Global Medical Device Podcast powered by Greenlight Guru

By Greenlight Guru + Medical Device Entrepreneurs

What's Global Medical Device Podcast powered by Greenlight Guru about?

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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Global Medical Device Podcast powered by Greenlight Guru episodes:

05.09.2024
#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List
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,...
05.02.2024
#365: Medical Device Reporting: The Do's and Don'ts
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...
04.30.2024
#364: Building a Partnership with your Regulatory Consultant
In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA...
04.25.2024
#363: Bringing a Self-Funded Medical Device to Market
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow surgery devices. Dr. Hunter shares his experience from the conception of a...
04.23.2024
#362: Managing Risk in Clinical Investigations
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. They delve into the dual aspects of risk management: ensuring product safety and the procedural...
04.19.2024
#361: Speaking the Language of IVD
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal consultant and IVD expert at Qserve Group. With over 25 years of experience,...
04.13.2024
#360: Is It Possible to "Buy" a QMS?
In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. The discussion unveils the complexities and common misconceptions surrounding QMS, drawing an intriguing analogy...
04.04.2024
#359: Project Management in MedTech
This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing...
03.21.2024
#358: FDAs Voluntary Improvement Program
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M; West trade show in Anaheim, California, to discuss the pivotal Voluntary Improvement Program (VIP). This conversation sheds light...
03.21.2024
#358: FDA's Voluntary Improvement Program
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M; West trade show in Anaheim, California, to discuss the pivotal Voluntary Improvement Program (VIP). This conversation sheds light...
03.07.2024
#357: The State of UDI Across the World
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and regulatory compliance. They embark on a comprehensive exploration of the ever-evolving landscape...
02.22.2024
#356: Quality Myths & Lessons Learned Part II
In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the world of medical device quality and reliability with expert guest Kevin Becker. They explore the nuanced challenges of ethical decision-making in the MedTech industry, the...
02.15.2024
#355: Mastering the Pitch: MedTech Innovations from Concept to Market
In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Blythe shares her wealth of experience, from her early days as a...
02.07.2024
#354: Advice for MedTech Regulatory Affairs Professionals
In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory...
01.30.2024
#353: How Artificial Intelligence is Impacting the MedTech Industry
In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are...
01.18.2024
#352: Fundamentals of Quality & Regulatory
In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech...
01.11.2024
#351: The State of AI & Clinical Investigations
In a today's conversation on the Global Medical Device Podcast, host Etienne Nichols engages with Dr. Maria Nyakern on the burgeoning integration of AI in medical devices. They delve into the European AI Act, discussing its impact on innovation and...
01.04.2024
#350: The Evolving Landscape of AI in MedTech
In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in medical devices. They discuss the role of the FDA, FTC, and other...
12.21.2023
#349: Climbing the MedTech Career Ladder - How to Get to the Top
In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early...
12.14.2023
#348: Considerations for IVD
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima Clinical Research. They delve into the specifics of In Vitro Diagnostics (IVDs) and explore the...
12.07.2023
#347: Human-Centered Design in Medical Devices
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Morven Shearlaw, co-founder of Fearsome, in a thought-provoking discussion on the essence of human-centered design in medical devices. Delve into the importance of understanding user...
11.30.2023
#346: FDAs eSTAR Program
This episode of the Global Medical Device Podcast delves into the world of FDA submissions, specifically focusing on the eSTAR program. Host Etienne Nichols leads an insightful discussion exploring the intricacies, benefits, and strategies for using eSTAR effectively in medical...
11.22.2023
#345: Using AI In MedTech
In this episode, we delve into the burgeoning world of artificial intelligence in MedTech. Listen as we discuss the skepticism and opportunities associated with AI, the revolutionary impact on product development, and provide practical advice for professionals looking to harness...
11.16.2023
#344: Becoming an Advisor to a Medical Device Company
In this episode, we delve into the multifaceted aspects of advisory roles within medical device startups. These discussions explore the nuanced differences between consulting and advisory work, the intricacies of the advisor-startup relationship, strategies for growth, and the delicate balance...
11.09.2023
#343: Recent FDA Draft Guidances
Description: In this episode, we discuss with with regulatory expert Mike Drues to dissect the evolving landscape of FDA medical device regulations. These discussions provide a comprehensive overview of the historical context and current implications of FDA guidances, with a...
11.02.2023
#342: Planning an FDA Submission
Description: In this episode, Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dives deep into the complexities of FDA submissions for medical devices. She sheds light on the nuances of different submission types,...
10.25.2023
#341: What NOT to say to FDA
Description: Dive into the enlightening world of FDA inspections with Etienne Nichols and Mike Drues. In this comprehensive episode, the duo decodes the essence of effective communication, the importance of managing expectations, and the art of proactive dialogue with the...
10.19.2023
#340: LDTs & the FDAs Proposed Ruling
Description: In this episode, host Etienne Nichols and Shannon Bennett, a regulatory affairs expert in the diagnostic testing space dive into the FDA's proposed rules for Laboratory Developed Tests (LDTs) and In Vitro Diagnostic products (IVDs). Shannon breaks down...
10.12.2023
#339: UDI and the State of EUDAMED
Description: In this episode, we discuss the past, present, and future state of EUDAMED. EUDAMED is the European Database for Medical Devices, and is part of the European Medical Device Regulation. While the EUMDR may have been published in...
10.06.2023
#338: Site Selection for Clinical Trials
Description: In this episode, we discuss how to select a site for a Clinical Trial. Joining us for the conversation is Isabella Schmitt, MBA, RAC, the Vice President of Life Science Solutions at Proxima Clinical Research. Isabella brings a...
09.21.2023
#337: Moving MedTech Forward - The Past, Present & Future of Greenlight Guru
Description: In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD) and Pall Johannesson. Together, they embark on a journey through the chronicles of...
09.14.2023
#336: From Academia to FDA Clearance (True Quality Roadshow - Boston)
Description: In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their recently cleared eye movement monitor. Listen as we unpack her journey...
09.08.2023
#335: Accelerating SaMD Development in a Compliant Agile way
Description: In this episode, we explore the impact of software development methodologies in the medical device industry. With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (such as Greenlight Guru),...
09.07.2023
#335: Accelerating SaMD Development in a Compliant Agile Way
Description: In this episode, we explore the impact of software development methodologies in the medical device industry. With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (such as Greenlight Guru),...
08.31.2023
#334: MedTech Funding and Preparing for Due Diligence
Description: Join Devon Campbell in MedTech funding. He unveils startup red flags, from data integrity to product maturity. His message? Know your weaknesses, fill the gaps. Considering cold-calling other Founders? It works. Understand your their investment landscape first. Recognize that...
08.25.2023
#333: Exploring Breakthrough Device Designation
Description: In this episode, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. They discuss pursuing breakthrough status, aligning marketing strategies with FDA review, and navigating the medical device industry. This episode provides a roadmap for this complex regulatory...
08.17.2023
#332: Regulatory Strategy and the Advantage of Diversity in MedTech
Description: In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex,...
08.10.2023
#331: 28 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues
Description: During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Dan tells the story of how...
08.03.2023
#330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?
Description In today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. This is a lesser known program, but there can be significant benefits from using it, which we talk about during...
07.27.2023
#329 The Right Way to Start a QMS: When, How, & What
Description Most people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start, and how do you know when you've...
07.20.2023
#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices
Description In April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device Software Functions." In today's episode, we speak with Mike...
07.11.2023
#327 Understanding the ROI of an eQMS
In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Some of the topics we explore are:3rd- party study by Hobson & CO that reveals significant...
07.07.2023
#326 CSA vs. CSV: Modern Validation for Modern MedTech
In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in the MedTech sector. She discusses the FDA's draft guidance from September 2022, the industry's response,...
06.30.2023
#325 The Role of dFMEAs in Risk Management for Medical Devices
How can dFMEA and ISO14971 work together? This topic is controversial but essential, and today’s guest is more than capable of tackling it. Risk management is one of the top 3 reasons why the FDA issues 483s, so it’s important...
06.29.2023
#325 The Role of dFMEAs in Risk Management for Medical Devices
06.22.2023
#324 Management Responsibility: The most important part of a QMS
Management responsibility is crucial to the success of a QMS… but what is it? What’s covered by the topic of management responsibility and who’s the responsible party? In today’s episode, you’ll hear from Sara Adams, Lead Auditor, Quality Engineer, and...
06.16.2023
#323 The Combination Products Handbook
Combination products are a difficult niche because they combine so many different elements. However, today’s guest literally wrote the book on the topic, and she’s joining the podcast to share her insights. In today’s episode, Susan Neadle and I spoke...
06.07.2023
Leaning into Lean Documentation
What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for today’s conversation, documentation. Steve Gompertz is a partner at QRX Partners and...
06.02.2023
Cybersecurity and the Future of MedTech
The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food and Drug Cosmetic Act has expanded the scope of the FDA...
05.26.2023
How AI Can Help You Manage Risk
With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and becoming more so due to increased risk measures, and it’s important to understand what’s...

What's Global Medical Device Podcast powered by Greenlight Guru about?

Download our free app to listen on your phone

Global Medical Device Podcast powered by Greenlight Guru episodes:

#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List

#365: Medical Device Reporting: The Do's and Don'ts

#364: Building a Partnership with your Regulatory Consultant

#363: Bringing a Self-Funded Medical Device to Market

#362: Managing Risk in Clinical Investigations

#361: Speaking the Language of IVD

#360: Is It Possible to "Buy" a QMS?

#359: Project Management in MedTech

#358: FDAs Voluntary Improvement Program

#358: FDA's Voluntary Improvement Program

#357: The State of UDI Across the World

#356: Quality Myths & Lessons Learned Part II

#355: Mastering the Pitch: MedTech Innovations from Concept to Market

#354: Advice for MedTech Regulatory Affairs Professionals

#353: How Artificial Intelligence is Impacting the MedTech Industry

#352: Fundamentals of Quality & Regulatory

#351: The State of AI & Clinical Investigations

#350: The Evolving Landscape of AI in MedTech

#349: Climbing the MedTech Career Ladder - How to Get to the Top

#348: Considerations for IVD

#347: Human-Centered Design in Medical Devices

#346: FDAs eSTAR Program

#345: Using AI In MedTech

#344: Becoming an Advisor to a Medical Device Company

#343: Recent FDA Draft Guidances

#342: Planning an FDA Submission

#341: What NOT to say to FDA

#340: LDTs & the FDAs Proposed Ruling

#339: UDI and the State of EUDAMED

#338: Site Selection for Clinical Trials

#337: Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

#336: From Academia to FDA Clearance (True Quality Roadshow - Boston)

#335: Accelerating SaMD Development in a Compliant Agile way

#335: Accelerating SaMD Development in a Compliant Agile Way

#334: MedTech Funding and Preparing for Due Diligence

#333: Exploring Breakthrough Device Designation

#332: Regulatory Strategy and the Advantage of Diversity in MedTech

#331: 28 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues

#330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?

#329 The Right Way to Start a QMS: When, How, & What

#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices

#327 Understanding the ROI of an eQMS

#326 CSA vs. CSV: Modern Validation for Modern MedTech

#325 The Role of dFMEAs in Risk Management for Medical Devices

#325 The Role of dFMEAs in Risk Management for Medical Devices

#324 Management Responsibility: The most important part of a QMS

#323 The Combination Products Handbook

Leaning into Lean Documentation

Cybersecurity and the Future of MedTech

How AI Can Help You Manage Risk