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 Jul 202510min
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 Jul 202513min
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 Jul 20258min
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
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
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
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)
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
