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Let's Combinate - Drugs + Devices

Subhi Saadeh
Combination Products
Medical Devices
FDA
Risk Management
Clinical Trials
ISO 13485
Quality Management
Pharmaceutical Industry
Pharmaceuticals
Drug Development
Pharma
Artificial Intelligence
Quality 4.0
Audits
Regulatory Compliance
Medtech
Drug-Device Combination Products
Good Manufacturing Practices
Mentorship
Continuous Manufacturing

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

PublishesWeeklyEpisodes249Founded5 years ago
Number of ListenersCategories
ScienceLife Sciences

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Artwork for Let's Combinate

Latest Episodes

One of the hardest parts of auditing is not knowing what to look for.It is deciding where to start. Do you trace a deviation? Walk the process? Focus on one department? Audit CAPA across the organization? Or pull on a thread that does not quite make ... more

In this final episode of the ICH Quality series, we walk through the most important concepts in ICH Q14 and how they fit into the broader ICH quality framework.

Rather than reviewing the guideline section by section, this episode focuses on the idea... more

ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances and drug products.Learn more:www.letscombin... more

In this episode, Subhi breaks down ICH Q12, the guideline focused on post-approval change management and pharmaceutical product lifecycle management.

The core question behind ICH Q12 is simple: once a product is approved, what is actually binding, w... more

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Recent Guests

Lucas Pianegonda
Founder of Gradical and Plastics Expert in Medical Technology
Gradical
Episode: 232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk
Joe Luminiello
CEO and co-founder of RCG Intel, specializes in competitive intelligence for biopharma
RCG Intel
Episode: 230 - How Pharma Misses Critical Market Signals with Joe Luminiello
Jennifer Rider
Analytical testing leader with 28 years at West and experience at Kindeva
West Pharmaceutical Services; Kindeva Drug Delivery
Episode: 229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
Georg Digel
Founder at Elevate CAPA, known as the CAPA Papa.
Elevate CAPA
Episode: 227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics
Elaine Tan
Specializes in the China market for regulatory compliance and access for medical devices.
MedTech Chopsticks
Episode: 226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
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

Host

Subhi Saadeh
Host and creator of the show; background in quality auditing for medical devices and pharma; leads conversations and topics across pharma, devices, and combination products.

Reviews

5.0 out of 5 stars from 38 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.

Host credibility and practical focus on QA and regulatory topics are frequently praised.
Listeners value the depth and applicability of regulatory topics and guest expertise.
Audio quality feedback suggests upgrading mic setup for a more studio-like sound.

Chart Rankings

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Talking Points

Recent interactions between the hosts and their guests.

229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
Q: How do ISO/USP standards fit into a platform approach for pre-fillable syringes and other devices?
Start from ISO for platform or device-specific methods, then tailor and validate those methods with the drug product to ensure a comprehensive, product-specific validation at the combination level; when needed, couple with USP approaches and consider how compendial verification aligns with ISO methods.
229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
Q: What is the practical difference between validating a method and validating a device, especially for combination products?
Validation centers on the method's reliability and transferability across samples, while device validation focuses on the actual hardware performance; for combination products you often validate the method with a surrogate device and then verify the platform with the real product.
229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
Q: Is it not possible to just take a functional method and run it through ICH Q2?
The discussion suggests that functional methods require more than a direct Q2 copy; you need to account for mechanical performance, surrogate devices, and platform validation to ensure the method truly reflects how the product behaves in real use.
226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
Q: Is there significant issues with misclassification?
Yes, misclassification can lead to significant regulatory challenges due to the differences in classification systems.
226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
Q: What is the main differences I could see here?
The main differences relate to the responsibilities of agents in China compared to unauthorized representatives in the EU.

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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?

The show centers on the regulatory, quality, and development challenges in the pharma, medical device, and combination products space, guided by practical host-led explanations and real-world anecdotes. Episodes frequently cover ICH guidelines, GMP, CAPA, design space, and market/regulatory strategy, often featuring experts who discuss material selection, regulatory pathways in different regions, and audit or testing frameworks. A notable strength is the host's ability to translate complex standards into actionable guidance for practitioners, with a bias toward risk management, lifecycle thinking, and cross-functional collaboration that helps listeners anticipate issues in development, submission, and post-market activities.

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Which podcasts are similar to Let's Combinate?

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

1. Let's Talk Risk! Podcast
2. HBR On Leadership
3. Snap Judgment
4. The Daily
5. Hidden Brain

How many episodes of Let's Combinate are there?

Let's Combinate launched 5 years ago and published 249 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. Lucas Pianegonda
2. Joe Luminiello
3. Jennifer Rider
4. Georg Digel
5. Elaine Tan
6. Stephen O'Rourke
7. Andy Robertson
8. Usman Ahmed

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