
Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people w... more
| Publishes | Weekly | Episodes | 223 | Founded | 4 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | Life SciencesScience | |||

In this short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means.
He compares batch vs. continuous, explains how a batch still exists in continuous manufacturing, and cov... more
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space.
This episode provides practical insights and strategies for overcoming these common hurdles to enhanc... more
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. more
In this episode of Let’s Combinate, Subhi Saadeh breaks down why more engineers in pharma, medical devices, and combination products should seriously consider becoming auditors. Sparked by a question at a PDA conference: “Why don’t more technical peo... more
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As a young biomedical engineer in BioPharmTech, this podcast is a good resource for pertinent topics in the medical device/pharmaceutical world. The only critique I have is the audio quality could be better. The sound cuts in and out sometimes for the guests. I'm guessing the audio is extracted from a zoom or teams interview. The host would serve himself well with a better mic and recording in a better studio-like room setting
Key themes from listener reviews, highlighting what works and what could be improved about the show.
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Focusing on the intersection of pharmaceuticals and medical devices, a range of topics including regulatory issues, quality assurance, and the development of combination products are discussed throughout the episodes. Notable themes include the integration of technical and regulatory perspectives, the importance of quality certifications, and the unique challenges presented by drug-device collaborations. The host also engages with industry experts, fostering a platform where listeners can gain insights from seasoned professionals about navigating the complexities of the industry. The podcast offers practical knowledge for individuals involved in drug development, medical technologies, and regulatory affairs, making it a valuable resource fo... more
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Let's Combinate launched 4 years ago and published 223 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
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Recent guests on Let's Combinate include:
1. Stephen O'Rourke
2. Andy Robertson
3. Usman Ahmed
4. Leonel Venegas
5. Mark Kramer
6. Monika Andraos
7. Susan Needle
8. Joey Frechin
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