In this conversation, Pablo Morales discusses his transition from a 16-year career at the FDA to joining Veranex, emphasizing his passion for medical device innovation and the importance of collaboration across disciplines. He shares insights on the lessons learned from his time at the FDA, the excitement of leading a diverse team, and the opportunities for transformation in medical device development, particularly through technology and regulatory strategies.
Key Takeaways:
- Diversity of thought and expertise is critical for innovation in medical device development. Veranex is uniquely positioned to support innovators, because its diversity of thought spans the entire product development lifecycle.
- Medical device success today isn’t just about innovation, it’s about integrating regulatory, clinical, and real-world evidence strategy from the start of development
- Plan for the total product lifecycle, not just the initial submission. Integrate regulatory, clinical, and engineering strategy early to reduce delays and costly redesigns.
- Patient-centered approaches and real-world evidence generation are key to transforming the industry.