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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
Quality Management System
Artificial Intelligence
Quality 4.0
Audits
Regulatory Compliance
Quality Control
Medtech
Drug-Device Combination Products
Good Manufacturing Practices

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

PublishesWeeklyEpisodes255Founded5 years ago
Number of ListenersCategories
Life SciencesScience

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Artwork for Let's Combinate

Latest Episodes

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?

In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, medical-device, and combination-product companies... more

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of how regulated businesses actually operate.

In this ... more

Most discussions about One QMS focus on harmonization.

But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organizations structure a QMS.

In this episode, I co... more

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and what it takes to build a drug-device combination p... more

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Recent Guests

Julia Anthony
Founder and Chief Strategy Officer of Solution Medical
Solution Medical
Episode: 245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector
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

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 States3 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

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Talking Points

Recent interactions between the hosts and their guests.

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector
Q: What is the core difference between existing therapies and what you aim to make practically usable for patients today?
The current standard requires complex reconstitution and handling under stress, with a 14-step process that can be performed by patients or caregivers in a life-threatening moment; the goal is a four-step pre-filled syringe or a two-step auto-injector that delivers hydrocortisone reliably, with easier handling and less room for error.
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.

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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. Medical Device made Easy Podcast
2. Global Medical Device Podcast powered by Greenlight Guru
3. The Rich Roll Podcast
4. Prof G Markets
5. Planet Money

How many episodes of Let's Combinate are there?

Let's Combinate launched 5 years ago and published 255 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. Julia Anthony
2. Lucas Pianegonda
3. Joe Luminiello
4. Jennifer Rider
5. Georg Digel
6. Elaine Tan
7. Stephen O'Rourke
8. Andy Robertson

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