In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk devices, and share invaluable advice on mitigating risks associated with clinical trials. Whether you're a newcomer or a seasoned professional in the MedTech industry, this episode offers essential insights to ensure your clinical studies are compliant and efficient.

Key Timestamps:

• 00:01:20 – Introduction to Dr. Mike Drues and his accolades.
• 00:05:30 – Explanation of IRBs and their role in clinical trials.
• 00:15:10 – Differences between traditional and commercial IRBs.
• 00:22:40 – Discussion on significant vs. non-significant risk devices.
• 00:32:00 – Importance of pre-submission meetings with the FDA.
• 00:44:15 – Steps to take when an IRB disapproves your clinical trial.
• 01:00:30 – Practical tips for choosing the right IRB for your study.

Quotes:

• "Most 510 devices do not need clinical data. But if you do, even for a non-significant risk device, vetting that with the FDA in advance is wise." – Dr. Mike Drues
• "You don't want to create a problem where none exists, but avoiding FDA consultation can lead to costly surprises later." – Dr. Mike Drues
• "The primary mission of an IRB is to ensure the safety of the patients at that institution." – Dr. Mike Drues

Takeaways:

Key Insights:

1. Understanding IRBs: IRBs are local entities responsible for the ethical oversight of clinical trials, ensuring patient safety and compliance.
2. Risk Classification: The classification of your device as significant or non-significant risk dictates whether FDA approval is needed for your clinical trial.
3. Strategic Pre-Submission: Engaging in a pre-submission meeting with the FDA can prevent costly delays and ensure your clinical trial meets all necessary endpoints.

Practical Tips:

1. IRB Shopping: If faced with an IRB denial, consider alternative institutions or commercial IRBs to avoid delays.
2. Comprehensive Submissions: Prepare thorough submissions for IRBs, including device descriptions, clinical trial protocols, and informed consent forms.
3. Physician Champions: Having a physician advocate at the institution can streamline the approval process and facilitate patient enrollment.

Future Questions:

1. How will the evolving landscape of MedTech regulations impact the approval process for new devices?
2. What role will real-world evidence play in future clinical trials for medical devices?
3. How can smaller companies navigate the complexities of FDA and IRB requirements effectively?

References:

• Etienne Nichols on LinkedIn
• Mike Drues on LinkedIn
• Greenlight Guru can help with Clinical Investigations
• Good Clinical Practices (GCP) regulations for IRBs

MedTech 101:

What is an IRB?

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of an IRB is to ensure the ethical and safe treatment of participants in clinical trials.

What is an IDE?

An Investigational Device Exemption (IDE) allows a medical device to be used in a clinical study to collect safety and effectiveness data. An IDE must be approved by the FDA for significant risk devices before a clinical study can begin.

Questions for the Audience:

• Poll: Have you ever faced challenges with IRB approvals for your medical device clinical trials? Share your experiences at podcast@greenlight.guru

Feedback:

We'd love your feedback on this episode! Please leave us a review on iTunes and share your suggestions for future topics. Email us at podcast@greenlight.guru

Sponsors:

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