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

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

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...

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...

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...