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(247)

061 - Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling

061 - Taguchi, Pugh, DFSS, Robust Design and Tolerancing with Skip Creveling

On this episode, I was joined by Skip Creveling, President and Founder of PDSS Inc. Skip walks through: Learning from Genichi Taguchi and Stuart Pugh The 7 Steps to Robust Design Design for Six Si...

30 Nov 202244min

060 - Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria

060 - Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria

Elena Kyria, CEO of Elemed joins the podcast and discusses: - Why People stay in roles and why they leave -Starting Elemed -The trusted advisory role that recruiters play -Community work on EU MDR an...

23 Nov 202242min

059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower

059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower

On this episode, I was joined by Ethan Drower, of Citemed. Ethan is a prolem-driven, software engineer and fellow Chicagoan who's focused on making literature review for EU MDR Clinical Evaluation Rep...

16 Nov 202241min

058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano

058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano

On this episode, I was joined again by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - PMSR and Risk Management  - Patient Safety, ...

9 Nov 202244min

057 - Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey

057 - Conferences, Expos, LinkedIn and Launching a Podcast with Rizwan Chaudhrey

On this episode, I was joined by Rizwan Chaudhrey, of RSK Life Sciences Media. Rizwan and I discuss: Launching Chats with Chaudhrey during the Pandemic Conferences and Expos How to use LinkedIn to...

2 Nov 202246min

056 - "Non-Promotional Compliance" with Darshan Kulkarni

056 - "Non-Promotional Compliance" with Darshan Kulkarni

On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University. Darshan and I discuss: - Non-Promotional Speec...

26 Okt 202233min

055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

On this episode, I was joined by Alexandra Benbadis, Usability Leader at Sanofi. Alexandra and I discuss: - Critical Tasks: What the guidance says , how to select them and what it means for HF study d...

19 Okt 202250min

054 - "EUDAMED" with Richard Houlihan

054 - "EUDAMED" with Richard Houlihan

On this episode, I was joined by Richard Houlihan, CEO of Eirmed. Richard and I discuss: - History of Eudamed (Starting with EU Legislation in 2010) - The 6 modules of Eudamed (PMS, Vigilance & Post-M...

12 Okt 202228min

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