Podcast

June 26, 2024

142 – Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls 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: 01:53 Material Qualification Discussion Begins 02:23 Material Qualification

June 19, 2024

141 – Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)

On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington. Dr. H James Harrington has a decorated career with

June 12, 2024

140 – Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM’s, Evaluating Skill and Mindset with Christian Espinosa

On this episode, I was joined by Christian Espinosa CEO of Blue Goat Cyber. On this episode, Chrsitian walks through: Timestamps 00:00 Introduction and Guest Overview 00:20 Christian Espinosa's Journey:

June 5, 2024

139 – FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance – Platform TechnologyDesignation Program for Drug Development Guidance for Industry 13:03 EMA Guidance – Questions

May 29, 2024

138 – Operations vs. Quality, KPI’s, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through: Timestamps 00:31 Larry's Perspective on Quality 03:21 Importance of

May 22, 2024

137 – The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through: Timestamps 00:38 Exploring

May 15, 2024

136 – Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura

On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through: Timestamps 00:29 Design Changes When No DHF

May 8, 2024

135 – Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson

On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses: Timestamps 03:11 The Formation and Impact of

May 1, 2024

134 – ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch

On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses: Timestamps 00:29 Exploring Software's Role in Medical Devices 02:29 Deep Dive into Cloud-Based Medical Devices 06:29

April 24, 2024

133 – A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell

On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry. Devon discusses: Timestamps 02:20 The Journey to Consulting: A Year of Saying No 03:09 Advising

April 17, 2024

132 – IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses: Leo Eisner, founder and principal compliance and regulatory

April 10, 2024

131 – Novel Sterilization Methods for Drugs, Devices & Combination Products, EMA Decision Tree/Assessing Aseptic Filling and Sterility Priniciples with Jeanne Moldenhauer

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss: Key Topics Assessing Drugs, Devices, and Combination Products for Sterility Methods

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