In a today's conversation on the Global Medical Device Podcast, host Etienne Nichols engages with Dr. Maria Nyakern on the burgeoning integration of AI in medical devices. They delve into the European AI Act, discussing its impact on innovation and the critical role of trustworthy systems in clinical research. The episode also touches upon the challenges and opportunities AI presents in MedTech, from data integrity to job displacement, and the human-centric approach to technology.

Key Timestamps:

• [00:00:00] Introduction to the podcast and topic of AI in medical devices
• [00:03:25] Greenlight Guru's streamlined product development for MedTech
• [00:05:15] Dr. Maria Nyakern's background and entrance into AI
• [00:07:30] Discussion on the European AI Act and its significance
• [00:13:45] Comparison of US and European approaches to AI regulation
• [00:18:55] The intersection of MedTech experience and AI governance
• [00:23:10] The importance of data quality and integrity in AI-driven clinical research
• [00:29:00] The human aspect in AI development and clinical trials
• [00:35:10] Ethical considerations and the future of AI in MedTech

Quotes:

• "AI systems...will be more cost-effective and less of a hurdle for companies to generate data sets for subsets of patients." - Maria Nyakern
• "Trustworthy AI systems must be worthy of humans." - Maria Nyakern
• "Embrace innovation with Greenlight Guru." - Etienne Nichols

Takeaways:

Latest MedTech Trends:

1. Increased integration of AI in clinical research.
2. The rise of wearable health monitors.
3. Advancements in surgical robotics technology.

Practical Tips:

1. Stay updated on AI regulations.
2. Invest in trustworthy AI systems.
3. Leverage AI for cost-effective data generation.

Future Predictions:

1. AI will play a larger role in personalized medicine.
2. There will be a push for global AI data sharing.
3. Expect AI to drive faster, more accurate diagnostics.

References:

• European AI Act
• Maria Nyakern on LinkedIn
• Etienne Nichols on LinkedIn

Questions for the Audience:

• Which AI-driven MedTech advancement excites you the most, and why?
• How do you envision healthcare changing in the next decade with the rise of MedTech innovations?"

We value your thoughts - if you enjoyed this episode, would like to give feedback, or have suggestions for future episodes, please email us at [email protected]

Sponsors:

Greenlight Guru

Today's episode is brought to you by Greenlight Guru, the only MedTech-exclusive Quality Management Software designed with the direct input of industry insiders. Dealing with cumbersome product development cycles? Facing the maze of regulatory compliance? Greenlight Guru is your guiding light. Our comprehensive software suite not only streamlines your processes but also helps prepare for the complexities of FDA and ISO compliance with ease.

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And for our Global Medical Device Podcast listeners, Greenlight Guru is offering an exclusive, guided walkthrough of their groundbreaking platform. Transform the way you bring devices to market and stay ahead of the MedTech curve. Visit greenlight.guru today and mention this podcast for your special offer. Embrace progress, with Greenlight Guru

In this insightful episode, Eric Henry and Etienne Nichols delve into the evolving landscape of AI in MedTech, focusing on regulatory compliance and the future of AI in medical devices. They discuss the role of the FDA, FTC, and other regulatory bodies, and explore the implications of AI in product development and quality assurance.

1. "We're seeing pushes into adaptive algorithms... algorithms that modify themselves in the field without human oversight." - Eric Henry
2. "The FDA and other regulators are no stranger to the issues in generative AI as well." - Eric Henry
3. "Keep an eye on the FTC... they have a tool called algorithmic disgorgement, which can have significant implications for AI in life sciences." - Eric Henry

1. FTC's Growing Role: The FTC may soon have broader enforcement authority over AI across various industries in the U.S.
2. Algorithmic Disgorgement: A tool that allows the FTC to force companies to delete an algorithm and all its associated training data.
3. Evolving Regulatory Landscape: The FDA is adapting its regulatory framework to accommodate AI, focusing on adaptive and generative AI.
4. Challenges with Locked Algorithms: Current regulatory frameworks primarily support locked algorithms, but there's a movement towards adaptive algorithms.
5. Impact of AI on Quality Systems: AI is set to revolutionize quality management systems and manufacturing processes in the life sciences.
6. Importance of Pre-Market and Post-Market Oversight: Both are crucial for ensuring the safety and efficacy of AI-driven medical devices.
7. The Role of CSA in AI Integration: The transition from CSV to CSA could influence how AI is integrated into software systems.
8. Harmonization of Standards: A significant challenge in AI regulation is the harmonization of numerous standards being developed globally.
9. Public-Private Partnerships: Collaborations like the AI Global Health Initiative are vital for advancing regulatory frameworks in AI.
10. The Need for Industry Engagement: Active involvement in AI-focused organizations can help businesses navigate the evolving regulatory landscape.

• Visit www.greenlight.guru for insights on streamlining product development in Medtech.
• Follow Eric Henry on LinkedIn for updates on AI, quality systems, and regulatory compliance.
• Explore the AI Global Health Initiative under AFDO and RAPS sponsorship.
• For questions or consultations, contact Eric Henry at [email protected]
• Visit Greenlight Guru to learn more how to prepare your QMS for the future of MedTech.

Listeners are encouraged to leave a review on iTunes and reach out to Etienne Nichols on LinkedIn for feedback.

In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, leveraging personal strengths, and the importance of networking and personal branding.

Quotes

1. "If you're not talking about the value that you add, how is anybody going to know what impact you're having?" - Elena Kyria
2. "Everything's uncertain really, isn't it? What you've got to have is a clear sense of forwards and just have a goal." - Elena Kyria
3. "Nobody goes to the gym and looks at the weights and gets fit. You have to do the reps." - Elena Kyria

Takeaways

1. Networking is Key: It's not just what you know, but who knows you and what they know you're doing.
2. Visibility of Achievements: Share your successes within your company; if you don't, others may not recognize your contributions.
3. Defining Success: Success doesn't always mean reaching the VP level; it's about personal satisfaction and contribution.
4. Strengths and Weaknesses: Focus on your strengths but be aware of your weaknesses and compensate with your team.
5. Career Paths: Understand the different career paths (leadership, expert, generalist) and what they entail for growth.
6. Communication Skills: Strong communication skills are paramount for leadership and for translating technical details to a broader audience.
7. Continuous Learning: Always seek new knowledge and experiences, no matter where you are in your career.
8. Adaptability: Be prepared to pivot and adapt to changes within the industry and your career.
9. Take Action: Don't just reflect on advice; apply it to make actual changes in your career approach.

Reference Links:

• Elena Kyria's LinkedIn
• Elemed
• Working Genius
• Greenlight Guru
• Etienne Nichols' LinkedIn

Remember to engage with the hosts and guests on LinkedIn for feedback and further discussions.

Don’t forget to leave a review on iTunes!

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In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Carmen Brown, the regulatory and quality affairs manager at Proxima Clinical Research. They delve into the specifics of In Vitro Diagnostics (IVDs) and explore the challenges and considerations faced by medical device manufacturers in the IVD pathway. Whether you're an industry veteran or new to the field of medical diagnostics, this conversation will enlighten you about the nuances of IVD regulatory compliance, risk assessment, and FDA interactions.

Episode Highlights:

1. IVDs are a Specialized Medical Device: Learn how IVDs, which include reagents, instruments, or systems for diagnosis, differ from other medical devices and what specific regulatory pathways they follow.
2. Risk Levels in IVDs: Understand the significance of classifying IVDs into class one, two, or three based on the risk of false or inaccurate results, and how this impacts regulatory strategy.
3. Pitfalls in Performance Characteristic Evaluation: Discover the complexities involved in evaluating the performance of multiband diagnostics and why traditional measures like sensitivity and specificity may not suffice.
4. Likelihood Ratios Over Sensitivity and Specificity: Grasp why likelihood ratios are a more appropriate statistical measure for multiband diagnostics and how they relate to pretest and posttest probabilities.
5. Clinical Relevance is Key: Recognize the importance of ensuring that the markers detected by IVDs are clinically meaningful and relevant to the condition being diagnosed.
6. FDA's Expectations for IVDs: Gain insights into the specific data and performance characteristics the FDA looks for in IVDs and the necessity of clinical data in regulatory submissions.

Quote:

"With IVDs, you're looking at it from the perspective of what's the risk of a false result or an inaccurate result. So you're looking at who's interpreting the results and the type of condition." ~Carmen Brown

Reference Links:

• Carmen Brown
• Proxima Clinical Research
• Greenlight Guru
• Etienne Nichols' LinkedIn

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In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Morven Shearlaw, co-founder of Fearsome, in a thought-provoking discussion on the essence of human-centered design in medical devices.

Delve into the importance of understanding user needs beyond surface-level assumptions and learn how Fearsome's approach to product development is setting new standards in MedTech.

From Glasgow's design desks to global market impacts, this episode is a deep dive into making MedTech better by truly connecting with the end-user experience.

Noteworthy Points:

1. The Pitfalls of Premature Solutions: Morven emphasizes the need for extensive user understanding before jumping to design conclusions, challenging the common industry haste to offer solutions.
2. The Evolution of Fearsome: Morven shares the growth story of Fearsome from a broad design firm to a specialized MedTech developer, emphasizing the value of a diverse industry background.
3. The Nuances of Usability: The conversation reveals the stark differences between consumer product design and medical devices, particularly the rigorous safety and risk management requirements in MedTech.
4. Defining the User: A deep dive into identifying the 'user' in medical device design, considering all stakeholders, from clinicians to patients and even those involved in device maintenance.
5. Real-world Feedback and Its Impact: Morven recounts a powerful anecdote where candid feedback from clinicians significantly redirected a product's development path.
6. The Risk and Reward of Human Factors: An exploration of how human factors, beyond safety, can become a competitive edge and a catalyst for enjoyable product experiences.
7. Regulatory Hurdles and Human-Centered Design: A critical look at the intersection of regulatory standards and human-centered design, advocating for earlier and more integrated human factors consideration.

Quote:

"Quality management is about quality, it's not just about proving that you can sell in the market because you've got a certain certification." - Morven Shearlaw

Reference Links:

• Morven Shearlaw
• Fearsome
• Greenlight Guru
• Etienne Nichols' LinkedIn

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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 CDRH
• Lisa Pritchard, Vice President of Regulatory, Quality, Clinical and Engineering at DuVal & Associates
• Kathy 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:

1. "Standardized submission means that the reviewer can quickly find information...a huge benefit for both applicants and reviewers." - Patrick Axtell
2. "Even after 30 years, I always open those help boxes in eSTAR...each submission is unique." - Lisa Pritchard
3. "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 Pritchard
• Kathy Herzog
• Etienne Nichols
• Greenlight Guru
• DuVal & Associates
• Client Alert: "eSTAR & I"
• FDA eSTAR Program webpage
• FDA electronic Submission Template guidance for 510(k) Submissions
• FDA electronic Submission Template guidance for De Novo Submissions
• YouTube video of FDA REdI Conference presentation on eSTAR by Lili Duan

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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:

1. AI is still in its early stages within the MedTech industry, with potential to save time and improve efficiency.
2. There is a noticeable skepticism about AI, with 65% of respondents doubting the accuracy of AI data.
3. Corporate executives are the highest users of AI at 60%, with manufacturing operations at 50%.
4. Product development and engineering, as well as clinical sectors, are also incorporating AI significantly.
5. Quality and regulatory sectors are the least to adopt AI, possibly due to trust issues in AI's data accuracy.
6. Early adopters of AI in MedTech, akin to early CAD users, may gain a competitive edge in the industry.
7. 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 LinkedIn
• AI in MedTech Report 2023
• Digital Guru
• Greenlight Guru
• Etienne 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:

1. The distinction between consulting and advisory roles, highlighting the long-term, relationship-focused nature of advisory work.
2. The critical role of experience and mentorship in guiding startups, enhancing their growth and success.
3. Strategies to transform challenges into opportunities, fostering innovation and resilience in the MedTech industry.
4. The importance of understanding and respecting employment contracts and avoiding conflicts of interest in advisory roles.
5. The necessity of due diligence and setting high standards in choosing companies to advise, to protect one's reputation.
6. The power of passive networking and the proactive seeking of advisors to fill knowledge gaps, especially in areas like quality systems.
7. Insights into equity and compensation in advisory roles, emphasizing realistic expectations and adequate self-compensation.
8. The value of accelerator programs like MassChallenge in connecting startups with experienced mentors and advisors.
9. 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 Campbell
• Prodct
• Greenlight Guru
• Etienne 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:

1. How the 510K, originally an exception, has ironically become the predominant pathway in medical device regulation.
2. That, despite efforts to raise regulatory compliance standards, the enforceability of current guidances is limited due to unchanged regulations.
3. Discussion of FDA's non-binding guidances balance between being commendable for clarity and somewhat overreaching, reflecting a nuanced industry challenge.
4. How evolving FDA thinking underscores the importance of aligning with contemporary standards, going beyond mere compliance.
5. That selecting predicates with past design-related recalls for 510K submissions poses legal challenges and necessitates reevaluating older predicates in light of new risks.
6. How clinical data requirements in medical device regulation are dictated by engineering and biological factors, not just regulatory pathways.
7. How demonstrating substantial equivalence can be complex, and small technological differences must not introduce new safety concerns.
8. 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 Drues
• FDA Guidance: Best Practices for Selecting a Predicate Device to Support a Pre-Market Notification [510k] Submission
• FDA Guidance : Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
• FDA Guidance: Evidentiary Expectations for 510(k) Implant Devices
• Greenlight Guru
• Etienne 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:

1. Strategic alignment of clinical trials with market launch timelines is crucial for successful FDA submissions.
2. Differentiating between submission types (510K, de novo, PMA) and how they are essential for navigating the regulatory landscape.
3. Early interactions with the FDA through Q submissions and how those interactions streamline the market submission process.
4. The importance of understanding and managing FDA review timelines, including potential pauses and extensions.
5. How utilizing eSTAR helps identify documentation gaps and assess submission readiness.
6. How pre-submission meetings with the FDA are instrumental in addressing potential gaps and receiving regulatory pathway guidance.
7. 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 LinkedIn
• Greenlight Guru
• Etienne Nichols LinkedIn

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