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