In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator.

Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality systems, and managing innovation within the MedTech industry. They dive deep into the challenges faced by MedTech companies, particularly small startups, and how to balance regulatory requirements with creativity and innovation.

Vincent also highlights the common pitfalls companies encounter with design controls and shares strategies to ensure R&D and production teams work in harmony.

• [00:01] – Introduction: Vincent Cafiso’s background as an FDA investigator and transition into industry.
• [04:15] – Crayo Consulting’s Scope: How Creo Consulting supports MedTech companies from launch strategy to compliance.
• [12:40] – Bridging R&D and Production: Overcoming challenges when R&D environments don’t align with production standards.
• [19:50] – Top Trends in Quality Systems: Addressing documentation gaps and missing standards in design history files.
• [27:10] – Management’s Role in Supporting Quality: The importance of management’s involvement in enforcing quality controls and processes.
• [38:30] – From FDA to Industry: How Vincent’s FDA background influences his approach to quality and compliance.
• [54:25] – Skip-Level Meetings and Breaking Silos: Enhancing collaboration and communication within large organizations.
• [1:06:00] – Final Takeaways and Advice: Building a culture of quality and fostering innovation while staying compliant.

1. “The regulations are written for tongue depressors and pacemakers—two very different devices. It’s up to the companies to interpret how to apply those rules to their specific products.” – Vincent Cafiso
2. “Documentation shouldn’t just be a checkbox for submission. There’s a lot more innovation happening that doesn’t make it onto paper because companies don’t realize its value.” – Vincent Cafiso

• Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework.
• Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance.
• Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality.

• Integrate Quality Early: Implement quality controls and validation processes at the R&D stage to avoid repeating tests or redesigns during production.
• Leverage Skip-Level Meetings: Encourage direct communication between upper management and employees for better understanding and faster issue resolution.
• Document Everything: Don’t treat documentation as a formality. Capture all the engineering studies and real data to support design decisions and regulatory submissions.

In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development.

Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuring product safety and regulatory compliance. They dive deep into IEC 60601, ISO 15223, and the regulatory landscape across global markets.

Leo also shares actionable advice on avoiding pitfalls, prioritizing standards, and ensuring compliance to bring safe, effective devices to market without delays.

• [03:20] – Introduction to Leo Eisner and his background in medical device standards
• [10:15] – Why standards like IEC 60601 are crucial for medical device development
• [18:45] – Steps for identifying the right standards for your product
• [27:00] – Common mistakes and the consequences of ignoring standards
• [38:50] – How to integrate standards into your design process
• [47:35] – How startups can navigate standards with limited resources
• [58:00] – Tools for staying updated on changing standards and regulations
• [1:09:40] – Final advice from Leo on ensuring regulatory success

• "When you really think about it, all this work leads to safer medical devices on the market—that’s crucial." – Leo Eisner
• "Standards may seem like obstacles, but they’re design inputs that ensure your device will work as intended in every scenario." – Etienne Nichols
• "If you don’t integrate standards early in the design phase, you bring design risk later into the project, which can be very costly." – Leo Eisner

MedTech Trends:

1. Regulatory Compliance as a Design Input – Standards such as IEC 60601 are not just hurdles but key design inputs.
2. Global Market Variations – Different countries have unique regulatory demands; understanding these early can avoid costly delays.
3. Atomic Standards – Future standards are becoming more "atomic," meaning they’ll be broken down into more easily applicable, smaller parts.

Practical Tips for MedTech Professionals:

1. Start Early with Standards – Review applicable standards in the initial design phase to avoid costly delays later.
2. Use the Right Tools – Tools like MedBoard and the FDA’s guidance database can help you stay updated.
3. Seek Expert Help – If you're a startup or lack in-house resources, work with a qualified consultant to navigate the regulatory landscape efficiently.

Questions for Future Developments in MedTech:

1. Will the move toward "atomic" standards streamline regulatory processes for startups?
2. How will global regulatory bodies harmonize standards across different markets?
3. What emerging standards will impact next-gen MedTech innovations like AI and robotic surgery?

• Greenlight Guru - Quality Management System & Electronic Data Capture solutions built by Medtech professionals for Medtech professionals.
• Leo Eisner on LinkedIn – Connect with Leo for expert insights on compliance and regulatory standards.
• IEC Standards – The international standard for...

In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development.

They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and manufacturing processes.

Perry shares insights from his extensive career, offering actionable strategies to simplify complex variables, avoid common pitfalls, and ensure a more effective and efficient development process.

• [00:02] – Introduction to Perry Parendo and his background in DOE
• [05:50] – What is DOE? Perry’s simple, non-technical definition
• [12:00] – Common problems DOE solves and its application in R&D
• [22:30] – Risk management and DOE’s role in reducing uncertainty
• [35:20] – Using DOE in manufacturing processes and real-world examples
• [48:10] – Common pitfalls and best practices when using DOE

• Perry Parendo: “Design of Experiments is a tool to assist in understanding a system. It’s not just a test plan; it’s a way to create structure and strategy in how you approach testing.”
• Etienne Nichols: “The life of an engineer really happens in that space between input and output—there’s so much to dial in, and that’s where tools like DOE really help.”

Key Insights on MedTech Trends:

1. DOE reduces risk: It plays a crucial role in risk management, especially in R&D, where understanding system behaviors early is key to mitigating issues down the line.
2. Structured problem-solving: DOE provides a data-driven, structured way to isolate variables and pinpoint causes, streamlining troubleshooting and optimization in product development.
3. Adaptability of DOE: It can be applied to both small and large-scale problems, from manufacturing issues to high-stakes R&D, making it essential for MedTech innovation.

Practical Tips for MedTech Professionals:

1. Start small with DOE: Focus on fewer variables when beginning to ensure you don’t get overwhelmed. Three to seven variables are typically manageable for early experiments.
2. Understand the limits of your tests: Avoid putting all variables into one test; break them down to ensure results are meaningful and actionable.
3. Validate your DOE: Don’t rely solely on DOE results—validate with real-world testing to confirm your findings.

• Perry Parendo: Founder of Perry Solutions, specializing in product development and process optimization through DOE. LinkedIn
• Connect with Etienne Nichols on LinkedIn.

Design of Experiments (DOE) is a statistical method used to determine how different variables (inputs) affect a process or product outcome (output). It’s widely used in MedTech for optimizing processes and solving manufacturing or product development issues by systematically testing different variables to identify the most influential factors.

1. Poll: How often do you use DOE in your medical device development...

In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur."

Dr. Parekh shares how her desire to create impactful medical devices led to the development of the COBRA-OS, a life-saving tool used in trauma care, including military and postpartum hemorrhage situations.

The conversation touches on the challenges and victories of securing funding, navigating regulatory hurdles, and maintaining a mission-driven company focused on patient impact. For those interested in MedTech, this episode provides inspiration, practical insights, and a behind-the-scenes look at innovation in healthcare.

Key Timestamps:

• [03:22] – Asha Parekh shares her transition from biomedical engineer to accidental entrepreneur.
• [12:35] – Developing the COBRA-OS and the moment Asha realized the life-saving potential of her product.
• [22:10] – The role of passion in overcoming challenges as a MedTech entrepreneur.
• [35:42] – The importance of securing funding and the challenges of working with quality and regulatory partners.
• [52:20] – How to craft a compelling pitch to secure funding for your MedTech device.
• [01:04:30] – Asha's milestone moments, including the COBRA-OS being used at Formula One race tracks.

Quotes:

• "Passion is what drives you through the tough days. It's what makes the challenges bearable because the impact you're making is worth it." – Asha Parekh
• "Pitching is an art form. Telling a compelling story about your product, especially one that saves lives, can make all the difference." – Asha Parekh
• "You are the expert on your device. Never forget that, even when you're leaning on regulatory experts. Trust your own knowledge of your product." – Asha Parekh
• "The moment I realized that COBRA-OS could save lives, I knew we had to pursue it full-time." – Asha Parekh

Key Takeaways:

Top 3 MedTech Trends:

1. Growing Impact of Trauma Care Devices – Devices like the COBRA-OS are becoming critical in high-risk environments such as military and emergency settings.
2. Regulatory Complexity – Expanding into international markets (e.g., achieving CE mark) requires navigating a web of regulatory requirements.
3. Funding & Innovation – Securing funding is pivotal for early-stage MedTech companies, especially when aiming for large-scale regulatory testing.

Top 3 Practical Tips for MedTech Entrepreneurs:

1. Find a Mission You’re Passionate About – It will sustain you through difficult phases.
2. Master the Art of Pitching – A compelling story can unlock funding opportunities.
3. Be Proactive in Regulatory Knowledge – Don’t rely solely on consultants; know your product’s regulatory pathway inside and out.

References:

• Frontline Medical Technologies – Learn more about COBRA-OS and its use in trauma care at Frontline MedTech.
• Greenlight Guru – For quality and regulatory management solutions, visit Greenlight Guru.
• Rook Quality Systems – Learn more about QMS consulting at Rook Quality Systems.
• Connect with Etienne Nichols on LinkedIn...

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products.

They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth.

Subhi shares his personal journey in podcasting, the impact of consistent content production, and the importance of lifelong learning.

They also dive into the intricacies of combination product definitions, regulatory pathways, and trends, offering listeners a well-rounded view of the current state and future potential of this evolving industry.

• [00:02] – Introduction of Subhi Saadeh and his background in combination products.
• [03:45] – The origin story of the Combinate Podcast and its impact on Subhi’s career.
• [12:32] – Overview of combination products and regulatory differences between the US and EU.
• [18:50] – Common misconceptions in drug-device integration.
• [28:10] – The evolving landscape of combination products and industry growth.
• [34:22] – Balancing technical and business aspects in MedTech.
• [46:15] – Notable episodes and guests from the Combinate Podcast.
• [56:30] – Final thoughts on lifelong learning and producing valuable content.

• Subhi Saadeh: "If I want to be a master at my craft, I need to be producing something in a way that is consistent."
• Etienne Nichols: "Teaching others is one of the best ways to instill that knowledge into yourself."
• Subhi Saadeh: "Drugs and devices aren’t as different as people think; it’s how they measure product quality that varies."

• Combinate Podcast: let’s combinate.com
• Subhi Saadeh’s LinkedIn Profile: Connect with Subhi
• FDA Regulatory Guidelines for Combination Products: Important for understanding the regulatory landscape.
• Book Reference: Quality is Free by Philip Crosby - A must-read for quality management professionals.
• Book Reference: Bottle of Lifes by Katherine Eban
• Etienne Nichols’ LinkedIn Profile:

In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Vernon Baker, a medical device guru, about key strategies for early-stage MedTech companies, particularly around implementing Quality Management Systems (QMS), supplier management, and compliance.

Vernon shares his experience of transitioning from engineering to quality and regulatory roles, emphasizing the importance of being a "jack of all trades" when hiring early quality managers. They discuss how small companies can navigate the complexities of ISO 13485, supplier audits, and regulatory intelligence. This episode is a must-listen for startup founders and quality professionals seeking to establish a strong foundation in MedTech.

• [00:02] – Introduction: Etienne Nichols introduces the topic of early-stage MedTech QMS implementation and guest Vernon Baker.
• [04:30] – Vernon’s Background: From mechanical engineer to quality expert in MedTech.
• [13:00] – Wearing Many Hats: How early hires in quality roles manage multiple responsibilities in small companies.
• [22:10] – Supplier Management: The importance of supplier audits and choosing the right partners.
• [35:45] – Management Reviews & Communication: Aligning quality efforts with company goals.
• [47:00] – Regulatory Intelligence: Staying updated with regulatory changes and standards.
• [59:20] – Final Advice: Qualities to look for in an early-stage quality manager.

• “You don’t have to be an expert in everything, but you do need to know where to find the answers.” – Vernon Baker on managing quality systems.
• “A good management review should feel like a real conversation about the direction of the company, not just a checkbox exercise.” – Vernon Baker on management reviews.
• “Supplier management is critical in small organizations. You’re outsourcing a lot, and you need to vet and audit your suppliers well.” – Vernon Baker on supplier controls.

MedTech Trends:

1. Focus on Flexibility: Early hires in MedTech quality roles need to be adaptable, covering everything from product development to regulatory compliance.
2. Supplier Audits Are Essential: Strong supplier management, including on-site audits, is vital to mitigate risks and ensure high-quality materials and components.
3. Regulatory Intelligence: Regularly updating your team on changing regulations and standards is crucial for maintaining compliance and avoiding costly mistakes.

Practical Tips:

1. Leverage Consultants: For niche areas like biocompatibility and regulatory changes, hiring external consultants can provide critical insights.
2. Invest in Training: Encourage your team to undergo formal training in ISO 13485, risk management, and process validation to build internal competency.
3. Use Document Templates: Start with pre-existing QMS templates and refine them according to your company’s specific needs.

• ISO 13485: The international standard for medical device quality management systems, which is essential for compliance in various jurisdictions.
• FDA Recognized Standards: Lists that guide device manufacturing and safety, critical for ensuring that products meet U.S. regulatory requirements.
• EU MDR: A sweeping update to European medical device regulations, requiring stricter quality and reporting...

In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Laura Maher to discuss the critical role of design assurance in medical device development.

They explore the importance of ownership in design and development documentation, delve into the complexities of design controls, and share practical insights on how to ensure compliance and streamline product development.

Laura shares her unique journey from quality control to product development, emphasizing the need for a multidisciplinary approach to create effective and safe medical devices.

• [00:00] - Introduction and Sponsor Messages
• [03:10] - Introducing Laura Maher and her background
• [06:45] - Who should own design and development documentation?
• [12:20] - The importance of understanding design controls
• [18:35] - The role of design assurance professionals
• [25:50] - Audience of design and development documentation
• [33:40] - The intersection of quality and product development
• [40:55] - Differences between design reviews and stage reviews
• [47:15] - Collaborative nature of risk management
• [55:30] - Essential skills for a design assurance professional
• [1:02:40] - Closing thoughts and resources

• "The value of design assurance professionals lies in their ability to bridge the gap between quality and development." - Laura Maher
• "Understanding the spirit of quality and innovation is as important as knowing the definitions in design controls." - Etienne Nichols
• "A design file is not just for launch; it’s a living document that supports the entire lifecycle of a device." - Laura Maher

Key Insights

1. Multidisciplinary Approach: Combining quality, regulatory, and product development knowledge is crucial for effective design assurance.
2. Documentation Ownership: Assigning clear ownership of design documentation can streamline development and ensure compliance.
3. Design Controls Understanding: A deep understanding of design controls helps in creating documentation that satisfies regulatory requirements and is audit-ready.

Practical Tips

1. Training and Education: Seek out training programs on design controls and quality management to build foundational knowledge.
2. Collaboration: Foster a collaborative environment where engineers, quality assurance, and regulatory teams work together on documentation.
3. Technical Writing: Develop strong technical writing skills to create clear and comprehensive design documentation.

• Greenlight Guru - Quality management software tailored for medical devices.
• Rook Quality Systems - Comprehensive compliance services for medical device companies.
• Ultimate Guide to Bringing a Medical Device to Market - A detailed resource for new and experienced MedTech professionals.

Design Controls: A set of practices and procedures for managing the design of medical devices to ensure they meet user needs and regulatory requirements.

Trace Matrix: A document that maps user needs to design inputs and outputs, ensuring all requirements are met.

Risk Management:...

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Matthew Wettergreen, Director of the Global Medical Innovation Master of Bioengineering program at Rice University. Dr. Wettergreen shares his extensive experience in developing client-based engineering design courses and discusses the importance of global and contextual perspectives in medical device innovation. They delve into the unique approaches of the Global Medical Innovation program, highlighting the critical role of diverse healthcare settings in shaping future medtech innovators.

Key Timestamps:

• [00:01:00] Introduction of Dr. Matthew Wettergreen and his background.
• [00:03:30] Overview of the Global Medical Innovation program at Rice University.
• [00:07:45] Importance of contextual and global perspectives in medical device innovation.
• [00:14:00] Experiences and lessons learned from Costa Rica’s healthcare system.
• [00:22:15] Discussing out-of-context healthcare settings in Brownsville, Texas.
• [00:30:00] Navigating healthcare hierarchies and observer bias in medical device innovation.
• [00:45:00] Differences between student learning processes and typical industry practices.
• [00:55:20] Practical tips for companies to broaden their medtech innovation perspectives.
• [01:05:30] Final thoughts on the importance of diverse lenses in medtech innovation.

Quotes:

1. "Understanding healthcare from a 360-degree view is important because it helps you to understand why those specific practices are done." - Dr. Matthew Wettergreen
2. "Our goal is to prepare students to enter the medtech industry in a range of jobs by simulating professional practice in diverse contexts." - Dr. Matthew Wettergreen
3. "Recognize that you're wearing a lens and train yourself to try and take off that lens and put on a new one." - Dr. Matthew Wettergreen

Key Takeaways:

Latest MedTech Trends:

1. The significance of global and contextual perspectives in medical device innovation.
2. The rising role of telemedicine in reaching low-income and underserved populations.
3. The importance of functional, cost-effective solutions in global healthcare settings.

Practical Tips for MedTech Enthusiasts:

1. Engage in clinical needs-finding activities to better understand the healthcare environment.
2. Encourage facilitated discussions and case studies within your organization.
3. Explore and appreciate diverse healthcare systems to innovate effectively.

Questions Predicting Future Developments:

1. How will telemedicine evolve to cater to the needs of the lowest SES populations?
2. What are the potential impacts of integrating global healthcare perspectives in local innovations?
3. How can medtech companies better prepare their employees to understand upstream and downstream processes?

References:

• Rice University's Global Medical Innovation Program
• Pumani CPAP Device
• Dr. Matthew Wettergreen on LinkedIn
• Etienne Nichols LinkedIn

MedTech 101:

• Telemedicine: Remote diagnosis and treatment of patients