Global Medical Device Podcast powered by Greenlight Guru

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 LinkedInetienne.nichols@greenlight.guruGG 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