Global Medical Device Podcast powered by Greenlight Guru

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 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 leaders and the importance of storytelling in quality and regulatory roles.[00:16:30] The significance of human factors in product design and learning from end-user feedback.[00:21:50] Project management skills for quality and regulatory professionals.[00:25:20] The concept of 'design freeze' in the MedTech space and its impact on product development.[00:29:55] Jennifer's insights on agility and adaptability in building a quality management system.Quotes:"A really good quality and regulatory professional needs to have really good project management skills." - Jennifer Mascioli-Tudor"It's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device." - Jennifer Mascioli-TudorMedTech Trends:An emphasis on proactive quality management to ensure patient safety and product efficacy.The rising importance of human factors and user-centered design in medical device development.The shift towards integrating software and digital solutions in medical devices.Practical Tips:Quality and regulatory professionals should hone their project management skills.Communication and storytelling are key in influencing business decisions and leadership.Always present solutions and alternatives when addressing compliance challenges.References:JMT Compliance ConsultingJennifer Mascioli-Tudor on LinkedInEtienne Nichols on LinkedInGreenlight Guru’s platform for Quality Management & Clinical InvestigationsQuestions for the Audience:Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?"Feedback:Love the episode? Have suggestions or topics you’d like to hear about? Email us at [email protected] and leave a review on iTunes!Sponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

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 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 Nyakern's background and entrance into AI[00:07:30] Discussion on the European AI Act and its significance[00:13:45] Comparison of US and European approaches to AI regulation[00:18:55] The intersection of MedTech experience and AI governance[00:23:10] The importance of data quality and integrity in AI-driven clinical research[00:29:00] The human aspect in AI development and clinical trials[00:35:10] Ethical considerations and the future of AI in MedTechQuotes:"AI systems...will be more cost-effective and less of a hurdle for companies to generate data sets for subsets of patients." - Maria Nyakern"Trustworthy AI systems must be worthy of humans." - Maria Nyakern"Embrace innovation with Greenlight Guru." - Etienne NicholsTakeaways:Latest MedTech Trends:Increased integration of AI in clinical research.The rise of wearable health monitors.Advancements in surgical robotics technology.Practical Tips:Stay updated on AI regulations.Invest in trustworthy AI systems.Leverage AI for cost-effective data generation.Future Predictions:AI will play a larger role in personalized medicine.There will be a push for global AI data sharing.Expect AI to drive faster, more accurate diagnostics.References:European AI ActMaria Nyakern on LinkedInEtienne Nichols on LinkedInQuestions for the Audience:Which AI-driven MedTech advancement excites you the most, and why?How do you envision healthcare changing in the next decade with the rise of MedTech innovations?"We value your thoughts - if you enjoyed this episode, would like to give feedback, or have suggestions for future episodes, please email us at [email protected]:Greenlight GuruToday's episode is brought to you by Greenlight Guru, the only MedTech-exclusive Quality Management Software designed with the direct input of industry insiders. Dealing with cumbersome product development cycles? Facing the maze of regulatory compliance? Greenlight Guru is your guiding light. Our comprehensive software suite not only streamlines your processes but also helps prepare for the complexities of FDA and ISO compliance with ease. Built-in quality management ensures your focus stays on innovation and speed to market, while our real-time dashboards provide clear visibility into every stage of the product lifecycle. It's time to accelerate your path to market, minimize risk, and release products with confidence. And for our Global Medical Device Podcast listeners, Greenlight Guru is offering an exclusive, guided walkthrough of their groundbreaking platform. Transform the way you bring devices to market and stay ahead of the MedTech curve. Visit greenlight.guru today and mention this podcast for your special offer. Embrace progress, with Greenlight Guru

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 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 on the FTC... they have a tool called algorithmic disgorgement, which can have significant implications for AI in life sciences." - Eric HenryTakeawaysFTC's Growing Role: The FTC may soon have broader enforcement authority over AI across various industries in the U.S.Algorithmic Disgorgement: A tool that allows the FTC to force companies to delete an algorithm and all its associated training data.Evolving Regulatory Landscape: The FDA is adapting its regulatory framework to accommodate AI, focusing on adaptive and generative AI.Challenges with Locked Algorithms: Current regulatory frameworks primarily support locked algorithms, but there's a movement towards adaptive algorithms.Impact of AI on Quality Systems: AI is set to revolutionize quality management systems and manufacturing processes in the life sciences.Importance of Pre-Market and Post-Market Oversight: Both are crucial for ensuring the safety and efficacy of AI-driven medical devices.The Role of CSA in AI Integration: The transition from CSV to CSA could influence how AI is integrated into software systems.Harmonization of Standards: A significant challenge in AI regulation is the harmonization of numerous standards being developed globally.Public-Private Partnerships: Collaborations like the AI Global Health Initiative are vital for advancing regulatory frameworks in AI.The Need for Industry Engagement: Active involvement in AI-focused organizations can help businesses navigate the evolving regulatory landscape.ReferencesVisit www.greenlight.guru for insights on streamlining product development in Medtech.Follow Eric Henry on LinkedIn for updates on AI, quality systems, and regulatory compliance.Explore the AI Global Health Initiative under AFDO and RAPS sponsorship.For questions or consultations, contact Eric Henry at [email protected] Greenlight Guru to learn more how to prepare your QMS for the future of MedTech.Listeners are encouraged to leave a review on iTunes and reach out to Etienne Nichols on LinkedIn for feedback.

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 or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, leveraging personal strengths, and the importance of networking and personal branding.Quotes"If you're not talking about the value that you add, how is anybody going to know what impact you're having?" - Elena Kyria"Everything's uncertain really, isn't it? What you've got to have is a clear sense of forwards and just have a goal." - Elena Kyria"Nobody goes to the gym and looks at the weights and gets fit. You have to do the reps." - Elena KyriaTakeawaysNetworking is Key: It's not just what you know, but who knows you and what they know you're doing.Visibility of Achievements: Share your successes within your company; if you don't, others may not recognize your contributions.Defining Success: Success doesn't always mean reaching the VP level; it's about personal satisfaction and contribution.Strengths and Weaknesses: Focus on your strengths but be aware of your weaknesses and compensate with your team.Career Paths: Understand the different career paths (leadership, expert, generalist) and what they entail for growth.Communication Skills: Strong communication skills are paramount for leadership and for translating technical details to a broader audience.Continuous Learning: Always seek new knowledge and experiences, no matter where you are in your career.Adaptability: Be prepared to pivot and adapt to changes within the industry and your career.Take Action: Don't just reflect on advice; apply it to make actual changes in your career approach.Reference Links:Elena Kyria's LinkedInElemedWorking GeniusGreenlight GuruEtienne Nichols' LinkedInRemember to engage with the hosts and guests on LinkedIn for feedback and further discussions. Don’t forget to leave a review on iTunes!*Interested in sponsoring an episode? Use this form and let us know!

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 challenges and considerations faced by medical device manufacturers in the IVD pathway. Whether you're an industry veteran or new to the field of medical diagnostics, this conversation will enlighten you about the nuances of IVD regulatory compliance, risk assessment, and FDA interactions.Episode Highlights:IVDs are a Specialized Medical Device: Learn how IVDs, which include reagents, instruments, or systems for diagnosis, differ from other medical devices and what specific regulatory pathways they follow.Risk Levels in IVDs: Understand the significance of classifying IVDs into class one, two, or three based on the risk of false or inaccurate results, and how this impacts regulatory strategy.Pitfalls in Performance Characteristic Evaluation: Discover the complexities involved in evaluating the performance of multiband diagnostics and why traditional measures like sensitivity and specificity may not suffice.Likelihood Ratios Over Sensitivity and Specificity: Grasp why likelihood ratios are a more appropriate statistical measure for multiband diagnostics and how they relate to pretest and posttest probabilities.Clinical Relevance is Key: Recognize the importance of ensuring that the markers detected by IVDs are clinically meaningful and relevant to the condition being diagnosed.FDA's Expectations for IVDs: Gain insights into the specific data and performance characteristics the FDA looks for in IVDs and the necessity of clinical data in regulatory submissions.Quote:"With IVDs, you're looking at it from the perspective of what's the risk of a false result or an inaccurate result. So you're looking at who's interpreting the results and the type of condition." ~Carmen BrownReference Links:Carmen BrownProxima Clinical ResearchGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 needs beyond surface-level assumptions and learn how Fearsome's approach to product development is setting new standards in MedTech. From Glasgow's design desks to global market impacts, this episode is a deep dive into making MedTech better by truly connecting with the end-user experience.Noteworthy Points:The Pitfalls of Premature Solutions: Morven emphasizes the need for extensive user understanding before jumping to design conclusions, challenging the common industry haste to offer solutions.The Evolution of Fearsome: Morven shares the growth story of Fearsome from a broad design firm to a specialized MedTech developer, emphasizing the value of a diverse industry background.The Nuances of Usability: The conversation reveals the stark differences between consumer product design and medical devices, particularly the rigorous safety and risk management requirements in MedTech.Defining the User: A deep dive into identifying the 'user' in medical device design, considering all stakeholders, from clinicians to patients and even those involved in device maintenance.Real-world Feedback and Its Impact: Morven recounts a powerful anecdote where candid feedback from clinicians significantly redirected a product's development path.The Risk and Reward of Human Factors: An exploration of how human factors, beyond safety, can become a competitive edge and a catalyst for enjoyable product experiences.Regulatory Hurdles and Human-Centered Design: A critical look at the intersection of regulatory standards and human-centered design, advocating for earlier and more integrated human factors consideration.Quote:"Quality management is about quality, it's not just about proving that you can sell in the market because you've got a certain certification." - Morven Shearlaw Reference Links:Morven ShearlawFearsomeGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 device regulatory submissions.To discuss this topic, we brought in the following experts:Patrick Axtell, Ph.D., the Senior Tools & Templates Engineer for the Office of Regulatory Products at CDRHLisa Pritchard, Vice President of Regulatory, Quality, Clinical and Engineering at DuVal & AssociatesKathy Herzog, Senior Regulatory, Quality & Compliance Consultant at DuVal & AssociatesAs of now, all 510K submissions must use the eSTAR program. eSTAR is designed to streamline the FDA submission process, making it more efficient and standardized. This episode is a must-listen for anyone in the medical device industry looking to navigate the complexities of FDA submissions with a focus on the evolving eSTAR program.Expert Insights:Patrick Axtell: Discusses the development of the eSTAR program, its purpose, and benefits, including standardization and automation in the submission process.Lisa Pritchard: Shares her 30-year experience in regulatory space and her initial skepticism about eSTAR, which later transformed into advocacy for the program.Kathy Herzog: Provides practical advice on using eSTAR, emphasizing the importance of understanding and navigating the program effectively.Key Strategies:Use the help features within eSTAR as a quality control check.Start at the beginning of the template to avoid missing critical sections.Prepare your submission content outside eSTAR before populating the template.Consider the executive summary as a mandatory, not optional, part of your submission for effective advocacy.Future of eSTAR: eSTAR is evolving to include more types of submissions (e.g., PMAs, presubs) and may soon incorporate AI and other technological advances for enhanced efficiency.Quotes:"Standardized submission means that the reviewer can quickly find information...a huge benefit for both applicants and reviewers." - Patrick Axtell"Even after 30 years, I always open those help boxes in eSTAR...each submission is unique." - Lisa Pritchard"The key with eSTAR is eSTAR(t). You just have to get started...no substitute for just getting familiar with the template." - Kathy HerzogReference Links:Lisa PritchardKathy HerzogEtienne NicholsGreenlight GuruDuVal & AssociatesClient Alert: "eSTAR & I"FDA eSTAR Program webpageFDA electronic Submission Template guidance for 510(k) SubmissionsFDA electronic Submission Template guidance for De Novo SubmissionsYouTube video of FDA REdI Conference presentation on eSTAR by Lili Duan*Interested in sponsoring an episode? Use this form and let us know!

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 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 full report and explore the resources mentioned in this episode by visiting the Reference Links below.Episode Highlights:AI is still in its early stages within the MedTech industry, with potential to save time and improve efficiency.There is a noticeable skepticism about AI, with 65% of respondents doubting the accuracy of AI data.Corporate executives are the highest users of AI at 60%, with manufacturing operations at 50%.Product development and engineering, as well as clinical sectors, are also incorporating AI significantly.Quality and regulatory sectors are the least to adopt AI, possibly due to trust issues in AI's data accuracy.Early adopters of AI in MedTech, akin to early CAD users, may gain a competitive edge in the industry.The development of AI tools like Greenlight Guru's risk intelligence can specifically aid MedTech professionals by streamlining processes like risk assessment.Quote:"It's kind of like an iceberg we're seeing the tip of the iceberg with the use of ChatGPT for manipulating your email, when in reality there's this whole other world under the water." - Wade SchroederReference Links:Wade Schroeder on LinkedInAI in MedTech Report 2023Digital GuruGreenlight GuruEtienne Nichols on LinkedInInterested in sponsoring an episode? Click here to learn more!

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 of equity and compensation in these roles. Devon Campbell shares invaluable advice and experiences, focusing on mentorship, relationship-building, risk management, and navigating the challenges of the MedTech startup ecosystem.Some of the highlights of this episode include:The distinction between consulting and advisory roles, highlighting the long-term, relationship-focused nature of advisory work.The critical role of experience and mentorship in guiding startups, enhancing their growth and success.Strategies to transform challenges into opportunities, fostering innovation and resilience in the MedTech industry.The importance of understanding and respecting employment contracts and avoiding conflicts of interest in advisory roles.The necessity of due diligence and setting high standards in choosing companies to advise, to protect one's reputation.The power of passive networking and the proactive seeking of advisors to fill knowledge gaps, especially in areas like quality systems.Insights into equity and compensation in advisory roles, emphasizing realistic expectations and adequate self-compensation.The value of accelerator programs like MassChallenge in connecting startups with experienced mentors and advisors.The importance of risk management and the strategic formation of diverse advisory boards to provide multifaceted guidance.Quote:"Having a board of diverse advisors can significantly enhance the quality of advice and direction for a startup." – Devon CampbellReference Links:Devon CampbellProdctGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Click here to learn more!

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 particular focus on 510K predicate selection, clinical data requirements, and the nuances of permanent implants. The conversations address the challenges and complexities inherent in aligning medical device design and development with contemporary FDA expectations and offer invaluable insights for professionals in Product Development, Quality Assurance, and Regulatory Affairs.Some of the highlights of this episode include:How the 510K, originally an exception, has ironically become the predominant pathway in medical device regulation.That, despite efforts to raise regulatory compliance standards, the enforceability of current guidances is limited due to unchanged regulations.Discussion of FDA's non-binding guidances balance between being commendable for clarity and somewhat overreaching, reflecting a nuanced industry challenge.How evolving FDA thinking underscores the importance of aligning with contemporary standards, going beyond mere compliance.That selecting predicates with past design-related recalls for 510K submissions poses legal challenges and necessitates reevaluating older predicates in light of new risks.How clinical data requirements in medical device regulation are dictated by engineering and biological factors, not just regulatory pathways.How demonstrating substantial equivalence can be complex, and small technological differences must not introduce new safety concerns.The definition of 'permanent implant' challenges traditional understanding, emphasizing the importance of biocompatibility and safety in regulation.Quote:"Just because you're meeting the standard, that just means that you're passing... That doesn't necessarily mean that you're making a safe and effective product." – Mike DruesReference Links:Mike DruesFDA Guidance: Best Practices for Selecting a Predicate Device to Support a Pre-Market Notification [510k] SubmissionFDA Guidance : Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] SubmissionsFDA Guidance: Evidentiary Expectations for 510(k) Implant DevicesGreenlight GuruEtienne Nichols' LinkedIn*Interested in sponsoring an episode? Click here to learn more!

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, such as 510K, De Novo, and PMA, and underscores the criticality of timelines, strategic planning, and a robust Quality Management System (QMS). Reynolds also guides listeners through effective FDA interactions, the eSTAR system, and the significance of building relationships with review teams. Her expertise illuminates the path to successful FDA submissions, emphasizing preparation, organization, and proactive engagement with regulatory bodies.Some of the highlights of this episode include:Strategic alignment of clinical trials with market launch timelines is crucial for successful FDA submissions.Differentiating between submission types (510K, de novo, PMA) and how they are essential for navigating the regulatory landscape.Early interactions with the FDA through Q submissions and how those interactions streamline the market submission process.The importance of understanding and managing FDA review timelines, including potential pauses and extensions.How utilizing eSTAR helps identify documentation gaps and assess submission readiness.How pre-submission meetings with the FDA are instrumental in addressing potential gaps and receiving regulatory pathway guidance.The importance of comprehensive preparation and organization facilitate expedited FDA review, despite uncontrollable factors.Quote:"Interact with FDA early and often. It's what ultimately will make your submissions as seamless as possible." - Ellie ReynoldsReference Links:Ellie Reynolds LinkedInGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 FDA. They reveal insights that every MedTech professional must know, breaking down the philosophy, challenges, and expectations surrounding inspections, all while blending unique "Mike Drues isms" and Etienne's candid takes.Some of the highlights of this episode include:Grasping the art of proactive communication with the FDA, laying the foundation for regulatory success.Delving into the essence of managing FDA's expectations during pivotal conversations.Exploring the unpredictability of FDA inspections and the mantra of always being prepared.Differentiating between inspections for class two/lower medical devices and class three devices.Unpacking the role of FDA registration in attracting the FDA's attention for inspections.Achieving the perfect equilibrium when providing information during inspections.Navigating through concerns raised by FDA reviewers and appreciating the value of swift responses.Navigating the nuanced gray areas, ranging from "sufficient investigation" to acknowledging and rectifying errors.Unveiling real-world scenarios where complaints in medical device manufacturing are addressed effectively.Quote:""The solution to most problems is more communication, not less." - Mike DruesReference Links:GG Academy - use Promo Code "podcast25" for a 25% discountGreenlight GuruVascular SciencesMichael Drues LinkedInEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 the past and present regulatory landscapes of LDTs, the differences between IVDs and LDTs, and what the FDA's changes could mean. They discuss the cost implications and the learning curve for labs new to FDA's processes. Shannon explains the FDA's four-year phased plan for labs to comply with the new rules, touching on the challenges at each phase, like the administrative burden and the influx of submissions the FDA might have to review. Focusing on the transition for new or modified tests, Shannon emphasizes the need for more guidance from the FDA and educational efforts to help labs understand the new terms and requirements. We also discuss the potential disruption to healthcare and urge labs to actively comment on the draft regulations to the FDA. Through engaging dialogue, this episode is a deep dive into the regulatory shifts in the lab industry, making it a great listen for those in the regulatory and healthcare fields.Some of the highlights of this episode include:Concerns regarding the handling of new or modified tests during the four-year phase-in period, emphasizing the need for clear guidance alongside historical tests.Discussion on a unique approach from the Valid Act called technology certification, aimed at easing submission and review burdens on both labs and the FDA.The significant educational effort required from the FDA to help labs navigate new terminologies and requirements.The potentially disruptive impact on healthcare, given the critical role laboratory testing plays.Encouragement for labs to actively provide comments on draft regulations to the FDA, advocating for a balanced approach to regulatory developments.Year One: The focus is on adverse event reporting, with Shannon suggesting additional FDA guidance to manage irrelevant adverse event reports.Year Two: registration and listing phase is discussed, pointing out the clerical burden on labs despite having most required information.Year Three: The introduction of Quality System Regulation (QSR) or Good Manufacturing Practice (GMP) requirements in year three is explored, with Shannon mentioning some overlap with existing CLIA compliant quality systems but highlighting FDA's additional documentation expectations.Year 3.5 & 4: Shannon delves into the submission of Premarket Approval Applications (PMAs) for high risk, low, and moderate risk tests in year three and a half and year four, underlining the challenge for labs in categorizing their tests and for the FDA in handling a potential influx of 80,000 to 100,000 new submissions.Quote:"I think the bottom line is this will be potentially very disruptive to the healthcare environment. Lab developed tests. There are studies that have shown that 70% of the information in the medical record is due to laboratory testing. So obviously, they play a really important role in the healthcare environment." - Shannon BennettReference Links:Shannon Bennett on LinkedInIVDs and LDTs: What’s the Difference?FDA Proposes New Rule to Regulate LDTs as IVDs: Here’s What’s at StakeGG Academy - use Promo Code "podcast25" for a 25% discountGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 2017, many companies are still unsure how to handle the submission of their UDI (Unique Device Identification) data.Joining us to discuss this topic is Richard Houlihan, an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions. His company EirMed with the website eudamed.com provides ongoing EUDAMED and regulatory submission support, training, an EUDAMED mobile search app, and software to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations. To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.We hope you enjoy this episode on EUDAMED!Some of the highlights of this episode include:After the European Commission's EUDAMED working group meeting in June 2023 and the publication of the minutes, we know that the legally required audit of EUDAMED will now take up to nine months and is to be completed in Q4 2024.Six months after the OJEU publication, EUDAMED will be deemed fully functional and EUDAMED will be mandatory. EUDAMED vigilance reporting for serious incidents will be mandatory from that point, Q2 2025 - the day after EUDAMED is fully functional.EUDAMED’s fully functional date is now expected to be Q2 2025. Ireland and France have already made EUDAMED mandatory for new products.For most medical device manufacturers, EUDAMED’s Actor, Device, and Certificate modules will be the only modules they'll use. These modules are already up and running. Quote:"...it's a hugely ambitious project. Now, the device module and the certificates module, they're both huge in themselves. The vigilance module, that's a whole ecosystem in itself and the clinical investigations for any poor devil involved in clinical investigations, this thing is an absolute monster, it's huge. But what they've done is they're putting them all together and they're connecting them all - in the real world, we would call that consolidation in a marketplace... I was told it was the second biggest It project ever undertaken by the Commission." - Richard HoulihanReference Links:Richard HoulihanEirMed (eudamed.com)GG Academy - use Promo Code "podcast25" for a 25% discountGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 wealth of knowledge and experience in the intricacies of clinical study site selection, shedding light on the critical role it plays in MedTech product development.In addition, we're joined by Samantha Pickett, an Associate Director at Proxima Clinical Research. Samantha dives deep into the key considerations for site selection, emphasizing the significance of patient demographics, regulatory compliance, and technological access.This was a fun conversation as we discussed how to navigate the complexities of regulatory landscapes, explore collaboration strategies, share best practices, and draw insights from real-world case studies.Some of the highlights of this episode include: 1. Why Site Selection Matters:In the realm of MedTech product development, site selection is the linchpin. It can make or break the trajectory of your innovation.Selecting the right geographic location and clinical trial site sets the stage for successful outcomes and paves the way for future success. 2. Key Considerations for Site Selection:Let's dig into the key considerations when selecting a site for your clinical study. Patient demographics, regulatory environment, and investigator expertise are vital factors.Infrastructure, access to cutting-edge technology, and the patient population at the site are equally critical aspects to consider. 3. Navigating Regulatory Landscape:Regulatory challenges can be formidable obstacles in the site selection process. We'll explore the complexities and implications these challenges can have.Tune in to learn about strategies that can help you navigate these hurdles, ensuring compliance and successful site selection. 4. Collaboration and Partnerships:Collaborating with research institutions, hospitals, and academic centers can be a game-changer. We'll discuss the numerous benefits this collaboration can bring to your site selection process.Moreover, we'll provide insights into strategies for establishing fruitful partnerships that enhance your site selection efforts. 5. Best Practices and Case Studies:Let's delve into real-world examples from the MedTech industry. We'll share success stories and case studies that illuminate the art and science of site selection.By extracting actionable insights and best practices from these examples, we aim to empower you in your own site selection endeavors.Quote:"Your aim should be to ensure everything aligns with expectations. The IRB's primary focus is patient protection, ensuring they comprehend the trial's details, risks, and benefits while safeguarding their privacy." ~Samantha PickettReference Links:Samantha PickettIsabella SchmidtGG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 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 amidst the waves of the changing remote work landscape. They share profound insights into navigating the maze of regulations in the medical device sector, underscoring the critical importance of resilience—captured by the evocative term "alligator blood"—to thrive in such a challenging environment.Drawing the curtain back on the transformative world of medical technology, this episode is a deep dive into the role of mindset coaching, poignant patient stories, and the horizon of MedTech. With glimpses into AI's impending role and technological leaps, interwoven with light-hearted tales of branded socks, Etienne, DD, and Pall craft a narrative that underscores the core values and vision that propel Greenlight Guru forward.Some of the highlights of this episode include:A deep dive into why thriving in MedTech hinges on a fervent love for the mission, an unwavering dedication to the community, and an undying drive to champion quality of life.The compelling origin story of Greenlight Guru, birthed from an unmistakable need to provide robust backing for medical device professionals.The courageous pivot of Smart Trial: How they chose to scrap months of effort and boldly embrace the future with cutting-edge technology.The resilience shown by Greenlight Guru during the COVID-19 storm: A seamless evolution from traditional office environments to adaptive global remote workspaces.How, even in a virtual setting, Greenlight Guru maintained a palpable culture that not only kept the team connected but resonated profoundly with customers.The blueprint for businesses in a post-COVID world: Understanding that adaptability and innovation aren’t just trends, but necessities for survival and growth.An exploration into the challenges and opportunities presented by regulatory shifts: For the forward-thinkers, these aren't mere hurdles, but potential goldmines.Why the term “Alligator blood” embodies the very resilience and fortitude required to chart the tumultuous waters of the MedTech industry.The secret sauce of MedTech success: A strategic focus on investing in individuals defined by their grit, fiery passion, and boundless ambition.A heartening reminder that MedTech’s real impact goes far beyond just technology—it's about making profound, tangible improvements in the quality of life.Quotes:"You have to fall in love with the space and the community and the patients, and the concept that improving the quality of life is everything if you're going to be successful here." - David DeRam"We all have almost unlimited capacity. We can do pretty much anything that we want to do... It comes down to are we going to quit or are we not going to quit? We know what to do... Which is why we invest in Mindset coaching. We talk a lot about energy, we talk a lot about intention, and we built our team on that culture." - David DeRamReference Links:David DeRam LinkedInPall Johannessen LinkedInGG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 from academia to startup life, explore the complexities of medtech communication, and delve into the intricate dance of securing FDA clearance. This was a fun conversation, with good Q&A at the end where we discuss the highs and lows of pioneering digital health solutions, the significance of a quality-first mindset in MedTech, and the art of crafting a passionate team.Some of the highlights of this episode include:Transitioning from academia to startup, and the demands of adaptability; navigating the real-world validation while staying solution-driven.Navigating the regulatory landscape, and the marathon that it is and how being FDA-cleared is just one of the many milestones.Building a quality-centric culture from day one to set the tone for long-term success in the MedTech space.How building a startup is akin to fixing a plane mid-flight – it's challenging but passion and clarity make it feasible.Tailoring communication, and how suiting it to the listener's background can be the game-changer in understanding and collaboration.Quote:"Management, speaking their language is super important. If I can compare it to what I already know, then that's easier." - Christy Sheehy-BensingerReference Links:Christy Sheehy-BensingerC-Light TechnologiesGG Academy - use Promo Code podcast25 for a 25% discountGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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), 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 care providers, device makers, and life sciences. Zach also founded Exos, a governance SaaS, and sold it in 2022.Weronika Michaluk, a jack-of-all-trades in biomedical engineering, business, and public health, leads HTD's Software as a Medical Device unit. With degrees from Miami and Warsaw, plus a Doctorate in Public Health, she's worked on everything from wireless ECGs to digital health consulting. At HTD, her laser focus on quality and customer satisfaction drives organizational success.Some of the highlights of this episode include:An introduction to "Compliant Agile," a balanced methodology for MedTech development that prioritizes customer interaction while maintaining regulatory compliance.The importance of choosing the right Quality Management System (QMS), highlighting the flexibility and feature-rich experience of Greenlight Guru.The need for companies to focus on their core competencies while being adaptable and compliant.The importance of a positive mindset and a well-defined success metric for any MedTech project.Quote:"Our mission is to make the industry more accessible, more human centric and more productive" - Zach MarkinReference Links:HTD Health pageHTD SaMD InsightsHTD SaMD ChassisZach Markin LinkedInWeronika Michaluk LinkedIn GG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 VCs and Angels have different risk profiles. Devon says know your funding options and their strings. It’s about terms and expectations, not just money.Think a sleek exterior hides internal flaws? Devon focuses on product readiness and QMS. Be manufacturing-ready and optimize. No shortcuts in MedTech.In a red-tape world, paperwork matters. It's about confidence, not bureaucracy. Devon shifts focus to quality systems as confidence builders. His point? "Unquestionable, indelible data—that’s what I can trust." Get organized, and confidence becomes your MedTech currency.Some of the highlights of this episode include:Knowing your weaknesses. It's important to recognize your gaps and seek the right help.Maintain data integrity. Full disclosure of data builds trust - no sugar-coating..Evaluating product maturity - good looks aren't enough; be manufacturing-ready.The importance of a strong Quality Management Systems (QMS). Document, document, document. No excuses.Risk Management isn’t a checkbox: it's an ongoing pledge to safety.Quote:"Unquestionable, indelible data—that's what I can trust. That's confidence." ~Devon CampbellReference Links:Devon CampbellProdctGG AcademyGreenlight GuruEtienne Nichols LinkedIn*Interested in sponsoring an episode? Use this form and let us know!

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 terrain.Learn about the benefits and scrutiny of the breakthrough designation, hear examples that emphasize the need for precise data and quality in the application process, and listen as we explain the planning and considerations for success, and how innovation can thrive within regulation.Some of the highlights of this episode include:The changes in CMS reimbursement, and how breakthrough devices no longer guarantee automatic CMS reimbursement.Planning for FDA Submission, and how to align with FDA timelines.Competitive Landscape - how achieving breakthrough is still possible, even if competitors have it.Whether or not it's worth pursuing Breakthrough Designation.The benefits of Breakthrough Designation Benefits (such as FDA priority review and potential marketing buzz).Quote:"Say you are a direct competitor with someone else, and they got breakthrough but they're not on the market yet... You can still get breakthrough for the same indication. FDA does not consider that as a cleared or approved alternative - even if they're miles ahead of you."Reference Links:Ellie Reynolds LinkedInProxima CROEtienne Nichols [email protected] AcademyGreenlight Guru*Interested in sponsoring an episode? Use this form and let us know!

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, who brings her rich experience of 12 years at the the FDA and Regulatory Strategy to discuss pressing issues and notable developments in the industry.Join us as we delve deep into crucial topics such as biases in medical device testing, the evolving approach of the FDA, and the importance of user-centric design. This episode offers a comprehensive look into the dynamic and ever-evolving realm of medical technology, emphasizing the balance of innovation and regulation.Highlights of the episode include:Skin Tone Bias in Medical Devices: Nada Hanafi spotlighted the biases in pulse oximeters, shedding light on how these devices often fail to perform efficiently across varied skin tones. A lack of diversity in validation tests, mostly relying on Caucasian young men, resulted in compromised health outcomes for others.Evolution and Transparency of the FDA: Nada traced the journey of the FDA, illustrating its transformation towards greater transparency and predictability. Emphasizing the human touch behind FDA's decisions, she dispelled the myth of the FDA being an impersonal "black box".Global Regulatory Movements: Highlighting a shift in the MedTech landscape, Nada pointed to the trend of global regulatory harmonization, particularly noticeable in the realm of software-based medical devices.Importance of User-Centered Design: Nada and the panel emphasized the significance of involving patients early in the design phase. Using tools like personas and human factor tables can lead to products that truly cater to users' needs, ensuring both usability and safety.Embracing Learning in MedTech: Nada's hope for companies to learn from past oversights and adapt to changing regulations stressed the crucial role of iteration and learning in medical device innovation.Navigating Modern MedTech Challenges: From addressing the significance of thorough documentation practices to discussing the challenges of regulating AI-driven medical devices, the discussion underscored the ever-evolving MedTech arena and the imperative need for regulators to stay updated.This episode paints a comprehensive picture of the medical device industry, addressing both its challenges and its advancements.Quote:"Medical devices shouldn't be designed with a one-size-fits-all approach. We've seen firsthand the impact of biases, like with pulse oximeters. It's crucial that we validate devices across diverse populations to ensure safety and efficacy for all."Reference Links:Nada HanafiMedTech ColorMedTech InnovatorVeranexEtienne NicholsTrue Quality RoadshowGreenlight Guru AcademyGreenlight Guru Software

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 his company weathered the early days of startup life, and how the pandemic - which took so many companies down - turned out to be the springboard that tested the culture that Dan and his co-founder had molded from the very beginning.If you're not familiar with our True Quality Roadshow - you should definitely check it out! It's a free half-day event at one of 6 cities across the world. Links below!Some of the highlights include:The role Velentium played in upscaling the production of ventilators during the pandemic - this was a significant achievement and showcases Velentiums leadership, collaboration, and company responsiveness during this worldwide crisis.Real-life challenges faced by companies, especially dramatic stories like the purchase of parts without a PO and the personal involvement of the leadership, and paint a vivid picture of commitment and dedication.The central theme of a company's mission ("We exist to change lives for a better world") and how it guides its decisions is foundational and deeply impactful.The pivotal role that company culture plays, even when compared to strategic planning.The long-term vision of a company, and we emphasize that while actions and technologies change, the core mission remains constant.The decisions Dan was faced with, such as how (or if!) to pay employees during a crisis, and we highlight the ethical considerations a company has to make, and how to stay aligned with a company's core values.The emphasis on finding clients to fund growth rather than relying on investors - this is not only pragmatic advice for startups but also provides a unique perspective on business growth.Quote:"Because as a leader, if you don't clearly know where you're headed, it's really hard to get a bunch of people to follow you. And I don't want people to follow me. I want them to race me up the mountain, which is the one that we've all decided to ascend together."Reference Links:Dan Purvis LinkedIn28 Days to Save The World bookEtienne Nichols LinkedInTrue Quality RoadshowVelentiumTexas Medical Center for Innovation

DescriptionIn 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 the episode. Some of the issues we discussed include:How utilizing this program can accelerate the submission process, or at least remove some uncertainty around the timelineWho this program is for - not just for small startups, but rather how even experienced Regulatory Affairs specialists working at large corporations can benefit from this program.Lastly, we don’t usually get into the specifics of cost and expenses, but we even discuss some of the differences in how much you’ll pay using the 3P510k route vs. the traditional submission route.Shawnnah Monterrey is the founder of BeanStock Ventures after nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for both startup and mature organization with emphasis on the development of medical instruments, life science, diagnostics, clinical applications.Reference Links:Shawnnah Monterrey on LinkedInBeanStock Ventures – 3P510kEtienne Nichols on LinkedInGreenlight Guru softwareFDAs 3P510k page

DescriptionMost 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 built it to the point it can stand on this own?In this episode, Rob MacCuspie, PhD, Manager of Regulatory and Quality Affairs at Proxima Clinical Research, Inc., discusses the best practices of companies he has worked with to help implement their Quality Management System in a manageable way.Takeaways:What is the difference in your QMS and a Document Management System?What is the most important aspect of a QMS?Who really needs a QMS, and when?What are the phases of a QMS?How to start building a QMS.Quote:""If my SOPs and training process can bring in somebody that has no experience and they can hit the ground running, I'm not worried if the auditor has any experience now in my space, right. Because I now have everything in place to show somebody how they can teach themselves and learn and get up to speed and walk through the process."Reference Links:Rob MacCuspie on LinkedInEtienne Nichols on LinkedInProxima Clinical ResearchGreenlight Guru software

DescriptionIn 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 Drues, PhD, President of Vascular Sciences, about artificial intelligence in medical devices, the history of this type of technology in the medical device field, and what this guidance means and doesn't mean. We hope you enjoy this episode of the Global Medical Device Podcast!Questions AskedWhat does artificial intelligence mean in software as a medical deviceWhy is this new draft guidance needed?What recommendation for medical device companies does the draft guidance provide?What are the challenges with validating the modifications for an ML-DSF? (Or are there other, greater challenges?)What are some of the specific items a PCCP should include?Does a PCCP negate a future need of a Letter to File or new 510k? What would necessitate an additional market submission?Quotes"I really try to stress what I call 'regulatory logic,' because if you understand the regulatory logic, really, all of this should be common sense." - Mike DruesReference LinksDraft FDA GuidanceEtienne NicholsGreenlight Guru

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 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, and the importance of efficiency and cost savings provided by a quality management system.Prioritizing success metrics, measuring outcomes, and holding ourselves accountable lead to better decision-making and improved effectiveness in the long run.Success criteria for customers implementing a quality management system include time to implement (time to value) and achieving specific outcomes.How Greenlight Guru aims to balance efficient setup and time to value for customers, focusing on milestones like entering documents and processing changes.The way different customer profiles require different approaches, such as providing guidance and templates for early-stage companies or assisting with migration for existing quality systems.The different functions Greenlight Guru offers, such as services like Guru Assist and GG Academy to support customers in their implementation and learning process."I think ultimately this whole study was really illuminating because it was able to give executive teams, buying teams the numbers that they needed to make a smart decision." ~Fran CruzReference Links:Etienne Nichols LinkedInIndependent Study on ROI of eQMSROI CalculatorGreenlight GurupKtQjeyoDImuAoc2OjH5

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, and the practical applications of it all. The conversation also covers the evolution of software validation processes, the cost of system implementation, and the importance of critical thinking in Quality System Regulations. The impact of AI on Quality Assurance, the changing dynamics of the CSA Modern Validation, and the role of Software Assurance in the life sciences industry are also discussed.Some of the highlights of today’s show include:The evolution of software validation processes, the cost of implementing a system in the life sciences industry, and the role of critical thinking in Quality System Regulations.FDA's draft guidance from September 2022, the industry's response, and its practical implementationsThe cultural shift and challenges that accompany the transition to CSA Modern Validation.The evolving relationship between life science companies and their technology vendors and how it can bring value to the organizationThe pivotal role of Computer Software Assurance (CSA) in the life sciences industry, including the unintended consequences Cybersecurity and how the FDA is looking to adopt this approach across multiple agenciesHow companies can stop spending resources on testing every feature and functionThe industry's shift towards automation and data-driven processesThe use of the word “validation” vs. “assurance”Links:Medical Device International ConsortiumCase for Quality Working GroupsFDA CSA Draft GuidanceEtienne Nichols LinkedInGG AcademyOmnibus BillGreenlight GuruQuotes: “Keep in mind if you talk software validation to anyone outside of life sciences, they're going to glaze over. Validation is not used. Software validation is not used outside of this industry.”“You could tell a lot about potential changes to a draft guidance based on the number of times you see certain things show up as a comment.”“Now look, if everything is high risk, then you didn't do a risk assessment, just like if everything's a high priority, you haven't prioritized anything.”

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 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 value of considering the patient perspective, the complexities of regulatory, ethical, and business obligations, and the benefits of tools like dFMEA and fault tree analysis.Some of the highlights of today’s show include:Understanding risk management in medical device designImportance of collaboration between dFMEA and ISO4971Exploring ISO14971 and FDA consensus standardsA top-down approach to risk management in medical device designConsidering the patient perspective in the risk management processThe complexity of regulatory, ethical, and business obligationsISO14971 as a regulatory burden ensuring patient safetyHow Greenlight Guru is designed to align with ISO14971Benefits of tools like dFMEA and fault tree analysisMapping dFMEA and ISO14971 for FDA reviewLinks:Wade SchroederEtienne Nichols [email protected] NationGG AcademyGreenlight GuruQuotes: “Put simply, it's all about telling the story of what could go wrong with your device and what harms could that lead to." -- Wade Schroeder "Before you even start your design, you’ve identified, ok, here’s the serious harms we need to avoid." -- Wade Schroeder

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 now Medical Device guru, on the subject of management responsibility and all that entails. Listen to the episode to learn what Sara is thinking about when she thinks about the topic of management responsibility. She shares her thoughts on quality policy, organizational structure, management review, and quality systems procedures. Some of the highlights of today’s show include:Whether a summary statement is enough, or whether the policy needs to be a paragraphWho the management representative is and what they are supposed to doWhy you need management review even if you’re not selling productsGetting executive management on board with a culture of qualityMaking management review meaningfulLinks:Sara AdamsEtienne Nichols LinkedInGG AcademyGreenlight GuruQuotes: “The quality policy should be the battle cry, the rally cry, the thing that pumps us up that we remember, not just words on a page.”“It is really important to have enough resources in the right roles to be able to meet the requirements of this regulation.”“Don’t just gloss over it. It is something that you have to do, but make it meaningful.”

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 on the topic of Combination Products, and specifically how she recently wrote the Handbook on this topic, with many co-authors from FDA.Susan is a recognized international Combination Products and Medical Device expert with over 30 years of industry experience. Her FDA peer-reviewed book, “The Combination Products Handbook: A Practical Guide” is available for purchase through CRC Press. Listen to the episode to hear about her past experience and how she ended up in products, how the different chapters of her book came to be, and how her collaborators were involved.Some of the highlights of this episode include:Susan’s past experiences in the industryHow Susan got into the combination products spaceSpecific examples of the multilingual approach Susan had to takeHow the different chapters in Susan’s books evolved and who collaborated with herWhat it was like to work with so many different professionals on the bookThoughts about challenges that may be addressed in the futureHow to harmonize language differences in the glossaryOvercoming the challenge of being a niche within a niche and juggling multiple fieldsHow industry knowledge interacted with FDA knowledgeMemorable quotes from Susan Neadle:“It was really a great adventure, being there right at the ground level when it all started.”“If people aren’t able to use the product effectively, they’re not going to take their drug, which means all sorts of other ramifications.”“It’s important to understand what are the combination inspection product criteria.”“It was great, although it would have been much easier if I was trying to write the book by myself, because I have control of my own timelines.”Links:Susan Neadle on LinkedIn20% Discount for The Combination Products HandbookCombination Products ConsultingEtienne Nichols LinkedInGreenlight Guru

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 has led initiatives in project management, engineering automation, configuration management, audit, and software development.During today’s episode, we’ll talk about the most important parts of a QMS, what differentiates a good QMS from a bad one, and how to prove ROI on a QMS. Steve will also discuss what he would do if he were starting a medical device company today. Listen to the episode to learn more about lean documentation and how you can learn to write for your actual audience – the workers – while still pleasing the auditors.Some of the highlights of this episode include:What it means to have lean documentation, and what the norm is in the MedTech communityHow to write for employees while meeting auditor requirementsBuilding a template for a standard operating procedureCollaboration between the production of a document and ownership of that documentMaking repairs on documentation vs. starting overProving the ROI on a good or bad QMSTaking care not to be overly prescriptiveThe importance of root cause analysis over treating symptomsMapping instead of including every SOP and repeating yourselfWhat management responsibility looks likeMaking documentation work better in terms of root causesMemorable quotes from Steve Gompertz:“I’m fond of telling people, ‘The auditors don’t work here. That’s not who these documents are for.’”“Done correctly, efficiency and effectiveness are not enemies.” “Everybody has a customer internally; everyone produces a product.”“On the quality systems pyramid, the smallest piece is the quality manual. So why is it the biggest document.”Links:Steve Gompertz LinkedInQRX PartnersEtienne Nichols LinkedInGreenlight Guru

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 beyond just "safety and efficacy" to include the cybersecurity of medical devices. This amendment resembles a watered-down version of the PATCH Act, which failed to pass in late 2022.As a result, on March 29, 2023, the FDA gained the legal authority to define and enforce medical device cybersecurity. So for today’s episode, we got THE leading minds in MedTech cybersecurity together to discuss what we need to do next. Chris Gates, Director of Product Security at Velentium, Chris Reed, Vice President of Product Security at Medtronic, and Ken Hoyme, CEO of Dark Star Consulting, join the podcast today to discuss the new guidelines, what the FDA can and can’t say about it, and what kinds of deficiencies you’ll be seeing in the future because of the new legislation.Some of the highlights of this episode include:How the FDA tried to clear a path for routine patches and updatesThe minimum that the omnibus bill is talking aboutNo longer needing to make the link between cybersecurity and safety and effectivenessWhen they have the legal authority to enforce cybersecurityWhy the document took so long to go throughSecurity architecture analysisWhy you should be referencing the April 2022 draftUnpatched vulnerabilities at the time of submissionThe effort needed to understand the FDA’s intentionsMemorable quotes from this episode:“Literally, if you’re not aware of this already, you’re already behind the 8-ball right now and there’s things you’ve got to do.”“Basically, if you think it might be a cyber device, it is a cyber device.”“Don’t sit there and try to be pedantic about this and say “I don’t need to do this because there’s a comma here.” It ain’t gonna work for you.”“A synonym for threat modeling really is security architecture analysis.”Links:Christopher GatesChris ReedKen HoymeVelentiumMedtronicDarkStar ConsultingMedical Device Cybersecurity in 2023 and Beyond SlidesEtienne Nichols LinkedInGreenlight Guru

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 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 changes to their devices. The company that he founded, Vertex was acquired by Greenlight Guru, where Tyler is now the Chief Scientist.Listen to the episode to hear Tyler explain more about data quality, the future of risk assessment, and how Bayesian statistics and analysis come into play.Some of the highlights of this episode include:When can we reach a point where we know the data is accurateThe future of risk assessment for MedTechWhy use a model for predicting riskHow this model impacts a companyThe change in trajectory for the medical device industryMemorable quotes from Tyler Foxworthy:“There is no such thing as absolutely perfect data, there’s only degrees of quality.”“I would like to see it as more rigor, in general, brought to the industry.”“This whole field of probabilistic risk assessment is firmly rooted in Bayesian analysis.”“This idea of using, bringing out tools and techniques and knowledge from other domains and fork lifting it into our industry, and making it valuable, to me there’s just something really intellectually appealing about that.”Links:Tyler Foxworthy LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to regulatory affairs professionals and regulatory affairs attorneys? Those are just a few of the items covered in today’s live discussion with Mark DuVal.Mark is the founder and president of Duval & Associates. He’s been in healthcare marketing and advertising for over 20 years and is a leading expert in medical device promotion. In today’s episode, you’ll learn his tips for creating “appropriately aggressive, yet compliant” ad campaigns. Learn from Mark’s expertise as he discusses the four buckets of knowledge for information sharing, the different perspectives between regulatory and legal, and how to think about the information provided with a medical device.Some of the highlights of this episode include:The difference in perspectives between a regulatory affairs professional and a regulatory affairs attorneyBest recommendations for regulatory affairs professionals when approaching off-labelExamples of when the dissemination or communication of on and off-label information comes into playGeneral and specific use, and being specific with your indication for useWhether a case study could be built around a physician’s off-label useHow compliance monitors sales for off-label promotionAd promo enforcement actionMemorable quotes from Mark DuVal:“The regulatory affairs professionals are, a lot of times, they’re biomedical engineers and scientists, and they are much more steeped in the medicine and the science as we would be as lawyers.”“It’s kind of a mantra I make everyone repeat when I do a training exercise – I make them repeat after me, truthful, not misleading, fairly balanced.”“You have every right to participate in social media. But again, you’re still regulated.”“We don’t feel people should unnecessarily leave money on the table, nor should they foolishly aggravate FDA and receive a warning letter and get told to cease and desist.”“When you’re in the trenches day-to-day, trying to convince them to use something that’s real-world data is work. It can be done, though!”Links:Mark DuValDuVal & AssociatesCardiac Arrest: 5 Years as a CEO on the Feds Hit List (book)Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended PracticesMedical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and AnswersWashington legal foundation caseGeneral/Specific Intended Use - Guidance for IndustryEtienne Nichols LinkedInGreenlight Guru

What 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 strong technical background.Listen to today’s episode to hear what Jon has to say about using Electronic Data Capture (EDC) systems in clinical investigations, the importance of data quality and what that really means, the tools available for clinical investigations, and educating leadership about clinical investigations.Some of the highlights of this episode include:The biggest challenges companies face during clinical investigationsWhat kinds of tools are available for clinical InvestigationsThe relationship between data quality and formattingThe impact a purpose-built tool has on a companyThe costs associated with clinical investigationsEducating leadership about clinical operationsWhat makes the best stand outMemorable quotes from Jón I. Bergsteinsson:“Data quality has everything to do with how you format your data.”“The leadership just doesn’t have that much of an understanding of what clinical operations do, so they need to be educated.”“When you have a person who’s very efficient, you can get 100 attributes in a couple of minutes.”“Digital first is what sets the best from the rest.”Links:Jón BergsteinssonSMART-TRIAL by Greenlight GuruEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

What 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 involves handling complaints, and how complaints are related to post-market surveillance.Some of the highlights of this episode include:What effect does shadowing doctors and seeing surgeries haveThe difficulties of a complaint handling role and how Brittney would structure the role in the companyRegulations around the complaint-handling processDifferent streams that come into play as far as complaints goManufacturer employee complaints on social mediaHow complaints are related to post-market surveillanceAdvice and recommendations for companies about complaintsMemorable quotes from Brittney McIver:“One of the things I wasn’t prepared for was the sheer volume of complaints sometimes.”“You always look at a complaint and try to determine whether it is a complaint or not.”“Any decision you’re making, you want to make sure that it’s informed and you have a rationale behind it.”“One of the things that you don’t want to happen is your customer not report the complaint to you, but they report it to the FDA.”Links:Brittney McIverEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

When bringing a medical device to the market, it’s important to be aware of the fatal 510(k) flaw. In today’s episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) program presents and how companies are dealing with it.Mike holds a Ph.D. in biomedical engineering, has served as an expert witness, and is one of the foremost regulatory minds, currently serving as the president of Vascular Sciences. Listen to today’s conversation to learn how to approach a 510(k) submission if your predicate had a recall, how to develop products that are safer and more effective, and the importance of tracing the genealogy of your predicate. Some of the highlights of this episode include:What happens when the predicate that you’d like to use for your 510(k) has undergone a Class 1 recallThe risk management element of using a predicate that’s undergone a Class 1 recallThe statistics about recall predicates used in 510(k)sHow the way the 510(k) is used has changed since it was first createdWhy the descendants of a predicate with a Class 1 recall are so much more likely to also undergo a recallSolving the problem of a predicate that’s been through multiple recallsConsidering competitor’s products or other products similar to the one yours is based onWhat post-market surveillance should entailThe direct and indirect economic impact of a Class 1 recallChanges that may happen with the FDA in the futureMemorable quotes from Mike Drues:“I can tell you that of the total number of devices that come onto the market, less than 5% are Class 3s.”“When the 510(k) was created half a century ago, it was intended to be an exception, not the rule.”“I do not advocate these simple-minded solutions like no 510(k) should allow to use a predicate that’s undergone a recall.”“Unfortunately, good news does not sell. Bad news sells.”Links:Mike DruesVascular Sciences510(k) GuidanceJAMA Study 1JAMA Study 2FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare YoursUltimate Guide to Postmarket Surveillance of Medical DevicesEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

What’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 companies and Medical Device Professionals. Listen to this episode to hear Brittani talk about the challenges of working through UDI & EU MDR implementation, the resources that helped her learn more about regulatory and quality, and what a day in the life of a Guru entails. Some of the highlights of this episode include:Resources that Brittani uses everyday in regulatory and qualityHow to identify a company's power centers and knowledge in a company and building social capitalCommon pitfalls Brittani sees during implementationExamples of things people don’t think to documentHaving knowledge dismissed due to youthConsistent questions MedTech professionals seeMemorable quotes from Brittani Smith:“I was in every audit that we were a part of from when I started to when I left the company, so audits are my jam.”“Everyone in regulatory is learning it on the job.”“I wasn’t afraid to be wrong, but I didn’t want to be wrong because I didn’t have the right resources.”“I think the simplest answer is I’d love to manage people.”Links:Brittani SmithEtienne Nichols LinkedInThe Essential Guide to Preparing your QMS for EU MDRUltimate Guide to UDI for Medical Devices Greenlight Guru AcademyGreenlight Guru

How 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 social capital in relation to suppliers. Some of the highlights of this episode include:Recommendations for employing the human side of supply and managementWhether not knowing the people involved make transactions easierTips and tricks for establishing human relationships in businessBest practices tips for companies beginning relationships at the beginningIf it’s helpful to know the relationship between a company you have a relationship with and another department who also has a relationship with themSuppliers and social capitalMemorable quotes from this episode:“I saw on Instagram or Buzzfeed or something that you can hire a Karen to be your customer service representative.” – Taylor Brown“In general, I would say you need people who can be both friendly and stuff like that, but keep their professionalism at the same time.” – Maxime Rochon“If I’m looking for a supplier, what is that supplier going to do for me specifically?” – Taylor Brown“We were taking the product the final mile for this manufacturing company who spent hundreds and hundreds of thousands of dollars – that person in the van better be the right person in the van. You just can’t pick any distribution company off the street. –Taylor Brown.Links:Maxime’s LinkedInPuzzle MedicalTaylor’s LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps?  In today’s episode, you’ll hear from Co-Founder and Operating Partner of CiteMed, Ethan Drower, on the topic of Systematic Literature Reviews for EU MDR Clinical Evaluation Reporting.In today’s conversation, we covered topics like where information for the literature review comes from, the types of tools used to make evaluations, and more. Listen to the episode to hear what Ethan has to say about the process of performing a CER, the mistakes and pitfalls he sees people make in the process, and what kinds of actionable steps companies can take.Some of the highlights of this episode include:What clinical evaluation reporting isThe big change in EUMDRThe process of performing a CERWhere people go to get the data for a CERHow to tell if a search is comprehensive enoughWhat mistakes Ethan has seen people makingThe process once the deliverable is submittedHow much time it takes for evaluations to go throughAdvice for companies going through the processMemorable quotes from Ethan Drower:“In comparison to the FDA, the big change, the big difference that’s happened with EUMDR is kind of a renewed scrutiny and focus on your actual data.”“It’s a compilation game, which is why nobody likes doing it. Because you have to bring in so many different pieces of data and different plans and that’s why it’s a difficult document to write.”“Once you’ve gone through the nightmare of pulling all this information together, now somebody has to read it.”“Don’t expect that what you searched and your process in the past, don’t expect it to just work and be glossed right over. It needs to be exceptionally thorough, and it needs to be iron tight.”Links:Ethan Drowers LinkedinCitemedEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

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 strategically.Some of the highlights of this episode include:Thinking in terms of manufacturingThings everyone ought to know about working cross-functionallyWhy starting from scratch may be betterWho needs to be looking at design controls and when they should be lookingThe difference between a design review and a stage reviewWhat Tom got to see that helped him understand how things workedWhat to look for on the manufacturing floorUsing the design control process strategicallyMemorable quotes from Tom Rish:“If you can get a tool in a certain spot you can do it, but if you can’t, you can’t.”“We like to say at Greenlight Guru: the outputs are the recipe.”“I think that a lot of times people use design reviews and stage reviews interchangeably.”“I can’t even put into words how valuable it was to go down to the manufacturing floor as an engineer.”Links:Tom Rish LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections.Recurring guest Mike Drues is the President of Vascular Sciences where he works to educate the industry and offers help to bring medical devices to market in the most effective way possible. Mike is a medical device professional possessing regulatory expertise who understands the ins and outs of the regulation systems in the medical device industry and is passionate about helping others better understand it as well.Listen to the episode to learn more about the most common mistakes companies make that result in Form 483s, what companies can do to avoid these mistakes, and how you should be thinking about root cause analysis.Some of the highlights of this episode include:Common reasons why companies get in trouble during FDA inspectionsWhy CAPA is specifically at the top of reasons for 483s and how to prevent thatExamples of design control problems and how to avoid themThe root causes of these issues and root cause analysisWhat complaint handling problems look likeWhat causes people not to handle complaints correctlyWhether anything about these problems is new or trendingWhat the FDA does when they find these problemsMemorable quotes from Mike Drues:“The emphasis should be on prevention, not correction.”“I consider myself to be a medical device professional, and I do not use the word “professional” lightly. Along with it comes the responsibility, including knowing what the heck you’re doing.”  “What is the point of getting complaints or post-market surveillance or anything else if you’re not going to act on it?”“I hate to say it, but we are the poster children for Einstein’s definition of insanity.”Links:Mike Drues LinkedInVascular SciencesEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

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 of the highlights of this episode include:Niki’s background and experienceThe process involved in being a verification engineerThe Greenlight Guru differenceThe steps that a verification engineer has to go throughTests used for verificationDifficulties with the steps for verificationThe career path to design assurance professionalThe biggest challenges about this rolePitfalls of design verificationMemorable quotes from Niki Price:“I wanted to be drawing body parts in an OR somewhere. Or illustrations in books.”“The best time I ever had was sitting at my desk running through thousands of lines of data and trying to make charts out of it. I loved it.”“Requirements are a lot of times going to be your acceptance criteria for your testing.”“You have to think about verification is for design inputs, validation is for user needs.”Links:Niki Price LinkedInEtienne Nichols LinkedInBeginner's Guide to Design Verification & Design Validation for Medical DevicesGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What 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 barriers between engineering and quality management, the challenges she experienced as a compliance manager, and what aspects of implementing an eQMS stand out for Maryann. Some of the highlights of this episode include:What the compliance manager role was like for Maryann and what it meant to herThe relationship with compliance across departmentsAuditing across sitesPains companies go through when looking for quality management systemsCultural barriers between engineering and quality controlCompliance manager challengesHow the quality management system is like a design projectThe contrast in quality manager vs. compliance matterImplementing an eQMS and the difference between that and a paper systemThe relationship between compliance and quality departmentsAdvice for people filling multiple rolesAdvice for companies working toward compliance and developing a quality mindset. Memorable quotes from Maryann Mitchell:“Engineers love to iterate, they love to tinker, but you need to be able to document something, and that’s the importance of it so you can go back to it if you need to.”“We built better processes going forward so we wouldn’t recreate this problem.’“I love that you get to defend your quality system.”“A quality system doesn’t work in a silo, and what I was seeing was departments working in silos.”Links:Maryann Mitchell LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

DHF, DMR, and DHR are easy to mix up when you’re just using the abbreviations – they sound a lot alike! And they are connected. But it’s important to understand the differences between them as well as how they interact with each other.Medical Device Guru Laura Court joins the podcast today to discuss these three documents – what you need to know about them, what to do with them, and why it matters. Listen to the episode to learn how Laura thinks about best practices, what companies get wrong, and how to improve when dealing with these three different kinds of documentation.Some of the highlights of this episode include:DHF vs. DMR vs. DHRWhat’s involved with the design history fileRecommendations for retaining the design history fileThe difficulties of paper filesWhat device master records areMaking sense out of device history recordsWhat goes into the DHR per the FDAHow engineers can do a better job of the feedback processThe change control process to update the DMRLaura’s additional advice about documenting earlyMemorable quotes from Laura Court:“I am on the onboarding and implementation side of our team for the gurus here, so I help get our customers started in the software.”“Your design history file is truly the history of how your product was developed.” “Don’t assume that you know everything. Even if you’ve been reading your DHF, you’re not going to know everything.”“Everything should go through document control.”Links:Laura Court LinkedInDesign History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?Etienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Why do quality professionals struggle with clear communication in writing? What’s the problem with jargon? These are some of the questions explored in today’s podcast.Joining the show this episode is Lesley Worthington. Lesley has 20 years of quality and regulatory experience in medical devices, and she uses that experience to work with individuals and teams to fine-tune their quality conversations, initiatives, and internal communications with the goal of creating more and better understanding of the role and concepts of quality assurance in organizations.Listen to the episode to hear Lesley’s take on how communication affects the outcome of audits, impacts the lives of quality professionals, and the common communication pitfalls Lesley sees in organizations. Some of the highlights of this episode include:Why writing to be understood is difficult for quality professionalsWhether it’s possible to get completely away from jargonCommon pitfalls that Lesley has seenThe length of attention spans and how reading and writing have changedThe importance of reading, including fictionWhat audits mean for communication and writingFear of writing differently from the way it’s always been doneLesley’s LinkedIn game and how she keeps up with all the writingOther important points that Lesley covers when teachingEmbracing the hatersMaking sure that everyone has the same visionLetting down your guardMemorable quotes from Lesley Worthington:“It’s not just about sounding different; it’s about the science of how we sound and how we read.”“The clearer your writing is, the more likely the reader will be to think that you know what you’re doing.”“Sometimes when things get really technical and really complex and really high-level, people lose the thread.”“The purpose of regulations are completely different from the purpose of procedures in your organization.”Links:Lesley Worthington's LinkedInLesley Worthington ConsultingEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today’s episode, he begins by reviewing some of the information in Part 1 of this discussion. He discusses how the current regulations and language around LDTs relate to the Theranos situation and what companies should be doing to ensure they’re ready when the VALID act goes through. Listen to this episode to hear what Mike has to say about the risks of LDTs, the engineering work that should go into LDTs, and how the regulations could be changed to close the Theranos loophole. Some of the highlights of this episode include:The risk behind LDTs vs IVDsWhether LDTs belong in the IVD categoryThe relationship between the LDT situation and TheranosPrinciples to use with LDTsWhat companies should be doing now in anticipation of the VALID actThe importance of a contingency planThe criteria for a legitimate LDTSpecific parameters to define an LDTLabelingTechnologyRiskRequiring hospitals to put LDTs through institutional review boardsBetter oversightCreating a EUA-like pathwayMemorable quotes from Mike Drues:“Even from a technology perspective, the technology of these LDTs is becoming much much more complicated.”“Long story short, I think Theranos took a fairly liberal interpretation of the words surrounding the LDT.”“I’m a biomedical engineer first and a regulatory consultant second. And that’s the order we should think about these things.”“Even though I’m a regulatory consultant, I’m not a fan of creating new regulation.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What’s the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today’s episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs.Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor. Some of the highlights of this episode include:Why Lab Developed Tests fit in with medical devicesWhat the difference is in LDTs and IVDsHow LDTs are regulatedExamples of LDTsWhy labs develop their own testsThe risk when it comes to LDTsWhy non-invasive LDTs can be listed as class 3Memorable quotes from Mike Drues:“A lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn’t regulate.”“Remember, regulation is about the interpretation of words.”“There is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it’s developed.”“If the hospital does one thing, they’re treated one way; if a company does exactly the same thing, they’re treated another way. Something’s not quite kosher about that logic.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What’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.Listen to the episode to hear what Kendyl has to say about the pain points of a paper QMS that can prompt making a switch to eQMS, challenges at the beginning of the switch, and a realistic timeline for implementing the new system. Some of the highlights of this episode include:The pain points of a paper-based QMSThe effectiveness of document-signing partiesWhat the implementation of the eQMS was likeWhat isn’t validated out of the boxComplaints or challenges in the beginningHow to ensure traceability between risk and design controlsWhat to do with the physical documents after switching to eQMSA realistic timeline from purchase to implementationMemorable quotes from Kendyl Williams:“I know Greenlight has definitely changed a lot since we used it last, and I love all the new features that have come out because I think they really help to set people up for success when getting into Greenlight.”“I think my team struggled initially with the nomenclature of documents.”“The sandbox is also just a fun place to poke around.”“What I usually tell people building an eQMS is to be intentional in your setup.”Links:Kendyl Williams LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What 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 of.Some of the highlights of this episode include:Different types of sterilizationDifferent sterilization modalitiesChoosing gas vs. radiationTools of the sterilization tradeWhat to do when you have dose audit failureWhat “too numerous to count” meansSterility pitfallsMemorable quotes from Laura Maher:“Biology is my main passion with chemistry kind of like behind it.”“People will talk your ear off about sterility all day, which is super fun.”“Packaging is a huge component of sterility because it IS your sterile barrier.”“If you have a chance to see a Gamma source, take it. It is really cool.”Links:Laura Maher’s LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru