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!

Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, shares insights on FDA submissions for medical devices. She discusses different submission types, early FDA interactions, eSTAR system, and building relationships with review teams. Reynolds emphasizes preparation, organization, and proactive engagement with regulatory bodies for successful submissions.

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!