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 Begins02:23 Material Qualification in Drugs vs. Devices04:00 Quality Standards in

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

14 days ago 23m 9s

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 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at

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

21 days ago 30m 50s

On this episode, I was joined by Christian Espinosa CEO of Blue Goat Cyber. On this episode, Chrsitian walks through:00:00 Introduction and Guest Overview00:20 Christian Espinosa's Journey: From Air Force to Cybersecurity03:41 Medical Devic

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

28 days ago 27m 43s

This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance - Platform TechnologyDesignation Program for Drug Development Guidance for Industry13:03 EMA Guidance - Questions & Answers for applicants, marketing autho

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

May 29th, 2024 47m 34s

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:00:31 Larry's Perspective on Quality03:21 Importance of KPIs in Management Review04:13 Management Review and Control0

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

May 22nd, 2024 18m 11s

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:00:38 Exploring Reliability in Combination Products01:17 The Importance of Subscrib

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

May 15th, 2024 39m 53s

On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through:00:29 Design Changes When No DHF Exists03:30 Challenges and Strategies in Document Management04:49 Improving

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

May 8th, 2024 41m 16s

On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses:03:11 The Formation and Impact of the Office of Combination Products04:16 Challenges and Changes in

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

May 1st, 2024 41m 49s

On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses: 00:29 Exploring Software's Role in Medical Devices02:29 Deep Dive into Cloud-Based Medical Devices06:29 The Intricacies of Software Development in Medica

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

Apr 24th, 2024 22m 26s

On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry.Devon discusses:02:20 The Journey to Consulting: A Year of Saying No03:09 Advising Startups: The Role of a Consultant05:08 The Shift to Consulting: E

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

Apr 17th, 2024 31m 11s

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses: 00:56 Evolution of Industry Standards02:00 The Impact of Standards on Medical Device Development02:10 St

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

Apr 10th, 2024 42m 53s

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss:- Assessing Drugs, Devices, and Combination Products for Sterility Methods- Regulatory Frameworks and EMA's Decision Tree

130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder

Apr 3rd, 2024 32m 25s

On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: 00:58 Exploring the Impact of QMSR on Medical Device Companies02:19 UDI Regulations05:18 Understanding the FDA's Approach to QMSR and Complian

129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens

Mar 27th, 2024 32m 59s

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, expect to learn from Alan about how reliability engineering concepts can be used for single use combinati

128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture

Mar 20th, 2024 52m 32s

On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso. Vin discusses: 01:35 Journey from Premed to FDA Investigator: VIN's Story07:25 Understanding the Impact of QMSR on

127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal

Mar 13th, 2024 48m 25s

On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk". In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode c

126 - Combination Products Collaboration, Turnover on MedTech/Pharma Project Teams, and Lessons from working with Intel's CEO with Mat Stratton, Founder of Coalition Ltd

Mar 6th, 2024 35m 54s

On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses:01:02 Venturing into Combination Products02:46 Andy's Journey into Healthcare Space04:48 Challenges in Deep Brain Stimulation08:55 The Im

125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh

Feb 28th, 2024 42m 4s

On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024. 0:00 Introduction05:09 Initial Reactions to the idea of the QMSR06:57 Hist

124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson

Feb 21st, 2024 31m 1s

On this episode, I was joined by Andy Robertson, founder of CQE Academy. In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship, taking on challenging assignments, and being a lifelong l

123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker

Feb 14th, 2024 45m 15s

On this episode, I was joined by Peter Baker, President @ Live Oak QA.The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culminating in his experiences in international

122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, and Networking in Pharma/MedTech with Jim Fries

Feb 7th, 2024 35m 59s

On this episode, I was joined by Jim Fries, CEO of Rx360.On this episode, Jim discusses the critical aspects of audits in medical technology and pharmaceutical sectors. He provides insight into the joint audit program that RX-360 rolled out, i

121 - Bench Scientist to Commercial Leader, Amgen in the early days, Challenges in Commercialization, Working in Startups vs. Large Companies, and Silos with Sayed Badrawi

Jan 31st, 2024 33m 26s

On this episode, I was joined by Sayed Badrawi, Pharma/MedTech Investor and Board Member.Sayed walks through starting at Amgen as a bench scientist and transitioning to the commercial side of the Pharma industry. Sayed provides advice for peop

120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi

Jan 24th, 2024 43m 6s

In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device. Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the

119 - What are the basics of Clean Rooms, RABS and Isolators in ISO14644 and EU Annex I? with David Simoens

Jan 18th, 2024 26m 25s

On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc.David discusses his broad background, including his roles in quality manufacturing, product development, and technical transfer. He delves into the diffe

118 - What are Drug/Device Master Files and When to Use for Combination Product Submissions? with Doug Mead

Jan 10th, 2024 37m 53s

On this episode, I was joined by Douglass(Doug) Mead, Combination Products Expert and Founder of CP Pathways.Doug presents a thorough walkthrough of drug master files (DMFs) and device master files (MAFs), their types, and their differences. D