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Let's Combinate - Drugs + Devices

Subhi Saadeh
FDA
Medical Devices
Risk Management
Combination Products
ISO 13485
FDA Regulations
QMSR
Quality Management
Medical Device Cybersecurity
Quality Control
H. James Harrington
Traceability
Product Development
Systems Engineering
Sterilization Methods
ISO 14971
IEC 60601
Insulin Pump Systems
Software Development Process
Drug Delivery Systems

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

PublishesWeeklyEpisodes223Founded4 years ago
Number of ListenersCategories
Life SciencesScience

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Artwork for Let's Combinate

Latest Episodes

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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Recent Guests

Stephen O'Rourke
Regulatory strategist and founder of Clarifi
Clarifi
Episode: 216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke
Andy Robertson
Founder of CQE Academy.
CQE Academy
Episode: 214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)
Usman Ahmed
CEO of Quetzal Therapeutics and former CEO of Nexus Pharmaceuticals
Quetzal Therapeutics
Episode: 213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
Leonel Venegas
Quality and regulatory professional with experience in combination products.
Precision Regulatory Consulting LLC
Episode: 212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products
Mark Kramer
Founding Director of FDA's Office of Combination Products
FDA
Episode: 211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer
Monika Andraos
Expert in data integrity and compliance
Dunamis Compliance
Episode: 209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
Susan Needle
Author of the Combination Product Handbook
Combination Products Consulting Services
Episode: 204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle
Joey Frechin
Senior Technical Program Manager in Medtech Consulting
Episode: 202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin
Jeff Gensler
Veteran quality and regulatory executive with over 30 years of experience in MedTech, Pharma, and Combination Products Quality
Quality 4.0 Consortium
Episode: 201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0

Host

Subhi Saadeh
Host with extensive experience in medical device, pharmaceutical, and combination product development, aiming to simplify complex topics in the industry.

Reviews

5.0 out of 5 stars from 37 ratings
  • 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 Podcasts
    4
    lblake09
    United States2 years ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

The podcast is regarded as a good resource for young professionals and individuals seeking insights into pharmaceuticals and medical devices.
Some critiques mention concerns about audio quality, suggesting improvements could enhance listening experience.
Listeners appreciate the in-depth discussions and knowledgeable guests from the industry.

Chart Rankings

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Talking Points

Recent interactions between the hosts and their guests.

213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
Q: What was the biggest moment for you regarding the sale of your facility?
The sale to Lilly for a billion dollars was a pivotal success that validated our efforts and caused significant interest from big pharma.
213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
Q: How did you decide as far as the level of which to commit to your manufacturing capabilities?
We were mindful of our product portfolio and the lead time needed, ensuring our equipment selection aligned with future needs.
213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
Q: What was the commercialization process like for this product?
We faced decisions about whether to proceed because the RLD had issues, but our product offered a great value proposition.
213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
Q: When you brought the idea of this specific drug to your parents, was it immediate that they were like, 'yeah, we can do it'?
They were optimistic and thought they could figure it out despite the challenges.
213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
Q: How did you decide the first few molecules beyond just looking at patent expiry dates?
I focused on finding our ability to win and looked where the bigger companies weren't competing effectively.

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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?

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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Which podcasts are similar to Let's Combinate?

These podcasts share a similar audience with Let's Combinate:

1. Medical Device made Easy Podcast

How many episodes of Let's Combinate are there?

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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What guests have appeared on Let's Combinate?

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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