Lance Edwards' Greenlight REI Podcast
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Global Medical Device Podcast powered by Greenlight Guru
Greenlight Guru + Medical Device Entrepreneurs
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
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Greenlight is a multiple award-winning digital marketing agency that designs, builds, deploys and measures marketing solutions and campaigns across Search, Social, Display, Mobile, eCommerce, and more, with the unwavering objective of achieving dramatic growth for its clients. Greenlight promotes brands and products in 29 languages and 32 territories on behalf of such clients as diverse as ghd, Dixons Carphone, Superdry, Laura Ashley, Millennium Hotels & Resorts, Hiscox, Footasylum and many ...
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The Asia-Hollywood Greenlight is a podcast where we interview experts about creating and distributing content for Hollywood and Asia.
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Great authors in conversation about their newest books, hosted by an independent bookstore in the heart of Brooklyn, NY. Books discussed are available for sale in our stores and at www.greenlightbookstore.com.
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Tired of waiting for permission to be creative, host and filmmaker Justin Giddings turned to crowdfunding to kickstart (lol) his filmmaking career. After successfully raising over $100,000 for his first two short films, Justin realized that crowdfunding was less about the money and more about expanding the empowerment and reach of an artist's voice. As more people sought out his advice, Justin launched www.thekickstarterguy.com, the #1 crowdfunding consultancy for filmmakers with over 145 la ...
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We help experts and professional advisors elevate your message to drive results in your business and impact in your life. Story Greenlight founder Jeff Bartsch is a visionary storyteller and coach who built his career over 20 years as a broadcast television editor in Hollywood, working with clients including ABC, NBC, Universal, Disney, Apple, and many others. His commentary has been featured in Time Magazine, USA Today, the Associated Press, and multiple textbooks. Story Greenlight is all a ...
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GreenLight Roofing and Remodeling started out as the dream of a man who wanted to own a family-operated business that would be passed down for generations. Matthew has spent his entire adult life in the roofing and construction industry and grew up swinging a hammer and using every tool he could get his hands on. Matt and Rebekah are passionate about their business, and the proof is in their longevity. They’ve been in the industry for more than a decade, and they’re excited to continue helpi ...
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#388: Elements of an Effective CAPA Program
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In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions…
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#387: The case for Real World Evidence Studies
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In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation. Simon breaks down NEST's critical role in catalyzing the use of RWE to stre…
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#386: The Danger of In-Home Use Medical Devices, Pt. 2
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In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these …
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#385: The Trouble with Home-Use Devices, Pt. 1
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In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings. They explore how home use devices, su…
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#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends
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In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality …
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#383: What Standards Apply to My Device?
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In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development. Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuri…
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#382: Design of Experiments - How and When to Use DOE
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In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development. They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and manufacturing processes. Perry shares insights from h…
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#381: MedTech Advice from an Accidental Entrepreneur
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In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur." Dr. Parekh shares how her desire to create impactful medical devices led to the development of the COBRA-OS, a life-s…
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#380: Navigating the Complex World of Combination Products with Subhi Saadeh
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products. They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth. Subh…
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Unlocking Real Estate Secrets: The Power of Land Trusts
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Unlocking the Secrets of Mobile Home Park Investment
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Unlocking Real Estate Success: Raising Private Money
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In this episode, Lance Edwards explores the vital role of private money in real estate success with expert Alan Cowgill. Alan shares his journey from corporate America to private lending, explaining the difference between private and hard money lenders and offering tips for finding private lenders. He also discusses deal structuring and provides a …
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#379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer
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In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Vernon Baker, a medical device guru, about key strategies for early-stage MedTech companies, particularly around implementing Quality Management Systems (QMS), supplier management, and compliance. Vernon shares his experience of transitioning from engineering to …
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#378: Who Owns the Design Controls Process?
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In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Laura Maher to discuss the critical role of design assurance in medical device development. They explore the importance of ownership in design and development documentation, delve into the complexities of design controls, and share practical insights on how to ensure compli…
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#377: Designing a Medical Device for a Global User
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Matthew Wettergreen, Director of the Global Medical Innovation Master of Bioengineering program at Rice University. Dr. Wettergreen shares his extensive experience in developing client-based engineering design courses and discusses the importance of global and …
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#376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights
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In this episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates. They delve into the recent FDA proposed rule for wound dressings, addressing the classification and regulatory impacts on medical device manufacturers. …
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#375: Direct to Consumer - The Future of Healthcare
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Gail Lebovic, an internationally recognized oncoplastic surgeon and innovative entrepreneur. They delve into the evolving landscape of MedTech, focusing on the shift from traditional reimbursement models to direct-to-consumer strategies. Dr. Lebovic shares her …
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#374: Clinical Evidence - The Key to Market Adoption
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In this episode, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies. Shaherah shares her extensive experience in the field, providing practical advice on securing funding, ensuring market access, a…
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#373: Creative Clinical Recruitment
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In this episode of the Global Medical Device Podcast, host Etienne Nichols, along with part-time co-host Stephanie Hinton, dives into the art of clinical trial recruitment with Dr. Kelly Palmer, Assistant Professor at the University of Arizona. Dr. Palmer shares her extensive experience and innovative strategies for overcoming recruitment challenge…
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#372: Getting Hired In MedTech
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In this episode of the Global Medical Device Podcast, host Etienne Nichols talks with Mitch Robbins, founder of the Anthony Michael Group, about the evolving landscape of hiring and job seeking in the MedTech industry in 2024. They discuss strategies for both employers and job seekers, emphasizing the importance of preparation, effective communicat…
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#370: Meet a Guru: Jamie Bihary
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In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Jamie Bihary, a Medical Device Guru at Greenlight Guru. Jamie shares her journey from biomedical engineering to her current role, where she helps companies transition from legacy quality management systems (QMS) to cutting-edge electronic QMS (EQMS). They discus…
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#371: Achieving ISO 13485 Certification
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In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification. The discussion covers the importance of gap analysis, the value of a compliant agile approach, and the benefits of using Greenlight Guru’s eQMS software. Li…
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#369: Advice to Medical Device Inventors
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In this engaging episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Ron Richard, a seasoned expert in the medical device industry with over 35 years of experience. The discussion delves into the essentials of bringing a medical device to market, from the inception of an idea to commercialization. Ron shares his journe…
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#368: Institutional Review Boards (IRBs)
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In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk de…
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#367: Interviewing the Interviewer
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In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Et…
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#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List
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In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates. The episode delves into the harrowing experiences of navigating sever…
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#365: Medical Device Reporting: The Do's and Don'ts
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In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up r…
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