Best Subhi Saadeh Podcasts (2024)

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#380: Navigating the Complex World of Combination Products with Subhi Saadeh 38:53

1h ago38:53

38:53

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products. They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth. Subh…

1
151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio 33:38

1h ago33:38

33:38

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Understanding the FDA's New Guidance: 05:05 Challenges in Supplier Management and the 08:22 Navigating Change Management 11:43 Insi…

1
150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar 38:58

28m ago38:58

38:58

On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses:00:00 Welcome to Episode 150!03:00 Challenges and Innovations in Ocular Drug Delivery09:30 Understanding Intravitreal Injections13:26 Regulatory Considerations for Ocular Products20:48 Innovations in Glaucoma Treatment29:1…

1
#379: Meet the Guru - Navigating Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer 36:08

1d ago36:08

36:08

Explore the essential role of quality management in small medical device companies with Vernon Baker, a seasoned engineer. Learn about core QMS activities, regulatory intelligence, effective communication with top management, and key skills for aspiring quality managers. Gain valuable insights on supplier management, risk assessment, and regulatory…

1
149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens 33:11

6h ago33:11

33:11

On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses:01:01 Recap of the Last Episode01:23 Understanding the Freeze Drying Environment01:46 Freeze Drying Equipment and Processes03:01 Cleaning and Validation in Freeze Drying03:58 Loading an…

1
#378: Who Owns the Design Controls Process? 34:40

24d ago34:40

34:40

In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Laura Maher to discuss the critical role of design assurance in medical device development. They explore the importance of ownership in design and development documentation, delve into the complexities of design controls, and share practical insights on how to ensure compli…

1
148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner 26:20

17d ago26:20

26:20

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. …

1
147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup 23:15

14d ago23:15

23:15

On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse-Wentrup PhD is a Research Director at Design Science, a global human factors consultancy focused on advancing healthcare technology through user research and design evaluation. After his studies in bi…

1
#377: Designing a Medical Device for a Global User 43:44

1M ago43:44

43:44

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Matthew Wettergreen, Director of the Global Medical Innovation Master of Bioengineering program at Rice University. Dr. Wettergreen shares his extensive experience in developing client-based engineering design courses and discusses the importance of global and …

1
146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens 35:58

28d ago35:58

35:58

On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of var…

1
#376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights 39:51

2M ago39:51

39:51

In this episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates. They delve into the recent FDA proposed rule for wound dressings, addressing the classification and regulatory impacts on medical device manufacturers. …

1
145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi 40:28

1M ago40:28

40:28

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reaut…

1
#375: Direct to Consumer - The Future of Healthcare 47:42

2M ago47:42

47:42

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Gail Lebovic, an internationally recognized oncoplastic surgeon and innovative entrepreneur. They delve into the evolving landscape of MedTech, focusing on the shift from traditional reimbursement models to direct-to-consumer strategies. Dr. Lebovic shares her …

1
144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo 35:36

1M ago35:36

35:36

On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: 00:00 Introduction and Guest Overview00:04 David DeSalvo's Career Journey02:13 Understanding Injection Systems04:22 Early Career at BD10:51 Transition to SHL17:50 Starting a New Venture24:54 Experience at …

1
143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young 29:22

1M ago29:22

29:22

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. Industry Comments are DUE 9/29/2024.Alan Stevens is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie wit…

1
142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin 30:26

2M ago30:26

30:26

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 Different Industries08:54 Quality Tools and Their Applications11:22 Material Qualification and Supplier Mana…

1
#374: Clinical Evidence - The Key to Market Adoption 47:04

2M ago47:04

47:04

In this episode, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies. Shaherah shares her extensive experience in the field, providing practical advice on securing funding, ensuring market access, a…

1
141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024) 23:09

2M ago23:09

23:09

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…

1
140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa 30:50

3M ago30:50

30:50

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 Device Cybersecurity: Challenges and Risks05:51 Freelance to Entrepreneurship: Founding Blue Goat Cyber07:05 Cybers…

1
#373: Creative Clinical Recruitment 49:27

3M ago49:27

49:27

In this episode of the Global Medical Device Podcast, host Etienne Nichols, along with part-time co-host Stephanie Hinton, dives into the art of clinical trial recruitment with Dr. Kelly Palmer, Assistant Professor at the University of Arizona. Dr. Palmer shares her extensive experience and innovative strategies for overcoming recruitment challenge…

1
139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh 27:43

2M ago27:43

27:43

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 applicants, marketing authorisation holders of medicinal products and notifiedbodies with respect to the implementation of theRegulatio…

1
#372: Getting Hired In MedTech 53:04

3M ago53:04

53:04

In this episode of the Global Medical Device Podcast, host Etienne Nichols talks with Mitch Robbins, founder of the Anthony Michael Group, about the evolving landscape of hiring and job seeking in the MedTech industry in 2024. They discuss strategies for both employers and job seekers, emphasizing the importance of preparation, effective communicat…

1
#370: Meet a Guru: Jamie Bihary 32:27

3M ago32:27

32:27

In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Jamie Bihary, a Medical Device Guru at Greenlight Guru. Jamie shares her journey from biomedical engineering to her current role, where she helps companies transition from legacy quality management systems (QMS) to cutting-edge electronic QMS (EQMS). They discus…

1
138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager 47:34

3M ago47:34

47:34

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 R…

1
#371: Achieving ISO 13485 Certification 45:35

3M ago45:35

45:35

In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification. The discussion covers the importance of gap analysis, the value of a compliant agile approach, and the benefits of using Greenlight Guru’s eQMS software. Li…

1
#369: Advice to Medical Device Inventors 43:53

3M ago43:53

43:53

In this engaging episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Ron Richard, a seasoned expert in the medical device industry with over 35 years of experience. The discussion delves into the essentials of bringing a medical device to market, from the inception of an idea to commercialization. Ron shares his journe…

1
137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens 18:11

3M ago18:11

18:11

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 N…

1
#368: Institutional Review Boards (IRBs) 49:21

3M ago49:21

49:21

In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk de…

1
#367: Interviewing the Interviewer 39:44

4M ago39:44

39:44

In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Et…

1
136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura 39:53

4M ago39:53

39:53

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 Ve…

1
#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List 55:39

4M ago55:39

55:39

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates. The episode delves into the harrowing experiences of navigating sever…

1
135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson 41:16

4M ago41:16

41:16

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 Struct…

1
#365: Medical Device Reporting: The Do's and Don'ts 40:55

4M ago40:55

40:55

In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up r…

1
#363: Bringing a Self-Funded Medical Device to Market 39:12

4M ago39:12

39:12

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow surgery devices. Dr. Hunter shares his experience from the conception of a simple yet effective surgical device through its development, struggles with initial licensing, and u…

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Subhi Saadeh Podcasts

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