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
• ashkon@engeniussolutions.com
• 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 podcast@greenlight.guru

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.

• [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.

• "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

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

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

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

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

• Love the episode? Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru and leave a review on iTunes!

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.

• 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.

• 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.

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