Global Medical Device Podcast powered by Greenlight Guru Greenlight Guru + Medical Device Entrepreneurs

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 & Associates
As 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 Herzog
Reference Links:
Lisa PritchardKathy HerzogEtienne NicholsGreenlight GuruDuVal & AssociatesClient Alert: "eSTAR & I"FDA eSTAR Program webpageFDA electronic Submission Template guidance for 510(k) Submissionsa...

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 Schroeder
Reference Links:
Wade Schroeder on LinkedInAI in MedTech Report 2023Digital GuruGreenlight GuruEtienne Nichols on LinkedIn
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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 Campbell
Reference Links:
Devon CampbellProdctGreenlight GuruEtienne Nichols' LinkedIn
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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 Drues
Reference 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
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Description:
In this episode, Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dives deep into the complexities of FDA submissions for medical devices.
She sheds light on the nuances of different submission types, such as 510K, De Novo, and PMA, and underscores the criticality of timelines, strategic planning, and a robust Quality Management System (QMS).
Reynolds also guides listeners through effective FDA interactions, the eSTAR system, and the significance of building relationships with review teams. Her expertise illuminates the path to successful FDA submissions, emphasizing preparation, organization, and proactive engagement with regulatory bodies.
Some of the highlights of this episode include:
Strategic alignment of clinical trials with market launch timelines is crucial for successful FDA submissions.Differentiating between submission types (510K, de novo, PMA) and how they are essential for navigating the regulatory landscape.Early interactions with the FDA through Q submissions and how those interactions streamline the market submission process.The importance of understanding and managing FDA review timelines, including potential pauses and extensions.How utilizing eSTAR helps identify documentation gaps and assess submission readiness.How pre-submission meetings with the FDA are instrumental in addressing potential gaps and receiving regulatory pathway guidance.The importance of comprehensive preparation and organization facilitate expedited FDA review, despite uncontrollable factors.
Quote:
"Interact with FDA early and often. It's what ultimately will make your submissions as seamless as possible." - Ellie Reynolds
Reference Links:
Ellie Reynolds LinkedInGreenlight GuruEtienne Nichols LinkedIn
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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 Drues
Reference Links:
GG Academy - use Promo Code "podcast25" for a 25% discountGreenlight GuruVascular SciencesMichael Drues LinkedInEtienne Nichols LinkedIn
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