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(248)

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

053 - "Duct Tape and Bubble Gum" with Chris Tsai

053 - "Duct Tape and Bubble Gum" with Chris Tsai

On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss: Value Engineering at Eastman Kodak in the 1990's Inventing and Deploying Concurrent Engineering Defini...

5 Okt 20221h 4min

052 - “All Work is Process” with Larry Mager

052 - “All Work is Process” with Larry Mager

On this special episode of the podcast, I was joined by Larry Mager. As the 52nd episode, I wanted to thank Larry for being my first interview a little more than a year ago! On this episode, Larry an...

28 Sep 202253min

051 - "EU MDR" with Bassil Akra

051 - "EU MDR" with Bassil Akra

On this episode, I was joined by Bassil Akra, the CEO of AKRA Team. Bassil and I discuss: EU MDR and Implementation Timeframe Notified Bodies, Competent Authorities, MOH's and the EU Commission Ar...

21 Sep 202244min

050 - "When No One is Listening" with James Somauroo

050 - "When No One is Listening" with James Somauroo

On this episode, I was joined by Dr. James Somauroo of SomX and The HealthTech Podcast. James and I discuss: HealthTech Communication Growing a Passion The HealthTech Podcast Healthtech Pigeon ...

14 Sep 202240min

049 - "What Does the Data Say?" with Shannon Hoste

049 - "What Does the Data Say?" with Shannon Hoste

On this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss: - FDA Human Factors Review for Combination Products (CDRH, CDER/DMEPA, OCP) - Huma...

7 Sep 202246min

048 - "Materials" with Hsinjin Yang

048 - "Materials" with Hsinjin Yang

On this episode of the podcast, I was joined by Hsinjin Yang of Pioneer Scientific Solutions. Hsinjin and I discuss: - Materials for Biomedical Applications - Mechanical Properties, Physical Propertie...

31 Aug 202234min

047 - "Truthful Not Misleading" with Darshan Kulkarni

047 - "Truthful Not Misleading" 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. - Free Speech and Promotional Compliance - Mis...

24 Aug 20221h

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