#380: Navigating the Complex World of Co...

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.

Key Timestamps:

• [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.

Quotes:

• 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."

References:

• 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: Connect with Etienne

MedTech 101:

Combination Products: Products that integrate two or more regulated components (drug, device, biologic) into a single entity. Regulatory pathways for these products can vary significantly depending on the primary mode of action (PMOA), which determines which FDA center will lead the review.

Questions for the Audience:

• Poll: What do you see as the biggest challenge in the development of combination products today?
• Discussion: How do you think global harmonization of MedTech regulations will shape the future of combination products? Share your thoughts with us at podcast@greenlight.guru.

Feedback:

Enjoyed the episode? We’d love to hear from you! Leave us a review on iTunes and let us know what topics you’d like to hear about in future episodes. You can also email us at podcast@greenlight.guru.

Sponsors:

This episode is brought to you by:

Rook Quality Systems - stay ahead of the curve with Rook Quality Systems' 'Quality As A Service.' Rooks proactive approach to compliance ensures you're always prepared for the latest regulations and industry standards. Don't wait for issues to arise—be proactive with Rook. Learn more at RookQS.com!

Greenlight Guru - the only eQMS built by medical device professionals, for medical device professionals. Get to market faster with confidence. Learn more at greenlight.guru.