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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 ...
 
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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Global Medical Device Podcast powered by Greenlight Guru

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Global Medical Device Podcast powered by Greenlight Guru

Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory

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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.
 
Welcome to the Combinate Podcast, a show that brings you closer to what makes MedTech and BioTech incredible, the people behind the scenes. I’ve worked on product development teams in the Medical Device and Pharmaceutical industries for the last decade of my life and my aim with this podcast is to understand. Each week, I sit down with leaders to examine the roadblocks in development and access we face and bring to light concepts and tools from our industry and others that will help address ...
 
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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show series
 
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed? This is the focus of today’s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascula…
 
David Albert is a physician, inventor, and serial entrepreneur. He is the Founder and Chief Medical Officer of Alivecor, the leading company in personal ECG technology. He has founded 5 companies, and sold two – one to Arrhythmia Research Technology and one to GE which he joined as Chief Scientist of GE Cardiology. David has 32 issued US patents an…
 
Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization process you should follow for your devices because this will lead to the question of which material you should use to build your device… So to help us have a clear understanding of how Sterilization …
 
On this episode, I was joined by Skip Creveling, President and Founder of PDSS Inc. Skip walks through: Learning from Genichi Taguchi and Stuart Pugh The 7 Steps to Robust Design Design for Six Sigma(DFSS) Six Sigma in Marketing Tolerancing and Critical Parameters Clyde "Skip" Creveling is the President & Founder of PDSS Inc. Skip has led the DFSS …
 
What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting compan…
 
Elena Kyria, CEO of Elemed joins the podcast and discusses:- Why People stay in roles and why they leave-Starting Elemed-The trusted advisory role that recruiters play-Community work on EU MDR and RAPSElena Kyria is an award-winning talent acquisition specialist in the Medtech industry. She is the CEO of Elemed and in charge of executive placements…
 
Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP… All of them talk about Risk Management. You should manage your risks. But why is this so important or even critical? This is what we will discuss with Kailash Kalidoss who is a Medical Device Engineer and also a …
 
What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode. Mark Alpert is the Director of Quality at Greenlight Guru and has a background working for a Notified Body, and was most recently the Vice President of Business Assurance Division for TUV SUD Ame…
 
On this episode, I was joined by Ethan Drower, of Citemed. Ethan is a prolem-driven, software engineer and fellow Chicagoan who's focused on making literature review for EU MDR Clinical Evaluation Reports(CER) more efficient, traceable and robust. Ethan and I discuss: - A problem-driven career - Challenges with EU MDR Clinical Evaluation Reports(CE…
 
You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer questions such as: – Why the US market and not the EU? – What was the interaction with consultants for the Quality and Regulatory aspects? – How is it to work with a Quality Management System? – H…
 
What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we spoke with Scott Carson on the future of buying and selling used medical devices. Scott has been in healthcare marketing, business development, sales, and management experience for more …
 
On this episode, I was joined again by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - PMSR and Risk Management - Patient Safety, Pharmacovigilance, Medical Affairs, Clinical Affairs in Medical Device and Pharma companies. - PMSR Regulatory Landscape Globally (Outside of the US) D…
 
In this episode, Cesare Magri from 4BetterDevices will explain to us why medical device manufacturers are making mistakes when they try to gather Clinical Evidence for their Software or IVD devices. You may have made also this mistake and it would be better to know that before your Notified Body rejects your application. You will understand how to …
 
The importance of cervical cancer screening in the U.S.Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening? Today’s episode features Chris Beddard, VP of US Marketing at BD. She joins the podcast today to discuss a product she and her team have been working on to improve the lives of wom…
 
On this episode, I was joined by Rizwan Chaudhrey, of RSK Life Sciences Media. Rizwan and I discuss: Launching Chats with Chaudhrey during the Pandemic Conferences and Expos How to use LinkedIn to build your personal brand Getting StartedRizwan is a blogger on Life Science/ Pharma Bio-Pharma from Drug Discovery to Drug Delivery and all things in be…
 
What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device companies. Kari Haab has been working in the medical device world for over 10 years. She’s a part-time mentor in residence at Western Michigan University and a Partner with Cantilever Busine…
 
This month we will have some updates on: Annex XVI ACRAS Event MDCG Agenda Commission Contact update Team-NB position paper on Off-label use Team-NB position paper on Cybersecurity New Notified Body for EU MDR Notified Body survey MHRA 12-month extension MHRA’s new Vigilance system Swiss Medtech proposal Team-PRRC annual meeting USA Medsun Malaysia…
 
On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University. Darshan and I discuss: - Non-Promotional Speech and Scientific Discussion - Medical Affairs vs. Sales and interaction with HCP's - Free Speech in Tech and what it might mean for Pharma Darshan Kul…
 
There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devices; many products are affected. Kyle Rose joins the podcast today to talk more about it. Kyle is the President of RookQS and works as a contract Quality Ma…
 
Patrick Jamnik is President of Episurf Medical, an orthopedic company who provides individualized technology for the treatment of painful joint injuries. In this episode Patrick shares why a company personal development plan may not be the best for your career, why you need to be a lifelong learner, how to seek out mentors and where to find them, w…
 
We are starting to get more and more questions on the PRRC and I think this episode will help you a lot to understand what your responsibility is when you sign a contract as PRRC. In this episode, I will talk with Elem Ayne, President of Team-PRRC. We will look at the questions that this association is receiving. We will also discuss the first Team…
 
What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? Today’s guest, Karandeep Singh Badwal, is a Regulatory Affairs Quality Consultant who is well-versed in EU MDR, and regularly works with medical companies producing Class I, II, and III medical devices. Listen as we talk about …
 
On this episode, I was joined by Alexandra Benbadis, Usability Leader at Sanofi. Alexandra and I discuss:- Critical Tasks: What the guidance says , how to select them and what it means for HF study design- Knowledge Tasks: Meeting regulatory expectations and evaluation the IFU- Usability, HF Studies and Residual RiskPrior to joining Sanofi as Usabi…
 
Dr. Agim Beshiri is the Chief Medical Officer at Nutromics, where they have developed technology for continuous diagnostic monitoring through a ‘lab-on-a-patch’ approach. Dr. Beshiri is a leading industry expert in developing medical affairs organizations and driving medical research and education. Prior to joining Nutromics, he contributed at Abbo…
 
Within this episode, I will explain to you how you can be MDSAP certified for your Medical Devices. The agenda for this episode is the following: What is MDSAP? Which countries are included in MDSAP? Standards and legislation requirements How to integrate MDSAP into your QMS? Who can audit you for MDSAP? How to verify that you are MDSAP-ready? Don’…
 
What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition, but it’s an important part of the process and impacts product development more than you may think at first. Orla Connaughton joins the podcast today to discuss design assurance with …
 
On this episode, I was joined by Richard Houlihan, CEO of Eirmed. Richard and I discuss: - History of Eudamed (Starting with EU Legislation in 2010) - The 6 modules of Eudamed (PMS, Vigilance & Post-Market Surveillance, Clinical Investigations, Certificates, Market Surveillance, Actor Registration) - Responsibilities for Economic Operators (Manufac…
 
Here is your Regulatory update. Don’t forget to check the show notes for all the links we will mention on this video. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to crea…
 
What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway? Will you know what it is if you encounter it? In today’s episode of the Global Medical Device Podcast, we have a wide-ranging conversation with Mike Baca about the lessons we can learn…
 
On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss: Value Engineering at Eastman Kodak in the 1990's Inventing and Deploying Concurrent Engineering Defining Design Robustness QFD and Design Control in Non-Regulated Industries Verb/Noun Pairs and Product Development Design for Manufacturability and Assembly …
 
Ethan Drower is the Founder and Operating Partner at CiteMed Solutions, who provide full Clinical Evaluation Report services for EU MDR. Ethan is a software engineer and entrepreneur, trained to identify problems and implement solutions. In this episode Ethan shares how to listen for new ideas, R&D differences and similarities in industries, buildi…
 
This week, we reached 200 episodes of the Podcast and I asked some of the stakeholders to share feedback on how this helped them achieve their objectives. I also asked some of my team members to tell me what their journey was since they are part of the team. So today, this is the result of the feedback and I also wanted to thank all the listeners a…
 
The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of problems, delays, and rejections. It only takes common sense and simple solutions to overcome these issues. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mik…
 
On this special episode of the podcast, I was joined by Larry Mager. As the 52nd episode, I wanted to thank Larry for being my first interview a little more than a year ago! On this episode, Larry and I discuss: - His experiences with Pharma and CRO clients vs. Medical Device - Predictive Quality Management across both medical device and pharma - M…
 
Andrew Buckler is the Founder, President and CTO of Elucid, a company that is focused on characterizing placque, with the goal of providing clinicians better information on placque stability, vessel structure, treatment options, and risk factors for cardiac events. In this episode, Andrew shares how to found a company when you have a significant am…
 
The selection of Notified Bodies in Europe can be a real challenge and I will explain to you in this Podcast episode how to do it so you can understand the process and get the real outcome for your projects. There are 33 Notified Bodies for EU MDR 2017/745 at the time of this podcast. This is lower than the number of Notified Bodies that were under…
 
How do you bring a medical device through the development process? What are issues that development engineers face during the different phases of the design controls process, especially when researching clinical evidence? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Keith and Kevin Kallmes of Nested Knowledge. Foll…
 
On this episode, I was joined by Bassil Akra, the CEO of AKRA Team. Bassil and I discuss: EU MDR and Implementation Timeframe Notified Bodies, Competent Authorities, MOH's and the EU Commission Article 117 & Drug/Device Combination Products Differences between MDD and MDR for Economic Operators His Favorite Book: EU MDR Dr. Bassil Akra spent the la…
 
Wie die IT-Security und das Risikomanagement für Medizinprodukte zusammenspielen sollten Wenden Sie sich bei weiteren Fragen an Christian Rosenzweig (Senden Sie eine E-Mail ) Prof. Dr. Christian Johner (via Kontaktformular) Webseiten: Übersicht über die regulatorischen Anforderungen an Medizinprodukte Seminar Risikomanagement mit Christian Rosenzwe…
 
Becoming the best PRRC ever is something that all PRRC should go for. The PRRC role is really important to avoid some situations that happened like the PIP scandal or recently the Philips issue. PRRC means Person Responsible for Regulatory Compliance and this is a mandatory role within the Medical Device industry. So if you still have no PRRC withi…
 
What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls companies fall into, and fundraising efforts? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Duane Mancini, CEO and Managing Partner at Project Medtech.…
 
On this episode, I was joined by Dr. James Somauroo of SomX and The HealthTech Podcast. James and I discuss: HealthTech Communication Growing a Passion The HealthTech Podcast Healthtech Pigeon Delegating vs. Creating Systems James is the founder of SomX: The Healthtech Agency and supports the best healthtech companies in the world. He covers health…
 
Die (regulatorischen) Herausforderungen von IVD-Plattformen in der Pathologie Wenden Sie sich bei weiteren Fragen an Dr. Sebastian Grömminger (Senden Sie eine E-Mail ) Prof. Dr. Christian Johner (via Kontaktformular) Micro-Consulting (Link auf Formular) Webseiten: Hilfe für medizinische Labore Fachartikel zu Lab Developed Tests…
 
You get a call from the US Customer border which are telling you that your products are blocked. Why that? Maybe because you have no importer defined for these products. And this is what we will explain to you today on this podcast episode. Stéphen Toupin from Dawa Medical is helping those manufacturers by being their Initial Importer and he will t…
 
The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling prevent 510(k) delays? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Jeff Barrett, CEO of J-Pac Medical, about packaging validation best practic…
 
On this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss: - FDA Human Factors Review for Combination Products (CDRH, CDER/DMEPA, OCP) - Human Factors vs. Usability Engineering vs. Design Validation - Risk Management and User Risk - Summative HF Evaluation and Sampling Shannon is the Presid…
 
Here are the links to the Regulatory Updates HOT TOPIC EUDAMED Timeline https://health.ec.europa.eu/system/files/2022-07/md_eudamed_timeline_en.pdf EU Call for application submission of EU Reference laboratories. https://health.ec.europa.eu/latest-updates/call-eu-reference-laboratories-sent-member-states-2022-08-05_en HPRA & Spain – EU Commission c…
 
What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance? In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to ov…
 
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