144 episodes
Combinate Podcast - Combining Drugs and Devices Subhi Saadeh
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- Science
Hello Combi-Nation!
Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on.
My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers.
Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!
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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 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and president of ASQ and has multiple quality awards named after him. He's currently the CEO of Harrington Management systems, an International consulting firm focused on performance improvement, strategic planning, and organizational alignment for both private and public organization. -
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:
00:00 Introduction and Guest Overview
00:20 Christian Espinosa's Journey: From Air Force to Cybersecurity
03:41 Medical Device Cybersecurity: Challenges and Risks
05:51 Freelance to Entrepreneurship: Founding Blue Goat Cyber
07:05 Cybersecurity in Medical Devices: Key Considerations
16:55 The Importance of Software Bill of Materials
27:48 Hiring for Cybersecurity: Skills Over Certifications
29:36 Book Recommendations and Closing Remarks
Christian Espinosa, founder and CEO of Blue Goat Cyber, is a leading medical device cybersecurity expert, driving advancements prioritizing patient safety and data integrity. His proactive and innovative approach defines his work. As the author of "The Smartest Person in the Room" and "The In-Between: Life in the Micro," Christian shares his journey from competitive to compassionate leadership. An avid adventurer, he enjoys extreme sports, heavy metal music, and spicy foods. His achievements as a certified skydiver, PADI divemaster, and Ironman triathlete underscore his commitment to personal growth and transformative leadership.
https://www.linkedin.com/in/christianespinosa/https://twitter.com/Ironracerhttps://bluegoatcyber.com/https://christianespinosa.com/ -
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 Technology
Designation Program for Drug Development Guidance for Industry
13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified
bodies with respect to the implementation of the
Regulations on medical devices and in vitro diagnostic
medical devices (Regulations (EU) 2017/745 and (EU)
2017/746)
18:25 USP - USP-Listed Device Monographs and Recommendations for Product Quality and Performance Testing of the Drug Component of Combination Products
20:10 Race Recap: Sugar Badger 50K
26:51 Conclusion
Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. Subhi is an Ironman Triathlete and a Marathoner/Ultramarathoner. -
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:
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 Management Review: Strategy and Tactical Levels
28:47 Operational and Systemic Levels of Management
30:15 Balancing Capability and Capacity
31:37 Improvement and Execution in Business Operations
37:25 The Role of CAPA in Quality Management
44:54 Building a Culture of Quality and Continual Improvement
46:36 Conclusion and Resources for Further Learning
Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at larry@mgmt-ctrl.com -
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:
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 Device Design
08:55 From FDA Reviews to Industry Insights
11:29 Fault Tree Analysis and Risk Management
14:17 Setting Reliability Expectations for Combination Products
15:32 Navigating Risk Culture and Acceptable Levels of Risk
Alan is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products. -
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:
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 of HemoTek. Chuck is a leader in the Medical Device & Combination Products space with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support.
https://ventura-solutions.com/