Description In April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device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 Questions AskedWhat does artificial intelligence mean in software as a medical deviceWhy is this new draft guidance needed?What recommendation for medical device companies does the draft guidance provide?What are the challenges with validating the modifications for an ML-DSF?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 Drues Reference LinksDraft FDA GuidanceEtienne NicholsGreenlight Guru


#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices

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In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates.  The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.Key Timestamps:[00:00:15] - Introduction by Etienne Nichols.[00:01:30] - Howard Root's background and the origins of Vascular Solutions.[00:05:00] - Mark DuVal introduces Howard Root, detailing his legal battles.[00:10:00] - Howard Root discusses the intricacies of his federal indictment and the subsequent trial.[00:30:00] - Discussion on corporate responsibility and regulatory implications in the MedTech industry.[00:50:00] - Audience Q&A; session with Howard Root and Mark DuVal.[01:10:00] - Closing remarks and takeaways.
Quotes:Howard Root: "We're not imposing rules at the bare legal minimum...we want to have a gray area. It’s why you drive 55 in a 60 zone."Mark DuVal: "Always be truthful, fairly balanced, and not misleading when discussing device applications."
Takeaways:Latest MedTech Trends:Increased scrutiny on off-label promotions highlights the need for clear regulatory strategies.Growing legal precedents emphasize the importance of corporate responsibility at all levels of operation.The role of ethical practices in sustaining innovation within the MedTech industry.
Practical Tips for MedTech Professionals:Ensure thorough understanding and compliance with FDA guidelines and local regulations.Implement robust training and compliance programs for all staff, particularly in sales and marketing.Engage experienced legal counsel to navigate complex regulatory landscapes.
Future Predictions in MedTech:Enhanced regulatory frameworks to better define and manage off-label use.Greater use of AI and data analytics to monitor compliance and ethical practices.Increased advocacy for legislative changes to protect innovators from aggressive legal challenges.
References:Howard Root's book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List"Mark DuVal on LinkedInDuVal & Associates Client AlertsFDA guidelines on off-label promotions<a href="https://www.linkedin.com/in/etiennenichols/" rel="noopener noreferrer"...

#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List

In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up robust reporting processes and explains how manufacturers can avoid common pitfalls. Key Timestamps:[01:20] Introduction of Lisa Van Ryn and discussion on FDA's Medical Device Reporting[05:45] Lisa's transition from the restaurant industry to medical devices[10:30] What triggers a medical device report to the FDA?[15:25] Role-play on handling complaints and determining reportability[25:00] Detailed explanation of the decision tree for reporting[35:15] Differentiating between device malfunctions and serious injuries[40:10] Real-life examples and clarifying complex reporting scenarios[50:30] The repercussions of late reporting and the importance of timing[55:20] Wrapping up and resources for deeper understanding
Insightful Quotes:"Every complaint needs to be evaluated to determine if it is reportable under 21 CFRR Part 803." - Lisa Van Ryn"Having a beginner’s mindset but the heart of a teacher is essential in the medical device industry." - Etienne Nichols"If you’re not considering the feedback as important, whether it’s reportable or not, you are missing valuable data." - Lisa Van Ryn
Key Takeaways:Understanding MDR: The importance of being thoroughly familiar with Medical Device Reporting guidelines to ensure proper reporting and compliance.Setting Up Processes: Tips on setting up an effective complaint handling system to manage and report incidents correctly.Common Pitfalls: Common issues manufacturers face and how to avoid them by implementing efficient and compliant processes.
References and Resources:Medical Device Reporting (MDR): How to Take Advantage of Your Electronic RecordsLisa Van Ryn on LinkedInEtienne Nichols on LinkedIn
Beginner’s Section: MedTech 101Medical Device Reporting (MDR): This refers to the regulatory process in which manufacturers are required to report certain types of incidents and malfunctions related to medical devices to the FDA.Serious Injury: A serious injury in the context of MDR is defined as an injury that is life-threatening, results in permanent impairment, or necessitates medical or surgical intervention to prevent permanent damage.Complaint Handling: The process by which manufacturers receive, review, and respond to customer complaints about the safety and quality of their medical devices.
Questions for the Audience:Poll: Do you believe current regulations on medical device reporting are sufficient for ensuring patient safety?
Feedback Request: We value your thoughts! Please leave us a review on iTunes and share your feedback. Your suggestions help us improve and guide our future topics. Email your thoughts and topic suggestions to podcast@greenlight.guru. Sponsors: This episode is brought to you by Greenlight Guru, a leading platform that offers MedTech companies a...

#365: Medical Device Reporting: The Do's and Don'ts

In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA regulatory pathways, Christine offers a wealth of knowledge. The discussion delves into the intricacies of working with regulatory consultants, the significance of FDA interactions, and practical tips for medical device startups aiming to maneuver through regulatory challenges successfully.Key Timestamps:[00:02:30] Christine's journey from biochemistry to medical device innovation[00:15:00] Insights on starting a medtech startup and the early failures[00:30:45] Effective collaboration with regulatory consultants[00:45:10] Handling FDA interactions and strategic submissions[01:00:20] Advice for medtech startups on navigating regulatory environments
Notable Quotes:"You're pitching all these awesome capabilities of your device, meanwhile on the FDA side, we're asking, who are you most like?" – Christine Luk"Every meeting is money. Making sure everybody is aligned and on the same page is crucial when dealing with consultants." – Christine Luk
Key Takeaways:Engage with local medtech communities and resources, such as accelerators or innovation hubs.Early interactions with the FDA can significantly influence your device’s regulatory pathway.Thorough documentation and clear communication with consultants are essential for effective project management.
References and Resources:Texas Medical Center Innovation InstituteProxima Clinical ResearchChristine Luk on LinkedInEtienne Nichols on LinkedIn
Call to Action:Feedback is crucial! Please email us your thoughts on this episode and suggestions for future topics at podcast@greenlight.guru Don’t forget to leave us a review on iTunes!Sponsor Segment:This episode is proudly sponsored by Greenlight Guru, a global leader in MedTech-specific software solutions. Whether you're in the clinical trial phase or ensuring compliance with quality standards, Greenlight Guru offers tailored solutions to streamline your processes. Their software is designed specifically for the medical device industry, helping companies accelerate their product development with confidence and compliance. Learn more about how Greenlight Guru can illuminate your path to market success by visiting their website at Greenlight Guru. Equip your team with the tools to simplify quality management and keep your focus on innovation and patient safety.

#364: Building a Partnership with your Regulatory Consultant

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow surgery devices. Dr. Hunter shares his experience from the conception of a simple yet effective surgical device through its development, struggles with initial licensing, and ultimate success in the market. The discussion highlights the importance of perseverance, the impact of regulatory insights, and the significant role of strategic innovation in enhancing patient outcomes.Key Timestamps:[00:45] - Introduction of Dr. Lee Hunter and his medical device journey.[05:30] - Challenges and breakthroughs in designing elbow surgery devices.[14:20] - The licensing journey and learning from initial failures.[22:50] - Insights into the current medical device market and innovations.[35:40] - Discussion on the importance of simplicity and efficiency in medical devices.[48:15] - Future directions in MedTech and advice for new innovators.
Memorable Quotes:"Sometimes the simplest solutions are the hardest to find but the most effective once implemented." - Lee Hunter
Key Takeaways:Innovation in MedTech: Dr. Hunter's journey emphasizes that true innovation often stems from a deep understanding of specific medical needs rather than broad technological applications.Challenges and Resilience: Early failures are often stepping stones to success, highlighting the importance of resilience and adaptability in the medical device industry.Future of MedTech: The potential for simpler, more effective devices that streamline medical procedures and improve outcomes is vast, urging current and future innovators to focus on practical and impactful innovations.
MedTech 101:In today's episode, terms like "elbow arthroscopy" and "lateral decubitus position" were discussed. Elbow arthroscopy involves a minimally invasive surgical procedure on the elbow using an arthroscope, while lateral decubitus position refers to the patient lying on their side, which is common during such surgeries.Call to Action:Did this episode on medical device innovation resonate with you? We would love to hear your thoughts and feedback. Leave us a review on iTunes and share your views on the future of MedTech innovations! For suggestions on future topics, please email us at podcast@greenlight.guruReferences:Hunter Medical DevicesDr. Lee hunter on LinkedInTennessee Orthopedic AllianceEtienne Nichols on LinkedIn
Sponsors:This episode is brought to you by Greenlight Guru, a leading company in medical device consulting. Their expertise and services align seamlessly with the needs of the MedTech community, helping bring revolutionary devices to the market efficiently. Check out their special offers for podcast listeners today!

#363: Bringing a Self-Funded Medical Device to Market

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. They delve into the dual aspects of risk management: ensuring product safety and the procedural risks associated with clinical protocols. Helene emphasizes the importance of a measurable, data-driven approach to balancing risks and benefits and discusses the challenges companies face in aligning their clinical investigations with stringent regulatory standards.Key Timestamps00:00:45 - Introduction to Helene Quie and the topic of risk management in clinical investigations.00:05:22 - Discussing the first leg of risk management: managing residual risks in product safety.00:17:50 - Exploring the second leg: the procedural risks in clinical protocols.00:28:30 - Challenges of enrollment and protocol design.00:35:45 - The impact of regulatory changes on clinical investigations.00:49:10 - Addressing the integration of artificial intelligence in medical devices.01:03:15 - Closing thoughts and call to action from Helene Quie.
Provocative Quotes"It's not just about managing risks; it's about ensuring that the benefits are powerful enough to justify those risks." - Helene Quie"Every clinical investigation introduces its own set of risks, not just from the product but from the study protocol itself." - Helene Quie"We must not only wear different glasses to see through the regulatory and practical aspects but also validate our views with the actual stakeholders involved." - Helene Quie
Key Takeaways1. Insights on MedTech Trends:The increasing importance of data in justifying product safety and efficacy.The shift from intuition-based to evidence-based risk assessment.Regulatory bodies are placing greater emphasis on comprehensive clinical evaluations.
2. Practical Tips for MedTech Professionals:Ensure that risk assessments are detailed and backed by solid data.Consider the practical aspects of clinical trial protocols from multiple perspectives.Stay updated on regulatory changes to adapt protocols and product development effectively.
3. Future Predictions in MedTech:Enhanced scrutiny and requirements for clinical investigations.Greater integration of AI and digital tools in medical devices.Potential regulatory adaptations to accommodate innovations.
ReferencesHelene Quie on LinkedInEtienne Nichols on LinkedInQMED ConsultingQuestions to ask for Clinical PreparationEUMDR and MDD Comparisons: Insights into how regulatory frameworks have evolved and their impact on medical device development.
MedTech 101For new listeners, this episode touches upon fundamental concepts like residual risk, clinical protocol, and risk-benefit assessment in the context of medical device clinical investigations. Understanding these terms is crucial for grasping the detailed discussions of the episode.Audience EngagementDiscussion Question: "What are your expectations for the future of healthcare with advancements in MedTech?"Feedback Request:...

#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices

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