The focus of this podcast episode is the critical importance of evaluating Electronic Quality Management Systems (EQMS) platforms at the appropriate stages of product development rather than waiting for a crisis to prompt action. I explore how proactive medtech teams that prioritize early evaluation of EQMS platforms position themselves for success, ultimately enhancing their capacity to bring safer and more effective medical devices to market. Joined by industry expert Andy Rogantino, we delve into the intricacies of when and how teams should consider EQMS solutions, emphasizing the necessity for a foundational quality system that supports regulatory compliance and operational efficiency. Our discussion also highlights the essential collaboration among product development, quality assurance, and leadership to ensure that the chosen EQMS aligns with the unique needs of each organization. By understanding these dynamics, we aim to equip medtech professionals with the knowledge to make informed decisions that will positively impact patient outcomes and organizational success.

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Takeaways:

• The most effective medtech companies evaluate EQMS platforms early in their development process to avoid regulatory headaches later on.
• Quality management systems should be viewed as the backbone of medical device development, essential for improving patient outcomes and compliance.
• Companies need to adopt a proactive mindset in quality management, as waiting for issues to arise can lead to dire consequences.
• A successful EQMS implementation requires collaboration across various departments including regulatory, quality, and product development.
• It is crucial for medical device teams to consider the user experience of the EQMS software, ensuring it is intuitive and effective for everyday use.
• Evaluating the ROI of an EQMS should encompass not only financial metrics but also improvements in efficiency and compliance readiness.

Links referenced in this episode:

• www.greenlight.guru
• podcastreenlight.guru

Companies mentioned in this episode:

• AbbVie
• Signal Therapeutics
• Second Nature
• Greenlight Guru

In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns.

They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfalls.

This discussion is vital for MedTech professionals seeking to understand the true nature of FDA expectations and build more robust quality systems.

• 00:04 – Introduction to common FDA compliance issues
• 02:02 – Discussion on FDA's policy of not naming individuals
• 05:45 – Mike Drues challenges the "pre-market" classification of common issues
• 09:20 – Documentation requirements for different device classes
• 11:35 – Mike’s take on the most common FDA issues (beyond the presented three)
• 15:40 – Root causes of common compliance problems and industry responsibility
• 20:00 – The role of regulation and FDA's responsibility in clarity
• 27:05 – Deep dive into design change and design creep
• 31:40 – Software changes and the "bug fix" mentality
• 35:45 – Marketing beyond authorized intended use with a real-world example
• 41:00 – Key takeaways and proactive compliance strategies

• "If the regulation makes sense, we shouldn't need it. If the regulation doesn't make sense, we shouldn't have it." — Mike Drues. This quote encapsulates Mike's philosophy on regulatory compliance, emphasizing that true professionalism means understanding inherent needs rather than just following rules.
• "You have a piece of software, you have a bug, you fix the bug… Is your job done? Absolutely not." — Mike Drues. This highlights a critical oversight in software development within MedTech, stressing the importance of holistic post-fix validation to prevent unintended consequences.

• Regulatory Misclassification: Many issues labeled by the FDA as "pre-market" (e.g., marketing beyond intended use, design creep) are fundamentally post-market compliance challenges. This distinction is crucial for companies to allocate resources effectively.
• Beyond Administrative Review: While administrative incompleteness accounts for a significant portion of 510(k) rejections (around 38%), the scientific and substantial equivalence reviews are major hurdles, with approximately 75% of 510(k)s rejected initially, primarily due to lack of substantial equivalence (85% of those rejections).
• Top Post-Market Violations: Historically, the most common reasons for FDA 483s and Warning Letters relate to CAPAs (12.5%), design controls (12.5%), and complaint handling (10.5%), collectively accounting for roughly 35% of all post-market issues. Companies should prioritize these areas.
• Software Change Management: Fixing a software bug is only the first step; a holistic review is essential to ensure no new problems are introduced and the device's safety, efficacy, and usability remain uncompromised.
• Intentionality vs. Compliance: Marketing a device beyond its authorized intended use, even if the device functionally performs beyond its cleared claims, carries significant regulatory and product liability risks. Companies should seek appropriate clearance for expanded claims rather than relying on off-label promotion.

• Etienne Nichols' LinkedIn
• Greenlight Guru

In this episode, Etienne Nichols and Matt Stratton, Director and Principal Consultant at Coalition, delve into the dynamic and complex world of neurotechnology.

They discuss the expansive definition of neurotech, the significant challenges in accelerating innovation—particularly concerning regulatory frameworks and cross-functional collaboration—and how a united industry voice can overcome these hurdles to bring life-changing devices to patients faster.

• 00:04 - Introduction to the episode and Matt Stratton
• 02:21 - Matt Stratton’s journey into neurotechnology and passion for acceleration
• 04:30 - Defining neurotech beyond traditional boundaries
• 07:11 - Major challenges preventing acceleration in neurotech
• 10:16 - The internal and external barriers to collaboration
• 13:40 - The "generalist vs. specialist" dilemma in neurotech expertise
• 17:03 - Optimizing existing neurotech and the future of advanced neuroscience
• 19:34 - What neurotech can learn from other medical device verticals
• 22:50 - The complexity of the brain: "What is normal?"
• 24:50 - Ethical considerations of neurotech advancements
• 26:27 - Overcoming competitive intelligence in collaborative communities
• 29:05 - Bridging the language gap between pharma and medical devices in neurotech
• 31:40 - Matt Stratton's call to action for the neurotech community
• 33:10 - Political challenges and maintaining focus on shared goals

• "I think the neurotech space is a bit broader than that because there are so many interrelated areas that are relying and using very similar technologies and ultimately aiming for the same patient groups...and will come across the same regulatory structures." — Matt Stratton
• Matt's expansive view highlights the interconnectedness of neurotech, emphasizing that a holistic approach to defining the field is crucial for effective collaboration and regulatory navigation.
• "If what ties us together is greater than the soil we stand on, then yeah, we can remain standing together." — Etienne Nichols
• Etienne's profound statement underscores the power of shared purpose and patient-centric goals in transcending political and competitive barriers within the medical device industry.

• Broadening the Neurotech Definition: Neurotech extends beyond neuromodulation and BCIs to include neurodiagnostics, neuromonitoring, neurological drug delivery, and neurosurgical devices. This broader perspective fosters greater collaboration and addresses common regulatory and patient needs.
• Challenges in Acceleration: Key hurdles include complex regulatory environments, the need for increased collaboration among diverse experts (neuroscientists, biologists, engineers), and adapting to emerging technologies like AI.
• The Power of External Collaboration: Bringing together different industry players helps establish a unified voice for regulatory changes, benchmark best practices, and break down barriers to faster progress, especially as neurotech pushes ethical and technological boundaries.
• Learning from Other Verticals: While neurotech faces unique challenges, insights from established fields like orthopedics and CRM, particularly regarding rapid product development (e.g., "Moore's Law" in tech), offer valuable lessons for accelerating innovation.
• Navigating Complexity and Ethics: The brain's inherent complexity and the fluid concept of "normalcy" introduce unique challenges for neurotech. This includes addressing profound ethical considerations, such as the potential for enhanced human capabilities to exacerbate societal inequalities.
• Fostering Open Dialogue: Community platforms that focus on "mundane"