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(258)

064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling

064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling

On this episode, I was joined again by Skip Creveling. During the last episode, Skip walked through Design for Six Sigma(DFSS), and finding/measuring what's important(critical parameters and toleranci...

21 Des 202254min

063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman

063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman

On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. Niedre discusses: - Challenges with glo...

14 Des 202248min

062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer

062 - Reimbursement in Europe, Access, Rebates, and Negotiation with Stefan Walzer

I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy.  Stefan discusses: Discounts, Rebates, and how Co-Paymen...

7 Des 202237min

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

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