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Global Medical Device Podcast powered by Greenlight Guru #435: ICYMI (In Case You Missed It!) Becoming a Regulatory Affairs ProfessionalIn 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 affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.Key Timestamps:[00:00:30] Introduction to Kavetha Ram...

2025-12-0144 min

Global Medical Device Podcast powered by Greenlight Guru #431: Meet Alex Naber: Insider Insights on Quality Systems, Design Quality, and MedTech's Patient-First EthosThis "Meet the Guru" episode introduces Alex Naber, a seasoned medical device consultant at Greenlight Guru, offering listeners a deep dive into his background and expertise. Alex shares his journey, beginning in bioengineering and progressing through roles in complaints, field action, design quality, and post-market quality management at a major orthopedic company (Zimmer Biomet). His experience highlights the crucial need for expert guidance in navigating complex MedTech regulations and quality management system (QMS) pathways.Alex and host Etienne Nichols discuss the immense value of having a diverse internal team of consultants to draw from—a collective knowledge ba...

2025-11-0326 min

Global Medical Device Podcast powered by Greenlight Guru #401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech IntegrityIn this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development. They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The conversation also tackles the shifting landscape caused by administrative changes in the U.S., the effects on clinical trials, AI-driven digital evidence, and what companies must do to stay compliant and innovative in a volatile regulatory environment.Key Timestamps:[02:30] – Introduction to Sarah Moeller and her role in ISO 18969 update...

2025-04-1048 min

Global Medical Device Podcast powered by Greenlight Guru #398: Game-Changing Connections in MedTech: Inside LSI with Scott PantelIn this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Scott Pantel, CEO and founder of Life Science Intelligence (LSI), to explore how LSI bridges the gap between medtech innovation and commercialization. Scott shares LSI’s origin story, the evolution of its events, and the importance of cultivating meaningful relationships within the medtech ecosystem. Learn how LSI’s global meetings—from Dana Point to Portugal, London, and Singapore—create spaces where deals happen, ideas flourish, and the future of patient care is shaped. Plus, Scott offers actionable advice for medtech founders preparing for inve...

2025-02-1335 min

Global Medical Device Podcast powered by Greenlight Guru #397: Winning Over Skeptics: the Key to Product Adoption in HealthcareIn this episode, Etienne Nichols sits down with Tiffany Ryder—healthcare advocate, physician assistant, and founder of Red Flag Hero—to discuss the complexities of product adoption in healthcare. Tiffany shares her journey from rural Louisiana to the NFL cheerleading squad and into emergency medicine, highlighting how personal experience shapes her patient advocacy.The conversation dives deep into why healthcare professionals are skeptical of new devices, how authenticity and storytelling improve adoption, and what MedTech professionals often overlook when pitching to clinicians. Tiffany also reveals the importance of grassroots movements within medical communities, why workflow integration matters more...

2025-02-0633 min

Global Medical Device Podcast powered by Greenlight Guru #394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike DruesIn this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data. With insights on using PMAs as a competitive strategy and overcoming internal resistance to h...

2024-12-0651 min

Global Medical Device Podcast powered by Greenlight Guru #393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin BushkoIn this episode of the Global Medical Device Podcast, Etienne Nichols talks with Justin Bushko, president of Concise Engineering and founder of MedTech Man. Justin shares his extensive experience in MedTech, guiding startups and major players alike through complex engineering challenges. From simplifying prototypes to pivoting product strategies, Justin emphasizes the importance of clear user needs, iterative testing, and knowing when to focus or adapt. Whether you’re an early-stage founder or an industry veteran, this conversation is filled with insights on navigating design, reducing costs, and succeeding in MedTech’s complex regulatory landscape.K...

2024-11-2933 min

Global Medical Device Podcast powered by Greenlight Guru #392: Verification and Validation in MedTech: A Practical Guide with Devon CampbellIn this engaging episode of the Global Medical Device Podcast, Etienne Nichols and Devon Campbell dive into the complexities of verification and validation (V&V) in medical device development. Whether you’re a medtech startup founder or an industry veteran, this conversation offers essential insights on creating robust V&V processes. Devon shares practical advice on defining user needs, writing strong design inputs, conducting pre-verification testing, and ensuring that verification protocols provide meaningful evidence. The discussion explores how to avoid common pitfalls, optimize your design reviews, and strategically approach V&V for complex devices, offering li...

2024-11-2258 min

Global Medical Device Podcast powered by Greenlight Guru #391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan AshfaqIn this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Adnan Ashfaq, a seasoned quality, regulatory, and validation specialist, to explore the critical role of developing a regulatory roadmap for medical device companies. Adnan breaks down the differences between a regulatory strategy and a regulatory roadmap, highlighting how a well-designed roadmap serves as a guiding document for market access and investor confidence. The conversation delves into how to navigate complex market regulations, assess classification and compliance needs, and identify opportunities for strategic global market entry. Adnan’s 25+ years of experience provide ac...

2024-11-1435 min

Global Medical Device Podcast powered by Greenlight Guru #390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon RasooliIn this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS). Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, culture over mandate, redundancy over duplication, and conciseness over verbosity. This conversation dives into strategies for optimizing QMS implementation, reducing overhead, and integrating quality culture company-wide. The episode wraps with tactical advice for new medical device founders on setting up their QMS for long-term success.

2024-11-0737 min

Global Medical Device Podcast powered by Greenlight Guru #389: Pre-determined Change Control PlansIn this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices. Originally developed for AI-based devices, the PCCP framework is now available for all types of medical devices, providing a way for manufacturers to get pre-approval for certain future device changes. Etienne and Mike explore the origins of PCCPs, the intricacies of implementing them, and how this regulatory tool may allow for faster device modifications without additional market submissions. They also examine...

2024-10-3144 min

Global Medical Device Podcast powered by Greenlight Guru #381: MedTech Advice from an Accidental EntrepreneurIn 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-saving tool used in trauma care, including military and postpartum hemorrhage situations. The conversation touches on the challenges and victories of securing funding, navigating regulatory hurdles, and maintaining a mission-driven company focused on patient impact. For those interested in MedTech, this...

2024-09-0543 min

Global Medical Device Podcast powered by Greenlight Guru #376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory InsightsIn 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. The discussion covers the historical context, the potential implications for the industry, and strategies for companies to navigate these changes.Key Timestamps:[00:00] - Introduction to the episode and guests[02:15] - Overview of Greenlight Guru's QMS software[04:30] - Introduction to the FDA's proposed rule on wound dressings[06:00...

2024-07-1839 min

Global Medical Device Podcast powered by Greenlight Guru #375: Direct to Consumer - The Future of HealthcareIn 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 journey of pioneering nasal health products during the COVID-19 pandemic, emphasizing the importance of flexibility and addressing real clinical needs. The conversation explores the broader implications for the future of healthcare, prevention, and patient empowerment.Key Timestamps:[02:15] – Introduction to Dr. Gail Lebovic and her background.[06:45] – Discussing the...

2024-07-1147 min

Global Medical Device Podcast powered by Greenlight Guru #374: Clinical Evidence - The Key to Market AdoptionIn 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, and achieving market adoption. They explore the nuances of clinical evidence, the significance of strategic planning, and the role of advisory panels in navigating the MedTech landscape.Key Timestamps:00:00 - 03:00 Introduction and Sponsor Message03:01 - 05:20 Introduction to Shaherah Yancy and her background05:21 - 10:30 Importance of Clinical and...

2024-06-2547 min

Global Medical Device Podcast powered by Greenlight Guru #370: Meet a Guru: Jamie BiharyIn 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 discuss the common challenges faced during these transitions, the importance of environmental monitoring in clean rooms, and practical advice for managing QMS implementations. Jamie also highlights the value of Greenlight Guru’s resources, including their robust partner network and support systems.Key Timestamps:00:00 - 02:00 In...

2024-05-3032 min

Global Medical Device Podcast powered by Greenlight Guru #371: Achieving ISO 13485 CertificationIn 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. Listeners will gain valuable insights into maintaining compliance and continuous improvement in the MedTech industry, as well as practical advice for navigating ISO 13485 certification.Key Timestamps00:00 - 02:00 - Introduction by Etienne Nichols02:00 - 05:30 - Introduction to HTD Health and their focus05:30 - 10:45...

2024-05-2845 min

Global Medical Device Podcast powered by Greenlight Guru #365: Medical Device Reporting: The Do's and Don'tsIn 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 robust reporting processes and explains how manufacturers can avoid common pitfalls.Key Timestamps:[01:20] Introduction of Lisa Van Ryn and discussion on FDA's Medical Device Reporting[05:45] Lisa's transition from the restaurant industry to medical devices[10:30] What triggers a medical device report to th...

2024-05-0740 min

Global Medical Device Podcast powered by Greenlight Guru #363: Bringing a Self-Funded Medical Device to MarketIn 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 simple yet effective surgical device through its development, struggles with initial licensing, and ultimate success in the market. The discussion highlights the importance of perseverance, the impact of regulatory insights, and the significant role of strategic innovation in enhancing patient outcomes.Key Timestamps:[00:45] - Introduction of Dr. Lee Hunter and his medical device journey.[05:30] - Challenges...

2024-05-0239 min

Global Medical Device Podcast powered by Greenlight Guru #364: Building a Partnership with your Regulatory ConsultantIn 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 regulatory pathways, Christine offers a wealth of knowledge. The discussion delves into the intricacies of working with regulatory consultants, the significance of FDA interactions, and practical tips for medical device startups aiming to maneuver through regulatory challenges successfully.Key Timestamps:[00:02:30] Christine's journey from biochemistry to medical device innovation[00:15:00] Insights on starting a medtech startup and the...

2024-04-3040 min

Global Medical Device Podcast powered by Greenlight Guru #361: Speaking the Language of IVDIn 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, Christie shares her extensive knowledge, discussing the nuances of IVDs, regulatory landscapes, and practical insights for professionals transitioning into or within the IVD sector.Key Timestamps:[00:00:45] - Christie Hughes's introduction and background in IVDs[00:03:30] - Discussion on the regulatory challenges and trends in 2023[00:15:22] - Differences between IVDs and other medical devices in terms of regulatory and operational...

2024-04-1944 min

Global Medical Device Podcast powered by Greenlight Guru #357: The State of UDI Across the WorldIn 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 of UDI requirements, shedding light on crucial deadlines, common pitfalls, and strategic insights for achieving global compliance. From the intricacies of European UDI requirements to the specifics of implementing UDI systems in markets like Australia and beyond, this episode is a treasure trove of actionable insider knowledge for medical device professionals navigating the complexities of UDI compliance....

2024-03-0752 min

Global Medical Device Podcast powered by Greenlight Guru #355: Mastering the Pitch: MedTech Innovations from Concept to MarketIn 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 marketer to leading significant product launches and achieving FDA breakthrough designations. The conversation revolves around crafting compelling pitches, understanding investor expectations, and navigating the challenges of presenting complex medical technologies to diverse audiences.Key Timestamps:[00:00:45] - Introduction to Blythe Karow and her background in MedTech.[00:03:22] - Insights into the dynamics of pitching to investors and adapting...

2024-02-1540 min

Global Medical Device Podcast powered by Greenlight Guru #354: Advice for MedTech Regulatory Affairs ProfessionalsIn 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 affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.Key Timestamps:[00:00:30] Introduction to Kavetha Ram...

2024-02-0744 min

Global Medical Device Podcast powered by Greenlight Guru #353: How Artificial Intelligence is Impacting the MedTech IndustryIn 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 reshaping healthcare. The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends."Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli00:00 - Introduction to AI in...

2024-01-3045 min

Global Medical Device Podcast powered by Greenlight Guru #352: Fundamentals of Quality & RegulatoryIn 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 companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.Key Timestamps:[00:00:50] Introduction to Jennifer Mascioli-Tudor and her extensive background in the MedTech industry.[00:03:30] Jennifer's origin story in quality and regulatory roles.[00:07:15] The pivotal learning moments in quality management and regulatory affairs.[00:10:45] Strategies for influencing business...

2024-01-1850 min

Global Medical Device Podcast powered by Greenlight Guru #351: The State of AI & Clinical InvestigationsIn 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 the critical role of trustworthy systems in clinical research. The episode also touches upon the challenges and opportunities AI presents in MedTech, from data integrity to job displacement, and the human-centric approach to technology.Key Timestamps:[00:00:00] Introduction to the podcast and topic of AI in medical devices[00:03:25] Greenlight Guru's streamlined product development for MedTech[00:05:15] Dr. Maria...

2024-01-1139 min

Global Medical Device Podcast powered by Greenlight Guru #350: The Evolving Landscape of AI in MedTechIn 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 regulatory bodies, and explore the implications of AI in product development and quality assurance.Quotes"We're seeing pushes into adaptive algorithms... algorithms that modify themselves in the field without human oversight." - Eric Henry"The FDA and other regulators are no stranger to the issues in generative AI as well." - Eric Henry"Keep an eye...

2024-01-0449 min

Global Medical Device Podcast powered by Greenlight Guru #345: Using AI In MedTechIn 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 AI's potential. Wade Schroeder, Medical Device Guru for Greenlight Guru, shares his expertise on MedTechs AI-powered tools that are redefining risk management and compliance. With a keen focus on the AI in MedTech Trend report, this conversation is a must-listen for those ready to lead at the forefront of medical device innovation. Check out the...

2023-11-2224 min

Greenlight Sports Podcast Greenlight Sports Podcast - RECAPPING WEEK 4In this new episode of The Greenlight Sports Podcast, Host Landon Kahler recaps week 4. Enjoy!

2023-09-2642 min

Global Medical Device Podcast powered by Greenlight Guru #337: Moving MedTech Forward - The Past, Present & Future of Greenlight GuruDescription: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 Greenlight Guru and SMART-TRIAL, exploring its growth, trials, and moments that defined its course. The conversation is sprinkled with heartfelt personal anecdotes, emphasizing the brand's commitment to unwavering quality and the pivotal shifts during the COVID-19 pandemic.The trio delves into the intricate dance of nurturing a thriving work culture in the MedTech arena, especially...

2023-09-2142 min

Greenlight Sports Podcast Greenlight Sports Podcast 9/19Welcome to the new episode of The Greenlight Sports Podcast! In this episode, Landon is by himself today. He will be reviewing Week 3 and going over the AP Top 25. Enjoy!

2023-09-2033 min

Greenlight Sports Podcast Greenlight Sports Podcast 9/15In this installment of The Greenlight Sports Podcast, Host Landon Kahler and Co-host Dade Davis pre-view CFB Week 3, talk about the Heisman race, play a game of sit or start, and give our upset picks for the week. Enjoy!

2023-09-1650 min

Greenlight Sports Podcast Greenlight Sports Podcast 9/11In this edition of the Greenlight Sports podcast host Landon Kahler and co-host Dade Davis breakdown Week 2 of CFB, react to Week 2 AP TOP 25, and play a game of overreaction and underreaction. Sit back and enjoy!

2023-09-1240 min

Greenlight Sports Podcast Greenlight Sports Podcast 9/8The first episode of the Greenlight Sports Podcast! Sit back and enjoy as host Landon Kahler and co-host Dade Davis break down Week 1 of CFB, talk about the TOP-25, and preview CFB Week 2. We hope you enjoy it!

2023-09-091h 03

Global Medical Device Podcast powered by Greenlight Guru #335: Accelerating SaMD Development in a Compliant Agile wayDescription: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), and go-to-market challenges for innovative medical devices.Zach, CEO of HTD Health, is a self-taught software engineer turned serial entrepreneur. His first venture, Fresh Corner Cafe, served fresh food in Detroit's food deserts for eight years. He then founded HTD Health to craft digital health solutions, pioneering the shift to virtual care. The company supports...

2023-09-0855 min

The Greenlight Personal Training Business Podcast Episode 18 - Personal Training Studio Business Plan - Part 1 - Core OfferingsIn this episode hosts Jeff and Dan dive into part 1 of their series in building a business plan for a personal training studio. Part 1 covers How to Develop Your Core offerings including finding your niche, solving one key problem and how to be the expert in it, the length and term of your initial offerings and how to price them correctly to ensure the business becomes sustainable. _________________ More about the Greenlight Personal Training Fitness Business Podcast The Greenlight Personal Training Business Podcast, a podcast built for gym owners, personal trainers, and fitness enthusiasts o...

2023-08-2418 min

The Greenlight Personal Training Business Podcast Episode 17 - A Fitness Entrepreneurs Story - With Cody SweetIn todays episode we sit down with Cody Sweet. Cody is a digital marketing expert and consultant in the boutique fitness space. He has also founded and owned Sweet Fitness kickboxing in Chico California, a boutique kickboxing studio, with some of the best branding, client experience and profit margins that you will find in the industry and is about to open location #2. Most recently Cody has become a Greenlight Franchise with his business partner Austin Garber when they opened Greenlight Chico in May 2023. We chatted with Cody about how he got his start in the...

2023-08-1739 min

The Greenlight Personal Training Business Podcast Episode 16 - The Most Important Metric in Franchising - The Pay Back PeriodOn this episode hosts Jeff and Dan dive deep into one of the most important metrics used to evaluate a Franchise investment. The Pay Back period. The payback period is defined as The total time its takes to recoup the initial investment from cash flows generated by the business. Listen to get an understanding of why this metric is important, where fitness franchises typically average on a payback period, and how Greenlight focused on creating one of the shortest payback periods in the industry. Link to article mentioned _________________ More about the Greenlight Personal Trai...

2023-08-0418 min

The Greenlight Personal Training Business Podcast Episode 15 - How Greenlight Can Save You Over $100,000 in Your First Year!In this episode hosts Jeff and Dan chat about how Greenlight can save new studio owners over $100k just in their first year alone. They go into detail about cost savings in equipment purchases, marketing budgets, brand and system development, pricing errors, pre-sales and client retention. If you are a personal trainer or fitness coach and have decided to open your own gym, then this one's for you! We built Greenlight to help you be successful by saving you time and money. _________________ More about the Greenlight Personal Training Fitness Business Podcast

2023-07-2730 min

The Greenlight Personal Training Business Podcast Episode 14 - A Coaches Story - With Laken Summerville - Greenlight's First Franchise OwnerIn todays episode we speak to Laken Summerville (Greenlights first franchise owner). Laken along with her business partner Deonte joined the Greenlight movement in 2022 with the intent to re-define the fitness industry and help clients attain permanent transformations that develop from the inside out. Laken began coaching small group fitness in 2012, and then nutrition coaching and personal training in the years to follow. In 2020, like many others, she came to the realization that impacting others and seeking internal fulfillment were way more valuable to her than the security of a conventional job. So after 8 years of being p...

2023-07-1843 min

Global Medical Device Podcast powered by Greenlight Guru #327 Understanding the ROI of an eQMSIn 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 reductions in setup time, full-time employee requirements, time spent on development and documentation, training time, and audit preparation time.The recent ROI Calculator developed by Greenlight Guru to help customers customize the study's findings to their specific inputs and demonstrate the value of the software for their business.The current economic climate, with budget cuts and limited investments...

2023-07-1151 min

The Greenlight Personal Training Business Podcast Episode 13 - How to Actually Improve Sales - With The Sales Objection System DojoIn today’s episode with sit down with Joe Marcoux and Jeff Burlingame of the Sales Objection System Dojo, to discuss how to continue to build your skill set in sales, and why training your skill set is a lifelong pursuit. Picture this: a health and fitness professional who wants to help people. They have a great offer. They have a big heart and truly want to help people. But every time this health pro speaks with a prospect, they crumble when they hear an objection. Objections like: It’s to...

2023-07-1045 min

Global Medical Device Podcast powered by Greenlight Guru #325 The Role of dFMEAs in Risk Management for Medical DevicesHow 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 to understand.In today’s episode, Wade Schroeder, a medical device guru with a master's degree from the University of Dayton, shares his insights on risk management in medical device design. Wade discusses the importance of a top-down approach, the collaboration between dFMEA and ISO4971, and how Greenlight Guru software aligns with ISO14971. The conversation covers the va...

2023-06-3036 min

Global Medical Device Podcast powered by Greenlight Guru How AI Can Help You Manage RiskWith 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 happening in the industry. To that end, today’s guest, Tyler Foxworthy, will share his expertise on the subject. Tyler Foxworthy was the Chief Data Scientist at Resultant, then the Chief Scientist at Demand Jump. Before founding his own company, he applied statistics and machine learning to help the medical device industry make informed decisions about c...

2023-05-2733 min

Global Medical Device Podcast powered by Greenlight Guru The Tools that Make Clinical InvestigationsWhat makes a clinical investigation run smoothly? In today’s conversation, you’ll hear from Jon Bergsteinsson as we speak about electronic data capture for clinical investigations. Jon has a master’s degree in biomedical engineering and is the founder of SMART-TRIAL by Greenlight Guru, which helps MedTech companies close the gap between their devices and clinical data. He was the CTO of SMART-TRIAL from 2013 to 2017, and since then has been leading SMART-TRIAL’s clinical operations. His valuable insights come from 10 years of experience in the MedTech clinical space plus a s...

2023-05-1337 min

The Greenlight Personal Training Business Podcast Episode 12 - An Interview with Jen Broxterman from Prosper Nutrition and Nutrition RxIn this episode we interview Jen Broxterman. Jen is a Registered Dietitian & Sports Nutritionist. She’s the founder of PROSPER Nutrition Coaching, a world-class nutrition certification designed specifically for gym owners and coaches. She's also a Foods & Nutrition university prof, and writer for Precision Nutrition. She's worked with clients from NHL hockey players and Olympic athletes, to everyday folks looking to eat and feel better. In the episode we chat about Jen's story into entrepreneurship, the strategies she uses to attain new clients, and how personal trainers and gym owners can improve the nutrition guidance they provide to...

2023-05-0735 min

Global Medical Device Podcast powered by Greenlight Guru Complaint Handling with Medical Device Guru, Brittney McIverWhat would you think about dealing with complaints all day? Today’s guest has some ideas. Brittney McIver is a Medical Device Guru at Greenlight Guru where she helps guide companies through the various quality and regulatory requirements and challenges that are unique to MedTech companies and Medical Device Professionals - like QMS implementation. Brittney has a bachelor’s degree in Biological Science, a master’s degree in Bioengineering from Clemson University, and is an ISO 13485 Lead Auditor.Listen to the episode to learn about Brittney’s experience shadowing doctors and watching surgery, the part of her job that...

2023-05-0338 min

The Greenlight Personal Training Business Podcast Episode 11 - An Interview with Deonte Mason - Greenlights First Franchise OwnerIn this episode we interview Deonte Mason. Deonte is a 10 year coaching and personal training vet. He’s worked in big box gyms, and as independent personal trainer, but most recently he became the very first Greenlight Personal training franchise owner with his business partner Laken Summerville. Deonte is hyper focused on seeing clients make real change and overcome obstacles. In this episode we talk to Deonte about his journey in fitness world, the struggles he faced while working in a big box gym and as an independent PT, and where he believes the fitness industry is headin...

2023-05-0346 min

Global Medical Device Podcast powered by Greenlight Guru Meet a Guru: Brittani SmithWhat’s it like to become a Medical Device Guru? In today’s episode, you’ll meet one of our newer Gurus, Brittani Smith, and find out more about her role and journey working through UDI implementation, EU MDR preparation, and finding her place in a MedTech company.Brittani is a Medical Device Guru at Greenlight Guru. Our Medical Device Gurus are part of what we call the Guru Edge here at Greenlight Guru. As a Medical Device Guru, Brittney helps guide companies through the various Quality and regulatory requirements and challenges that are unique to MedTech compan...

2023-04-2129 min

Global Medical Device Podcast powered by Greenlight Guru Why Building Supplier Relationships Is So ImportantHow do human relationships impact supplier management in the medical device field? Today you’ll hear from Taylor Brown, a Medical Device Guru and Manager of Onboarding and Implementation for Greenlight Guru, and Maxime Rochon, the Director of Quality Assurance and Clinical Affairs for Puzzle Medical.In this episode you’ll hear about why building supplier relationships is so important and some of the best practices for those relationships. Listen to the episode to hear how Taylor and Maxime are thinking about whether and how human relationships make things easier, tips for new companies establishing beginning relationships, and...

2023-04-1335 min

Global Medical Device Podcast powered by Greenlight Guru Building Your Design Controls (and Pitfalls to Avoid)What do engineers need to understand about manufacturing? How can you apply that knowledge to design controls? On today’s episode, our guest Tom Rish covers the topic of Design Controls. Tom is the Director of Guru Services at Greenlight Guru and a Product Development Engineer in Orthopedics.Listen as we talk about the differences between user needs and design inputs and the pitfalls companies get into when building design controls. Tom also shares what he thinks people should understand about cross-functionality, why it sometimes makes sense to start from scratch, and using the design control process st...

2023-03-2935 min

Global Medical Device Podcast powered by Greenlight Guru V&V Activities from a Verification Engineer POV - How Hard Could It Be?What’s the difference between design verification and validation, and why are these activities so important?Today’s guest is Niki Price. Niki is a Medical Device Guru with 15 years of experience in medical devices who worked in production, quality, product development, and project manager. Today she discusses questions like what is being tested by design verification and what is being tested by design validation.Listen to the episode to hear Niki discuss what’s involved in being a verification engineer, tests used for verification, and the biggest challenges she experiences in her role. Some...

2023-03-1632 min

Global Medical Device Podcast powered by Greenlight Guru Understanding the 'Compliance Manager' RoleWhat are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest.In today’s episode, we spoke with Maryann Mitchell on the topic of Compliance Management. Maryann Mitchell is a Solutions Engineer at Greenlight Guru and is part of what we call our Guru Edge. She has more than 15 years of experience in Medical Devices and has worked in a variety of quality and regulatory roles.Listen to the episode to learn what Maryann has to share about the cultural barrie...

2023-03-0921 min

The Greenlight Personal Training Business Podcast Episode 10 - New Client Sales - Solving for the Internal and External StruggleIn this episode, hosts Dan and Jeff sit with Dave Bess. Dave is one of the co-founders of Greenlight Personal Training. He has been in the fitness industry for 15 years, starting out as a personal trainer in the big box world. Dave Bess is also co-owner of PT Legends. He has a passion for teaching gym owners and fitness professionals how to sell high ticket transformations. Dave loves to workout on his tonal and spend time with his amazing wife and young son. Dave's passion for fitness and life have earned him the nickname, the Kool-Aid Man. Our...

2023-03-0136 min

Global Medical Device Podcast powered by Greenlight Guru Implementing an eQMS after Switching from PaperWhat’s involved in switching from a paper-based QMS to an eQMS? What kinds of difficulties do companies experience when making that change? Today’s guest will explain her experiences with making that switch.In today’s episode, you’ll hear a conversation with Kendyl Williams on the topic of Implementing an eQMS. Kendyl is a Medical Device Guru at Greenlight Guru. When it comes to implementing an eQMS - Kendyl has experienced the sales process and has also implemented it for her company, and now she works with companies to help them implement the new software as well...

2023-02-0231 min

Global Medical Device Podcast powered by Greenlight Guru Essentials of Sterilization for Med Device ProfessionalsWhat tools do sterilization engineers need the most? What’s the difference between sterilization modalities? Those are some of the points that our guest will be talking about in today’s conversation.Laura Maher previously appeared on the podcast to talk about UDI, and now she’s here to talk more about sterilization. Laura is a Medical Device Guru at Greenlight Guru and is a self-proclaimed sterilization enthusiast. Listen to the episode to learn what Laura has to say about Gamma vs. EO, new modalities recognized by the FDA, and the sterility pitfalls Laura has experienced or heard...

2023-01-2637 min

The Greenlight Personal Training Business Podcast Episode 9 - The 3 Keys to New Client OnboardingIn this episode, hosts Dan and Jeff sit down to discuss the 3 keys to a powerful new client onboarding process. When selling PT programs or transformations, clients will expect a high quality service based on the high price that they pay. After reviewing the 3 Keys, Jeff and Dan will take you through the entire 10 point checklist that used at Greenlight for our new client onboarding. ________ The Greenlight Personal Training Business Podcast, a podcast built for gym owners, personal trainers, and fitness enthusiasts on how to open operate and scale a brick and mortar gym or s...

2023-01-2426 min

Global Medical Device Podcast powered by Greenlight Guru UDI: 101What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode, you’ll hear from two guests with UDI experience. You’ll learn a lot about UDI and learn where to find some fantastic resources that can increase your knowledge.Laura Maher and Brittani Smith are both Medical Device Gurus and Greenlight Gurus. Their jobs involve guiding companies through regulations and quality requirements and challenges unique to MedTech companies and medical device professionals, and UDI is among those ch...

2023-01-2133 min

The Greenlight Bookstore Podcast S3, Ep. 8: The Greenlight Poetry Salon: Renia White & Aracelis Girmay (January 12, 2022)Created and hosted by poet and former Greenlight bookseller Angel Nafis, Greenlight’s Poetry Salon welcomes locally and nationally celebrated poets for a powerful and moving evening of poetry and performance. For our triumphant return to in-person Salons, we welcomed Renia White and her collection Casual Conversation, alongside esteemed poet Aracelis Girmay (The Black Maria), who selected it for BOA Editions's Blessing the Boats Selections. White’s debut poetry collection strikes up a conversation, considering what’s being said, what isn’t, and where it all comes from, probing the norms and mores of everyday interactions. Listen back to a revere...

2023-01-1257 min

Global Medical Device Podcast powered by Greenlight Guru Auditing the AuditorFor some people, audits are terrifying. But today’s guest says you need to learn to love the audit process, and she shares information that can help you do that.Sara Adams is a Medical Device Guru at Greenlight Guru. Medical Device Gurus are part of Greenlight Guru’s “Guru Edge.” Medical Device Guru’s help customers onboard to their new software and guide them through the various regulatory requirements and challenges unique to MedTech companies and Medical Device Professionals.Listen to the episode to hear Sara share some of her wisdom about audits. She talks abou...

2023-01-0741 min

Global Medical Device Podcast powered by Greenlight Guru What is MedTech Lifecycle Excellence?Why is the state of MedTech culture and tools the way it is? How should the industry be thinking about moving away from generic compliance and toward MedTech Lifecycle Excellence?Jon Bergsteinsson, co-founder of SMART-TRIAL by Greenlight Guru, is a MedTech professional and clinical affairs expert. Jon is also involved in educating and helping the MedTech industry get safe and effective devices to market faster and more efficiently.Listen to the episode to learn more about how MedTech is different from pharmaceuticals and other similar fields in the industry, why it’s important to look at...

2023-01-0645 min

Global Medical Device Podcast powered by Greenlight Guru The Best of Jon & Mike Through the YearsToday’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31st.In honor of many podcast episodes featuring Jon and Mike Drues, this episode is a tribute to some of the best episode topics that the two of them have tackled. They review some of their favorite episodes and throughlines of their discussions throughout the time they’ve been podcasting together. Listen to Jon and Mike discuss how they met, which episodes stuck out for them, an...

2022-12-2950 min

The Greenlight Personal Training Business Podcast Episode 8 - Are You Ready To Own A Gym?In this episode, hosts Jeff and Dan sit down to discuss their list of "8 Readiness Factors" to help aspiring gym owners understand whether they are personally and professionally ready to take the plunge into entrepreneurship. The 8 factors are: 1.Understanding your perfect day 2.Motivation over passion 3.Ability to take action 4.Patience for financial success 5.Sales acumen 6.Risk Tolerance 7.Financial resources 8.Willingness to ask for help If you're a personal trainer or someone who has a desire to be a gym owner this epi...

2022-12-1426 min

Global Medical Device Podcast powered by Greenlight Guru What "Exempt" Means with Respect to Medical Devices & RegulatoryHow should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed?This is the focus of today’s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.Listen to the episode to learn how Mike is thinking about the meaning of 510(k) exem...

2022-11-3052 min

Global Medical Device Podcast powered by Greenlight Guru Developing a Regulatory StrategyWhat is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru.Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn how Mike thinks about competitive regulatory strategy, delays in complying with regulation, and reimbursement and regulatory strategy.Some of the highlights of t...

2022-11-2343 min

Global Medical Device Podcast powered by Greenlight Guru We Achieved ISO Certification! Now What?What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode.Mark Alpert is the Director of Quality at Greenlight Guru and has a background working for a Notified Body, and was most recently the Vice President of Business Assurance Division for TUV SUD America.Listen to the episode to hear what Mark has to say about how he uses a quality system as a competitive advantage, what companies should be doing after they achieve certification, and how...

2022-11-1743 min

Global Medical Device Podcast powered by Greenlight Guru The Importance of Cervical Cancer Screening in the U.S.The importance of cervical cancer screening in the U.S.Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening? Today’s episode features Chris Beddard, VP of US Marketing at BD. She joins the podcast today to discuss a product she and her team have been working on to improve the lives of women. Chris is passionate about bringing awareness about health options to women around the world. Listen to the episode to hear what Chris has to say about why the test she’s been...

2022-11-0419 min

Global Medical Device Podcast powered by Greenlight Guru Customer Discovery for Medical Device CompaniesWhat is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device companies.Kari Haab has been working in the medical device world for over 10 years. She’s a part-time mentor in residence at Western Michigan University and a Partner with Cantilever Business Partners, and an independent consultant for start-up organizations. Prior to this role, she was Vice President of Product Strategy, at Aquaro Histology. Kari has implemented quality management systems and led the launch of products through development, clinic...

2022-11-0238 min

Global Medical Device Podcast powered by Greenlight Guru Common QMS Mistakes SaMD Companies MakeWhat pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? Today’s guest, Karandeep Singh Badwal, is a Regulatory Affairs Quality Consultant who is well-versed in EU MDR, and regularly works with medical companies producing Class I, II, and III medical devices.Listen as we talk about what a quality management system is and what the goal of a QMS is, the importance of validating software, and the differences between AI and machine learning, among other things. Some of the highlights of t...

2022-10-2145 min

The Greenlight Personal Training Business Podcast Episode 7 - A Personal Trainers Path - With Scott CarpenterIn this episode, hosts Dan and Jeff sit with Scott Carpenter. Scott is one of the co-founders of Greenlight Personal Training. He has been in the fitness industry for 15 years, starting out as a personal trainer at Lifetime fitness. Scott has since opened 6 personal training studios in the Scottsdale region, and currently spend his time as the co-founder of PT Legends, a gym metering service that will help you establish bolt-on High-Ticket Transformational offers to your gyms programs. Scott has recently published a book about everything he teaches in PT Legends, it's available on Amazon. Our conversation with...

2022-08-2634 min

The Greenlight Personal Training Business Podcast Episode 6 - A Greenlight Studio As Your Next LocationIn this episode, hosts Dan and Jeff sit down to discuss the opportunity that a Greenlight Studio provides to gym owners seeking to open a second location. They break down how the systems, operations, fulfillment, marketing, sales and support from HQ create were created to solve the major pinpoints and problems that gym owners have. If you're a current gym owner, you don't want to miss this episode. The Greenlight Personal Training Business Podcast, a podcast built for gym owners, personal trainers, and fitness enthusiasts on how to open operate and scale a brick and mortar gym or...

2022-08-0314 min

Global Medical Device Podcast powered by Greenlight Guru Preventing the Death of Medical Device SalesThe medical device sales industry is slow to change. It’s behind on how hospitals and physicians adopt and adapt to buying, sales strategies are out of date, and increased costs are leading to diminished returns. What are specific tactics that MedTech companies can take to develop their sales process?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Omar Khateeb about preventing the death of medical sales with new data that shows where you can find prospective buyers for your medical device products.Omar is the founder of Khateeb and Co...

2022-07-1448 min

The Greenlight Personal Training Business Podcast Episode 5 - Key Performance Indicators (KPI's)In this episode, hosts Dan and Jeff sit down to discuss the good the bad and the ugly of key performance indicators for gym owners. You'll get an understanding of why the number of members a gym has is a poor indication of business success, how total revenue is just the starting point for great performance, and why profit is king when it comes to valuing a brick and mortar gym. The Greenlight Personal Training Business Podcast, a podcast built for gym owners, personal trainers, and fitness enthusiasts on how to open operate and scale a brick a...

2022-06-2112 min

The Greenlight Personal Training Business Podcast Episode 4 - When to Open a Second LocationIn this episode hosts, Jeff and Dan sit down to discuss when is the best time for gym owners to open a second location. They break down, a checklist of "must haves", common mistakes, and the biggest obstacles that come with trying to scale a brick and mortar gym to multiple locations. If you're ready to open second location ask yourself: -How complex is your business to operate? -Can you teach your systems or do they rely on you as the owner? -Is every role in your business defined to the la...

2022-06-0916 min

The Greenlight Personal Training Business Podcast Episode 3 - How To Hire TrainersIn this episode hosts, Jeff and Dan sit down to discuss the best process to hire trainers as a gym or studio owner. They will provide a deep dive into the tools used to find the best trainers, how to narrow down your prospects to the best candidates, and what are the "can't miss" steps to ensure you choose the right candidate. The Greenlight Personal Training Business Podcast, a podcast built for gym owners, personal trainers, and fitness enthusiasts on how to open operate and scale a brick and mortar gym or studio. Your hosts, J...

2022-06-0226 min

Global Medical Device Podcast powered by Greenlight Guru Approaching Cybersecurity & Usability as a SaMD CompanyHow do you balance security and usability of software as a medical device (SaMD)? It’s not easy and trade-offs may need to be made by device companies in order to give users what they want and need to safely use it as intended.In this episode of the Global Medical Device Podcast Etienne Nichols talks to Abbas Dhilawala, a cybersecurity and SaMD expert with Galen Data, about a new approach to cybersecurity and usability for SaMD companies to ensure products are both secure and user-friendly.Abbas has 18 years of experience developing enterprise-grade software for th...

2022-05-2836 min

The Greenlight Personal Training Business Podcast Episode 2 - Discussing the Greenlight Motto: Less Clients, More ImpactLess Clients, More Impact. The Greenlight motto, that is something a bit unusual in the gym industry. Most gyms require hundreds, if not thousands of clients to reach profitability. This creates a strain on staff and systems, and requires large marketing spends, and overhead costs to be successful. Greenlight gyms focus on a high client value in small spaces, and with low overhead. In this episode, hosts Dan and Jeff break down the motto, and dig into how it's accomplished and who impact is created. The Greenlight Personal Training Business Podcast, a pod...

2022-05-1917 min

The Greenlight Personal Training Business Podcast Episode 1 - State of the IndustryHosts Jeff and Dan sit down to introduce you to the Greenlight Personal Training Business Podcast and discuss the state of the fitness and gym industry coming out of the pandemic. They discuss how the industry has shifted, the mindsets of consumers and where the biggest opportunity is for gyms and fitness entrepreneurs. The Greenlight Personal Training Business Podcast, a podcast built for gym owners, personal trainers, and fitness enthusiasts on how to open operate and scale a brick and mortar gym or studio. Your hosts, Jeff Larsh and Dan...

2022-05-1920 min

Global Medical Device Podcast powered by Greenlight Guru How Medical Device Intellectual Property Protection Varies by SectorWhen developing a product in the medical device space, how does intellectual property (IP) protection work in the private sector versus at an academic institution, like a university? When is a patent needed and when is it not?In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Neil Thompson, Kevin Buckley, and Stephanie Willerth about intellectual property and why it's important to understand the difference between inventorship and ownership.Some of the highlights of this episode include:At a university, Stephanie describes the process that professors and...

2022-03-1036 min

Global Medical Device Podcast powered by Greenlight Guru Shaking Things Up: What's Next for the Global Medical Device PodcastGlobal Medical Device Podcast host and founder of Greenlight Guru, Jon Speer, always says he has the best job in the world. He gets to talk to amazing medical device professionals and hear about amazing products and technology improving the quality of life. Now, there’s an opportunity to take the most listened to podcast in the medical device industry in a new direction by introducing a second voice to the show to share a variety of contexts and perspectives around the why behind what we do that matters.In this episode Jon is joined by Etienne Ni...

2021-12-1634 min

Global Medical Device Podcast powered by Greenlight Guru How Augmented Reality (AR) is Revolutionizing HealthcareTechnology can accelerate the transformation of healthcare to improve health, quality of life, safety, and security. Augmented reality (AR) is finding its way into the healthcare ecosystem and there’s greater potential for it to be revolutionary, not just evolutionary.In this episode of the Global Medical Device Podcast Jon Speer talks to Jennifer Esposito, Vice President and Managing Director of Magic Leap's Health business unit, about AR in healthcare, explaining what it is and is not, as well as how it compares and contrasts to virtual reality (VR), machine learning (ML), and artificial intelligence (AI).

2021-12-0925 min

Global Medical Device Podcast powered by Greenlight Guru Why Usability MattersUsability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Michaela Kauer-Franz, CEO of Custom Medical, which offers usability engineering and testing for medical devices.Listen as the two medical device industry veterans discuss the topic of usability and how companies should be designing medical devices with usability in mind so they are easy to use, safe, and supportive for the end user.Some...

2021-11-2425 min

Global Medical Device Podcast powered by Greenlight Guru Past, Present, Future State (and World) of Quality in the Medical Device IndustryQuality 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 quality, about the past, present, and future global landscape of medical device quality.Some of the highlights of this episode include:Mark and Jon agree that the medical device industry is at a crossroads currently because Europe is...

2021-09-2327 min

Global Medical Device Podcast powered by Greenlight Guru Meet a Guru: Maryann MitchellWhat 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 Greenlight Guru team.Listen as Maryann shares fascinating details about her day-to-day working with device companies who are evaluating the Greenlight Guru Medical Device Success Platform (MDSP) to better understand their product and business needs and how Greenlight Guru's...

2021-09-0215 min

Global Medical Device Podcast powered by Greenlight Guru eQMS in Academia: Practical Learning for Biomedical Engineering StudentsHave you ever thought about the versatility of an eQMS? As it turns out, the use of one medical device eQMS solution in particular is extending across multiple sectors.In this episode of the Global Medical Device Podcast, Jon Speer talks to Renee Rogge and Devin Hubbard, two academic professors/faculty members of biomedical engineering programs which are involved with the Greenlight Guru Academic Partner Program. Jon, Renee, and Devin discuss their work together in the program and Renee and Devin share their experiences using the eQMS from Greenlight Guru in the classroom and how...

2021-07-2936 min

Global Medical Device Podcast powered by Greenlight Guru Tips for Running Better Management ReviewsHow efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from these critical checkpoints while still satisfying compliance needs.In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, senior medical device guru at Greenlight Guru. Together, Taylor and Jon discuss the nuances of management reviews to help medical device managers and executives make better decisions for teams to achieve greater outcomes.Some of the highlights of this episode include:Learn...

2021-07-2024 min

Global Medical Device Podcast powered by Greenlight Guru Meet a Guru: Ryan BehringerGuru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device companies. These Gurus form an elite team of medical device experts who serve Greenlight Guru customers in a variety of ways to ensure success throughout their product journey.In this episode of the Global Medical Device Podcast, Jon Speer talks to Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru.Listen to this episode to learn about Ryan's professional journey which brought him to Greenlight Guru and how he's helping companies with design of experiments, design controls...

2021-07-1427 min

Global Medical Device Podcast powered by Greenlight Guru Managing Clinical Data ActivitiesMany medical device companies experience challenges with managing clinical trials even in the most ideal settings, so what happens when big changes occur, like COVID-19 and new regulations, that compound those challenges? If only there was a solution...In this episode of the Global Medical Device Podcast, Jon Speer talks to Pall Johannesson, CEO and co-founder of Smart-Trial – a digital platform that helps medical device companies manage many, if not all, clinical data activities.Listen to Pall’s story about his solution for managing clinical trials, which has many similarities to that of Greenlight Guru, as h...

2021-07-0824 min

Global Medical Device Podcast powered by Greenlight Guru Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay AheadIf 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 Manager, and Jesseca Lyons, Operations and Enablement Guru, to join the show and explain to listeners what Greenlight Guru Academy is and how the eLearning platform is helping users around the world advance their medical device careers.Some highlights of this episode include:

2021-06-0331 min

Global Medical Device Podcast powered by Greenlight Guru Understanding the Value of a Medical Device GuruHave 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 Greenlight Guru.Tom shares his unique insights into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers beyond the software itself, and how the "...

2021-05-2732 min

GreenLight Other Choice ENG - Ep. 5 - Grow Yourself - with Mario Grabner - raw uncut audioFrom time to time, we experience hard times, unforeseen events, unexpected outcomes. There're external influences and then there's our response to these and to the circumstances. On this episode of GreenLight Other Choice, i talk with Mario Grabner about how to grow ourselves, protecting from external influences, and more. Mario has been learning with more than 25 trainers, including 2 co-founders of Neurolinguistic Programming. To help people dealing effectively with difficult challenges, Mario has been sharing techniques that protect us from external events. Have a question or feedback? Reach out...

2021-05-2349 min

GreenLight Other Choice PT - Ep. 4 - Criando Impacto - com Helena Antónia Silva - áudio sem ediçãoNeste episódio da GreenLight Other Choice, estive à conversa com a Helena Antónia Silva, da Vintage For a Cause! 😀 O tema de partida é criar impacto ao fazer upcycling. O que é isso? Ouve esta conversa e descobre! 😉 Falámos de sustentabilidade, de pegada ecológica, e muito mais. Partilhando outras escolhas e ações que causam impacto. 🌱 Tem uma pergunta ou feedback? Entre em contato com @greenlight.joao.pombeiro ou através de qualquer contato que encontrar neste podcast. Gostou do conteúdo? Quer apoiar? Faça um donativo e...

2021-05-231h 08

GreenLight Other Choice ENG - Ep. 3 - Empower Your Voice - with Inês Moura - raw uncut audioI'm honored and grateful to welcome my dear friend Inês Moura on this episode of GreenLight Other Choice! Inês is a notorious and excellent vocal coach for leaders. She's based in Brussels and has been helping leaders to find and develop their unique voice to create more impact! Want to discover more about your unique voice? Listen to this talk. :) Note: Briefly distracted, i started talking in portuguese in the beginning of this episode :D But after a couple of minutes we switch to english and th...

2021-05-231h 03

Global Medical Device Podcast powered by Greenlight Guru Meet a Guru: Laura CourtWhat 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 Guru, and Laura shares tips for success she's learned along the way.Some of the highlights of this episode include:Laura gained hands-on manufacturing experience because she believes medical device professionals can’t design a product well if...

2021-05-1928 min

The Greenlight Bookstore Podcast SPECIAL EPISODE: Greenlight All-Star Revue + Virtual Reopening (December 24, 2020)Greenlight celebrates the re-opening of its stores with a star-studded evening with many of our favorite authors, MC’ed by poet Saeed Jones! Listen to Jia Tolentino read a nonfiction piece about her unborn child; Nathan Englander read from the beginning of his novel kaddish.com; Min Jin Lee read from an essay about public speaking from the New York Times; Jonathan Lethem surprise us by reading his poetry; Nicole Dennis-Benn read from her novel Patsy; Colson Whitehead read from his not-yet-published next novel Harlem Shuffle; Lev Grossman read from his forthcoming children's novel The Silver Arrow; Ann Patchett rea...

2020-12-241h 23

Global Medical Device Podcast powered by Greenlight Guru Meet a Guru: Erica LoringWhat makes Greenlight Guru unique? It’s Guru edge⁠—a team of medical device professionals with decades of industry experience whose primary role within the company is to enable customer success. In this episode of the Global Medical Device Podcast, Jon Speer talks to Erica Loring, a medical device guru at Greenlight Guru. Erica shares her unique career journey working in the healthcare sector, which ultimately led her to enter the medical device and in-vitro diagnostic device space where she now provides world-class quality and regulatory support to device companies. Prior to joining Greenlight Guru, Erica worked in both the pharma...

2020-10-2838 min

Global Medical Device Podcast powered by Greenlight Guru Meet a GURU: Jesseca LyonsWhat makes Greenlight Guru unique? It’s Guru edge, composed of a team of medical device experts with over seventy years of combined industry experience. In this episode of the Global Medical Device Podcast, Jon Speer talks to Jesseca Lyons, a senior medical device guru at Greenlight Guru, a self-proclaimed design control junkie with a mechanical engineer background. Listen as Jesseca shares her insights on the importance of design controls and how a deep understanding of the different pieces and parts can lead to improved outcomes for both the device and patients who use it. Some highlights of this episode in...

2020-07-1537 min

Global Medical Device Podcast powered by Greenlight Guru Meet a Guru: Taylor BrownWhat makes Greenlight Guru unique? The Guru Edge⁠—a team of medical device professionals with over eight decades of combined industry experience. Greenlight Guru’s mission is to improve quality of life, and those of customers, through True Quality products managed through its medical device quality management system (MDQMS) software. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, a medical device guru for Greenlight Guru’s Customer Success team with 7+ years of industry experience. Taylor shares her valuable insights and learnings from auditing quality management systems as a certified Lead Auditor for ISO 13485. Some hig...

2020-07-0143 min

Global Medical Device Podcast powered by Greenlight Guru Tips to Help You Prepare for an FDA InspectionOn today’s episode, we’re introducing the newest addition to the greenlight.guru team, Jessica Lyons. Jessica is a 2007 graduate of Rose-Hulman Institute of Technology and has worked in the medical device product development for nearly 10 years. She worked in custom integration at Beckman Coulter, then worked on getting medical devices transferred to manufacturing at CRI, a medical device contract manufacture. Jon and Jessica are discussing FDA inspections. “It doesn’t matter your size, shape or how long you’ve been around. You’ll go through an FDA inspection.” – Jon Speer No one looks forward to having the FDA come to inspect...

2019-11-0729 min