Episodes

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 d...

Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything? In this episode of Let’s Combinate, Subhi Saadeh sits down with Dominick Romano, founder of D...

Nearly two-thirds of companies believe Quality 4.0 will transform their operations in the next five years yet fewer than 20% have started, and most haven’t even reached the planning stage. In this conversation, Larry Mager br...

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In this episode of Let’s Combinate, Subhi Saadeh sits down with Jim Collins, a leader in drug delivery with over 30 years of experience at Eli Lilly, Sanofi, and now as an advisor and board member. Jim shares the history of c...

In this episode of Let's Combinate, host Subhi Saadeh is joined by long-time friend and Senior Technical Program Manager Joey Frechin, who brings a wealth of experience in med tech consulting. They discuss the intricacies of ...

In this episode of Let’s ComBinate, Subhi Saadeh sits down with Jeff Gensler, a quality and regulatory leader with 30+ years in MedTech, pharma, and combination products. Jeff takes us inside FDA warning letters, consent decr...

In this milestone episode, I reflect on what it’s taken to record, edit, and release 200 episodes focused on medical devices, pharma, and combination products. I share three hard-earned lessons not just about the industry, bu...

In this episode of Let’s Combinate, host Subhi Saadeh is joined by Mark Burchnall, Director of Engineering at PSN Labs, to break down the evolving role of mechanical modeling and simulation in medical device and combination p...

In this episode of Let's Combinate, host Subhi Saadeh highlights five critical aspects of the FDA's new Quality Management System Regulation (QMSR) that you may have missed. Subhi explains the historical context of QSR and IS...

In this episode of Let’s Combinate, host Subhi Saadeh breaks down the critical role of quality agreements in the pharmaceutical and medical device industries.A quality agreement is a written document that defines GxP responsi...

From Episode 195 with Archana Sah In this clip of the larger interview with Archana Sah, she covers the critical phases and elements of clinical trials—from phase one focusing on safety to phase three assessing effectiveness ...

In this episode, I go over 8 lessons to maximize your first 90 days in Life Sciences. These include understanding the impact of their roles, adopting a professional mindset, passing the first 90-day test, avoiding the 'silent...

In this episode of Let's Combinate, Archana shares her insights on the critical factors involved in designing clinical trials, from phase one safety profiling to pivotal phase three trials. She also discusses the importance o...

In this episode I sit down with Mike Denzer, a mechanical engineer, inventor, and trusted leader in the combination product space. We talk about the power of networking not just as a tool for finding your next job, but as a f...

In this episode of Let’s Combinate, host Subhi Saadeh is joined by Kirk Petyo, Partner at Talent Factory Medical and Talent Factory Recruiting. If you're a bioengineering student, recent grad, or early-career professional try...

If you’ve ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical, high-level explanation of what a combination product is. It’s meant for anyone ...

You’ve heard it before: If it’s not documented, it didn’t happen. But in life sciences, documentation isn’t just a formality—it’s the foundation of trust, compliance, and product quality. In this episode, Subhi Saadeh breaks ...

Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective ...

Ever wondered who’s really behind the regulations you follow in pharma and medical devices? In this episode of Let’s ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test...

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 be...

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 dis...

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 stu...

Documentation Hierarchy and Best Practices in Quality Systems with Aaron SnyderIn this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultan...