Global Medical Device Podcast powered by Greenlight Guru

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:

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:

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:

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.

Key Timestamps

• [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.

Quotes

"The requirements that you have fulfilled in the earlier stages might not be sufficient to enter market. They need to have local testing [and] need to compliant with the local standard." - Elaine Tan

"For China, NMPA would like to actually emphasize that you need to select a predicate which has been approved in China markets already... This product have to be already registered to be valid and to be applicable to be used as a predicate device." - Elaine Tan

Takeaways

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.

References:

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.

Key Timestamps

• [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.

Quotes

"It's a rewarding thing to just understand that you don't need to know everything. I think that's a thing that... people should realize and they should reach out to other people that are smarter or more experienced in realms that they don't understand." - Alex Naber

"I think what got me into MedTech was more of the ethos behind it... We're creating products to make patients' lives better, to impact our world, our society in a positive manner, to give a better quality of life to individuals." - Alex Naber

Takeaways

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.

References