Podcast

February 8, 2023

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: Key Topics Translating lessons from

February 1, 2023

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: Key Topics His experience leading combination

January 25, 2023

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

January 18, 2023

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: Key Topics His book Mythical Medical Benefit (As part

January 11, 2023

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. Key Topics Following career tracks, "experience", and

January 4, 2023

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: Fran DeGrazio. President & Principal Consultant at Strategic Parenteral

December 28, 2022

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

December 21, 2022

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 tolerancing). In this

December 14, 2022

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: Key Topics Challenges with

December 7, 2022

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,

November 30, 2022

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

November 23, 2022

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

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