Building a Partnership with your Regulatory Consultant

In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector.

From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA regulatory pathways, Christine offers a wealth of knowledge. The discussion delves into the intricacies of working with regulatory consultants, the significance of FDA interactions, and practical tips for medical device startups aiming to maneuver through regulatory challenges successfully.

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Key Timestamps

• [00:02:30] Christine's journey from biochemistry to medical device innovation
• [00:15:00] Insights on starting a medtech startup and the early failures
• [00:30:45] Effective collaboration with regulatory consultants
• [00:45:10] Handling FDA interactions and strategic submissions
• [01:00:20] Advice for medtech startups on navigating regulatory environments

Key Takeaways

1. Engage with local medtech communities and resources, such as accelerators or innovation hubs.
2. Early interactions with the FDA can significantly influence your device’s regulatory pathway.
3. Thorough documentation and clear communication with consultants are essential for effective project management.

Links: 

• Texas Medical Center Innovation Institute
• Proxima Clinical Research
• Christine Luk on LinkedIn
• Etienne Nichols on LinkedIn

Memorable quotes:

• "You're pitching all these awesome capabilities of your device, meanwhile on the FDA side, we're asking, who are you most like?" – Christine Luk
• "Every meeting is money. Making sure everybody is aligned and on the same page is crucial when dealing with consultants." – Christine Luk

Feedback:

Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Sponsor:

This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed specifically for medical device companies. Streamline your processes and stay compliant with Greenlight Guru.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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