thoughts and what I've personally happen in the real world. Break into Medical Device Sales Online Course: https://courses.newtomedicaldevicesales.com/yt/ Guide For Breaking into Medical Device Sales Ebook: ht…
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Medica 2023 was really a great event and I am please to provide you here with a summary and interviews with multiple actors. You’ll see that this is so diverse. We met with Startups, Service Providers, Notified Bodies and asked them the questions you would like to ask. So don’t miss this opportunity first to understand what is MEDICA and second to …
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#352: Fundamentals of Quality & Regulatory
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In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project man…
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