Let's Combinate - Drugs + Devices

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 Review and Control 09:09 Operational Framework and Business Structure 18:46 Effective Business Processes 24:42 Understanding Role Expectations and Aggregating Work 25:51 Ma...

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 Importance of Subscribing and Feedback 01:36 Alan Stevens Shares His Expertise 02:40 Understanding Reliability: Definitions and Nuances 03:46 Component vs. System Reliability in D...

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 Management 04:49 Improving Design Inputs and Risk Management 21:37 Leveraging Tools for Better Traceability and Compliance Charles Ventura is the Founder of Ventura Solutions and CEO...

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 Challenges and Changes in the Regulatory Landscape for Combination Products 07:53 Understanding FDA Titles and Organizational Structure 11:03 From FDA to Biogen: Transitioning to Ind...

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 Development in Medical Devices 26:33 The Future of Medical Devices in the Cloud Era 32:56 The Potential Impact of Tech Giants on MedTech 39:50 Embracing Digital Transformation...

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 No 03:09 Advising Startups: The Role of a Consultant 05:08 The Shift to Consulting: Embracing Joy and Impact 09:21 Navigating the Startup Ecosystem: Challenges and Opportunities 13:31 Building a Positive Team Culture and Avoiding Arrogance 19:12...

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 Development 02:10 Standards and Regulatory Challenges 02:42 Standards in Medical Devices and Emerging Technologies 13:19 The Auditing Experience 17:59 The Challenge of Maint...

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 (Link) - Novel Methods: liquid phase sterilization, ionization, physics based sterilization, high pressure sterilization, glass bead sterilization, infrare...

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 QMSR and Compliance 18:02 The FDA's Inspection Techniques and the Future of QMSR 31:55 Where to Find Aaron and Closing Thoughts Aaron Snyder is a quality management s...

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 combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. And the roles of standards and guidance in combinat...

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 Impact of QMSR on Industry 16:24 The FDA's Approach to Inspections and Compliance 27:45 The Shift Towards Quality Culture in FDA Inspections 31:07 Real-World Insights 3...

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 covers the confusion surrounding the mandatory nature of risk management in particular and we spend the second half of the episode talk about ri...

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 Stimulation 08:55 The Impact of working with Andy Grove 10:42 The Struggle with Parkinson's Disease 13:20 The Speed of Product Development 16:09 Collaboration Challenges in...

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 QMSR 06:57 History of the Device cGMP's, QSR, and QMSR 11:52 What's changing in 21 CFR 820? 24:59 What's changing in 21 CFR 4 and Combination Products 33:20 Comme...

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 learner. Andy stresses the importance of honing soft skills for effective leadership and suggest stepping out of the comfort zone by exploring opportunities ou...

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 locations like India and China. The discussion outlines the FDA's diverse focus areas, from food to medical devices and clinical trials, and how oper...

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, its working, and benefits. He addresses the challenges faced, emphasizing the need for relationship building and constant growth via listening and questionin...

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 people considering their career paths and emphasizes the importance of gaining expertise in a particular area before making significant career changes. He also...

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 distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and persons responsible for regulatory compliance. Munir ex...

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 differences between isolators and RABs—two types of equipment used in clean rooms, critical for sterile processing. David also starts to touch on the standards a...

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. Drawing on his industry experience, he explains advantages, challenges, and practical ways to handle and maintain these files in biopharma companies. Doug pr...

On this episode, I was joined by Khaudeja Bano, VP of Quality for Combination Products at Amgen. In this episode, the we discuss the details related to post-market safety reporting for combination products. The conversation extends to the comparison connecting safety and quality, the importance of cross-functional teams for risk management, and the approach towards health hazard assessments. Addit...

In this episode, I was joined by Jeanne Moldenhauer, a sterilization expert to discuss all things gas sterilization. Jeanne and I explore how efficiency is determined by the seal of the container and the type of material being sterilized. Jeanne discusses its application in medical devices, the challenge of permeability, and its comparative cost-effectiveness. Jeanne delves into how the sterilizat...

On this episode, I was joined by Katherine Eban, the New York Times best-selling author of "Bottle of Lies". In this episode, Katherine dives deep into her decade-long investigation into the quality issues prevalent in generic drug manufacturing overseas. Eban highlights the need for improving transparency in the pharmaceutical industry. She shares some inspiring stories of dedicated pro...

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne talks through the different methods of irradiation like gamma, beta, microwave, x-ray, and ebeam, their respective pros and cons, as well as their environmental impacts. Jeanne also delves into the practical considerations associated with this sterilization method. This includes important fac...