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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Jaksot(258)

198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed

198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed

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 histori...

23 Heinä 202510min

197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong

197 - Quality Agreements Explained: How to Protect Yourself When Things Go Wrong

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 ...

16 Heinä 202513min

Combi Crumbs: Clinical Trials 101 – From Safety to Strategy

Combi Crumbs: Clinical Trials 101 – From Safety to Strategy

From Episode 195 with Archana SahIn 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 ...

12 Heinä 20258min

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 Heinä 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 Heinä 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 Kesä 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 Kesä 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 Kesä 20254min

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