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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Avsnitt(257)

031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

031 - "The Five Stages Of Regulatory Grief" with Michelle Lott

On this episode of the podcast, I was joined by Michelle Lott of Lean RAQA. Michelle and I discuss: - Her background starting at a manufacturing site and moving into QA and RA - Being Outspoken and Ho...

4 Maj 20221h 19min

030 - "Why Don't I Try?" with Marc Koska

030 - "Why Don't I Try?" with Marc Koska

On this episode of the Combinate Podcast, I was joined by Marc Koska, Founder of Apiject. Marc and I discuss: The Importance of Understanding a Problem Developing Models for Courtrooms in the US Vi...

27 Apr 20221h 37min

029 - "Purpose" with Marla Phillips

029 - "Purpose" with Marla Phillips

On This Episode, I was joined by Marla Phillips of Pathway for Patient Health. Marla and I discuss: Pathway for Patient Health Training the Next Generations - What students can do? Quality for th...

20 Apr 20221h 34min

028 - "How Much Does Poor Quality Cost?" with H. James Harrington

028 - "How Much Does Poor Quality Cost?" with H. James Harrington

This is Part 2 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss: His Book - Poor Quality Costs(PQC) Why Cost of Qu...

13 Apr 20221h 10min

027 - "Become a Historian of the Problem" with Duane Mancini

027 - "Become a Historian of the Problem" with Duane Mancini

On this episode, I was joined by Duane Mancini, CEO and Managing Partner of Project Medtech and host of the Project Medtech Podcast. Duane and I discuss: Why he enjoys working with Startups Reimbur...

6 Apr 202259min

026 - "Quality" with H. James Harrington

026 - "Quality" with H. James Harrington

This is Part 1 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss: His first experience in Quality at 6 years old ...

30 Mars 202250min

025 - “The Frying Pan to the Fire” with Edwin Bills

025 - “The Frying Pan to the Fire” with Edwin Bills

On this episode of the podcast we had Edwin Bills, a Risk Management Expert that was on the committees for ISO14971:2019, ISO TR24971:2020 and AAMI TIR 105:2020. Ed and I discuss Combination Products ...

23 Mars 20221h 31min

024 - "Operating Under Constraints "with Naveen Agarwal

024 - "Operating Under Constraints "with Naveen Agarwal

On this episode of the podcast, Naveen Agarwal PhD from Creative Analytics Solutions. Naveen and I discuss: Running almost 1500 miles and the importance of constraints Risk Management Vigilance v...

16 Mars 20221h 12min

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