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...

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere streamlining, the change is mandatory, with an effective and fully enforceable date of February 2, 2026. The episode addresses industry complacency and details critical steps manufacturers must take immediately.

The episode debunks the myth that familiar quality documents like the DHF, DMR, and DHR are being eliminated. While the specific terms are removed from the regulation's language, their substance is retained and mapped to new, ISO-aligned conceptual requirements: the Device Master Record (DMR) becomes the Medical Device File (MDF), the Design History File (DHF) becomes the Design and Development File (DDP), and the Device History Record (DHR) is captured in the Batch or Lot Record. The host emphasizes that internal documents can retain the old terminology, provided a clear regulatory mapping is established.

Crucially, compliance requires more than just an ISO 13485 certificate. Two major philosophical shifts must be addressed: the explicit requirement for integrating lifecycle risk management as the DNA of the entire QMS, and the loss of the audit privilege, which makes internal audit reports, supplier audit reports, and management review records inspectable regulatory evidence. Furthermore, manufacturers must comply with retained, US-specific requirements under the QMSR's prevalence rule, especially concerning mandatory record content (§ 820.35) and specific labeling and packaging controls (§ 820.45).

1. [0:50] QMSR: The biggest shakeup to US quality requirements since 1996.
2. [2:00] Effective Date: February 2, 2026—the clock is ticking.
3. [2:42] The Goal: Harmonization with ISO 13485:2016 to reduce redundancy for global manufacturers.
4. [3:50] Myth 1 Busted: The FDA is eliminating the DHF, DMR, and DHR (Documentation Dissolution).
5. [5:10] Terminology Shift: DMR > Medical Device File (MDF, ISO 13485 Clause 4.2.3).
6. [6:30] Terminology Shift: DHF > Design and Development File (DDP, ISO 13485 Clause 7.3.10).
7. [7:40] Terminology Shift: DHR > Batch or Lot Record (ISO 13485 Clause 7.5.1).
8. [8:40] The Practical Takeaway: Internal naming is fine, but regulatory mapping is mandatory.
9. [10:30] Critical Shift 1: Risk Management is the DNA of the QMS—Explicitly required across all clauses.
10. [13:00] Critical Shift 2: Loss of the Audit Privilege—Internal audit and management review records are now inspectable.
11. [17:00] Critical Shift 3: Retained FDA Specifications (Prevalence Rule).

The MedTech talent landscape has undergone a significant "reset" in the two years since Elena Kyria, founder and CEO of Elemed, last joined the podcast. Driven by factors like the rise of AI, economic volatility, and post-pandemic shifts, the dynamic has swung from a "war for talent" (many jobs, few candidates) to a market flooded with applicants, often overwhelming internal recruitment teams. This shift, exacerbated by simple application processes like LinkedIn's Easy Apply, makes it challenging for good candidates to cut through the noise and for companies to manage high application volumes.

To thrive in this new environment, MedTech professionals, particularly those in Quality Assurance (QA) and Regulatory Affairs (RA), must expand their focus beyond technical competence. Elena stresses the growing importance of transverse skills (the essential human skills like communication, negotiation, and leadership) and, critically, AI literacy. With the pressure on companies to "do more with less," AI is creating an environment where smaller, highly productive teams are favored. This doesn't mean roles will disappear, but professionals must embrace technology to eliminate tedious tasks and focus on high-value, strategic work.

Navigating the job market now requires a more intentional and proactive approach, especially to access the hidden job market where the best unadvertised roles reside. Tactics include direct networking with hiring managers and active professional branding. Furthermore, the global regulatory environment's fragmentation—especially between the US (FDA) and EU (MDR/IVDR)—is impacting how companies build their teams, favoring remote work and strategic location choices that factor in the local talent pool and employment laws.

• 1:50 - The MedTech Talent Shift: From "War for Talent" to a "Reset"
• 4:45 - The impact of high volume and "easy apply" on candidate experience
• 6:15 - Immediate disqualification criteria and "gaming" the application system
• 7:35 - Strategies for accessing the hidden job market (networking and strategy)
• 9:20 - The controversial impact of AI on QA/RA roles and the need for efficiency
• 11:30 - Future-proofing your career: Why leaders and junior professionals must embrace AI
• 13:55 - Understanding transverse skills (soft skills) and business acumen
• 15:40 - The QA/RA role in the age of AI: Focusing on the 30% of high-value expertise
• 17:00 - Tactics for achieving AI literacy: Small wins, experimentation, and habit stacking
• 19:45 - Why the "hidden job market" exists (confidentiality, exclusivity, and pipeline)
• 21:30 - Positioning yourself externally: The power of active contribution on LinkedIn
• 23:45 - The importance of speaking at industry events (e.g., RAPS) to build credibility
• 24:55 - Strategic advice for founders building remote, global teams
• 26:15 - The impact of US vs. EU regulatory fragmentation on talent selection

• Prioritize AI Literacy: MedTech professionals must proactively experiment with AI tools (like note-takers and regulatory intelligence systems) to automate up to 70% of tedious tasks. Waiting for...

This episode tackles the complex challenge of applying the hardware-centric clauses of ISO 13485 to Software as a Medical Device (SaMD). Adnan Ashfaq, founder of Simply Medica, joins Etienne Nichols to dissect how traditional standards intended for physical manufacturing must be creatively interpreted for the virtual world of software development, where apps update weekly and cloud-based systems evolve in real-time. The conversation zeroes in on the often-muddy areas of production and service provision (Clause 7.5), emphasizing that these clauses are far from non-applicable, requiring a "virtual manufacturing space" mindset.

A significant focus is placed on the Software of Unknown Provenance (SOUP), treating these building blocks as purchased components that require robust supplier evaluation and validation, bridging Clause 7.5 (production) with Clause 7.4 (purchasing). The discussion extends to crucial concepts like the Software Bill of Materials (SBoM), the complexity of Agile vs. Waterfall approaches within the standard's framework, and the essential role of the new FDA Computer Software Assurance (CSA) guidance in risk assessment.

Beyond production, the experts explore the application of resource management (Clause 6), specifically addressing infrastructure, contamination control (malware/ransomware), and the critical need for a well-documented Design Transfer to Production (Clause 7.3.8) evidenced by a complete software release package, including all 62304 requirements. The episode provides actionable insights for quality and compliance professionals struggling to maintain speed and innovation while strictly adhering to regulatory requirements.

• 01:45 - The changing landscape: Why traditional MedTech rules struggle with modern software updates.
• 03:50 - Historical context of ISO 13485 and its non-distinction between hardware/software.
• 05:05 - Starting Point: Clause 7.5 (Production and Service Provision) and the "Virtual Manufacturing Space" concept.
• 06:20 - Unpacking Software of Unknown Provenance (SOUP) and its link to Clause 7.4 (Purchasing).
• 08:35 - The necessity of validating the development environment (GitHub/GitLab) and building blocks.
• 11:10 - Applying Clause 4.1.6 (Software Validation) to SOUP items and master validation plans.
• 12:20 - Applicable vs. Non-Applicable Clauses: Sterilization/Cleanliness vs. Installation.
• 13:55 - Clause 4.2.3 (Medical Device File) for SaMD: E-labels, UDI, System Architecture, and SBoM.
• 16:30 - Cybersecurity controls and the manufacturer's responsibility for identifying state-of-the-art standards.
• 17:35 - Defining "Production" for continuously updating software and managing significant vs. non-significant changes.
• 20:15 - Clash of Standards: Agile development, ISO 13485, and the missing documentation for version control risk assessment.
• 21:30 - Clause 6.3 & 6.4 (Resource & Work Environment): Looking at data security, access controls, and contamination (malware/ransomware).
• 24:45 - Clause 7.3.8 (Design Transfer to Production): The need for a formal software release package and the importance of the Software Design Trace Matrix.
• 26:00 - The 16 essential documents needed to meet IEC 62304 requirements.
• 27:10 - Production controls when the user influences the outcome (customizable features,...

In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove of knowledge for anyone looking to stay ahead in the MedTech realm.

Key Timestamps:

• [00:00:30] Introduction to Kavetha Ram and the episode's focus
• [00:05:15] Discussion on the challenges and opportunities of new regulations
• [00:10:40] Insights into the importance of confidence and adaptability in the regulatory field
• [00:15:20] Kavetha's journey and advice for emerging professionals
• [00:25:00] The role of innovation and collaboration in MedTech advancements
• [00:35:10] Strategies for professionals to stay relevant and proactive

Quotes:

• "Regulations are not just hurdles; they are stepping stones to innovation and safety in MedTech." - Kavetha Ram
• "Embracing change in regulations is not an option but a necessity for MedTech's future." - Etienne Nichols
• "Diversity in teams isn't just about varied backgrounds; it's about unlocking unique perspectives that drive innovation." - Kavetha Ram

Key Takeaways:

Insights into MedTech Trends:

1. Regulatory changes are both a challenge and an opportunity for innovation.

Practical Tips for MedTech Enthusiasts:

1. Stay updated with regulatory changes and understand their implications.
2. Engage in continuous learning and skill development.
3. Foster collaboration across disciplines to enhance innovation.

References:

• Kavetha Ram's LinkedIn Profile
• Etienne Nichols' LinkedIn Profile
• Greenlight Guru

Questions for the Audience:

• "What advice do you have for budding Regulatory Affairs professionals?"

Reach out to us and let us know what you thought of the episode at podcast@greenlight.guru

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Sponsors:

This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Greenlight Guru's platform streamlines product development and compliance, making the process more efficient and less risky. Discover how Greenlight Guru can accelerate your product development at www.greenlight.guru.

This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile practices, risk management, and the necessity for a patient-focused approach. The discussion sheds light on how companies can navigate regulatory landscapes, manage project risks, and drive innovation to enhance patient care.

Key Timestamps:

• 00:00:15 - Introduction of Perry Parendo and the episode's focus
• 00:03:50 - Discussing the challenges of MedTech product development and regulatory hurdles
• 00:12:20 - Agile methodologies vs. traditional project management in MedTech
• 00:22:35 - The importance of risk management and Monte Carlo simulation in project planning
• 00:34:10 - Perry's perspective on innovation, compliance, and balancing project priorities
• 00:45:55 - Strategies for efficient and effective product development processes

Quotes:

• "We're so focused from a compliance point of view on patient and health risk, we're not focused on project risk. And when I worked in the defense industry, we were hugely focused on project risk," Perry Parendo
• "There's waterfall, there's agile, there's Toyota, there's set based design, and there's APQP in the automotive industry. They're all a blend. There's no organization that's doing purely the theoretical of any one of those processes," Perry Parendo

Takeaways

Insights on MedTech Trends:

1. The convergence of agile and traditional methodologies tailored to MedTech's unique demands.
2. The rising importance of advanced risk management techniques, like Monte Carlo simulations, in navigating project uncertainties.
3. A call for innovation that transcends regulatory compliance to genuinely benefit patient care.

Practical Tips for Listeners:

1. Adopt a flexible approach to project management by integrating various methodologies based on project needs.
2. Prioritize risk management early in the development process to foresee and mitigate potential challenges.
3. Always align product development objectives with the ultimate goal of improving patient outcomes.

Questions for Future Developments:

1. How will evolving regulatory standards shape the next generation of medical devices?
2. What role will patient feedback play in the design and development of future MedTech innovations?
3. Can MedTech sustain its pace of innovation while ensuring safety and compliance?

References:

• Perry Parendo on LinkedIn
• Etienne Nichols on LinkedIn
• Behavioral Grooves podcast with Annie Duke - Thinking in Bets
• Book - Someday is Today, Ron Richard
• Youtube video - the Heartbeat of New Product Development
• Quality Culture for Product Design Success
• Design News Columns