#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

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

1. MedTech Trends:

• 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.

2. Practical Tips for MedTech Professionals:

• 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.

3. Questions for Future...