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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 ...
 
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
 
Every medicine in your pharmacy has a human story behind it. Real people doing real work and living real lives. We all have romantic ideas about scientists working late into the evening or doctors dropping everything to answer a phone call about a patient. You can almost envision the moment when one of those researchers finally solves an intellectual puzzle and leaps into action. Their eyes go from an empty stare to an alert laser-like focus. They sit a bit taller and start to read frantical ...
 
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 ...
 
Gregory Laurence, MD introduces cell surgery and explains the purpose of this podcast series addressing the role of the use of stem cell and stromal vascular fraction. Regenerative medicine, in its broadest definition, includes: Nutrition, risk avoidance, exercise, bioidentical hormone replacement therapy (BHRT), platelet rich plasma (PRP), and cell surgery (the topic of this series). There is much confusion regarding the cellular area of regenerative medicine. It has not been fully determin ...
 
For 50 years, Drug and Therapeutics Bulletin (DTB) has provided rigorous and independent evaluations of, and practical advice on, individual treatments and the overall management of disease for doctors, pharmacists and other healthcare professionals. DTB has always been wholly independent of the pharmaceutical industry, Government and regulatory authorities. DTB is also free of advertising and other forms of commercial sponsorship. Please subscribe to the DTB podcast to get episodes automati ...
 
Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences ...
 
Baptist Management System (BMS) is an improvement system that focuses on creating a holistic management system built on purpose, people, and process. BMS exist within the overall operating system of Baptist Memorial Health Care. BMS promotes and is based on the following 11 Guiding Principles: Respect, Humility, Trust, Empathy, Perfection, Process Focus, Scientific Thinking, Quality at the Source, Flow and Pull, Constancy of Purpose, Systemic Thinking. As we embed the 11 Guiding Principles i ...
 
Learn more about the physicians and services of South County Health anywhere, anytime! South County Health Talks is a podcast series that interviews providers of South County Health about the health care topics that affect you and your loved ones. Available on our website and on various third-party applications you can download on your smart devices.
 
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Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device professionals can enjoy additional, sought-after training courses in the already popular educational platform, Greenlight Guru Academy, through a new partnership with Medical Device HQ. In this episode of the Global Medical Device Podcast, Jon Speer …
 
Clinical Investigation is one of the toughest process within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and expensive process. In this episode, Helene Quie from Qmed Consulting, will help us understand how to perform it in a good way. This episode will answer some of the questions you have about C…
 
Mike Langlois is a Supply Chain expert, working his way up from the bottom to become Senior VP of Supply Chain for two large and widely recognized Integrated Delivery Networks (IDNs), Ascension Healthcare and Beaumont Health. He helped develop the strategies and tactics for the groups and introduced some truly innovative programs. In this episode M…
 
Welche Anforderungen (nicht nur) Medizinprodukte erfüllen müssen, die über einen Netzstecker verfügen und in den USA verkauft werden sollen Wenden Sie sich bei weiteren Fragen an Beat Keller (keller@imt.ch) Prof. Dr. Christian Johner (via Kontaktformular)Beat Keller, Prof. Dr. Christian Johner による
 
Paula Fessler oversees all nursing operations at WMCHealth’s flagship Westchester Medical Center, Maria Fareri Children’s Hospital and the Behavioral Health Center in Valhalla, as well as MidHudson Regional Hospital in Poughkeepsie. Westchester Medical Center serves Hudson Valley, northern New Jersey, and southern Connecticut. After earning an unde…
 
Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated single-use endoscope to market. Heather joined EvoEndo in 2019 after completing the Stanford Biodesign Fellowship for medical device innovation. She completed her PhD at the University of Colorado (CU) - Boulder's ATLAS program, where she developed…
 
Becoming a seller is a pretty straightforward venture, with you only caring about your customers. But being a sales leader is on an entirely different level. Jumping into this position means you are getting a much larger circle of people to please. In this first episode of a three-part series, Samuel Gbadebo is joined by Terry Coutsolioutsos of Sie…
 
What did FDA report as the most-cited issues during medical device inspections for the fiscal year of 2020? Understanding the data can help you prepare against making these common, avoidable mistakes during your next quality system inspection. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences…
 
Dr. Toussaint is an internist, a former healthcare CEO, a coach, and the author of the bestseller On the Mend. Link to claim CME credit: https://www.surveymonkey.com/r/3DXCFW3 CME credit is available for up to 3 years after the stated release date Contact CEOD@bmhcc.org if you have any questions about claiming credit.…
 
Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member feeling and working at their best. Now, breathe out, letting out a sigh of relief knowing that's fully within the realm of possibility — through mindset training. In this episode of the Global Medical Device Podcast, Jon Spee…
 
Medical technology is getting so advanced that medical professionals can perform surgeries hundreds of kilometers away from their patients. The majority of this cutting-edge technology is still in the works and not ready for use right now, but it's being developed. Christian Pusateri is a Business Development Manager at ClaroNav who specializes in …
 
We talked a lot about the regulatory requirements for your Medical Devices. Now let’s talk about something more technical which is the Biological Evaluation following ISO 10993-1 or also called Biocompatibility. This is something that is key for the Medical Device Manufacturers but it is also not well understood. So Ana Luiza Cassin Duz, a Clinical…
 
What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the medical device industry? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the HHS proposal, which focuses on down-classifying and exempting more than 80 types…
 
Ted Newill is an expert in medical device sales and marketing. In this episode we examine why some technologies are adopted while others are not - even if there is clinical proof that they should be. We explore issues impacting long-term adoption in the pre-product release, product release, and post-release phases along with how people react to cha…
 
Today’s guests are Greg Yap and Jean-Paul (JP) Sanday from Menlo Ventures where fundraising is the #1 priority for almost every founder in life sciences. Menlo’s 5 P framework for investing: Program, Platform, Portfolio, Partnerships, and People. Greg invests in teams trying to solve major problems in life science and health care, with a special in…
 
Shlomit Schaal, MD, PhD, MHCM, Professor and Chair of the Department of Ophthalmology and Visual Sciences at UMass Memorial Medical Center and the University of Massachusetts Medical School, is a clinician-scientist specializing in the cutting-edge medical and surgical treatment of complex vitreoretinal diseases. She serves as the President of UMas…
 
If you love learning and want to level up your medical device industry knowledge on topics such as audits, document management, design controls, risk management, and more, Greenlight Guru Academy is your education destination. In this episode of the Global Medical Device Podcast, Jon Speer invites colleagues Aaron Lucas, Training and Education Mana…
 
Most C-Suite individuals are promoted to their current position since they are top performers and extremely responsible with their job. But many people who reach this level often still lack the required executive skills, which is where leadership coaching comes into play. Samuel Gbadebo continues his discussion with Eric Turbiville, President and C…
 
Wie die MDR die Klassifizierung von Standalone-Software ändert und was die Auswirkungen (nicht nur) auf DIGA-Hersteller sind. Wenden Sie sich bei weiteren Fragen an Dr. Philip Heimann (via E-Mail) Prof. Dr. Christian Johner (via Kontaktformular)Dr. Philip Heimann, Sven Büttner, Prof. Dr. Christian Johner による
 
Ok, this month the EU MDR is LIVE so we will talk about that. The date of application for EU MDR 2017/745 was May 26th, 2021 and there is a lot of information that I will share with you. We will talk about EU MDD bye bye party Webinars EU MDR impact on other countries Swixit Turkxit IVDR 2017/746 Notified Body Situation MDCG guidance IMDRF guidance…
 
Have you ever had to “sell” your brand to someone? To do this effectively, you must master the art of networking and selling whatever it is that you bring to the table. In this episode of the Global Medical Device Podcast, Jon Speer talks to Chip Helm, a Dental School dropout turned National Sales Manager of a multi-billion-dollar medical device co…
 
Dr. Wouter van Furth is a neurosurgeon at Leiden University Medical Center in the Netherlands who is interested in better clinical results with the help of evolving surgical techniques and technological advancements. In this episode he shares information on the education and healthcare systems in the Netherlands, medical technology breakthroughs an…
 
Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in privacy. Sidekick Health was founded by two doctors, who worked for years treating patients with lifestyle-related illnesses. They explored ways to prevent chronic illnesses, help patients manage them, and improve their quality of life. Sidekic…
 
Dr. Hickson is the Founding Director of the CPPA, which he founded in 2002, and now serves in an advisory capacity as Executive Medical Director of Clinical Improvement Education for VHAN. Hickson, an internationally recognized expert in patient safety, medical malpractice and its causes and prevention, has for the past six years served as Vanderbi…
 
Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software? In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at G…
 
Imagine that you’re giving a speech on a podium in front of a hundred people. How would you feel? Are you giving off the correct body language and confidence? Those are some of the things people look for in a leader - to have that executive presence. Without that, your next promotion may take some time. Join your host, Samuel Gbadebo, and his guest…
 
Last year we had reviewed the result of the EU MDR Survey made by Climedo and this year we check the difference. Do you think that there will be a big change? Climedo has decided to ask questions related to the EU MDR but also to the context due to Coronavirus. So we are now looking at the result and you’ll see that there are some changes. But stil…
 
The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companies it serves. The Guru team is comprised of industry experts with a knack for helping companies succeed; each of whom have a specific skillset and knowledge base that companies can tap into and leverage throughout their medical device journey. In this…
 
Mike Morton has over thirty years of regulatory, clinical and quality experience in the medical device industry, including serving as Vice President for Corporate Regulatory Affairs at Medtronic, on the Board of Directors for the Regulatory Affairs Professionals Society, and serving on FDA and other regulatory body working groups . In this episode …
 
In this podcast, James Cave (Editor-in-Chief) and David Phizackerley (Deputy Editor) review the June issue of DTB. The list of articles mentioned in this podcast:The Editorial “COVID-19 vaccination in pregnancy” - https://dtb.bmj.com/content/59/6/82DTB select “Stepping down asthma treatment” - https://dtb.bmj.com/content/59/6/85Review “Prescribing …
 
Ken Snyder, the executive dean and chief administrative officer of the Jon M. Huntsman School of Business, joined the Shingo Institute as the executive director in 2015. Mr. Snyder has served as a member of the Shingo Executive Advisory Board for the past eight years and has intimate knowledge of the Institute and its history. Mr. Snyder has served…
 
What makes Greenlight Guru unique? It’s the 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 Laura Court, a medical device Guru at Greenlight Guru, about her journey in the medical device industry, which ultimately brought her to Greenlight …
 
Today’s guest is Lisa Helmonds, Vice President of Quality Services and Operations at MWA Consulting, which helps companies bring life-saving products to market and scale successfully. Lisa has more than 30 years of training in the areas of manufacturing and quality assurance for the pharmaceutical, biotechnology, and medical device industries. Also…
 
Great leadership is more than just having the highest position. It’s about being an effective leader that knows how to treat your people and connect with them on the same level. Samuel Gbadebo talks with Jay Pendleton, the Director of Talent and Strategy in Medtronic, about his discoveries as he took on the role and what it means to be a medical de…
 
Ein kurzer Überblick über die neuen, geänderten und außer Kraft gesetzten nationalen Gesetze und Verordnungen Wenden Sie sich bei weiteren Fragen an das Johner Institut (via Kontaktformular). Weitere Informationen finden Sie auf diesen Webseiten: MPAMIV MPDG Seite des Bundesgesundheitsministerium mit Gesetzen und Verordnungen…
 
MDR is coming In 1 week and before that, I asked Erik Vollebregt from Axon Lawyers about some questions that I receive. We will talk about: – EU MDR IVDR postponement or not? – Economic Operators date of application – PRRC do we need it from day 1 – Exclusion from EU MDR – OEM OBL rules from May 26th, 2021 And Erik announces the content of its book…
 
As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the guidance, support, and resources they need to fulfill their important roles in the medical device industry. In this episode of the Global Medical Device Pod…
 
Paul Harkness has spent his career in hearing care, helping patients and providers. In this episode Paul explains the prevalence of hearing loss, why it occurs, how hearing loss actually effects patients, the newest trends in hearing care technology, how care is delivered and by whom, and what the business models are. He also shares how his company…
 
“I don't think a bioethicist is normally who people have come to their elementary school career day. So, we are a novel breed to many people.” Alison Bateman-House, PhD That is how our latest guest on Improbable Developments reflected on her chosen profession, bioethics. It is a field where scientists do not ask the questions about whether they can…
 
Lynn D. Martin, MD, MBA is the Medical Director, Continuous Improvement and Innovation at Seattle Children’s. He is a Professor of Anesthesiology and Pediatrics (adjunct) at the University of Washington School of Medicine. He received his M.D. from the University of Washington and his M.B.A. for the University of Tennessee. He completed residencies…
 
Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles are one of the highest in demand in the medical device industry. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mitch Robbins, founder and managing director at The Anthony Michael Group. Listen as Mitch shares his unique in…
 
Jobs these days can get so specific that you didn’t even know they existed. Just like the medical device sales industry, medical device sales leader Jay Pendleton never even knew it existed back in 2007. Jay is the Director of Medtronic and has been in the sales and management industry for over 18 years. Join Samuel Gbadebo and Jay Pendleton as the…
 
Andy Levien, President and CEO of ArcScan talks to Robert about expanding his medical device company internationally and into China. ArcScan was founded in February 2007 in Golden, Colorado. Their product, the ArcScan Insight® 100 is the leading, very high frequency ultrasound device that images the entire anterior segment of the eye, including beh…
 
What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)? In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO). Together, Isabella and Jo…
 
In this episode of the Podcast, we will explain to you what is the Emergency Use Authorization (EUA) that can be started in the US. And to help us, I have invited Michelle Lott from Lean RAQA. This process was used a lot recently for Coronavirus products but you will see with Michelle that this process was changed so many times that it can create s…
 
Wie gebrauchstauglich die Corona-Schnelltests sind und wie die Usability-Tests sich von anderen Medizinprodukten unterscheiden. Wenden Sie sich bei weiteren Fragen an das Team des Johner Instituts (via Kontaktformular) Webseiten: Usability Services des Johner Instituts Fachartikel [Usability Tests in Zeiten von Corona](…
 
Dr. Aaron Ali and Dr. John Schlitt are experts in translating world-class physician education into customer loyalty. In this episode they discuss how to deliver educational experiences that allow clinicians to learn, practice and experiment, leading to better clinical outcomes, more efficient procedures and satisfied customers. Medical device compa…
 
Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible. In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP o…
 
Dr. Gandhi is responsible for advancing the Zero Harm movement, improving patient and workforce safety, and developing innovative health care transformation strategies. In addition, Dr. Gandhi is leading the Press Ganey Equity Partnership to advance equity in health care. Link to claim CME credit: https://www.surveymonkey.com/r/3DXCFW3 CME credit i…
 
However challenging and full of pressure the medical industry is, nothing can overpower someone with authentic leadership. Samuel Gbadebo continues his discussion with Kris Krustangel, Vice President of Business Development for Saluda Medical, as he now talks about his life as a leader and manager in medical sales. He explains how he balances his p…
 
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