Podcast

March 8, 2023

075 – Shortages, Pricing, Mastering New Skills, and Building Deep Understanding with Ben Locwin

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: Key Topics FDA Drug Shortages Report Drug Shortages

March 1, 2023

074 – Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman

On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through: Key Topics Article 117 requirements for Combination Products

February 22, 2023

073 – Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal

On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a

February 15, 2023

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: Key Topics Eliminating the need for instruction through good

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

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