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

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,

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

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 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

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

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

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

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

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

In this episode of Let's Combinate , host Subhi Saadeh welcomes back Skip Creveling, a global expert in program management and Six Sigma methodologies. Skip shares his extensive experience helping

Understanding GXPs: Essential Good Practices for Bioengineering ProfessionalsIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned bioengineer with ten years of experience in the pharma and medical device