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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
Quality Control
H. James Harrington
Traceability
Product Development
Systems Engineering
Sterilization Methods
ISO 14971
IEC 60601
Insulin Pump Systems
Software Development Process
Needle Safety Devices

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

PublishesWeeklyEpisodes191Founded4 years ago
Number of ListenersCategories
ScienceLife Sciences

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Artwork for Let's Combinate

Latest Episodes

In this episode of Let’s Combinate, Subhi Saadeh—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his journey to becoming a Certified Qualit... more

What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?

In this episode of Let’s Combinate, Subhi Saadeh breaks down the key distinctions between QbD, u... more

YouTube

In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career pr... more

In this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in qua... more

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Recent Guests

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
Eric Sugalski
Founder and CTO of Archimedic
Archimedic
Episode: 181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?
Gwen Acton
Leadership Coach for the Life Sciences space
CEO of Vivo Group
Episode: 180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
Joanna Gallant
Author of the article "Someone, Everyone or No One, Who Owns Quality and Who Should"
Episode: 179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing
Catherine Ebon
Investigative journalist and author of the book "Bottle of Lies"
Episode: 179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing
Shelly Amster
A pioneer with a lifetime of experience in reproductive health
Three Daughters
Episode: 173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's
Doug Mead
A regulatory expert with a wealth of experience in medical devices and combination products.
Rhizome AI
Episode: 172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead
Dr. Timothy Aungst
Pharmacist, professor, and digital health expert.
Digital Apothecary
Episode: 167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst
Marta New
CEO of Radius Research, with a background in venture capital and CRO.
Radius Research
Episode: 165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New

Host

Subhi Saadeh
Host of the podcast and an experienced professional in the medical device and pharmaceutical industries, inviting guests to simplify complex topics and share expertise.

Reviews

5.0 out of 5 stars from 31 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 Statesa year ago

Listeners Say

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

Listeners appreciate the high-quality content focused on pertinent topics in medical devices and pharmaceuticals.
There are notable critiques regarding audio quality that could be improved, suggesting the need for better recording equipment.

Chart Rankings

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Talking Points

Recent interactions between the hosts and their guests.

184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained
Q: What drove the shift from consumer products to medical devices and what role does program management play in product development?
Skip highlights that his transition to program management in medical devices was driven by observing the chaotic nature of project management methods and the inefficiencies caused by differing management styles. He emphasizes the need for standardized processes, particularly in highly regulated industries to ensure success.
179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing
Q: What motivated you to write that article?
Joanna Gallant wanted to address the complexities of quality ownership in organizations after working with a company to establish a strong quality culture.
180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
Q: What does optimizing the group output look like in terms of action ability?
Gwen explains that leaders often confuse being technically proficient with being effective in their management role, advocating for maximizing team results instead of doing everything yourself.
180 - MIT Leadership Expert Reveals Management Secrets for Scientists!
Q: Was there a specific situation where you were like, okay, I think I actually need to focus less on the technical work, and I get people really rallied behind good leadership principles?
Gwen observed that running an organization necessitated more non-technical skills that were essential for leadership, realizing her passion and skill set for leadership was significant.
172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead
Q: How does AI enhance the searchability of the Drugs at FDA database?
AI algorithms improve the ability to find specific regulatory information in unstructured data quickly.

Audience Metrics

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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?

This podcast explores the intricate interplay between pharmaceuticals and medical devices, focusing on a broad range of topics relevant to industry professionals. Episodes cover critical themes such as quality management systems, product development, regulatory compliance, and innovations in drug delivery methods. Notable discussions include mentorship in the industry, in-depth examinations of regulatory practices, and insights from experts on leadership and quality ownership. Uniquely, the host draws from over a decade of experience in the field, encouraging a journey towards mastery for listeners at all levels of expertise, making this a valuable resource for anyone involved in the life sciences sector.

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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. Huberman Lab
3. The Tucker Carlson Show
4. Pivot
5. The Rich Roll Podcast

How many episodes of Let's Combinate are there?

Let's Combinate launched 4 years ago and published 191 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. Skip Creveling
2. Eric Sugalski
3. Gwen Acton
4. Joanna Gallant
5. Catherine Ebon
6. Shelly Amster
7. Doug Mead
8. Dr. Timothy Aungst

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