Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

Let's Combinate - Drugs + Devices with Subhi Saadeh episodes

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 in Drugs vs. Devices
04:00 Quality Standards in Different Industries
08:54 Quality Tools and Their Applications
11:22 Material Qualification and Supplier Management
26:37 Regulations and Quality by Design
27:45 Closing Remarks and Guest's Current Work
Ben's Article: Catalent Acquisition by Novo Holdings: Evolution of the Industry(?)
Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.
31 min
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 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.
24 min
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:
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/
31 min
June 05, 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 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 - <1157> 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.
28 min
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:
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 [email protected]
48 min
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:

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.
19 min
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:
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/
40 min
May 08, 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:
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 Industry and Building Medical Device Competency
16:41 Insights into FDA and Industry Dynamics: Conferences, Regulations, and Mindset Shifts
20:05 Combination Product Mindset in Large Organizations vs. Startups
21:54 Navigating Small Company Dynamics and Supply Chain Management
22:29 The Importance of a Combination Product Mindset
25:14 Challenges and Evolution of Combination Products
26:42 Global Perspectives on Combination Products
27:30 Digital Health: The New Frontier
35:02 Quality Culture and Open Communication
Anthony started his career as a naval officer on ships before transitioning to the civilian side of government. He served nearly 20 years at FDA as a reviewer, branch chief, and division director. In his time at FDA, he was one of the original regulatory policy-makers for combination products on the CDRH side. He has led the development of sevral guidance documents that are still in use more than 10 years after he left FDA. He has been active in industry advocay groups and standards efforts related to combination products for nearly 20 years. Since leaving FDA in 2013, Anthony has been developing and leading device and combination product teams in biotech, biopharma, and digital health companies from startups to global scale. He is presently the Vice President of Regulatory Affairs and Quality at Windgap Medical, a drug delivery device startup in Watertown, Massachusetts. He is also an adjunct professor at Northeastern University in the Regulatory Affairs Program and advises companies in the digital health field.
LinkedIn url: https://www.linkedin.com/in/anthony-w-77abaa3?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=android_app
42 min
May 01, 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:

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 in MedTech
40:50 Closing Thoughts and Where to Find More

Richard Koch is the founder of KochSaMD and is an expert in ISO62304, Medical Device Software and SaMD.

https://www.linkedin.com/in/richardkoch/
https://kochsamd.ch/
https://puriapp.com/
42 min
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:
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 The Philosophy Behind Prodct: Focusing on Medical Devices
20:55 A Personal Touch: The Impact of 'Born to Run'
21:59 Closing Thoughts and Where to Find Devon
Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development.
https://www.devonccampbell.com/
23 min