Navigating the Complex World of Combination Products

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.

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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.

Top takeaways from this episode

1. Focus on Flexibility: Early hires in MedTech quality roles need to be adaptable, covering everything from product development to regulatory compliance.
2. Supplier Audits Are Essential: Strong supplier management, including on-site audits, is vital to mitigate risks and ensure high-quality materials and components.
3. Regulatory Intelligence: Regularly updating your team on changing regulations and standards is crucial for maintaining compliance and avoiding costly mistakes.

Practical tips for MedTech professionals

1. Leverage Consultants: For niche areas like biocompatibility and regulatory changes, hiring external consultants can provide critical insights.
2. Invest in Training: Encourage your team to undergo formal training in ISO 13485, risk management, and process validation to build internal competency.
3. Use Document Templates: Start with pre-existing QMS templates and refine them according to your company’s specific needs.

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.

Related links

• Combinate Podcast: let’s combinate.com

• Subhi Saadeh’s LinkedIn Profile: Connect with Subhi

• Etienne Nichols’ LinkedIn Profile: Connect with Etienne
  

• 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

Memorable quotes from this episode

• "If I want to be a master at my craft, I need to be producing something in a way that is consistent." - Subhi Saadeh
• "Teaching others is one of the best ways to instill that knowledge into yourself." - Etienne Nichols
• "Drugs and devices aren’t as different as people think; it’s how they measure product quality that varies." - Subhi Saadeh

Audience 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.

Sponsors

• Greenlight Guru: Streamline your medical device processes with Greenlight Guru’s quality management and electronic data software. Visit Greenlight Guru to learn more.
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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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