Episodes
143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan…
On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry. I...
142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Qualit…
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 Q...
141 - Lessons from the Life and Legacy of Quality Guru H. James Harri…
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 ...
140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software,…
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 Cybersecurity...
139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combina…
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 & Answers for applicant...
138 - Operations vs. Quality, KPI's, Management Controls, Process Imp…
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 Quality 03:21 Importance of KPIs in Management Review 04:13 Management R...
137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety…
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 Products 01:17 The Impo...
136 - Systems Engineering for Combination Products, User Needs, Desig…
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 Exists 03:30 Challenges and Strategies in Document Manageme...
135 - Combination Products Mindset, MDUFA and Combination Products, F…
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 Products 04:16 Challen...
134 - ISO62304, Software Development Process, SaMD, Closed Loop Syste…
On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses: 00:29 Exploring Software's Role in Medical Devices 02:29 Deep Dive into Cloud-Based Medical Devices 06:29 The Intricacies of Software Deve...
133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility…
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 Shi...
132 - IEC 60601, A Life Without Standards, Evolution of Standards, St…
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 Standards 02:00 The Impact of Standards on Medical Device Developm...
131 - Novel Sterilization Methods for Drugs, Devices & Combination Pr…
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 ...
130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & …
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 Companies 02:19 UDI Regulations 05:18 Understanding the FDA's Approach to...
129 - Reliability for Combination Products, Infusion Pumps and Recall…
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 s...
128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadav…
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 Story 07:25 Understanding the I...
127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk P…
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 saf...
126 - Combination Products Collaboration, Turnover on MedTech/Pharma …
On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses: 01:02 Venturing into Combination Products 02:46 Andy's Journey into Healthcare Space 04:48 Challenges in Deep Brain Stimul...
125 - Unpacking the Quality Management System Regulation(QMSR) Final …
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 Introduction 05:09 Initial Reactions to the idea of the...
124 - 5 Steps to Becoming a Phenom Quality Pro with Andy Robertson
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 b...
123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, D…
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...
122 - Intricacies of Joint Audits, Rx360, Supply Chain Security, Netw…
Navigating Audits in Med Tech and Pharma: A Conversation with Jim, CEO of RX-360 In this episode of the Combinate podcast, host Suby interacts with Jim, CEO of a member-driven consortium, RX-360, that focuses on supply chain ...
121 - Bench Scientist to Commercial Leader, Amgen in the early days, …
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 provi...
120 - EU MDR R&R: What's the difference between Legal Manufacturer, A…
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...