Let's Combinate - Drugs + Devices

Let's Combinate - Drugs + 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 who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!

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Episoder(247)

196 - How to Win Your First 90 Days in Pharma and MedTech

196 - How to Win Your First 90 Days in Pharma and MedTech

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 t...

9 Jul 20259min

195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah

195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah

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 d...

2 Jul 202547min

194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer

194 - Drug Delivery Innovation, Networking in Pharma, and Building a Career That Matters with Mike Denzer

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 ...

25 Jun 202519min

193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025

193 - Bioengineering Grads: Here’s What Recruiters Actually Want to See in 2025

In this episode of Let’s Combinate, host Subhi Saadeh is joined by Kirk Petyo, Managing Partner at Talent Factory Medical and founder of Talent Factory Recruiting. If you're a bioengineering student, ...

18 Jun 202547min

192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)

192 - What Is a Drug/Device Combination Product? (Non-Technical, Under 5 Minutes)

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 i...

11 Jun 20254min

191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity

191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity

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 epis...

4 Jun 202513min

190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong

190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong

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 regula...

28 Mai 202515min

189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?

189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?

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 influ...

21 Mai 202517min

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