Global Medical Device Podcast powered by Greenlight Guru

This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. Host Etienne Nichols and guest Mike Drues discuss the philosophy of building a usable system rather than a "museum of SOPs," emphasizing that the standard list of QMS sections should be viewed as a starting point rather than an exhaustive checklist.
The conversation examines the critical differences between 510(k), De Novo, and PMA pathways regarding manufacturing requirements. While a 510(k) submission may not strictly require detailed manufacturing information at the time of filing, Mike explains why companies must remain audit-ready from the moment they register their establishment with the FDA. The discussion clarifies the timing of registration and the "radar" companies enter once they become commercially active.
Finally, the dialogue focuses on a "triage" approach for resource-constrained startups. By prioritizing Design Controls and Risk Management during early development, teams can remain compliant and ethical without over-investing in post-market systems, such as complaint handling, before they have a product on the market. Mike warns against the dangers of "copy-and-paste" quality systems, urging manufacturers to use professional judgment to tailor their processes to their specific technology.
Key Timestamps
00:00 - Introduction to QMS requirements and guest Mike Drues.
03:45 - The core sections of a QMS according to the Quality System Regulation.
05:12 - Why the QSR list is a starting point, not a stopping point.
08:20 - Regulatory vs. Ethical vs. Economical: The three legs of the medical device stool.
10:30 - Do you need a full QMS for 510(k) vs. PMA submissions?
13:15 - Understanding the timing and strategy for FDA Establishment Registration.
15:40 - The Triage Approach: Which QMS sections matter most during early development?
19:00 - The dangers of boilerplate SOPs and non-specific quality manuals.

Quotes
"This is a starting point. This is not a stopping point... Use your own good judgment." — Mike Drues"The goal is not really to build a museum of SOPs; the goal is a quality management system that teams will actually use." — Etienne NicholsTakeaways
Prioritize the Big Four: During the development phase, focus your limited resources on Design Controls, Risk Management, Document Control, and Supplier Quality Management.
Understand Pathway Nuances: While 510(k) submissions don't require manufacturing details, you must be fully compliant and ready for inspection once your establishment is registered and the product is launched.
Avoid Boilerplate SOPs: Quality systems must be specific to your organization. Including irrelevant device types or procedures in...

Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why the traditional model of the "rigid, perfect leader" is no longer sustainable. She shares her personal journey—from being one of the first IVF babies in the U.S. to navigating life-threatening health complications—and how these experiences shaped her mission to help others lead with authenticity.
The conversation centers on the concept of "SOS moments," which Dr. Hoffmann defines as those critical points of distress or crisis that occur in both personal lives and product development. By applying her CEC framework—Curiosity, Empathy, and Connection—leaders can transform these high-pressure moments into stories of strength. This approach is particularly vital in MedTech, where the ultimate goal is to serve patients during their own most vulnerable SOS moments.
Etienne and Jenny also explore the intersection of human leadership and emerging technology. While AI continues to streamline technical workflows, Dr. Hoffmann argues that human empathy and curiosity remain irreplaceable assets for innovation. The episode concludes with a practical look at the return on investment (ROI) for "opening up," demonstrating how personal connection leads to higher quality products, better team retention, and the resilience needed to survive the "messy middle" of product development.
Key Timestamps
00:00 - Introduction of Dr. Jenny Hoffmann and her background in MedTech and innovation.
01:28 - Motivation for writing Open Up: Scaling impact through vulnerable storytelling.
04:23 - The shift from the "perfectly composed" leader to the vulnerable leader.
05:45 - Dr. Hoffmann’s personal origin story: Being one of the first IVF babies in the U.S.
08:30 - Listening to the "whisper" and the courage required to respond to inner intuition.
10:14 - The ROI of Vulnerability: How personal connection drives higher quality and team motivation.
14:39 - Defining SOS moments: Turning distress signals into leadership strengths.
18:42 - The CEC Method: Breaking down Curiosity, Empathy, and Connection.
20:25 - AI in MedTech: Why human empathy is the one thing machines cannot replace.
25:57 - Strategic Sharing vs. Oversharing: How to lead by example without losing professional boundaries.
28:52 - The power of storytelling for engineers and data-driven professionals.

Quotes
"The leader is the first one to step out on the bridge that no one’s sure if they want to cross. You paint that vision of the bridge, and then you’re the first one to step out on it." - Dr. Hoffman"If we can put empathy first and think about how we are each a patient first... then we can uncover the real needs to

In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare.
The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends.
"Validation of AI tools in MedTech requires a staged adoption to build confidence due to the inherent uncertainty in AI outcomes." - Ashkon Rasooli
00:00 - Introduction to AI in MedTech
05:15 - Discussing AI's deterministic vs. statistical nature
12:30 - AI in diagnostics: Radiology, Cardiology, and Neurology
20:45 - Wearable health monitors and patient-driven health data
28:10 - The role of AI in medical device operations and manufacturing
35:00 - AI at the point of care: Enhancing patient and clinician experience
42:15 - Regulatory challenges and the future of AI in healthcare

Key Takeaways:
1. Latest MedTech Trends:
The integration of AI in diagnostics is growing, particularly in radiology, cardiology, and neurology, aiding in more accurate and quicker diagnoses.
Wearable health monitors are empowering patients to take control of their health data, leading to personalized healthcare solutions.

2. Practical Tips for MedTech Enthusiasts:
Stay informed about the latest AI advancements and regulatory guidelines to leverage AI effectively in MedTech.
Consider the ethical implications and ensure bias mitigation in AI model training and deployment.

3. Predictions for the Future:
Increased adoption of AI across various healthcare sectors, including surgery and patient care management.
Evolution of regulatory frameworks to better accommodate and oversee AI-driven medical devices.

References:
Ashkon Rasooli on LinkedIn
[email protected]
Engenius Solutions
AFDO/RAPS Working Group
Etienne Nichols on LinkedIn

Sponsors:
This episode is brought to you by Greenlight Guru, a comprehensive solution designed to streamline MedTech product development and ensure regulatory compliance. Discover how Greenlight Guru can accelerate your projects at www.greenlight.guru
Share your thoughts and questions with us at [email protected]

In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.
Key Timestamps:
[00:00:50] Introduction to Jennifer Mascioli-Tudor and her extensive background in the MedTech industry.
[00:03:30] Jennifer's origin story in quality and regulatory roles.
[00:07:15] The pivotal learning moments in quality management and regulatory affairs.
[00:10:45] Strategies for influencing business leaders and the importance of storytelling in quality and regulatory roles.
[00:16:30] The significance of human factors in product design and learning from end-user feedback.
[00:21:50] Project management skills for quality and regulatory professionals.
[00:25:20] The concept of 'design freeze' in the MedTech space and its impact on product development.
[00:29:55] Jennifer's insights on agility and adaptability in building a quality management system.

Quotes:
"A really good quality and regulatory professional needs to have really good project management skills." - Jennifer Mascioli-Tudor
"It's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device." - Jennifer Mascioli-Tudor

MedTech Trends:
An emphasis on proactive quality management to ensure patient safety and product efficacy.
The rising importance of human factors and user-centered design in medical device development.
The shift towards integrating software and digital solutions in medical devices.

Practical Tips:
Quality and regulatory professionals should hone their project management skills.
Communication and storytelling are key in influencing business decisions and leadership.
Always present solutions and alternatives when addressing compliance challenges.

References:
JMT Compliance Consulting
Jennifer Mascioli-Tudor on LinkedIn
Etienne Nichols on LinkedIn
Greenlight Guru’s platform for Quality Management & Clinical Investigations

Questions for the Audience:
Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?"

Feedback:
Love the episode? Have suggestions or topics you’d like to hear about? Email us at [email protected] and leave a review on iTunes!

Sponsors:
This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss the transformative state of artificial intelligence within the MedTech regulatory and quality space. Reflecting on her recent personal experience as a surgical patient, Michelle shares a unique perspective on the critical importance of the devices and quality systems that keep the industry running.
The conversation dives deep into the "Great Rewiring" of the medical device industry. Michelle outlines how we have moved past the initial phase of AI skepticism and "AI fatigue" into a period of hyper-acceleration. With the introduction of the FDA’s ELSA and the implementation of the EU AI Act, the industry has reached a point where AI is no longer a side project but a fundamental requirement for operational longevity.
Finally, the episode provides a roadmap for both organizations and individual contributors. Michelle introduces her "Holy Trinity" framework for AI implementation—Data, Workflow, and Agents—and explains why the next two years will be defined by the "Invisible Colleague" or AI copilot. For junior professionals, the message is clear: knowledge is now a commodity, and the real value lies in the ability to ask high-quality, strategic questions.
Key Timestamps
00:00 – Introduction and Michelle Wu’s background in MedTech and AI.
03:45 – A founder’s perspective: Michelle’s personal experience in the OR seeing her clients' devices.
08:12 – The 2025 Inflection Point: FDA ELSA, EU AI Act, and global AI expectations.
11:50 – From billable hours to value-based output: How AI is disrupting the consulting business model.
15:35 – Micro-timestamp: 2026 Predictions. The shift toward universal AI Copilots and Agents for every MedTech role.
18:22 – The Holy Trinity of AI: Breaking down Data Layers, Workflow Automation, and AI Agents.
22:10 – Case Study: How a top-tier MedTech company automated 17,000 quality and regulatory tasks.
27:45 – The 56.8% Salary Premium: Why AI literacy is the most important skill for young RAQA professionals.
31:15 – Shifting from memorization to "Clarity of Mind" and high-quality inquiry.

Quotes
"Knowledge is a commodity now. Previously, regulatory consultants or professionals stood out by their knowledge. Now, with AI leveling the field, the capability lies in those who can ask high-quality questions." - Michelle Wu, Nyquist AITakeaways
AI Literacy is a Financial Multiplier: LinkedIn data shows that non-engineering knowledge workers with AI literacy can command a salary premium of up to 56.8%.
The 80/20 Rule of Automation: Approximately 80% of current RAQA tasks are tedious, manual, or administrative. Successful teams are using AI to automate that 80%, allowing humans to focus on the 20% that is strategic and high-value.
The Three-Layer AI Strategy: To effectively implement AI, companies should look at the Data Layer (intelligence), the Workflow Layer (automation of specific tasks), and the Agent Layer (autonomous "employees").
Value-Based Billing: As AI reduces the time required for regulatory submissions and gap analyses, the industry is moving away from the "billable hour" toward pricing based on the value and quality of the output.

References
Nyquist AI: Michelle Wu’s platform specializing in global regulatory intelligence and AI-driven workflow automation for MedTech.
FDA ELSA: The...