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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

PublishesWeeklyEpisodes260Founded5 years ago
Number of ListenersCategories
Life SciencesScience

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Artwork for Let's Combinate

Latest Episodes

Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality.

In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually means, the difference between sampling by attribu... more

In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug delivery device market is headed and what it takes fo... more

After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change.

Starting now, new episodes will go live Mondays at 5:00 AM CT.

To everyone who watches, listens, shares, or has been part of the journey: thank you. This p... more

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today.

In thi... 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 founder; long-time practitioner in quality auditing for medical devices and pharma, with a focus on regulatory strategy, lifecycle quality, and risk management.

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.

Listeners appreciate the depth on quality and regulatory topics, with actionable frameworks for audits and change management.
The host translates complex regulatory concepts into accessible guidance, though pacing can be dense for newcomers.
Guests are often experienced practitioners delivering practical, real-world insights rather than theory.
Some feedback mentions audio quality could be improved in interviews, suggesting better mic and room setup.

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?

Two recurring threads shape this show: the intersection of drugs and medical devices, and the regulatory, quality, and lifecycle questions that connect development to market. Episodes frequently unpack quality systems, audits, ICH/Q-series guidelines, and practical path-to-approval topics, with a strong emphasis on risk management, design control, and lifecycle thinking for combination products. Listeners likely include professionals building or evaluating quality systems, regulatory affairs experts, and engineers navigating both pharma and MedTech, seeking actionable insights, real-world implications, and strategic guidance for compliance and market access. A notable strength is the host's deep industry experience and ability to translate ... more

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Which podcasts are similar to Let's Combinate?

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

1. Global Medical Device Podcast powered by Greenlight Guru
2. Prof G Markets
3. The Daily
4. Planet Money
5. Up First from NPR

How many episodes of Let's Combinate are there?

Let's Combinate launched 5 years ago and published 260 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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