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Let's Combinate - Drugs + Devices

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

PublishesWeeklyEpisodes214Founded4 years ago
Number of ListenersCategories
Life SciencesScience

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Artwork for Let's Combinate

Latest Episodes

As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersection of AI, GMP, and Quality 4.0, exploring both the ... more

In this episode, I talk with Monika Andraos of Dunamis Compliance about how organizations can navigate group think and approach data integrity the right way.

We cover risk culture, CSV vs. data integrity, ALCOA++, data governance, and practical tip... more

In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the process of discovering molecules that modulate biologica... more

In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. They cover where the standard came from, why FDA introduced it in their 2020 draft guidance, and what i... more

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Recent Guests

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
Mark Burchnall
Director of Engineering at PSN Labs
PSN Labs
Episode: 199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall
Archana Sah
A clinical leader in pharma with over 30 years of experience
Episode: 195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah
Mike Denzer
Renowned mechanical engineer in the Combination Product space
Episode: 194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer
Kirk Petyo
Managing partner at Talent Factory Medical and founder of Talent Factory Recruiting.
Talent Factory Medical
Episode: 193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025
Skip Creveling
A global leader in program management with decades of experience in product development, particularly in highly regulated industries like medical device, pharma, and aerospace.
Episode: 184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained

Host

Subhi Saadeh
A seasoned expert in medical device, pharmaceutical, and combination product development with over a decade of experience. Saadeh focuses on mastering complexities within these fields and prompts discussions aimed at simplifying industry challenges.

Reviews

5.0 out of 5 stars from 36 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.

Some critiques mention audio quality issues that occasionally impact the listening experience, suggesting improvements could enhance overall quality.
Listeners appreciate the engaging content and the expertise of the guests, noting that it serves as a great resource for professionals in the biopharmaceutical and medical device industries.
The informative discussion and practical insights provided are highly valued by an audience eager to grow their knowledge in these specialized fields.

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Talking Points

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209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
Q: How would you advise someone who's unfamiliar with data integrity to start understanding it?
Get good training and start by engaging with someone on the Data Integrity Team to assist you.
209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
Q: How do you help people answer the question of whether a dashboard or tool needs validation?
Assess the impact on patient safety, product quality, and data integrity to determine the need for validation.
209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
Q: What is data integrity?
Data integrity includes the completeness, accuracy, reliability, and trustworthiness of data.
205 - Why Less Than 20% of Companies Have Started Quality 4.0
Q: How do you distinguish between somebody who can actually help implement quality 4.0 versus somebody who's paying lip service to a new concept?
There are companies that might have done it on their own or brought in people, but expertise could be early; it's more about understanding the holistic approach to implementing Quality 4.0.
205 - Why Less Than 20% of Companies Have Started Quality 4.0
Q: How important is it to have a roadmap?
It's very important because the concept of expanding the role of Quality to manage Little Q Quality is huge.

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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?

Focused on the intersection of pharmaceuticals and medical devices, the content features in-depth conversations with industry experts about the complexities involved in combination products. Topics range from regulatory affairs and quality management to clinical trial design and risk management, providing valuable insights for professionals in the life sciences sector. The unique conversational style invites both newcomers and seasoned veterans to explore critical issues, innovations, and best practices within the field, encouraging a collaborative approach to problem-solving and knowledge sharing.

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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. Medical Device made Easy Podcast
3. TED Radio Hour
4. RAQA Today
5. The Ezra Klein Show

How many episodes of Let's Combinate are there?

Let's Combinate launched 4 years ago and published 214 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. Monika Andraos
2. Susan Needle
3. Joey Frechin
4. Jeff Gensler
5. Mark Burchnall
6. Archana Sah
7. Mike Denzer
8. Kirk Petyo

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