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 formal company training risks falling behind competitors who are already seeing a compounding effect from daily micro-improvements.
• Master Transverse Skills: Beyond technical QA/RA knowledge, focus on building "hard soft skills" like negotiation, communication, leadership, and financial/business acumen. These are the differentiating skills that AI cannot replicate and will define the strategic value of the future professional.
• Shift from Lurker to Contributor: Use LinkedIn strategically. Instead of passively scrolling, actively engage by adding meaningful, subject-matter expert comments to relevant posts. This builds credibility and positions you as a known contributor, enhancing your professional brand.
• Tap into the Hidden Job Market: Rely less on mass applications and more on strategic networking, building long-term relationships, and direct outreach to hiring managers. The best, often confidential, roles are frequently filled through these non-advertised channels.
• Global Teams Require Legal Due Diligence: Founders building remote teams must be acutely aware of local employment laws and benefits (e.g., maternity leave differences) in each geography. Talent decisions shouldn't just be based on cost or tax benefits but must factor in the available skill density in that location.

• Elemed: Elena Kyria's consultancy focused on MedTech executive hiring and recruitment strategy.
• RAPS (Regulatory Affairs Professional Society): Mentioned as a key platform for professional development and speaking opportunities within the MedTech regulatory field.
• Greenlight Guru QMS & EDC Solutions: Greenlight Guru's Quality Management System (QMS) helps MedTech companies simplify compliance, while their Electronic Data Capture (EDC) platform streamlines clinical trial data management.
• Etienne Nichols' LinkedIn: linkedin.com/in/etiennenichols

In the MedTech industry, we often talk about technical skills—the specific knowledge needed for a job, such as knowing the difference between the FDA's 510(k) and the EU's MDR requirements.

Transverse Skills (historically called "soft skills") are the human abilities that apply across all roles and industries, and they are becoming the most critical skills for MedTech professionals in the age of AI.

Simple Analogy: Think of a medical device engineer:

• Technical Skill: Being able to design a circuit board or write a V&V protocol.
• Transverse Skill: Being able to clearly communicate the risks of that circuit board design to the management team, or negotiate with a supplier on quality specifications.

As AI takes over tasks like drafting initial documents or summarizing regulations, the uniquely human skills—like critical thinking, ethical judgment, leadership, and strategic communication—are what add true, irreplaceable value to a MedTech company.

Did this episode shift your perspective on AI or the job market? Your feedback helps us shape future content. We are committed to providing personalized and actionable advice to MedTech professionals globally. Please send your thoughts, reviews, or suggestions for future topics directly to [email protected].

This episode of the Global Medical Device Podcast is brought to you by Greenlight Guru. In a market where MedTech talent must be highly productive and efficient, your tools should support that goal. Greenlight Guru offers solutions that help your teams do more with less: our industry-specific QMS streamlines your compliance and quality processes, while our EDC solution digitizes and simplifies your clinical data capture. Visit greenlight.guru to learn how you can upgrade your system to match your highly skilled workforce.

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, disclaimers).

• Adopt a "Virtual Manufacturing Space" Mindset: Treat your development environment (e.g., source control systems like GitHub/GitLab, compilers, cloud platforms) as a production floor that requires the same level of validation and control as a physical cleanroom or factory floor, satisfying ISO 13485 Clause 7.5.
• Validate SOUP as Purchased Products: Any Software of Unknown Provenance (SOUP) or open-source components must be treated as "purchased product" under Clause 7.4, requiring documented supplier verification, impact assessment, and validation (or documented rationale for non-validation) before integration into your SaMD.
• Contamination Control is Cybersecurity: ISO 13485 Clause 6.4.2, Contamination Control, must be applied to the digital sphere. This includes safeguards against malware, ransomware, unauthorized code, and data corruption, emphasizing the non-negotiable need for robust cybersecurity controls in your Quality Management System (QMS).
• Formalize the Software Bill of Materials (SBoM): The SBoM, detailing all software components, libraries, dependencies, and their version controls, is a key deliverable under Clause 4.2.3 (Medical Device File), acting as the digital equivalent of a Bill of Materials for Design Transfer to Production (Clause 7.3.8).
• Bridge Agile with Documentation: When using Agile development, ensure every iteration, bug fix, or patch includes a documented risk assessment (connecting to ISO 14971) and change history to satisfy ISO 13485’s traceability and control requirements, preventing potential non-conformances in audit.

• Etienne Nichols' LinkedIn: linkedin.com/in/etiennenichols
• ISO 13485:2016 (specifically Clauses 7.5, 7.4, 4.2.3, 6.3, 6.4, 7.3.8)
• IEC 62304 (Medical device software – Software life cycle processes)
• FDA Computer Software Assurance (CSA) Guidance: The new guidance replacing older process validation guidance, focusing on a risk-based approach (High Risk vs. Low Risk) for validating software tools.
• AAMI TIR 45 (Guidance on the use of agile practices in the development of medical device software)

SOUP refers to software components that have been developed for purposes other than being part of the medical device, and for which the developer did not use a medical device quality management system (QMS) process. In simple terms, it's off-the-shelf software (like an open-source library, a commercial operating system, or a third-party module) that you integrate into your SaMD.

Analogy: If you are building a custom, high-end car (your medical device), the engine block (the SaMD code) is custom-made. However, you decide to use commercially available tires, a standard battery, and a third-party GPS system (the SOUP items). While convenient, you can't be 100% sure how those other developers built them. To use them in your regulated medical product, you must perform your own testing and validation (verification) on the SOUP components to ensure they work reliably and safely within your device's specific intended use, treating them as if you purchased them from an outside supplier under Clause 7.4.

We thrive on your expertise and insights. If you have questions about applying ISO 13485 to your specific SaMD project, or if you'd like to suggest a topic for a future deep-dive, please send us an email. We read every message and offer personalized responses to help you navigate the complexities of MedTech compliance.

Contact us at: [email protected]

This episode discussing the critical balance of innovation and compliance in SaMD is brought to you by Greenlight Guru. In a world where software updates are weekly, using antiquated paper-based or general-purpose QMS systems is a compliance risk. Greenlight Guru offers MedTech-specific solutions, including a leading QMS platform and an advanced EDC solution, that are designed to handle the complexity of modern device development, like seamless traceability for your Software Bill of Materials and automated audit trails, ensuring you stay compliant with standards like ISO 13485 and IEC 62304.

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 [email protected]

Also, if you enjoyed this episode, please leave us 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. 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
• Practical Monte Carlo Analysis

Questions for the Audience:

• Poll: Which MedTech advancement do you believe will have the most significant impact on healthcare in the next decade?
• Discussion: How do you envision the future of healthcare changing with the continuous integration of MedTech innovations?

We're eager to hear your thoughts on this episode and your suggestions for future topics. Please share your feedback and leave us a review on iTunes!

For in-depth discussions and questions, email us at [email protected]

Sponsors:

This episode is brought to you by Greenlight Guru, the only quality management system (QMS) and electronic data capture (EDC) software designed specifically for the medical device industry. Make your product development process smoother, faster, and compliant with Greenlight Guru. Discover the difference at www.greenlight.guru

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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This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation’s stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting the country's rapid execution, intense internal competition, and the shift from low-end manufacturing to a focus on high-level innovation. A key risk is that existing international certifications (like ISO and IEC) do not guarantee compliance, requiring local type testing and adherence to specific national standards.

The conversation addresses how global medical device companies can structure their strategy amid ongoing geopolitical shifts and the "China for China" policy, which favors domestic products through initiatives like the Volume-Based Procurement (VBP). Strategies such as the dual-strategy approach—localizing low-consumable manufacturing while protecting high-technology IP through joint ventures or careful CMO/CDMO selection—are explored as pragmatic ways to secure market presence and margin. Understanding the regulatory landscape, particularly the NMPA's 2021 overhaul, is crucial for success.

Finally, Elaine provides practical guidance for regulatory professionals intimidated by the market. This includes understanding the specific regulatory and clinical pathways, performing a gap analysis against Chinese standards (Product Technical Requirements or PTR), and the critical process of selecting and qualifying a local partner/agent. Elaine reveals a specific, often overlooked hurdle: the agent must possess an NMPA-approved CA (Certification Authorization) USB key to electronically submit registration files on behalf of the foreign manufacturer, a critical piece of the submission puzzle. The discussion also touches on leveraging special zones, like the Hainan Free Trade Zone, for crucial real-world data collection applicable to the Chinese population.

• [02:40] Introduction to Elaine Tan, MedTech Chopsticks, and the show’s focus on the China market.
• [05:05] High-level risks and rewards: complexity, lengthy registration, local testing requirements, and IP concerns.
• [08:08] Discussing the NMPA's 2021 regulatory overhaul and the geopolitical shift toward "China for China."
• [11:00] The Dual Strategy approach: balancing low-end localization with protecting high-tech IP.
• [14:48] Using CDMOs/CMOs for pilot projects to manage financial investment risk.
• [16:20] Leveraging the Hainan Free Trade Zone (Bo’ao region) for pre-market clinical data collection and urgent needs product access.
• [18:42] Ethological differences and their impact on clinical data justification (e.g., Pulse Oximeters).
• [20:17] NMPA predicate search: The importance of using the Chinese Classification Catalog to find registered, local predicate devices.
• [23:00] Guidance for overwhelmed regulatory professionals entering the China market: Clinical strategy and Product Technical Requirements (PTR).
• [25:52] Pitfalls in partner selection: The necessity of the NMPA-approved CA (Certification Authorization) USB key for submissions.
• [29:30] Partner qualification: Ensuring the agent can support Post-Market Surveillance (PMS) and QMS self-inspection requirements.
• [30:52] Final pitfall: International compliance (ISO/IEC) does not automatically ensure China compliance.

1. Mandatory Localization is Key: Be aware that high international compliance (ISO, IEC) does not substitute for mandatory local type testing and adherence to China's specific Product Technical Requirements (PTR). Factor this into your R&D and budget early on.
2. Employ a Dual-Strategy for IP: For high-tech, innovative products, avoid placing core IP entirely within China. Consider a hybrid structure using joint ventures, strategic CMO/CDMO partnerships, or utilizing international patents to safeguard your know-how while localizing the manufacturing of less innovative consumables.
3. Leverage Special Pathways: Explore regional initiatives like the Hainan Free Trade Zone (Bo’ao region). This area allows for early, pre-market clinical collaborations to collect essential real-world data on the Chinese population, which is often required to justify clinical significance based on ethological differences (differences based on race/demographic).
4. Vet Your China Agent Rigorously: The most critical qualification for your foreign regulatory agent is not just experience, but their possession of the NMPA-issued CA (Certification Authorization) USB key. Without this physical credential, they cannot electronically submit your registration files.
5. Understand NMPA Predicate Rules: When developing your clinical strategy, the NMPA requires the selection of a predicate device that is already approved and registered in the Chinese market, regardless of whether it is domestic or foreign-made. Use the NMPA Classification Catalog to find the correct "common name" to search their database effectively.

• NMPA (National Medical Products Administration): The regulatory authority in China responsible for medical device approvals and oversight.
• Product Technical Requirements (PTR): A key NMPA requirement document defining the specific performance, testing, and compliance standards for a medical device in China.
• Hainan Free Trade Zone (Bo'ao region): A special economic and medical tourism zone that permits the use of certain internationally approved, urgently needed medical devices before formal NMPA registration, allowing for local clinical data collection.
• Elaine Tan's LinkedIn
• Etienne Nichols' LinkedIn: Connect with Etienne

Ethological Differences: In the context of medical devices and clinical trials, "ethological differences" refers to the variations in biological, anatomical, or physiological characteristics between different human races or demographic populations. A classic example is a pulse oximeter: because the device measures oxygen saturation based on light absorption in the blood, the different skin tones across populations can affect the light's absorption rate. Therefore, data collected only on one demographic may be insufficient to prove clinical safety and efficacy in another, requiring local testing for products sensitive to these population differences.

CA (Certification Authorization) USB Key: This is a crucial physical piece of hardware, similar to a security token, issued by the NMPA to accredited foreign manufacturer agents. It functions as a unique digital signature and login credential, which must be plugged into a computer for the agent to access the NMPA's electronic platform and successfully submit all regulatory and registration documents. Its possession is non-negotiable for an agent handling foreign medical device registrations.

We want to hear from you! Your feedback is invaluable in shaping the future of the Global Medical Device Podcast. Did this discussion help clarify your strategy for the Chinese market? Do you have experience with the NMPA's CA key or the Hainan Free Trade Zone? Send your comments, feedback, or suggestions for future topics directly to [email protected]. We emphasize personalized responses, so reach out—we’d love to hear your insights.

This episode is brought to you by Greenlight Guru, the only MedTech-specific platform providing both QMS (Quality Management System) and EDC (Electronic Data Capture) solutions. Navigating the regulatory complexities of the Chinese market, including meeting the rigorous Product Technical Requirements (PTR) and managing extensive documentation, demands a specialized system. Greenlight Guru's platform is designed to streamline compliance for multiple global markets, ensuring you have a secure and compliant foundation for your device’s entire lifecycle, whether you're dealing with local type testing or post-market surveillance audits.

This "Meet the Guru" episode introduces Alex Naber, a seasoned medical device consultant at Greenlight Guru, offering listeners a deep dive into his background and expertise. Alex shares his journey, beginning in bioengineering and progressing through roles in complaints, field action, design quality, and post-market quality management at a major orthopedic company (Zimmer Biomet). His experience highlights the crucial need for expert guidance in navigating complex MedTech regulations and quality management system (QMS) pathways.

Alex and host Etienne Nichols discuss the immense value of having a diverse internal team of consultants to draw from—a collective knowledge base that helps solve complex problems for clients. They emphasize that quality professionals don't need to know "everything" but rather must have the right resources and a "beginner's mindset" to guide companies effectively. The conversation also explores how modern software, like Greenlight Guru's QMS and EDC solutions, eliminates common industry pain points, such as fragmented, error-prone spreadsheet-based design controls by building true, linked traceability directly into the eQMS.

Finally, the discussion touches on the philosophical "why" of the medical device industry: the patient. Alex shares a personal story about how orthopedics improved his grandfather's quality of life, underscoring the importance of maintaining a patient-first ethos. They conclude by discussing the upcoming QMSR transition, reassuring listeners that compliance is manageable, especially for those already adhering to ISO 13485.

• [01:50] Alex Naber's MedTech Career Path: From Bioengineering to Design Quality and Post-Market Management.
• [04:30] The Power of Pooled Expertise: Why Greenlight Guru's Consultant Team is a "Sherpa up the mountain."
• [07:35] The Problem with Spreadsheets: Comparing traditional Design Control methods to modern eQMS traceability.
• [11:00] Accelerating Compliance: How Greenlight Guru's QMS Templates dramatically cut implementation time.
• [13:30] The Bloated QMS: Why adopting procedures from large corporations may hinder small-to-midsize companies.
• [16:00] Design Quality Explained: Marrying R&D/Product Development with QMS compliance.
• [21:30] The MedTech Ethos: Focusing on the patient and improving quality of life.
• [27:00] CAPA Management Insights: The critical distinction between Correction and Corrective Action.
• [30:25] Navigating the QMSR Transition: Reassurance that compliance isn't "that deep" if you are already ISO 13485 compliant.

1. Seek a Unified Quality Solution: Fragmented quality processes (e.g., design controls in spreadsheets separate from the QMS) introduce significant regulatory risk. Adopting an eQMS, like the Greenlight Guru QMS solution, creates true traceability and dramatically streamlines compliance.
2. Design Quality as a Partner, Not Police: Design Quality Engineers should actively partner with R&D, not just enforce rules. This involves educating product development teams on the why behind documentation and regulations to collaboratively find compliant solutions.
3. Implement CAPA Early and Correctly: A robust CAPA process is essential long before market entry. Quality professionals must know the difference between a correction (fixing the immediate issue) and a corrective action (addressing the root cause) to prevent systemic non-conformances.
4. Leverage QMS Templates for Speed: For new or growing companies, utilizing pre-validated QMS templates, like those offered by Greenlight Guru, can cut months off the time required to establish a 13485 or FDA CFR Part 820/EU MDR compliant system.
5. QMSR is Not Overwhelming: As the QSR evolves into the Quality Management System Regulation (QMSR), companies already adhering to ISO 13485 will find the transition is relatively minor, primarily requiring minor updates rather than a complete overhaul of their existing QMS.

• Alex Naber's LinkedIn
• Etienne Nichols' LinkedIn: Connect with Etienne
• ISO 13485:2016: The international standard specifying requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Relevance: This is the foundation for managing QMS changes, including the QMSR transition.
• Quality Management System Regulation (QMSR): The upcoming modernization of the FDA’s Quality System Regulation (21 CFR Part 820), harmonizing U.S. requirements with ISO 13485. Relevance: The central regulatory change discussed at the end of the episode.

Design Quality: In the medical device industry, Design Quality (DQ) is a specialized function within the Quality Assurance (QA) department. Its role is to ensure that the process used to design and develop a new medical device is compliant with the company's QMS procedures and applicable regulations (like FDA 21 CFR Part 820 or ISO 13485). Think of Design Quality as the engineer's compass and map for compliance—they guide the R&D team to make sure every requirement, test, and risk mitigation is properly documented and linked, preventing costly issues down the line. Without DQ, R&D teams might build a great product that can't be legally sold.

Correction vs. Corrective Action: These two terms are often confused in quality management:

• Correction: The immediate action taken to fix a non-conforming issue. Example: A batch of surgical instruments has burrs, so the correction is to re-polish them.
• Corrective Action (CAPA): A deeper, systemic action taken to eliminate the root cause of a non-conformance so it does not happen again. Example: The corrective action is revising the manufacturing work instruction to include mandatory daily calibration of the machine causing the burrs.

We want to be your trusted voice in MedTech! We are committed to providing the most useful, actionable insider knowledge in the industry. Please help us by sharing your thoughts on this episode, suggesting future topics, or leaving a personalized review on your favorite podcast platform.

Send your feedback, topic ideas, and questions directly to [email protected]. We personally read every email and truly value your input.

This episode of the Global Medical Device Podcast is brought to you by Greenlight Guru, the only MedTech-specific platform that provides both a powerful Quality Management System (QMS) and industry-leading Electronic Data Capture (EDC) solutions. Alex Naber, an expert consultant from Greenlight Guru, highlights in this episode how integrating your design controls—the subject of his design quality expertise—directly into a compliant eQMS is the key to accelerating product development, eliminating audit anxiety, and truly improving the quality of life for patients. To learn more about how Greenlight Guru's dedicated solutions can streamline your path to market, visit www.greenlight.guru.

In this episode, host Etienne Nichols and guest Dr. Allison Komiyama, CEO and Founder of Blue Stocking Health, dive into a fascinating dialogue about the language used in healthcare and MedTech, particularly the terms patient, customer, and user. They explore how these words influence the perception of care, service, and the entire medical device development process. The conversation touches on the friction and inefficiencies that arise when the relationship dynamic is unclear, highlighting the different nuances between passively receiving treatment and being an active consumer of health services.

The discussion delves into the historical context of the word "patient," which is rooted in the Latin patior, meaning 'to suffer.' Dr. Komiyama shares insights from industry conferences, noting that many individuals prefer to be called a "person" or an "empowered patient" rather than a passive sufferer. This ties directly into the growing movement of individuals seeking to own their health and be active participants in their care, fueled by readily available information and a focus on health span over just disease treatment.

Ultimately, the key takeaway for MedTech innovators is the importance of understanding their end-user and tailoring their language—in labeling, clinical studies, and human factors testing—to align with the user's preferred terminology. The shift from "caregiver" to "care partner" is highlighted as a prime example of evolving language that acknowledges a collaborative, mutual relationship, moving away from a hierarchical structure to one of shared purpose.

• [0:01:25] - Introduction to Dr. Allison Komiyama and Blue Stocking Health's mission to amplify the good of MedTech.
• [0:04:14] - Discussion begins: Patient vs. Customer vs. User in MedTech.
• [0:06:05] - The etymology of "patient" (patior, to suffer) and the push for "person" or "empowered patient."
• [0:08:22] - Historical context: Passivity of the patient role and the doctor's assumed knowledge.
• [0:09:50] - The impact of consumerism, AI, and the "health span" movement on patient empowerment.
• [0:12:35] - The value of seeking multiple opinions and the role of patient priorities in customizing care.
• [0:15:30] - Shifting terminology: Why "caregiver" is moving toward "care partner."
• [0:18:22] - How language diversity enriches the conversation and enhances communication.
• [0:21:00] - Tying diverse language use to MedTech innovation and product development.
• [0:22:15] - The importance of understanding end-user biases and assumptions in MedTech.
• [0:24:25] - Impactful personal stories: How specific interactions define a positive care experience.
• [0:29:10] - Concluding thoughts: Why plurality and qualifiers (e.g., "empowered patient") may be the ideal goal.

"I think there's a lot of folks at FDA even that we're like, we don't want to use the word patient. We want to use the word person. And patient actually comes from the term patior, which means to suffer." - Dr. Allison Komiyama

1. Regulatory & Clinical Strategy: When defining the target population for your device—in 510k, IDE, or PMA submissions—be mindful of the terminology. Consider using terms like "end-user," "person living with [condition]," or "care partner" alongside "patient" to reflect a modern, inclusive understanding of the device's human context.
2. Human Factors & Usability: Language directly impacts product use. As an R&D or Human Factors professional, align your labeling and instructions with the language that resonates most with your defined user group. Utilizing terms like "care partner" for non-professional support ensures that instructions for use are mutually supportive and not hierarchical.
3. Marketing & Communication: MedTech companies should audit their external communications, including advertisements and white papers. A focus on "customer service" aspects (efficiency, speed, clear communication) can resonate more with the consumer/customer mindset than traditional "patient" messaging, provided it is balanced with clinical integrity.
4. Quality Management Systems (QMS) & Design Input: Use diverse language during design input collection to capture a broader range of needs. Focus groups that employ words like "user experience" and "customer journey" often uncover different, yet equally critical, insights compared to those solely focused on "patient safety" and "treatment protocol." Greenlight Guru's QMS and EDC solutions help capture and manage these diverse inputs effectively, ensuring alignment with both clinical and user needs.
5. Professional Dialogue: Embrace "strong opinions held loosely." MedTech leaders should cultivate internal and external dialogues that challenge existing assumptions about user terminology. A willingness to be corrected is key to identifying blind spots in product development and market strategy.

• Dr. Allison Komiyama's LinkedIn
• Etienne Nichols' LinkedIn: Connect with Etienne
• Blue Stocking Health: A company dedicated to redefining and amplifying the conversation around medical technologies.
• The Media Bias Chart / Ad Fontes Media (Vanessa Otero): Mentioned in the episode as an example of thoughtful dialogue and understanding different perspectives.

Caregiver vs. Care Partner

In the MedTech and healthcare world, the distinction between Caregiver and Care Partner is an important example of evolving language.

• Caregiver: Traditionally, this term suggests a one-way, hierarchical relationship where one person provides care and the other passively receives it. It often implies a professional role or a person solely responsible for the physical needs of another.
• Care Partner: This term signifies a mutual, collaborative relationship. It acknowledges that the person with the health condition is an active participant in their own care and that their support person (spouse, family member, friend) is working alongside them to manage the condition. It's a key linguistic shift that promotes empowerment and shared decision-making.

Analogy: Think of a dance. A Caregiver might be seen as the instructor directing every move, while a Care Partner is an equal on the dance floor, moving together with shared goals and rhythm.

We want to hear from you! Do you prefer to be called a patient, a customer, or a partner in your health journey? Your feedback drives our content and helps us bring the most relevant topics to the MedTech industry. Send your thoughts, episode reviews, and topic suggestions directly to us at [email protected]. We read every email and aim to offer personalized responses.

This episode of the Global Medical Device Podcast is brought to you by Greenlight Guru. In a complex and evolving industry, managing your processes efficiently is critical. Greenlight Guru provides the industry's leading suite of solutions: a Medical Device QMS to simplify compliance and accelerate product development, and Clinical Data Solutions (EDC) to streamline and digitize your clinical trials. The ability to embrace a user-centric approach, whether you call them a patient or a customer, requires robust quality and clinical data infrastructure—precisely what Greenlight Guru delivers. Learn how their solutions can power your next-generation medical device innovation.

This episode, hosted by Etienne Nichols, delves into the critical impact of a U.S. government shutdown on the medical device industry, specifically focusing on the Food and Drug Administration (FDA). Guest Michael Nilo, President and Principal Consultant of Nilo Medical Consulting Group and a former FDA Scientific Reviewer, offers an insider's perspective on which FDA functions halt and which remain active during a funding lapse. He clarifies that while the processing of new, user-fee-supported marketing applications like PMAs and 510(k)s typically stops, essential activities like active review of already-filed submissions, post-market safety surveillance, enforcement of recalls, and Investigational Device Exemption (IDE) reviews continue, drawing on existing user fee reserves.

The discussion pivots to the significant slowdowns that occur, notably the suspension of non-MDUFA-goal-tied interactions, such as Q-submissions (Pre-Submissions) and most interactive reviews. For startups and small manufacturers, the halting of the crucial small business designation processing can be particularly detrimental, leading to astronomically higher user fees once the government reopens. Michael emphasizes that the industry should anticipate this political risk and plan submission timelines strategically, positioning a government shutdown as an "uncontrollable natural disaster" that requires proactive risk mitigation.

Michael provides actionable advice for MedTech leaders to pivot during a shutdown. He recommends using the enforced delay to significantly improve the quality of submissions—making them easier to navigate and review once the FDA is fully operational—to gain a crucial advantage over the backlog of queued submissions. Furthermore, companies should utilize the time to focus on parallel activities such as process validation, refining quality systems, and strengthening commercial and reimbursement strategies. Michael stresses the importance of remembering the core mission: getting life-improving technologies to patients, and using any delay as an opportunity to emerge stronger and more prepared for commercial launch.

Key Timestamps

• 1:45 - The initial effects of a shutdown: What truly stops at the FDA (new submissions) versus what keeps running (existing reviews, IDEs, post-market surveillance).
• 3:50 - Why active review of filed submissions continues—the role of the user fee "reserve."
• 5:58 - Critical functions that stop or slow down: Pre-submissions (Q-subs), interactive reviews, new policy guidance, and routine inspections.
• 7:25 - The major impact of halting the small business designation process on user fees for new manufacturers.
• 8:36 - MDUFA (Medical Device User Fee Amendments) explained: How user fees fund the FDA and maintain operations during a lapse.
• 11:51 - Direct effects on a MedTech company's runway and the loss of interactive review.
• 13:17 - Actionable advice: Improving submission quality for easier review to mitigate the post-shutdown backlog.
• 15:00 - Strategic pivot: Focusing on parallel work like process validation and quality system refinement.
• 16:03 - Communicating with investors and partners: Positioning the shutdown as an uncontrollable event and shortening the commercial launch gap.
• 18:50 - Looking ahead: Planning submissions around budget resolution deadlines to anticipate shutdown risk.
• 20:53 - Final advice: Keeping the patient-focused mission in mind and maximizing internal efforts.

Quotes

Takeaways

1. Regulatory Strategy & Submission Quality: Use any government shutdown delay to drastically improve the navigability and clarity of your marketing submission (PMA, 510(k)). A well-organized, hyperlinked, and clear application will likely be processed faster by reviewers facing a post-shutdown submission backlog.
2. Financial Risk & Small Business Designation: Small medical device manufacturers should anticipate potential government shutdowns and file their small business designation application well in advance. Failure to process this designation during a lapse can result in paying the full, significantly higher user fee, which dramatically impacts startup runway.
3. Operations & Quality Focus: While regulatory submissions are stalled, pivot R&D and Quality teams to focus on parallel work streams. This includes advancing process validation, completing outstanding quality system activities (e.g., risk management file updates), and solidifying commercialization and reimbursement strategies.
4. IDE Reviews Continue: Companies initiating clinical trials should note that Investigational Device Exemption (IDE) submissions are generally considered essential and will still be reviewed within the MDUFA 30-day timeline. This is one of the few submission types that allows for continued progress during a shutdown.
5. Leverage User Fee Systems: Understand that the FDA's user fee structure (MDUFA) ensures that key pre- and post-market safety functions, as well as active review of existing applications, can be maintained for a period, acting as a crucial shock absorber for the industry.

References

• Michael Nilo's LinkedIn
• Etienne Nichols' LinkedIn: Connect with Etienne
• MDUFA (Medical Device User Fee Amendments): The legislation that authorizes the FDA to collect fees from companies that submit certain marketing applications for medical devices, which funds a significant portion of the agency's device-related activities and performance goals.
• IDE (Investigational Device Exemption): An FDA process that allows a device that is not yet legally marketed to be used in a clinical study to collect safety and effectiveness data. IDE reviews are generally protected during a shutdown.

MedTech 101 Section: User Fees and the MDUFA Buffer

When the U.S. government shuts down, it means Congress hasn't passed a budget, and non-essential federal agencies must pause most operations because their taxpayer funding stops. However, the FDA has a financial safety net for its medical device work: User Fees, authorized by the Medical Device User Fee Amendments (MDUFA).

Think of MDUFA as a dedicated savings account funded by MedTech companies. When a company submits a major application like a 510(k) or PMA, they pay a fee. This money goes into a separate reserve. When a government shutdown happens, the FDA can tap into this reserve to keep essential, MDUFA-related work going. This includes the salaries of reviewers who are already working on your application, ongoing post-market surveillance, and crucial safety functions. The money acts as a buffer, allowing the FDA to continue its core mission for a limited time, which is why existing reviews aren't immediately halted. New submissions, however, often can't be processed because that intake and processing function is deemed non-essential and is not typically covered by the emergency user fee funding.

Feedback Call-to-Action

We thrive on your input! If this discussion about government shutdowns and MedTech strategy sparked any thoughts, or if you have a topic you'd like us to cover, we want to hear from you. Email us directly at [email protected]. We personally read every email and are committed to providing you with the most relevant and actionable MedTech insights.

Sponsors

This episode is brought to you by Greenlight Guru, the only MedTech-specific platform providing end-to-end solutions. Don't let a government shutdown pause your internal quality momentum. Leverage Greenlight Guru's eQMS and EDC solutions to keep your product development, design controls, and clinical data management moving forward, ensuring your systems are inspection-ready and helping you build a submission so flawless it cuts through the FDA's post-shutdown backlog. Visit www.greenlight.guru to learn more.

This episode of the Global Medical Device Podcast, hosted by Etienne Nichols with guest Shannon Decker, CEO of VBC1 and an expert in healthcare transformation, dives deep into the science of how adults learn, contrasting pedagogy (child-centered learning) with andragogy (adult-centered learning). The discussion reveals why traditional training methods, like handing new hires 40 SOPs to read, are often ineffective for experienced professionals in the MedTech industry.

Shannon explains the core principles of andragogy: adults are self-directed, problem-centered, and bring a vast reservoir of experience to the table (schema theory). They are less motivated by sequential, externally guided learning and more by what is relevant, timely, and what is in it for them. This self-directed approach means successful training in MedTech requires catering to intrinsic motivation and providing tactile, real-world practice rather than just videos or documentation.

The conversation pivots to practical applications across the medical device lifecycle. Shannon shares compelling examples, like improving physician adoption of a medical device by shifting the focus from extrinsic financial rewards and regulatory compliance to the intrinsic motivation of improving patient health outcomes. By making users part of the development process and using performance feedback to tap into a professional's competitive spirit, organizations can achieve significantly higher engagement and successful adoption of new technologies.

• [03:20] What is Andragogy? How adults learn differently than children.
• [04:45] The role of schema theory and existing experience in adult learning.
• [05:40] Why the traditional "drop 40 SOPs" on a new hire’s desk fails adults.
• [07:15] Case Study: The challenge of low medical device adoption and the missing education piece.
• [08:50] The power of tactile practice and addressing user confidence (e.g., misusing the device).
• [11:00] Contrasting Andragogy (self-directed) vs. Pedagogy (directed/sequential).
• [14:10] Applying adult learning to device development: solving the user's problem.
• [16:45] How to boost adoption: Intrinsic motivation and making users part of the process.
• [18:20] The key physician motivator: Desire to help people over money or administrative requirements.
• [21:10] Behavior science: Focusing on influential champions and mid/top performers for diffusion.
• [22:45] The "Gold Star" effect: Using competitive spirit and relevant KPIs for motivation.

1. Stop Relying on Documentation for Training: Adult learners need tactile input and practice. Replace or supplement large volumes of SOP reading with project team involvement, practical exercises, and hands-on use to build confidence and retention.
2. Focus on the "What's In It For Me" (WIIFM): When designing a medical device or a training program, identify the user’s intrinsic motivations. For clinicians, this is often the desire to improve patient outcomes—lead with this message rather than revenue or regulatory burden.
3. Build Champions, Not Just Compliance: Instead of solely focusing energy on low performers or the loudest voices, identify respected, influential leaders (champions) to pilot and advocate for new technology. Their positive experience drives the Law of Respect and encourages wider adoption.
4. Use Performance Data as a Motivator: Feedback and benchmarking can tap into a professional’s competitive spirit. Monitor device usage and provide timely, relevant feedback (the "Gold Star" effect) using KPIs that matter to their professional values, not just revenue goals.
5. Make Users Part of the Process: Involve clinicians and end-users in the development cycle early on. Actively listening to their challenges and integrating their feedback ensures the final product is designed to solve their problems and fits seamlessly into their existing workflow.

• Dr. Shannon Decker's LinkedIn
• Etienne Nichols' LinkedIn: Connect with Etienne
• Schema Theory: Discussed as the framework for how adults integrate new information with their existing base of knowledge and experience.

Pedagogy and Andragogy are two core concepts in education theory that explain how different groups of people learn.

• Pedagogy (Child Learning): This is the traditional model where the teacher is in charge. Learning is directed, sequential, and structured by an authority figure (e.g., a child must learn A before they learn B). The child relies on the teacher for direction and motivation.
• Andragogy (Adult Learning): This model recognizes that adults are fundamentally different learners. Adult learning is self-directed, problem-centered, and motivated by relevance. Adults must understand why they need to know something and how it immediately applies to their lives or work. They also leverage their deep existing experience base (their schema) to evaluate new information.

Why it matters in MedTech: In a fast-paced field like medical devices, requiring an engineer to passively read 40 procedural documents (a pedagogical approach) is inefficient. Using an andragogical approach—by giving the engineer a project, showing them how the procedure solves a real-world problem, and having them practice the task—results in faster adoption, greater compliance, and better performance.

We want to hear from you! Do you use andragogy principles in your training? Have a question about leveraging intrinsic motivation in your team?

Send your feedback, episode reviews, or topic suggestions directly to the Podcast Producer: [email protected]. We read every email and your input helps shape the future of the Global Medical Device Podcast.

This episode is brought to you by Greenlight Guru, the only MedTech-specific platform with both a next-generation QMS and an integrated Electronic Data Capture (EDC) solution.

In an industry where successful training and adoption rely on integrating quality with practical use, Greenlight Guru helps you eliminate disconnected, clunky systems. By integrating your quality processes (QMS) with your clinical data capture (EDC), you ensure your teams are operating on the same source of truth, making it easier for adult learners—from R&D to clinical investigators—to understand and adopt your technology. Get the purpose-built platform that helps you design and build higher quality devices faster. Learn more at greenlight.guru.