In this episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates. They delve into the recent FDA proposed rule for wound dressings, addressing the classification and regulatory impacts on medical device manufacturers. The discussion covers the historical context, the potential implications for the industry, and strategies for companies to navigate these changes.Key Timestamps:[00:00] - Introduction to the episode and guests[02:15] - Overview of Greenlight Guru's QMS software[04:30] - Introduction to the FDA's proposed rule on wound dressings[06:00] - Mark DuVal discusses the broad implications of the proposed rule[12:45] - Kathy Herzog explains the performance requirements and administrative record[22:00] - Discussion on industry response and potential litigation[30:30] - Impacts on existing and new products in the market[40:20] - Strategies for companies to navigate the proposed changes[50:00] - Broader implications for the FDA and potential future regulations[60:00] - Final thoughts and ways to stay informedQuotes:"This proposed rule feels like a solution in search of a problem." - Mark DuVal"It's unsustainable that small wound dressing manufacturers would have to bear that burden on the back of an individual wound dressing." - Kathy Herzog"FDA's move to over-regulate well-settled product categories is deeply concerning." - Mark DuValKey Takeaways:MedTech Trends:The FDA's proposed rule could significantly impact the classification and regulation of wound dressings.There is substantial industry opposition to the proposed rule, with many companies and trade associations voicing their concerns.The broader implications of the FDA's actions suggest a shift towards more aggressive regulatory measures.Practical Tips:Stay informed about regulatory changes and participate in comment periods to voice concerns.Prepare for potential new testing and data requirements by reviewing current performance testing protocols.Engage with industry groups and legal experts to understand the full impact of proposed regulations.Future Developments:How will the FDA address industry pushback and potential litigation against the proposed rule?Will there be additional guidance from the FDA to help manufacturers navigate the new requirements?What other product categories might the FDA target for reclassification in the near future?References:Greenlight Guru QMS SoftwareFDA Proposed Ruling on Wound DressingsDuVal & Associates Client Alert on FDA Proposed RuleAlliance of Wound Care StakeholdersWashington Legal FoundationConnect with Etienne Nichols on LinkedInMedTech 101:Classification of Medical Devices: Medical devices are classified into three categories based on their risk level: Class I (low risk), Class II (moderate risk), and Class III (high risk). The FDA's proposed rule aims to classify certain wound dressings, potentially impacting their regulatory requirements.510(k) Clearance: A premarket submission to the FDA demonstrating that the device to be marketed is at least as safe and effective, substantially equivalent, to a legally marketed device.Questions for the Audience:Poll: How do you think the FDA's proposed rule on wound dressings will impact innovation in the medical device industry? Email us at podcast@greenlight.guruFeedback:We'd love to hear your thoughts on this episode! Please leave us a review on iTunes and let us know how we're doing. For suggestions on future topics, email us at podcast@greenlight.guruSponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Elevate your quality, boost your productivity, and bring your devices to market faster with Greenlight Guru. Check out www.greenlight.guru for more information and special offers for our listeners.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Gail Lebovic, an internationally recognized oncoplastic surgeon and innovative entrepreneur. They delve into the evolving landscape of MedTech, focusing on the shift from traditional reimbursement models to direct-to-consumer strategies. Dr. Lebovic shares her journey of pioneering nasal health products during the COVID-19 pandemic, emphasizing the importance of flexibility and addressing real clinical needs. The conversation explores the broader implications for the future of healthcare, prevention, and patient empowerment.Key Timestamps:[02:15] – Introduction to Dr. Gail Lebovic and her background.[06:45] – Discussing the shift from traditional payer models to direct-to-consumer strategies.[12:30] – Challenges faced during the COVID-19 pandemic and pivoting strategies.[20:00] – The importance of flexibility in MedTech innovation.[30:10] – The significance of nasal health and hygiene.[40:25] – Going to market on Amazon and its impact on the business.[50:50] – Future trends in MedTech and women's healthcare.[01:05:15] – Advice for aspiring MedTech entrepreneurs.Quotes:"People are smart, our patients are smart, and all of our patients are consumers." – Dr. Gail Lebovic"Healthcare is really not healthcare; it's really sick care." – Dr. Gail LebovicTakeaways:Key Insights:The shift from traditional reimbursement models to direct-to-consumer strategies can enhance patient care and accessibility.Prevention and self-care are becoming increasingly important in the healthcare landscape.Innovation in MedTech requires flexibility, robust research, and addressing real clinical needs.Practical Tips:Stay open to changing strategies based on market demands and environmental factors.Ensure your product stands out by maintaining high clinical standards, even in consumer markets.Utilize platforms like Amazon to reach a broader audience while maintaining rigorous quality controls.Future Questions:What new preventive health products will emerge in the next five years?How will the healthcare system adapt to increasing patient empowerment and self-care trends?References:Greenlight Guru – For all-in-one QMS software designed specifically for the medical device industry. Visit Greenlight Guru.Silicon Valley Innovations – Founded by Dr. Gail Lebovic, introducing anatomically directed drug delivery. Learn More.Dr. Gail Lebovic on LinkedIn – Connect with Dr. Lebovic for more insights into MedTech innovations. Connect on LinkedIn.Nasoclenz on Amazon - Check out how Silicon Valley Innovations is marketing their products direct-to-consumer on Amazon. Learn more.MedTech 101:Direct-to-Consumer (DTC) Strategy:A direct-to-consumer (DTC) strategy involves marketing and selling products directly to consumers, bypassing traditional healthcare providers or payers. This approach can increase accessibility, reduce costs, and empower patients to take control of their health.Nasal Hygiene:Nasal hygiene refers to the practice of cleaning and maintaining the nasal passages to prevent infection and improve overall respiratory health. Similar to brushing teeth, regular nasal cleansing can help remove pollutants, allergens, and pathogens.Discussion Question:What are your expectations for future healthcare changes due to advancements in MedTech? Email us at podcast@greenlight.guruFeedback:We'd love to hear your thoughts on this episode! Please leave us a review on iTunes and email us your feedback and suggestions for future topics at podcast@greenlight.guruSponsors:This episode is sponsored by Greenlight Guru, the industry's leading eQMS software designed to ensure compliance, accelerate innovation, and simplify the entire product lifecycle for medical device companies. Visit Greenlight Guru to learn more and get a special offer for podcast listeners.

In this episode, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies. Shaherah shares her extensive experience in the field, providing practical advice on securing funding, ensuring market access, and achieving market adoption. They explore the nuances of clinical evidence, the significance of strategic planning, and the role of advisory panels in navigating the MedTech landscape.Key Timestamps:00:00 - 03:00 Introduction and Sponsor Message03:01 - 05:20 Introduction to Shaherah Yancy and her background05:21 - 10:30 Importance of Clinical and Regulatory Strategies10:31 - 17:15 Challenges of Securing Funding and Developing Strategy17:16 - 25:45 Differences Between Market Access and Market Adoption25:46 - 33:50 Developing Effective Clinical Plans for Market Adoption33:51 - 39:40 Importance of Evidence and Study Design39:41 - 48:00 Examples and Case Studies from Early Stage Companies48:01 - 55:15 Endpoints for Market Adoption55:16 - 01:02:30 Strategies for Novel Technologies01:02:31 - 01:07:45 Final Advice and Contact InformationNotable Quotes:"Market access is a milestone. Market adoption is the goal." - Shaherah Yancy"Understanding the problem you’re solving is crucial for your strategy." - Shaherah Yancy"Don’t be afraid of clinical evidence; it’s your key to success." - Shaherah YancyKey Takeaways:MedTech Trends:Strategic Planning is Essential: Early and comprehensive planning for clinical and regulatory strategies can significantly enhance a company's chances of success.Clinical Evidence is Critical: Collecting robust clinical data is vital for both market access and long-term market adoption.Market Adoption Over Market Access: The ultimate goal should be market adoption, not just getting to market.Practical Tips:Form Advisory Panels: Engage with surgeons and clinical experts early to guide product development and market entry strategies.Comprehensive Studies: Design studies that include both primary endpoints for regulatory approval and secondary endpoints for market adoption.Prepare for Limited Market Releases: Use limited market releases to gather real-world evidence and refine products before a full launch.References:Research Lifecycle Solutions: Shaherah Yancy's company, specializing in clinical and regulatory strategies for MedTech. RLC SolutionsGreenlight Guru Clinical: The sponsor of this episode, offering a platform for streamlining clinical trials. Greenlight Guru ClinicalEtienne Nichols LinkedIn: Connect with Etienne on LinkedIn for more insights. Etienne Nichols LinkedInMedTech 101:Clinical Evidence: Data collected from clinical trials and studies to demonstrate the safety and efficacy of a medical device.510(k) Clearance: A premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device.PMA (Pre-Market Approval): The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.Audience Questions:Poll: What MedTech advancements are you most excited about in 2024? Email us at podcast@greenlight.guru with your thoughts!Discussion: What changes do you expect to see in healthcare due to MedTech innovations in the next five years? Share your thoughts at podcast@greenlight.guruFeedback:We'd love to hear your feedback on this episode! Leave us a review on iTunes and let us know what topics you’d like us to cover in future episodes. Email us at podcast@greenlight.guru with your suggestions and feedback.Sponsors:Greenlight Guru Clinical: Revolutionize your clinical trials with Greenlight Guru Clinical. Discover how our platform can help you streamline processes, ensure compliance, and accelerate your time to market. Visit Greenlight Guru Clinical for more information and special offers for our listeners.

In this episode of the Global Medical Device Podcast, host Etienne Nichols, along with part-time co-host Stephanie Hinton, dives into the art of clinical trial recruitment with Dr. Kelly Palmer, Assistant Professor at the University of Arizona. Dr. Palmer shares her extensive experience and innovative strategies for overcoming recruitment challenges, emphasizing the importance of community engagement, tailored approaches, and flexibility. The discussion highlights how to recruit diverse populations, manage logistical complexities, and ensure participant engagement, ultimately enhancing the success of clinical trials.Key Timestamps:[00:02] – Introduction by Etienne Nichols[00:52] – Introduction of Dr. Kelly Palmer by Stephanie Hinton[03:15] – Kelly Palmer’s background and approach to recruitment[06:45] – Strategies for effective participant recruitment[12:30] – Building relationships with community organizations[18:00] – Overcoming practical challenges in clinical trials[26:45] – Using technology for data capture and improving efficiency[36:10] – Stories of recruitment challenges and solutions[45:00] – Key takeaways and advice for clinical trial professionalsQuotes:"Recruitment is not just about numbers; it's about building trust and relationships within the community." - Dr. Kelly Palmer"Think outside the box and always track your efforts to understand what works best." - Dr. Kelly Palmer"In research, you have to be flexible and ready to adapt to the needs of your participants." - Stephanie HintonTakeaways:MedTech Trends:Community engagement is crucial for successful recruitment in clinical trials.Leveraging technology can streamline data capture and reduce errors.Flexibility and adaptability are key to managing logistical challenges in research.Practical Tips:Develop strong relationships with community organizations to build trust and facilitate recruitment.Implement electronic data capture systems to improve efficiency and accuracy.Always have backup plans for logistics and be prepared to pivot quickly.Future Predictions:Increased use of AI and technology to enhance recruitment and data management.Growing emphasis on diversity and inclusion in clinical trial populations.Greater collaboration between researchers and community organizations.References:Greenlight Guru Clinical – Learn more about their all-in-one clinical development platform.IU School of Medicine – Collaboration with community organizations for recruitment.Dr. Kelly Palmer on LinkedInStephanie Hinton on LinkedInEtienne Nichols on LinkedInMedTech 101:Clinical Trial Recruitment: The process of enrolling participants into clinical trials, crucial for gathering data to test the efficacy and safety of new medical devices or treatments. Effective recruitment strategies ensure diverse and representative sample sizes, enhancing the reliability of study outcomes.Electronic Data Capture (EDC): A digital system for collecting and managing clinical trial data in real-time, reducing errors associated with manual data entry and improving data accuracy and efficiency.Call to Action: Share your thoughts by emailing us at podcast@greenlight.guru and participate in our audience poll on MedTech advancements!Feedback:Enjoyed this episode? Leave us a review on iTunes! Your feedback helps us improve and reach more listeners. Connect with Etienne Nichols on LinkedIn and share your thoughts or suggest future topics.Sponsors:This episode is brought to you by Greenlight Guru Clinical. Simplify your clinical evidence generation with their powerful platform. Visit Greenlight Guru Clinical to request a personalized demo and learn more about their special offers for our listeners.

In this episode of the Global Medical Device Podcast, host Etienne Nichols talks with Mitch Robbins, founder of the Anthony Michael Group, about the evolving landscape of hiring and job seeking in the MedTech industry in 2024. They discuss strategies for both employers and job seekers, emphasizing the importance of preparation, effective communication, and proactive networking. Mitch shares actionable tips to enhance the interview experience and improve hiring outcomes, making this episode essential listening for anyone involved in MedTech recruitment.Key Timestamps:[00:00] - Introduction and overview of the episode[03:15] - Mitch Robbins on the current state of the MedTech job market[07:30] - Importance of candidate experience in the hiring process[12:45] - Preparing for job interviews: Insights and tips[25:10] - Effective networking strategies for job seekers[35:00] - Onboarding new hires: Best practices[45:30] - Overcoming the challenges of layoffs and finding new opportunities[55:00] - Final thoughts and advice from Mitch RobbinsQuotes:"The more value you demonstrate throughout the interview process, the more leverage you create for yourself." - Mitch Robbins"Hiring is a team sport. It takes a team to court a candidate." - Mitch Robbins"Always try to think above the line, like, how can I get to this person warmly?" - Mitch RobbinsTakeaways:Key Insights about the Latest MedTech Trends:The current job market has shifted to favor employers, making candidate experience crucial.Networking and leveraging personal connections are more important than ever for job seekers.Proactive follow-ups and personalized communication can significantly increase your chances of landing a job.Practical Tips for Listeners Interested in MedTech:Prepare thoroughly for interviews by researching the company and understanding their needs.Utilize LinkedIn and other professional networks to connect with potential employers and peers.Be proactive in your job search by reaching out directly to hiring managers and using creative approaches like video introductions.Questions Predicting Future Developments in the Field:How will the increasing reliance on remote work impact hiring practices in the MedTech industry?What new technologies will emerge to assist with the hiring and onboarding process?How will the balance of power between employers and job seekers continue to evolve in the next few years?References:Greenlight Guru - The game-changing solution for medical device companies looking to streamline their quality and clinical processes. Anthony Michael Group - Mitch Robbins' executive search firm specializing in the MedTech industry. Mitch Robbins on LinkedInEtienne Nichols on LinkedInMedTech 101:For new listeners, here are some basic terms and concepts discussed in this episode:EQMS (Enterprise Quality Management Software): Software that helps manage quality processes within an organization.EDC (Electronic Data Capture): Systems used to collect clinical trial data electronically.Regulatory Submissions: Documentation required by regulatory bodies to approve new medical devices for market release.Questions for the Audience:Audience Poll: What MedTech advancement do you think will have the biggest impact on patient care in the next five years? Email us at podcast@greenlight.guru.Discussion Question: How do you see the role of remote work evolving in the MedTech industry? Share your thoughts with us at podcast@greenlight.guru.Feedback:We value your feedback! Please leave a review on iTunes and let us know how we're doing. Your input helps us improve and bring you more valuable content. For suggestions on future topics, email us at podcast@greenlight.guru.Sponsors:This episode is sponsored by Greenlight Guru. Streamline your quality and clinical data management with Greenlight Guru's EQMS and EDC platforms. Visit Greenlight Guru to learn more and take your medical device company to the next level.

In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Jamie Bihary, a Medical Device Guru at Greenlight Guru. Jamie shares her journey from biomedical engineering to her current role, where she helps companies transition from legacy quality management systems (QMS) to cutting-edge electronic QMS (EQMS). They discuss the common challenges faced during these transitions, the importance of environmental monitoring in clean rooms, and practical advice for managing QMS implementations. Jamie also highlights the value of Greenlight Guru’s resources, including their robust partner network and support systems.Key Timestamps:00:00 - 02:00 Introduction and Jamie Bihary’s background02:01 - 05:30 A day in the life of a Medical Device Guru at Greenlight Guru05:31 - 10:15 Common challenges faced by new MedTech companies10:16 - 15:00 Jamie’s journey from biomedical engineering to Greenlight Guru15:01 - 20:30 Implementing EQMS and document migration process20:31 - 25:45 Importance of environmental monitoring in clean rooms25:46 - 30:10 Transitioning from legacy systems to EQMS30:11 - 35:00 The value of internal audits and giving/receiving feedback35:01 - 40:15 Greenlight Guru’s partner and alliance network40:16 - 45:00 Key advice for companies starting or transitioning QMSQuotes:"Our system had done really well with past audits, so it was crucial that we made the transition smoothly and accurately." – Jamie Bihary"Everyone in your organization impacts product quality in some capacity." – Jamie BiharyTakeaways:Key Insights:Transitioning from legacy QMS to EQMS can significantly streamline quality management processes and enhance efficiency.Internal audits and open communication are vital for continuous improvement and compliance in the MedTech industry.Practical Tips:Establish a detailed implementation plan for QMS transitions to ensure a clear and documented process.Utilize the resources and support offered by partners and consultants to manage workload and expertise gaps.Regularly conduct internal audits and encourage a culture of feedback to identify and rectify potential issues early.Future Questions:How can smaller MedTech companies best leverage partnerships to stay competitive?References:Greenlight Guru: Learn more about their EQMS solutions and support network.FDA Database: Reference for regulatory guidelines and compliance.LinkedIn Profile of Jamie Bihary: Connect with Jamie for more insights and support.MedTech 101:Quality Management System (QMS): A QMS is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organization's activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.Electronic Quality Management System (EQMS): An EQMS is a digital version of a QMS, offering automated processes, real-time data access, and integration with other enterprise systems to enhance compliance, efficiency, and overall quality management.Questions for the Audience:Poll: What is the biggest challenge you face when transitioning from a legacy QMS to an EQMS? Email us your answers at podcast@greenlight.guru.Feedback:We’d love to hear your feedback on this episode! Please leave a review on iTunes and share your suggestions for future topics. Email us at podcast@greenlight.guru.Sponsors:Greenlight Guru: Elevate your QMS with Greenlight Guru’s cutting-edge EQMS solutions, designed specifically for the MedTech industry. Visit Greenlight Guru to learn more and take advantage of special offers for our listeners.

In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification. The discussion covers the importance of gap analysis, the value of a compliant agile approach, and the benefits of using Greenlight Guru’s eQMS software. Listeners will gain valuable insights into maintaining compliance and continuous improvement in the MedTech industry, as well as practical advice for navigating ISO 13485 certification.Key Timestamps00:00 - 02:00 - Introduction by Etienne Nichols02:00 - 05:30 - Introduction to HTD Health and their focus05:30 - 10:45 - Discussion on the importance of ISO 13485 certification10:45 - 14:30 - Steps and preparations for achieving ISO 13485 certification14:30 - 20:00 - Benefits and features of using Greenlight Guru’s eQMS20:00 - 25:00 - Challenges and changes faced during the certification process25:00 - 30:00 - Practical tips for preparing for an ISO 13485 audit30:00 - 35:00 - Continuous improvement and future goals for HTD Health35:00 - 40:00 - Closing thoughts and advice from Weonika Michaluk and Zach MarkinNotable QuotesWeronika Michaluk: "Do a proper gap analysis and also think whether you have enough knowledge internally... it will make your life easier to reach out to a partner or consultant."Zach Markin: "In services, there’s not one ideal agile, but the right flavor of agile for the work that needs to be done."Weronika Michaluk: "Using Greenlight Guru made our lives easier, especially in managing traceability and ensuring compliance."Key TakeawaysPractical Tips for MedTech EnthusiastsGap Analysis: Conduct a thorough gap analysis to understand current capabilities and areas needing improvement.Internal Expertise: Ensure you have the necessary internal expertise or consult with experienced partners.Continuous Improvement: Regularly update and improve your processes to maintain compliance and efficiency.ReferencesISO 13485 Certification: Learn about the ISO 13485 standard for medical devicesVisit Greenlight Guru for eQMS software solutionsHTD HealthWeronika Michaluk on LinkedInZack Markin on LinkedInConnect with Etienne Nichols on LinkedIn.MedTech 101Explainer for New ListenersISO 13485: An international standard that outlines the requirements for a quality management system specific to the medical device industry. It ensures that organizations consistently meet customer and regulatory requirements related to medical devices.QMS (Quality Management System): A structured system of procedures and processes covering all aspects of design, manufacturing, and distribution to ensure products meet regulatory standards and customer expectations.CAPA (Corrective and Preventive Action): A process within a QMS to investigate and correct the root causes of identified issues and prevent their recurrence.Audience EngagementPoll QuestionWhat MedTech innovation are you most excited about?Email your thoughts to podcast@greenlight.guru and let us know!Discussion QuestionWhat do you expect will be the most significant change in healthcare due to MedTech advancements in the next decade? Share your thoughts and join the conversation by emailing podcast@greenlight.guru.Feedback RequestWe'd love to hear your feedback on this episode! Please leave us a review on iTunes and share your thoughts on LinkedIn. Your input helps us improve and bring you the most valuable content. Email us at podcast@greenlight.guru with your suggestions for future topics and any questions you have.SponsorsGreenlight GuruThis episode is brought to you by Greenlight Guru. Simplify your ISO 13485 certification journey with Greenlight Guru’s eQMS software. Our platform is designed to streamline document control, audit prep, and risk management, keeping you ahead of the compliance curve. Visit Greenlight Guru to learn more and take the first step towards simplifying your certification process.

In this engaging episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Ron Richard, a seasoned expert in the medical device industry with over 35 years of experience. The discussion delves into the essentials of bringing a medical device to market, from the inception of an idea to commercialization. Ron shares his journey, the importance of effective elevator pitches, the nuances of regulatory pathways, and practical tips for aspiring inventors. With insights on avoiding common pitfalls and strategies for securing funding, this episode is a treasure trove for anyone interested in MedTech innovations.Key Timestamps:[00:00] - Introduction and Ron Richard’s background[04:50] - Early successes in inventing and bringing products to market[10:30] - Validating ideas and market need[17:15] - Regulatory pathways: 510(k) vs. PMA[24:00] - Class I products and direct-to-consumer strategies[30:45] - Funding strategies: Family and friends, VC, and IPO[42:20] - Overcoming pitfalls and avoiding shiny object syndrome[49:10] - The importance of having a clear cap table[55:30] - The chasm: Making the leap from idea to market[01:01:45] - Final takeaways and advice for MedTech innovatorsQuotes:Ron Richard: “One of the biggest things I tell inventors is that in order for you to raise money, people have to trust you and like you. You have to share within 30 seconds what your product does and what problem it solves.”Etienne Nichols: “Pioneers get shot, settlers get rich. You can be innovative with a 510(k) product by making evolutionary improvements.”Ron Richard: “The road to success is always under construction. Be prepared for obstacles and have a plan to navigate through them.”Key Takeaways:Practical Tips:Elevator Pitch: Develop a concise and compelling elevator pitch that clearly communicates your product’s value.Validate Early: Use focus groups and stakeholder interviews to validate your idea before heavily investing.Funding Strategy: Start with family and friends for initial funding, then approach VCs once you have patents and prototypes.Future Predictions:Increased Scrutiny: Regulatory bodies like the FDA may become more stringent, requiring more comprehensive testing and validation.Telemedicine Integration: Future medical devices will likely need to integrate telemedicine capabilities to stay competitive.AI and Diagnostics: Artificial Intelligence will play a significant role in diagnostics and personalized medicine, offering new avenues for innovation.References:Ron Richard's Book: "Someday is Today: Get Your Ideas Out of Your Coffee Cup and on the Market" - [Amazon Link]Etienne Nichols' LinkedIn: Etienne Nichols on LinkedInRon Richard’s Website: Inventing Starts TodayMedTech 101:Basics of Medical Device Classification:Class I: Low risk, often exempt from premarket notification (510(k)).Class II: Moderate risk, typically requires 510(k) premarket notification.Class III: High risk, requires PMA (Premarket Approval) with extensive data.Questions for the Audience:Poll: What MedTech innovation do you think will have the most significant impact in the next five years? (Options: AI-driven diagnostics, wearable health monitors, surgical robots)Share your thoughts with us at podcast@greenlight.guruFeedback:We’d love to hear your thoughts on this episode! Leave us a review on iTunes and send your feedback or suggestions for future topics to podcast@greenlight.guru. Your input helps us improve and bring you the most valuable content.Sponsors:Unlock MedTech success with Greenlight Guru’s industry-leading Quality Management Software (eQMS) and Electronic Data Capture (EDC) solutions!Why Choose Greenlight Guru?Purpose-Built for MedTech: Our eQMS and EDC solutions are designed specifically for the unique needs of medical device companies, ensuring compliance with FDA, ISO, and other global regulations.Streamline Compliance: Easily manage document control, risk management, and CAPA processes with eQMS, and streamline clinical data management with our intuitive EDC system.Accelerate Time to Market: Efficiently navigate regulatory pathways and bring your innovative products to market faster with our integrated, user-friendly platforms.Enhance Product Quality and Data Integrity: Maintain the highest standards of quality throughout your product lifecycle, from design and development to post-market surveillance, while ensuring robust data capture and management.Expert Support: Benefit from our team of MedTech experts who understand your challenges and are dedicated to your success.Unlock the full potential of your medical device company with Greenlight Guru. Visit greenlight.guru Greenlight Guru – Your Partner in Quality, Compliance, and Clinical Data Management. Because in MedTech, quality and data integrity are everything.

In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk devices, and share invaluable advice on mitigating risks associated with clinical trials. Whether you're a newcomer or a seasoned professional in the MedTech industry, this episode offers essential insights to ensure your clinical studies are compliant and efficient.Key Timestamps:00:01:20 – Introduction to Dr. Mike Drues and his accolades.00:05:30 – Explanation of IRBs and their role in clinical trials.00:15:10 – Differences between traditional and commercial IRBs.00:22:40 – Discussion on significant vs. non-significant risk devices.00:32:00 – Importance of pre-submission meetings with the FDA.00:44:15 – Steps to take when an IRB disapproves your clinical trial.01:00:30 – Practical tips for choosing the right IRB for your study.Quotes:"Most 510 devices do not need clinical data. But if you do, even for a non-significant risk device, vetting that with the FDA in advance is wise." – Dr. Mike Drues"You don't want to create a problem where none exists, but avoiding FDA consultation can lead to costly surprises later." – Dr. Mike Drues"The primary mission of an IRB is to ensure the safety of the patients at that institution." – Dr. Mike DruesTakeaways:Key Insights:Understanding IRBs: IRBs are local entities responsible for the ethical oversight of clinical trials, ensuring patient safety and compliance.Risk Classification: The classification of your device as significant or non-significant risk dictates whether FDA approval is needed for your clinical trial.Strategic Pre-Submission: Engaging in a pre-submission meeting with the FDA can prevent costly delays and ensure your clinical trial meets all necessary endpoints.Practical Tips:IRB Shopping: If faced with an IRB denial, consider alternative institutions or commercial IRBs to avoid delays.Comprehensive Submissions: Prepare thorough submissions for IRBs, including device descriptions, clinical trial protocols, and informed consent forms.Physician Champions: Having a physician advocate at the institution can streamline the approval process and facilitate patient enrollment.Future Questions:How will the evolving landscape of MedTech regulations impact the approval process for new devices?What role will real-world evidence play in future clinical trials for medical devices?How can smaller companies navigate the complexities of FDA and IRB requirements effectively?References:Etienne Nichols on LinkedInMike Drues on LinkedInGreenlight Guru can help with Clinical InvestigationsGood Clinical Practices (GCP) regulations for IRBsMedTech 101:What is an IRB?An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of an IRB is to ensure the ethical and safe treatment of participants in clinical trials.What is an IDE?An Investigational Device Exemption (IDE) allows a medical device to be used in a clinical study to collect safety and effectiveness data. An IDE must be approved by the FDA for significant risk devices before a clinical study can begin.Questions for the Audience:Poll: Have you ever faced challenges with IRB approvals for your medical device clinical trials? Share your experiences at podcast@greenlight.guruFeedback:We'd love your feedback on this episode! Please leave us a review on iTunes and share your suggestions for future topics. Email us at podcast@greenlight.guruSponsors:Greenlight GuruRevolutionize your clinical study process with Greenlight Guru’s state-of-the-art electronic data capture (EDC) system, designed specifically for the medical device industry. Streamline your clinical data management, ensure compliance, and make informed decisions with real-time insights. Visit Greenlight Guru today to learn more and take advantage of our special offers for podcast listeners.

In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Etienne shares practical tips and personal anecdotes that reveal the nuances of the MedTech industry, making this episode a treasure trove of knowledge for both new and seasoned professionals.Key Timestamps:[02:15] - Introduction and Etienne’s journey to becoming a podcast host[12:30] - The importance of vulnerability and honesty in product development[22:45] - Balancing quality for audits versus operational benefits[30:10] - Human factors and usability in MedTech product development[37:55] - Simplifying quality management systems[45:00] - The mantra of learn, lead, and love in networking[54:20] - Encouraging emerging entrepreneurs to own their expertise and impact regulationsQuotes:"The heart of the problem is the seed of the solution.""Quality management documents should benefit your company first and be audit-ready second.""Be genuinely curious. Assume the person in front of you knows something worth listening to."Takeaways:Key Insights on the Latest MedTech Trends:Human factors and usability are often misunderstood but crucial in MedTech product development.Quality management systems should be practical and beneficial for the company, not just for audits.Networking is more than collecting business cards; it's about building meaningful connections.Practical Tips for MedTech Professionals:Be vulnerable and honest about the state of your projects.Focus on solving the right problems and avoid over-engineering.Create quality management documents that are easy to understand and useful for your team.Questions Predicting Future Developments:How will AI and machine learning shape the future of MedTech product development?What emerging trends in usability and human factors will impact regulatory changes?How can MedTech companies better prepare for cybersecurity challenges?References:Greenlight Guru - Quality management software for medical devices.Etienne Nichols - LinkedInDevon Campbell - LinkedInProdct LLC - Devon's advisory firmFred Crosby’s Quality is Free - A book on quality management principles.Beginner's Section: MedTech 101Quality Management System (QMS): The system that outlines the processes and procedures to ensure product quality.Human Factors and Usability: The study of how people interact with products to improve design and user experience.Regulatory Strategy: The plan for complying with regulations to bring a medical device to market.Questions for the Audience:Poll: What do you think will be the most impactful MedTech advancement in the next five years? Email us your thoughts at podcast@greenlight.guruFeedback:We'd love to hear your feedback on this episode! Please leave us a review on iTunes and share your thoughts and suggestions for future topics. Email us at podcast@greenlight.guru with your ideas and comments.Sponsors:This episode is sponsored by Greenlight Guru. Their all-in-one platform is designed specifically for the unique needs of the medical device industry, helping you maintain compliance, reduce risk, and improve quality. Visit www.greenlight.guru today to learn how their platform can transform your medical device development process.