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)

072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa

072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa

On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through: - Eliminating the need for instruction through good design - Drug/De...

15 Feb 202353min

071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols

071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols

On this episode, I was joined by Etienne Nichols, who is a Medical Device Guru and Host of the Global Medical Device Podcast. Etienne Discusses: -Translating lessons from the Steel Industry into MedT...

8 Feb 202359min

070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen

070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen

On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses: - His experience leading combination product...

1 Feb 202350min

069 - EU MDR Extension with Michelle Lott

069 - EU MDR Extension with Michelle Lott

On this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry.  If you'd like to hear more about Michelle checkout episod...

25 Jan 202317min

068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge

068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge

On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses: · His book Mythical Medical · Benefit (As part of Benefit/Risk) · PRR...

18 Jan 202347min

067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True

067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True

On this episode I was joined by Jane M. True, VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead at Pfizer. • Following career tracks, "experience", and non-linear career prog...

11 Jan 202347min

066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio

066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions. Fran and I discuss: Her career at West Pharmaceuticals starting in the lab and ret...

4 Jan 202355min

065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh

065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh

This solo episode walks through 8 of the quality lessons I learned by losing 100lbs over the last 10 years. They are: Change takes time Change starts from a small decision More pain does not equ...

28 Des 202229min

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