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Medical Device Insights

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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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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.
 
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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Medical Sales Live

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Medical Sales Live

Medical Sales Live

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Medical Sales Live brings together numerous Medical Device professionals to discuss the latest in technology, career development, sales strategy, product innovation, hiring practices, and so much more. Join us every other Monday to hear the latest and greatest in all things medical devices!
 
TrackMy® Solutions is a web application company centered initially around the healthcare industry using Open API platforms to create better patient facing applications. We focus on the health data elements present in a patient’s electronic health record and pull those into our applications using API Integration. We then make this data easily viewable in our application and allow a patient to track their overall health. TrackMySolutions.us
 
The Medical Sales Podcast is a podcast for people who want to get into medical sales and medical sales reps who want to advance their careers. We interview top medical sales reps and leading sales executives from all over the country in pharmaceuticals, medical devices, genetic testing, diagnostic lab sales and more. You’ll laugh, you’ll learn and you’ll be inspired. If you would like to learn more about my programs visit https://evolveyoursuccess.com
 
Join us on DeviceAlliance's Podcast: MedTech Radio where we interview today's brightest minds in Southern California's medical device industry. Each episode deconstructs complex topics and provides the tactics, tools, and strategies to overcome tomorrow's challenges. DeviceAlliance strives to be the one-stop-shop at the center of the medical device ecosystem helping drive collaboration, innovation, and career development for all device professionals in Southern California.
 
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MedTech True Quality Stories

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MedTech True Quality Stories

Powered by Greenlight Guru with host Jon Speer + Medical Device Leaders, Entrepreneurs, Executives, Inventors & Pioneers, MedTech, Innovation, R&D, Quality, Regulatory

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This is MedTech True Quality Stories, hosted by Jon Speer, founder and VP of QA/RA at Greenlight Guru. Each week, we embark on a new storytelling journey with different MedTech executives as they share real-world, actionable best practices for medical device leaders. Listeners will gain invaluable insights into how these industry pioneers are successfully imagining, implementing, and improving True Quality medical devices.
 
MediStrategy with Kip Piper offers informative interviews with healthcare leaders and insights on hot business and policy issues in Medicare, Medicaid, and health reform. Health executives, policymakers, entrepreneurs, authors, and other influencers share challenges and opportunities in America’s rapidly changing $3.2 trillion health care system. MediStrategy is hosted by Kip Piper, a national expert on Medicaid, Medicare, and the Affordable Care Act (ACA or Obamacare). An influential consul ...
 
SMASH stands for "Serious Medical Advisors Saving Healthcare" and "IT" stands for Information Technology. Through this podcast we intend to invite guests who provide powerful feedback that will impact listeners and help to inspire a revolution in healthcare of those who are like-minded, educated, and technology driven, to engage collectively in the transformation of healthcare as we know it. We will engage in tantalizing topics that surround what it means to think differently when it comes t ...
 
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healthHackers™

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healthHackers™

healthHackers™

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healthHackers® is a YouTube channel and website featuring insights from remarkable figures in health, hosted by former British TV news journalist & presenter, Gemma Evans. The audio tracks from Gemma's guest interviews are posted to Spotify, SoundCloud and Apple Podcasts. To watch videos - including Gemma's trials with cutting-edge wellness products and tech devices - head to youtube.com/healthhackers. Or read articles and get discounts on health tech at healthhackers.org. THE LEGAL BIT: The ...
 
What is the state of information technology now? That’s the focus of each Inertia episode. The question is a broad one as tech intersects across many industries and themes: personal computers, portable devices from the iPhone to GPS systems, microprocessors, applications, social media, search, medical technology, broadcasting and TV, music tech, online commerce, graphics, cloud computing, security, storage, mobility, and enterprise hardware and software... and anything else that references I ...
 
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Their Own Devices

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Their Own Devices

Marc Groman and David Reitman

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No matter how tech savvy you are, your kids likely have you beat. Digital natives see the world in a fundamentally different way than all previous generations. This makes 21st century parenting an unprecedented challenge. Join Marc Groman, an Obama White House tech and privacy adviser, and David Reitman, an adolescent medical doctor, for candid discussions and helpful tips about screen time, social media, sexting, privacy, online gaming, and other challenges facing parents today. Marc and Da ...
 
Taking inspiration from trees, scientists have developed a battery made from a sliver of wood coated with tin that shows promise for becoming a tiny, long-lasting, efficient and environmentally friendly energy source. Their report on the device — 1,000 times thinner than a sheet of paper — appears in the journal Nano Letters.
 
Welcome to The Launchpad Podcast, powered by ACTO, Omnichannel Education for Life Sciences. We discuss commercialization strategies for drugs and devices across the globe, that challenge the status quo. We also highlight change agents working to disrupt life sciences and their strategies for success in the complex post-market promotion landscape.
 
We believe Mission and Margin is the business of healthcare. Business of Healthcare (BOH) interviews feature innovations sustainably improving healthcare Mission & Margin. Each discussion includes a healthcare executive and innovator concentrating on the same problem. Think “Nightline” or “How I Built This” just for healthcare. Recent guests have included Bernadette Spong, Chief Financial Officer, Orlando Health, Paul Kusserow, President & CEO, Amedisys, Blake Marggraff, Founder & Chief Exec ...
 
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show series
 
In this episode, we will discuss CMR which are some substances that can be dangerous for your health. They are classified by legislation and we will explain to you what you should do. Ana Luiza Cassin Duz, Clinical Specialist will help us to define what are the MDR requirements and how you can follow the rules and be compliant. In a previous episod…
 
In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, founder and CEO of InControl Medical, which designs and manufactures patented devices for the control of incontinence. Listen to Buzz share his valuable insights from spending four decades in the medical device industry, developing products that addr…
 
Going into the medical device world is challenging, especially if you want to go to trauma. You will need to change your lifestyle because of the challenges that will come with it. Discover the story of Justin Rhodes and how he got introduced into the medical device world. Learn about his journey into being a trauma medical sales rep to later co-fo…
 
Hannah Zerphy is a Managing Member of Orlaithe Consulting, a firm specializing in federal contracting. Hannah worked inside the VA as a Warranted Contracting Officer and a Training Coordinator for VA FSS, so she knows how the process works and how companies should present their products and opportunities. In this episode Hannah shares how to regist…
 
The author of ‘Bumpin’ - the Modern Guide to Pregnancy’, Leslie Schrock, joined me for this special episode of healthHackers® to talk all about essential preparation for labor and delivery in a hospital setting.Leslie’s book has been described as the “new pregnancy bible” and came about because of her feelings of helplessness following several comp…
 
Is there an easy, mess-free way for consumers to compost in their own homes? In this episode of the Xtalks Food Podcast, Sydney talks about smart food waste composters, new devices that can transform food waste into compost in a matter of days. Whereas traditional composting can take up to months to break down food waste, require worms, emit odors …
 
In this episode, Ryan Melchior, Senior Manager of Sales Operations at Shockwave Medical, speaks to us about the role Sales Operations plays in the structure of the commercial team and how they enable growth. We also chat about the different avenues a Medical Sales College graduate is equipped for within a commercial team beyond a traditional sales …
 
Recently EUDAMED made a major Update which was the release of the Device registration module. This is something that all Medical Device manufacturers need to listen to as this may impact their workload. Richard Houlihan from Eudamed.com accepted to come and tell us more about this update and provide you also with some advice on how to manage it. So…
 
How has 7shifts, an employee scheduling and management software, revolutionized the restaurant industry? In this episode of the Xtalks Food Podcast, Sydney introduces the team to 7shifts, a program capable of scheduling foodservice employees, enabling managers to focus on their businesses. Hear clips from Sydney’s interview with Jordan Boesch, the …
 
What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional information request (AI request)? What do you do for requests that seem overly burdensome? Thanks to a new FDA pilot program known as the Least Burdensome Flag, manufacturers now have a process and methodology they can deploy if and when this scenario ari…
 
One way to be successful in life is to just be humble. Treat others how they want to be treated, not how you want to be treated. Join your host Samuel Gbadebo and his guest Chip Helm in the second part of the interview. Learn the difference between commercial and government hospitals. Find out how Chip got started in writing his books, Everyday Sal…
 
In this episode of Medical Sales Live, we hear from Brian Giuliano, Electrophysiology Sales Representative at Boston Scientific. Brian shares how attending a specialized technical school helped him successfully enter medical sales, and how education can positively affect the opportunities available to new reps. He also speaks to the importance of s…
 
Here are all the topics that we will cover during this regulatory update. Don’t forget to contact easy medical device if you need an EU-authorised representative, a Swiss representative or a UK-responsible person. HOT TOPIC Implementing Rolling Plan: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_rolling-plan_en.pdf EUROPA IVDR e…
 
Welcome back SMASHers to a new episode with Bob, Jonny B Lightning and Danny from SOHO where the tantalytical topic of "Healthcare Payment Models" is poked, prodded, and interrogated for life, liberty, and the success of modern healthcare! Which way should we go? Left or Right? Value Based or Alternative? Meaningful Use or Quality? As we round the …
 
Why throw away “wonky” fruits and vegetables if they could be put to better use? In this episode of the Xtalks Food Podcast, Sydney introduces Ayesha to Dash Water, a UK-based sparkling water brand that uses upcycled produce. As one of the only sparkling water brands that uses “wonky” produce, Dash Water has made a name for itself and is planning t…
 
Recently MDCG issued the guidance on Article 16 of the EU MDR & IVDR. This provided some surprises. So now in certain circumstances, some importers or distributors will need a Notified Body for their products. Erik Vollebregt from Axon Lawyers will explain to us those cases and why this is important that importers and distributors are becoming on t…
 
Jordan Chase has seen hiring from inside a company, as well as from a recruiter’s perspective. Jordan spent over a decade at Medtronic, in human resources and talent acquisition. He’s spent the last decade as an outside search consultant with his group, Chase Medsearch. They focus primarily on customer facing positions in sales & marketing with a s…
 
Irvine is home to over 15,000 businesses, and life sciences and medical device companies constitute one of the fastest-growing sectors. With a global focus on the Medtech industry, the need to build an infrastructure that can support the explosive forecasted growth is more crucial than ever. A well-educated, job-ready workforce, world-renowned R&D …
 
In this episode, we hear from Bill Davis, Senior Sales Management Executive as our guest. Bill has enjoyed an incredible career in the surgical and cardiology device markets with roles that started with carrying a sales bag and ultimately to his position as the Divisional Vice President of US Coronary Sales for Abbott Vascular. Bill offers us great…
 
Why have food mashups garnered so much attention in 2021? In this episode of the Xtalks Food Podcast, Sydney explains why food mashups, ordinary foods that are combined to create unusual pairings, found success throughout the pandemic and gives some notable examples. The team discusses the role of marketing and exclusivity in advertising food mashu…
 
Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify! In this episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in q…
 
Shelly O’Donovan is a recognized expert in persuasive communication who helps people in medical device and pharma communicate more effectively. Shelly is CEO of Authentic Influence Group and also a lecturer at Wharton. The first part of her career was in government, before she made the move to industry, spending 9 years at GSK. In this episode Shel…
 
Clinical Data is key for the Medical Device Regulation MDR 2017/745. Today on this Podcast Episode, I have invited Jon Bergsteinsson from Smart Trial. And we will discuss Digital tools to collect data. History of Clinical Data Collection Difference between Big and small companies Use of CRO for collecting data Difference on Clinical Investigation a…
 
In this episode, we hear from Scott Reynolds, Watchman Territory Manager at Boston Scientific. Scott shares his personal journey, from college graduate to cold calling, to entering medical sales and building a successful career. Listen in to hear how Scott permanently changed his life and the trajectory of his family tree through medical sales. Wat…
 
Can a new method of freezing food drastically cut down on energy and emissions? In this episode of the Xtalks Food Podcast, Sydney talks about isochoric freezing, in which foods are stored in a firm, sealed container made of hard metal or plastic, filled with a liquid like water and placed in a freezer. The team discusses why this method is a more …
 
When he was 25 years old, Jacob McLaughlin moved from being an athletic trainer to a surgical sales representative for one of the top medical device companies in the world. He used some traditional techniques for breaking in, but also some that were very non-traditional, including documenting his journey in his podcast, New to Medical Device Sales …
 
When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Dr…
 
How can you become the best salesperson you can be? First, get back to people. Second, to be on time is to be early. Samuel Gbadebo's guest today is Chip Helm, the #1 National Bestselling Author of Everyday Sales Wisdom. Chip has been the National Sales Manager of Cook Medical for 36 years. In this episode, you get the opportunity to listen to his …
 
Die Geheimwaffe für eine kürzere Time 2 Market oder ein regulatorisches Minenfeld? Wenden Sie sich bei weiteren Fragen an Matthias van der Staay (vanderStaay@imt.ch) Prof. Dr. Christian Johner (via Kontaktformular) Webseite: https://www.johner-institut.de/blog/iec-62304-medizinische-software/code-generierung/…
 
We are at 9 months of the EU IVDR 2017/746 date of application. So let’s t talk of the Transition period for such products. We have done that also for MDR 2017/745 when the date was nearly due. So today we’ll tell you about: Differences between IVDD 98/79/EC and IVDR The Hard Transition Period – The Soft Transition Period The UDI transition period …
 
In this episode, we hear from Julia Marquardt, Corporate Accounts Executive with Boston Scientific. Julia imparts the wisdom gained from hiring dozens of medical sales representatives and interviewing hundreds of candidates as a senior leader in the medical device industry. You'll hear the top 5 attributes hiring managers look for in candidates, an…
 
Can a prebiotic, better-for-you beverage replace traditional soda? In this episode of the Xtalks Food Podcast, Sydney introduces the team to Poppi, a prebiotic soda brand that recently received millions in funding from several celebrity investors. The team discusses the role celebrities and social media play when advertising beverages and wonders w…
 
There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices. In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry. Listen to this episode as Jon and Christie offe…
 
Barbara Strain is an expert in Value Analysis and Management. Barbara has forty-one years of provider experience, thirty-four of them in the University of Virginia Health System where she led teams in Value Management and Supply Chain Analytics. Barbara is one of the founders of the Association of Healthcare Value Analysis Professionals (AHVAP), an…
 
First of all, I am not encouraging anyone to sue anyone. This is only educative content to know what is possible and what is the best strategy to do it. We will talk about the reason one company would sue its Notified Body and also about the good method and the bad method to do it. Some of the discussions are based on real-life experience. Anyway, …
 
15 episodes deep and Bob and Jonny B Lightning dive into all facets of "Pricing Transparency" in Medical Device and healthcare. How does it affect of the overall cost of healthcare? Will transparency help to eliminate waste and drive efficiencies in healthcare to the forefront? The Hospital Price Transparency rule went into effect on January 1, 202…
 
Are WunderEggs the world’s first plant-based hard-boiled eggs? In this episode of the Xtalks Food Podcast, Sydney introduces the team to Crafty Counter, an Austin, Texas-based startup that created WunderEggs, a plant-based dupe that looks, cooks and tastes like a chicken egg. The team compares the analogue to the real thing in terms of price and nu…
 
What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru edge⁠—a team of medical device professionals with a ton of industry experience. In this episode of the Global Medical Device Podcast Jon Speer talks to Maryann Mitchell, a Medical Device Guru and Solutions Engineer who has recently joined the Greenlig…
 
Barbara Strain is an expert in Value Analysis and Management. Barbara has forty-one years of provider experience, thirty-four of them in the University of Virginia Health System where she led teams in Value Management and Supply Chain Analytics. Barbara is one of the founders of the Association of Healthcare Value Analysis Professionals (AHVAP), an…
 
This month we will cover a lot of specific rules that are applied in some countries: USA UK France Finland Switzerland And then we’ll look at Events planned, Notified Bodies, MDCG guidances released, and the Podcast episodes. Enjoy! Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. A…
 
You’ve got a great idea for a medical device! Now what? Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success. With the explosion of Medtech opportunities for startups, what are the current best s…
 
How has the COVID-19 pandemic changed the way brands and retailers hand out food samples? In this episode of the Xtalks Food Podcast, Sydney discusses how food sampling has changed in retail settings and at home, with many companies shifting to e-commerce or online grocery orders as a means to send out samples. The team discusses whether in-store s…
 
Medical device companies need to tell slightly different versions of their stories depending on the intended audience—investors, suppliers, regulators, clinicians, and patients—and each version must be strategically crafted and told in order to convey the right message. In this episode of the Global Medical Device Podcast Jon Speer talks to Brad Pe…
 
Dr. Nishi Viswanathan is the Director of Texas Health Catalyst, a program inside Dell Medical School at The University of Texas at Austin that provides researchers, innovators and entrepreneurs customized guidance on product development from industry and clinical experts as well as milestone-based seed funding. In this episode Nishi shares the prob…
 
Software as a Medical Device is really a difficult topic. First, because it is quite new in the EU Regulation, and second because we cannot make a generality and should consider each software one by one. In this episode, we asked directly a Notified Body to tell us exactly how we should view this field and what are the tips or warnings. So I have i…
 
Rational Emotive Behavior Therapy (REBT) and how to choose the way you feel about… anything.When I watched a video of psychologist Dr Debbie Joffe Ellis giving a presentation in which she suggested that anxiety, anger, and other emotions are a CHOICE, I knew I had to invite her to appear as a guest on healthHackers® so she could share with all of y…
 
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