A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
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Join Sunrise Labs on the Making Bright Ideas Work podcast to discuss the ins and outs of bringing medical devices to life, and their impact on the industry and beyond.
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The go-to podcast for anyone looking to transform their business! Join host Amanda Desuacido, CEO of My Mountain Mover, as she interviews top industry leaders and business owners who are reaching new heights through premier virtual outsourcing. Expect creative productivity tips, business insights, and testimonials of how virtual assistants have revolutionized businesses around the world.
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A podcast series for healthcare leaders who are looking for fresh perpsectives, bold solutions and inspiration in their journey to advance value based care.
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Episode #193 Doing What’s Good for Patients, Doctors, and Society: A True Partner in Value-Based Care with Farzad Mostashari, CEO, Aledade
47:00
47:00
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47:00Dr. Farzad Mostashari is the Co-Founder and CEO of Aledade. He has spent his career at the forefront of healthcare policy and health information technology. Dr. Mostashari is the former National Coordinator for Health IT at the Department of Health and Human Services, and served as a distinguished expert at the Brookings Institute’s Engelberg Cente…
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Episode #192 Words are Magic: Reimagining the Patient Experience with Erica Olenski, Patient Care Advocate, PR Strategist, Mom
51:57
51:57
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51:57With years of experience as a PR strategist for healthcare technology companies, Erica Olenski has spent her career working at the intersection of innovation and care. From guiding early-stage startups to consulting with multinational organizations, she developed a unique understanding of how to best use technology to improve healthcare. Her expert…
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Development Considerations for OTC Medtech, Part 2
59:44
59:44
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59:44In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re continuing our conversation about over-the-counter (OTC) medical devices. If you haven’t already enjoyed part 1 of the discussion, please be sure to listen to that one first. In this segment, we look at more specific regulatory- and des…
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Development Considerations for Over-the-Counter Medtech, Part 1
47:21
47:21
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47:21In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing over-the-counter (OTC) devices and aspects developers need to keep in mind for these devices. A variety of topics are covered, from regulatory questions to human factors design to cleaning protocols. Real-world examples are u…
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Episode #191 The Healthcare Revolution is Coming with David W. Johnson, Founder and CEO, 4sight Health
53:28
53:28
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53:28Our guest today is David Johnson, CEO of 4sight Health and author of the new book, The Coming Healthcare Revolution: 10 Forces that Will Cure America’s Health Crisis. Prior to starting 4sight, a think tank promoting market-driven healthcare reform, Dave spent 28 years of his career in healthcare investment banking. This background and his Harvard p…
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Device Descriptions in Regulatory Submissions
51:34
51:34
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51:34In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing a common part of a regulatory submission—the device description. While this element may seem to be straightforward, an extraordinary number of challenges originate with this portion of a submission. This discussion reviews th…
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Episode #190 Taking Care of People to Take Better Care of Patients with Andrew Molosky, President and CEO, Chapters Health System
51:00
51:00
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51:00This is the last episode of our Fall 2024 Season, and it’s a powerful one. On the show today is Andrew Molosky, the President and Chief Executive Officer of Chapters Health System. Under Andrew’s leadership, Chapters has redefined its position to become the nation’s largest not-for-profit, end-of-life care organization and a leading community-based…
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Episode #189 Driving the Next Generation of Research and Clinical Care…With Data with Mitesh Rao, MD, MHS, Founder and CEO, OMNY Health
32:40
32:40
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32:40“… If it’s garbage in, it’s gonna be garbage out.” Boy, am I familiar with that truth. And it prevails across so many areas of healthcare, but maybe none more so than the data we generate and our ability to distill something useful and usable out of that data. On this episode of Creating a New Healthcare, I talk with Dr. Mitesh Rao, the Founder and…
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Regulatory Ramifications Due to the Presidential Election
53:45
53:45
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53:45In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the potential implications for the medical device regulatory sector as a result of the U.S. presidential election. This recording took place two weeks following the election results. In addition, we speak about some recurring…
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Regulatory Considerations with an Assisted Suicide Machine
50:41
50:41
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50:41In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re drawing inspiration from an item I wrote about recently in one of my MPO editor’s letters. Specifically, I’m referring to the news of an assisted suicide machine that was being considered for introduction in Switzerland, where assisted …
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Episode #188 Check Your Premise: What to do when a great product and a thriving market don’t equal a growing business with Mike Murphy Managing Partner, Sunstone Management Advisors
46:10
46:10
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46:10On the show today is Mike Murphy, a distinguished growth leader with over 30 years experience as a C-level executive, specializing in healthcare and insurance. Mike’s expertise spans M&A due diligence, post-merger integration, and turnaround strategies, consistently improving earnings and gross profit. Examples of some of his significant achievemen…
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Episode #187 Go Where the Competition Isn’t…To Those That Need it the Most with Dan McDonald, Founder and CEO and Lauren Barca, VP of Quality at 86Borders
44:02
44:02
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44:02When your guest starts a business in healthcare with the adage “Go where the competition isn’t”, you know it’s going to be an interesting conversation. On the podcast today, I’m honored to have Dan McDonald, Founder and CEO of 86Borders and Lauren Barca, VP of Quality for 86Borders. Dan co-founded the company in 2014 with a clear mission: to revolu…
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Episode #186 Who Really Pays for Higher Healthcare Costs? with Zack Cooper, Associate Professor of Public Health and Economics, Yale University
1:01:49
1:01:49
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1:01:49Zack Cooper is a health economist whose work is focused on producing data-driven scholarship that can inform public policy. He currently serves as an Associate Professor of Public Health and Associate Professor of Economics at Yale University in addition to being the Director of Health Policy at Yale’s Tobin Center for Economic Policy. Zack’s resea…
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Episode #185 Humanizing the Medical Supplies Industry with Better Health with Naama Stauber Breckler, CEO of Better Health
49:12
49:12
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49:12Our guest today is Naama Stauber Breckler, Co-Founder and CEO of Better Health, a medical supply and support platform that bundles peer coaching, education, and delivery of medical supplies to help people manage their chronic conditions at home. Naama is a true humanistic rebel leader dedicating her entire entrepreneurial journey to creating human-…
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Episode #184 Extending Time by Outsourcing Chronic Care Management with Brian Esterly, CEO of TimeDoc Health
44:22
44:22
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44:22Our expert guest on this episode is Brian Esterly, who was appointed CEO of TimeDoc Health in August 2023. Brian brings more than 25 years of healthcare leadership experience to this role. Prior to this he served as the Chief Growth and Strategy officer at Centria Healthcare. Working with healthcare systems, primary care providers, FQHC’s and Medic…
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Predetermined Change Control Plans, Part 2
57:41
57:41
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57:41In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue speaking on the topic of predetermined change control plans. Potential scenarios for their use are discussed, examples are provided, and role of PCCPs for manufacturing processes are explored. If you haven’t yet listened to Part 1…
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Predetermined Change Control Plans, Part 1
48:29
48:29
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48:29In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA’s recent guidance documents regarding predetermined change control plans (PCCP). The first guidance addresses PCCPs for artificial intelligence (AI) and/or machine learning (ML) based devices (click here to hear an earlier …
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Episode #183 Improving Maternal Healthcare in America: Why it’s not just a “Nice to Have” with Ann Somers Hogg, Director of Health Care, Clayton Christensen Institute
28:39
28:39
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28:39Ann Somers is the Director of Health Care at the Clayton Christensen Institute. Her research focuses on drivers of health (a.k.a. social determinants of health), maternal health, and the pathways to improve them. Ann Somers holds an MSPH in Health Policy and Management from UNC-Chapel Hill and a BS in Commerce from the University of Virginia. Last …
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Episode #182 The Power of AI in Chronic Disease Management: The Ibis Touch with Piali De, CEO, Senscio
49:55
49:55
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49:55Piali De, PhD is a talented physicist who started her career developing artificial intelligence systems for the United States defense departments. In 2010, Dr. De founded Senscio Systems, a digital health company redefining chronic care management with the nation’s first AI-powered home-to-clinic digital therapeutics platform called Ibis. Senscio’s…
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What is a CAPA and How Do You Best Use It?
58:13
58:13
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58:13In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re focusing in on a regulatory piece that’s been mentioned numerous times with regard to other topics we’ve discussed. This episode is focused on CAPA or corrective and preventive action. We’re digging into the CAPA, what it is, its purpos…
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Episode #181 Decrease the Spend, Increase the Profit with Data with David Kirshner, Managing Partner, LogicSource
43:46
43:46
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43:46Money. Not always the most inspiring or sexiest topic in healthcare, but one that is critical if we are going to change the system for the better. Today on the podcast, we welcome David Kirshner, Managing Partner at LogicSource, to talk about their approach to helping health systems improve efficiency and decrease costs so they can redirect funds w…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing what the process should be for a company once they receive a 483 or warning letter from the FDA. Best practices, first steps to take, who is responsible, and potential strategies for avoiding them are shared. Specifically, th…
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Special Episode – Doing Humanity in Healthcare with Joe Machiote
28:52
28:52
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28:52Joe Machiote spent the first decade of his career in the hotel and dining operations industry and has nearly 30 years of experience working in the fields of HR, Diversity & Inclusion. He currently serves as Chief Diversity and Inclusion Officer for Premier, Inc. We’re airing this interview on the podcast as a means of introducing you to the type of…
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Episode #180 Ableism in American Healthcare with Megan Morris, PhD, MPH
45:57
45:57
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45:57We’re excited to share this discussion with Megan Morris, PhD, MPH in the first episode of the 8th season of Creating a New Healthcare! Dr. Morris is currently an Associate Professor in the Division of General Internal Medicine in the Department of Medicine at the University of Colorado, Anschutz. In her work, she focuses on provider-level and orga…
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Episode #179 A heart doctor’s quest for healing and happiness – with Jonathan Fisher, MD FACC
54:49
54:49
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54:49In his recently published book, Just One Heart, Dr. Fisher draws upon the vast body of scientific literature on positive psychology and wellness, as well as the teachings of mindfulness and stoicism which have withstood the test of time for over two and half millenia. A major take home point is that the ability to manage our thoughts and emotions i…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re revisiting real-world evidence (RWE), which is a topic that’s been getting some attention. So today, we’re going to look at what’s driving that attention and discuss the reasons behind it. We’ll also talk about how the FDA is seeking to…
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Episode #178 Is AI the transformational catalyst we’ve been waiting for? – with Robert Pearl, MD, former CEO of Kaiser Permanente
55:14
55:14
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55:14Dr. Robert Pearl has recently published a 3rd book entitled ‘ChatGPT MD’. His ‘co-author’, as he calls it, was ChatGPT itself. With this book, Robbie brings his unique perspectives as a practicing surgeon, an accomplished CEO, an author of numerous publications and books, a Stanford Graduate Business School and Medical School Professor, and one of …
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The Most Dangerous Devices to Hit the Market
40:42
40:42
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40:42In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re taking a look at several devices that unfortunately ended up being quite dangerous even though they made it to the market and were used by healthcare professionals. Some of these may have been brought up previously the Netflix documenta…
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Episode #177 Fighting the ‘Othering’ mindset in Healthcare – with Stella Safo, MD, founder & CEO of ‘Just Equity for Health’
37:29
37:29
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37:29If you’ve ever wondered, ‘But what can I do? – please listen to this episode. Dr. Stella Safo, a Harvard-educated, Ghanaian-American physician, provides us all with her wisdom, experience and courageous efforts in addressing that question. In this interview we’ll cover: Some shocking and saddening stats on healthcare inequities & disparities in the…
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Episode #176 A New Approach to Maintaining Your Motivation & Healthful Habits – with Kyra Bobinet, MD, CEO & founder of Fresh Tri
34:33
34:33
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34:33So, it turns out that how we frame failure is far more important than how we manage success, in determining our motivation and our ability to sustain healthful and positive behavior change. Our guest today, Dr. Kyra Bobinet, is a long-standing expert, clinician and entrepreneur in the field of behavior change. Her company, Fresh Tri, applies a uniq…
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Headline-Generating Medical Device Safety Concerns
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49:16
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49:16In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing a few stories in the news that tie into the safety of medical devices. First, a story regarding plastic syringes made in China that were deemed not to be used by the FDA. The other story is about a report indicating third-part…
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Episode #175 An AI-enabled Solution for Affordable & Accessible Primary Care – with Neal Khosla, Co-founder & CEO of Curai Health
50:50
50:50
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50:50Friends, The very first question I asked our guest today, Neal Khosla, was, “If AI is the solution, what’s the problem?” His response was disarmingly true. We don’t have enough Primary Care providers and they don’t have enough time. When I asked Neal to define AI, he didn’t go into the usual tech jargon. Instead, he described the specific needs pat…
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Episode #174 Saving Lives Through Hospital-based Operations Management with Eugene Litvak PhD, President & CEO of the Institute for Healthcare Optimization
1:10:19
1:10:19
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1:10:19Friends, I think you’ll all understand this. Every once in a while an issue comes along which has such importance and urgency that you’re compelled to do something about it. In this case, I had a phone call with our expert guest a week ago, and ten minutes into the discussion, I stopped him and said ‘we have to do this podcast interview immediately…
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Episode #173 The ‘Data Humanity Lab’ – A Radical Contribution to Next-Gen Public Health & Health Equity with Brian Urban, MS, MBA, MPH, Director of Innovation & Emerging Markets at Finthrive
44:55
44:55
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44:55Friends, The digital/data revolution in healthcare is upon us, and amongst other things, it’s recreating public health, population health and health equity. One of the groups at the forefront of this movement is the ‘Data Humanity Lab’ at Finthrive. In this episode, we’ll hear directly from one of the emerging leaders in the field, Brian Urban – th…
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Episode #172 The Perverse World of Employee Health Benefits & How Change Might Be Coming – with Chris Deacon, J.D., founder of VerSan Consulting & former Director NJ State Health Benefits Program
47:51
47:51
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47:51There are over 160 million Americans who get their health benefits through their employers. Nearly 40% of all healthcare expenditures in the U.S. is paid for by self-insured employers. For decades, these benefits have been mismanaged – contributing to unsustainable costs and suboptimal health outcomes; and leading to a prolonged wage stagnation and…
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Episode #171 Operationalizing Love in Healthcare Organizations – with Stephanie Feals & Dr. Apurv Gupta
51:39
51:39
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51:39Friends, The number one question I get asked after my presentations and seminars is, “But Zeev, what can I do?” Making positive humanistic change in healthcare seems daunting, if not impossible. The system is incredibly entrenched. And yet, in this interview we’re going to hear examples of leaders who have used the principle of ‘love’ to create pos…
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Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
51:35
51:35
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51:35In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the latest annual list put out by ECRI, an independent authority on healthcare technology and safety, on their top 10 health technology hazards for 2024. The full list is available at the organization’s website, which is at w…
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Episode #170: One Place for All Your Health & Care – with Glen Tullman, CEO of Transcarent
39:19
39:19
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39:19Friends, This episode is a must-listen, not only for healthcare leaders, but for CEO’s, CFO’s and CHRO’s of every self-insured employer in the US. One of the most crippling problems in American healthcare is the cost of care through self-insured employers – which is how approximately 40% of all healthcare is paid for in the US. As our guest puts it…
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Episode #169: Disrupting the Inequities in American Healthcare – with Kameron Matthews MD, JD, Chief Health Officer at Cityblock Health
52:24
52:24
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52:24Friends, What most of us are unaware of is that the health of the American public is worsening in relation to other developed nations – despite having, by far, the costliest and arguably most sophisticated healthcare system in the world. Our life span is decreasing. Inequities in care and disparities in health outcomes are worsening. The Washington…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional review boards. We’re taking a look at what these are, how they relate to medical device approvals, and why they are important. Specifically, the following questions are addressed: Could you please expla…
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Episode #168: Going Beyond Creating a New Healthcare
26:33
26:33
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26:33Watch out folks! A new day in Creating a New Healthcare is coming… Creating a New Healthcare has an updated look and an updated focus. Over the past six months, I’ve been speaking with healthcare audiences across the country about my recently published book, ‘Beyond the Walls’, which is about getting beyond our limiting legacy thinking. There are 3…
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Episode #167: A Master Class in Humanizing the Healthcare Experience – with John Boerstler, Chief Veterans Experience Officer, Dept of Veterans Affairs
51:55
51:55
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51:55Friends, This interview should be required listening for every chief experience officer, every marketing officer, every chief medical officer and every chief executive officer in American healthcare. Why? Because – when benchmarked against other public and private healthcare systems the VA outperforms on patient experience and consumer trust metric…
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Episode #166: From Casualty to Courageous Leader – with Todd Otten MD
44:13
44:13
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44:13Friends, This is a remarkable journey – of a physician who has gone from burnout to creating positive ‘ripples of change’ in our healthcare system. He went from being a casualty of our healthcare system to being a courageous leader. In listening to Dr. Otten’s story, I was moved from anger to elation, and I suspect you will be as well. What’s profo…
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Episode #165: The VA as a “test kitchen” for care transformation in US healthcare – with Dr. Cole Zanetti
57:34
57:34
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57:34Friends, This dialogue is a Master Class in Care Transformation – likely owing to our guest’s unique background, which includes preventive medicine, public health, and clinical informatics. It should be required listening for all healthcare executives and managers – both clinical and administrative – as well process/quality improvement professional…
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Episode #164: Part 2 – The On-Going Racial Bias in Pulse Oximetry Measurement – with Meir Kryger MD, Professor Emeritus, Yale School of Medicine
31:54
31:54
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31:54Friends, This is Part 2 of an interview that is one of the most startling I’ve posted over the past 8 years. The revelation here is that the pulse oximeters we’ve been using for decades, to measure oxygen in the blood, are not always accurate in people of color. They may overestimate the amount of oxygen in the blood and miss low oxygen levels – po…
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Reimbursing Breakthrough Designation Products
51:18
51:18
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51:18In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the journey that’s occurred with regard to getting reimbursement tied to the FDA’s Breakthrough Designation Program (BDP). It’s been planned, called off by CMS, put into proposed legislation, but we still don’t have a definitive so…
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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by FDA regarding the 510k regulatory pathway. The subject matter of the three were: best practices for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectation…
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Episode #163: A Strategy to Provide Personalized Primary Care for Seniors – with Vivek Garg, MD, the Chief Medical Officer at Humana’s Primary Care Organization
55:34
55:34
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55:34Friends, Primary care for seniors is different from care for younger patients. Yet, very few providers across the country have a different and distinct strategy to care for their aging senior patients. In this interview, we’ll be introduced to an organization that has made taking care of seniors a priority. The fundamental problems with attempting …
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Episode #162: Addressing Racial Bias in Pulse Oximetry Measurement – with Neil Friedman, COO & Co-Founder of BodiMetrics
39:10
39:10
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39:10Friends, This interview is one of the most startling I’ve posted to date. In this episode, we discover that pulse oximeters – which measure blood oxygen levels – are not always accurate in people of color. Mounting evidence suggests that they’re far less accurate in people of color than in white people. They can overestimate the amount of oxygen sa…
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Episode #161: Advanced Primary Care – with Neil Wagle, Chief Medical Officer at Devoted Health
55:45
55:45
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55:45Friends, As we’ve described and discussed before in this podcast, Primary Care in the US is on life-support and the prognosis does not look good. The implications for all of us is dire – as we look at what is nothing less than the demise of primary preventive care in our country. Our guest today has devoted his career to trying to revive and save p…
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