Let's Combinate - Drugs + Devices
Subhi SaadehHello 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 | 235 | Founded | 4 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | ScienceLife Sciences | |||
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Latest Episodes
In this episode of Let’s Combinate, Subhi Saadeh speaks with Jen Riter about analytical method validation for drug device combination products. The discussion explores how traditional drug analytical validation under ICH Q2 differs from validating fu... more
Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in living systems where products cannot be fully charac... more
Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.
Timestamps
00:00 Welcome and Guest Intro
00:53 The ... more
In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance under the NMPA.
The conversation explores why Weste... more
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Reviews
- Great content and knowledgeable guests
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
Apple Podcasts4lblake09
United States2 years ago
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Apple Podcasts | #146 |  Japan/Science/Life Sciences |
Apple Podcasts | #162 |  Denmark/Science/Life Sciences |
Apple Podcasts | #165 |  Mexico/Science/Life Sciences |
Apple Podcasts | #166 |  Austria/Science/Life Sciences |
Apple Podcasts | #177 |  Switzerland/Science/Life Sciences |
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Frequently Asked Questions About Let's Combinate
What is Let's Combinate about and what kind of topics does it cover?
A commercially focused deep-dive into drug-device development, regulatory strategy, and quality management for life sciences. Episodes frequently cover ICH guidelines, regulatory pathways across regions, post-market lifecycle considerations, and practical challenges in combining drugs with devices. Conversations with industry professionals explore CAPA, stability, validation, manufacturing, and global standards, often tying theory to real-world applications for teams working at the intersection of pharma and medtech. Notably, the show emphasizes bridging pharmaceutical and device expectations, helping listeners streamline development, compliance, and market access while highlighting practical pitfalls and process improvements.
Where can I find podcast stats for Let's Combinate?
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How many listeners does Let's Combinate get?
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What are the audience demographics for Let's Combinate?
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How many subscribers and views does Let's Combinate have?
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Which podcasts are similar to Let's Combinate?
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How many episodes of Let's Combinate are there?
Let's Combinate launched 4 years ago and published 235 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
How do I contact Let's Combinate?
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What guests have appeared on Let's Combinate?
Recent guests on Let's Combinate include:
1. Georg Digel
2. Elaine Tan
3. Stephen O'Rourke
4. Andy Robertson
5. Usman Ahmed
6. Leonel Venegas
7. Mark Kramer
8. Monika Andraos
To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.