Let’s Combinate – Combining Drugs and Devices

In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor design inputs can slow down product development and lead to issues in market compliance. He stresses the importance of spending adequate time on creating design inputs and the benefits of concurrent engineering to refine specifications. The discussion also covers the relationship between design inputs and risk controls, and Chuck introduces his Design Input Essentials course aimed at helping companies accelerate product development. 00:00 Welcome to the Comedy Podcast 00:04 Introducing Chuck Ventura 00:29 The Importance of Design Inputs 02:07 Challenges with Design Inputs 03:07 Impact on Product Development 04:18 Common Pitfalls in Design Inputs 06:15 Design Verification Issues 10:22 Best Practices for Design Inputs 14:11 Link Between Design Inputs and Risk Controls 18:45 Chuck Ventura's Design Input Course 20:31 Closing Remarks

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/

On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc.

On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the challenges posed by longer-acting drugs, higher viscosities, and large injection volumes. Laxman also discusses his transition from large corporations to startups and the multifaceted nature of scaling up projects. 00:00 Introduction to the Combinate Podcast 00:56 Understanding the Intersection of Medical and Pharmaceutical Industries 02:56 Challenges in Medical Devices and Pharmaceuticals 03:22 Governance and Risk Management in Healthcare 08:13 Transitioning from Big Pharma to Startups 15:46 Trends in Injection Delivery Systems 28:38 Challenges in Home Administration and Sustainability 31:07 Scaling Up in the Pharmaceutical Industry 32:47 Conclusion and Contact Information

Laxman Halleppanavar is currently the Head of Portfolio Strategy and Management at Credence MedSystems, leading the Injectable Device Portfolio Strategy and Management team for internal and external customer endeavors. Previously, Mr Halleppanavar was the Director - PharmSci Technical Team Lead at Pfizer. He came to Pfizer upon its acquisition of Hospira where Mr Halleppanavar was responsible for combination product development from early-stage development to manufacturing scale up leading to commercial launch. Prior to Pfizer, Mr Halleppanavar was the Program Manager at GE Healthcare responsible for development, manufacturing, and commercialization of multiple medical device/patient monitoring platforms namely, patient worn devices, blood pressure cuffs, bedside monitoring devices, networked central & remote monitoring stations.

On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC.

In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program.

Laurie discusses the definitions, scope, and expectations of combination product manufacturers, addressing the FDA's inspection types, regulatory requirements, and expectations.

Laurie also highlights common misconceptions, especially among contract manufacturers (CMOs) and the importance of proper audit and supplier management practices. Laurie shares insights and practical advice for ensuring compliance, emphasizing the gaps between drug and device regulations and how to effectively bridge them.

Chapters: 00:56 Understanding FDA Compliance Programs 02:33 Types of FDA Inspections 03:04 Mock Audits and Process Validation 03:45 Combination Product Manufacturer Definition 04:38 Inspection Guides and Compliance 06:47 Supplier Controls and Responsibilities 09:20 Challenges in Mock Pre-Approval Inspections 16:32 Supplier Management and Quality Agreements 24:19 Contract Manufacturers and Design Control 25:03 Conclusion

Laurie Auerbach is an industry consultant with over 20 years of experience in quality and regulatory compliance, serving in management and consulting roles for startup to major global manufacturers in the medical device, in vitro diagnostic, and combination product industries. Laurie conducts internal and supplier audits and mock pre-approval and post-approval inspections for compliance with ISO 13485, ISO 14971, §820, and §4, and EU MDD, IVDD, and EU MDR. She also conducts training for biopharmaceutical sponsors and device platform manufacturers on combination product regulatory requirements, including focused training on design control, risk management, CAPA, supplier controls, and inspection readiness. Laurie serves as Vice Chair of the ISPE Combination Products Community of Practice and is an active member of PDA, AAMI, RAPS, TOPRA, and DIA.

On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct.

Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma environments and startups, shedding light on the significant time and resource investments required for successful IVD development.

---------------------------------- Chapters: Exploring In Vitro Diagnostics with Devin Campbell In this episode of the Combinate Podcast, host Subhi Siddek welcomes back Devin Campbell, founder and managing director of Product Know You, to discuss in vitro diagnostics (IVDs). They delve into various aspects of IVD development, including the clinical implications, risk management, and distinctions between companion diagnostics and precision medicine. They also cover regulatory pathways, lab-developed tests, and the rigorous validation processes involved. The conversation aims to demystify the complexities of IVDs for professionals in pharma and medical devices.

-------------------------------------- 00:00 Introduction 01:58 Understanding In Vitro Diagnostics (IVDs) 05:26 Companion Diagnostics and Precision Medicine 08:49 Lab Developed Tests (LDTs) 12:39 IVD Development Process 15:27 Risk Management in IVDs 20:17 Clinical Testing and Validation 29:12 Challenges and Considerations in IVDs 37:04 Conclusion and Contact Information

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/

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 explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system and the impact of sterilization processes on functionality. Fran also discusses the scope of USP 382, covering vials, syringes, pens, IV bags, and blow-fill-seal containers, emphasizing the need for harmonization with ISO standards. The episode highlights the necessity for pharmaceutical sponsors to generate data on the system to comply with USP 382 and prepare for its 2025 implementation. 00:00 Introduction to the Combinate Podcast 01:08 Understanding USP 382 and Its Importance 01:41 Differences Between USP 381 and USP 382 03:50 Challenges and Responsibilities in Compliance 07:49 Impact of Sterilization on Stoppers 11:11 Upcoming Changes and Industry Adaptation 15:21 Functional Performance Tests and System Understanding 19:04 Broader Scope: IV Bags and Alternative Packaging 21:33 Conclusion and Contact Information

Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals. She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products.

Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas. DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018.

Frankly Fran Newsletter: https://www.drugdeliveryleader.com/doc/setting-the-bar-for-drug-product-quality-part-the-evolving-practice-of-particle-testing-0001

This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380).

In this episode, Etienne and I discuss:

02:50 The Start of the Combinate Podcast

06:00 Efficiency and Tools in Podcast Production

08:40 Understanding Combination Products

09:43 Regulatory Frameworks and Definitions

13:46 Challenges and Misconceptions in the Industry

20:47 Evolution of Regulations: QMSR and Part 4

22:05 Exploring Unique Podcast Episodes

25:56 The Pyramid of Regulations

30:40 The Role of Coaching and Mentorship

32:59 Trends in Combination Products

35:23 Recommended Books and Final Thoughts

37:04 Encouragement for Lifelong Learning

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.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market

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 Insights on Regulatory Compliance

25:26 The Importance of Dimensional Tolerances

32:56 Closing Thoughts

Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals. She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products.

Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas. DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018.

Frankly Fran Newsletter: https://www.drugdeliveryleader.com/doc/setting-the-bar-for-drug-product-quality-part-the-evolving-practice-of-particle-testing-0001

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 Delivery 09:30 Understanding Intravitreal Injections 13:26 Regulatory Considerations for Ocular Products 20:48 Innovations in Glaucoma Treatment 29:18 The Personal Impact of Vision Loss 35:40 Book Recommendations and Final Thoughts

Maysaa Attar is the Senior Vice President of R&D at Bausch & Lomb, leading global pharmaceutical and consumer product research and development. She has held prominent leadership positions at Abbvie and Allergan and holds a PhD in Pharmaceutical Sciences from the University of Southern California (USC), where she also serves as a professor.

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 Episode 01:23 Understanding the Freeze Drying Environment 01:46 Freeze Drying Equipment and Processes 03:01 Cleaning and Validation in Freeze Drying 03:58 Loading and Automation in Freeze Drying 06:27 Detailed Breakdown of Freeze Drying Components 15:24 Refrigeration and Temperature Control 17:25 Vacuum Systems and Filter Racks 20:18 Challenges in Freeze Drying and Validation 28:08 Advanced Freeze Drying Considerations 31:38 Conclusion and Contact Information

David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin ⁠⁠here⁠⁠ or at [email protected]

**About David Simoens:**

David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.

**Key Specializations:**

- Aseptic Fill/Finish including Lyophilization

- New Product Introductions

- Cytotoxic and High Potency Environments

- Integrated Commissioning, Qualification, Validation

- Radiopharmaceuticals

- Business growth and optimization

- Enterprise Quality Management Systems

- Career coaching

**Contact Information:**

For all business inquiries, please reach out to David and his team at [email protected]. For information requests, email them at [email protected]. Feel free to connect and message him on LinkedIn.

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. Leo highlights the challenges and strategies for documenting standards assessments and emphasizes the importance of leveraging existing standards to avoid unnecessary development. The episode also covers tips for small and large companies, the significance of early research, and the essential stakeholders involved in standards assessment.

Chapters:

00:00 Introduction to the Combinate Podcast

01:03 Guest Introduction: Leo Eisner

01:19 Understanding Standards Applicability

07:45 Documenting Standards Assessments

12:03 Challenges and Best Practices

20:56 Final Thoughts and Contact Information

Leo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance & regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies & support to help them through the medical device product compliance maze based on his experience.

He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.

Links:

Website: https://eisnersafety.com/

Blog: https://eisnersafety.com/industry_news/ & Sign-up for newsletter on right side of

page (1/2 way down)

LinkedIn: linkedin.com/in/leoeisnersafetyconsultants

Contact Us: https://eisnersafety.com/contact_eisner_safety/

Schedule a call: https://eisnersafety.com/schedule-call/

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 biomedical engineering and postgraduate research at the University of Muenster, Germany, as well as work for the Centre for Global eHealth Innovation (Toronto) and GE Healthcare (Wuxi, China), he joined Design Science’s U.S. office in 2016. At Design Science, David supports clients in developing and approving medical devices and combination products for the U.S and E.U. markets. He currently is leading efforts to open Design Science’s first European office in Munich, Germany. He completed his PhD at the University of Münster in 2024.

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 various drugs on the process, types of stoppers, and differences between lyophilized and liquid-filled vials. David shares insights on the technical aspects, including pressure, temperature, and time management, as well as equipment considerations and challenges in the lyophilization cycle. 00:00 Introduction and Guest Introduction 01:21 Podcast Overview and Purpose 02:12 Importance of Lyophilization 03:04 Lyophilization Process Explained 04:35 Vial Filling and Stoppering Differences 09:44 Freeze Drying Process 15:45 Primary and Secondary Drying 16:56 Backfilling and Final Steps 30:20 Equipment and Technology 34:41 Conclusion and Guest Contact Information

David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin ⁠here⁠ or at [email protected]

**About David Simoens:**

David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.

**Key Specializations:**

- Aseptic Fill/Finish including Lyophilization

- New Product Introductions

- Cytotoxic and High Potency Environments

- Integrated Commissioning, Qualification, Validation

- Radiopharmaceuticals

- Business growth and optimization

- Enterprise Quality Management Systems

- Career coaching

**Contact Information:**

For all business inquiries, please reach out to David and his team at [email protected]. For information requests, email them at [email protected]. Feel free to connect and message him on LinkedIn.

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 reauthorization and the Food and Drug Omnibus Reform Act)

15:51 International Harmonization Efforts

22:36 Combination Products and Policy Work

30:10 The Importance of Advocacy and Education

35:22 Closing Thoughts and Personal Insights

Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing

Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor’s degree in Bioengineering from the University of California, Berkeley, his doctorate and master’s degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.

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 Overview 00:04 David DeSalvo's Career Journey 02:13 Understanding Injection Systems 04:22 Early Career at BD 10:51 Transition to SHL 17:50 Starting a New Venture 24:54 Experience at Emergent BioSolutions 29:40 Current Role at Kindeva 32:56 Book Recommendation and Conclusion David DeSalvo is the Vice-President of Combination Product Development at ⁠Kindeva Drug Delivery⁠. He is an expert in drug delivery devices (combination products) and has invented, designed, developed and launched multiple devices. His work has resulted in dozens of highly successful unique drug-device combination products, including many industry-first innovations. https://www.daviddesalvo.com/

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 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. Rumi Young, Meng, RAC is the Director of Regulatory Policy at Novo Nordisk. Rumi joined Industry from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.

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.

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.

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/

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.

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]

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.

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/

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

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/

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/

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 Maintaining and Updating Standards
• 29:49 Concluding Thoughts and Where to Find More Information

Leo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance &amp; regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies &amp; support to help them through the medical device product compliance maze based on his experience.

He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.

Links:

• Website: https://eisnersafety.com/
• Blog: https://eisnersafety.com/industry_news/ &amp; Sign-up for newsletter on right side of
• page (1/2 way down)
• LinkedIn: linkedin.com/in/leoeisnersafetyconsultants
• Contact Us: https://eisnersafety.com/contact_eisner_safety/
• Schedule a call: https://eisnersafety.com/schedule-call/

• U.S. TAG 62D - https://www.aami.org/detail-pages/opentext-gateway-standards-committee/u.s.-tag-62d---electromedical-equipment-committee
• EV - WG 13 - Lens Removal and Vitrectomy Devices Working Group- https://www.aami.org/detail-pages/opentext-gateway-standards-committee/ev-wg-13---lens-removal-and-vitrectomy-devices-working-group
• JWG 9 Lens removal and vitrectomy devices for ophthalmic surgery - https://www.iec.ch/dyn/www/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:2472,25

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, infrared, microwave Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.

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 systems expert and is the VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products. Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP’s topics on his YouTube channel: Quality Systems Explained.

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 combination product approval. 03:32 The Story Behind 'Captain' Allen Stevens 06:52 The Challenges of Infusion Pumps and Recalls 13:34 The Intricacies of FDA's Rule-making and Guidance Process 21:44 The Future of Reliability in Combination Products 30:46 A Book That Changed Life: Systems Thinking in Safety 32:44 Wrapping Up: The Impact of Engineering on Public Health 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.

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

35:34 The Impact of Quality Culture on Inspections

44:22 Transitioning from FDA to Industry

49:51 Building a Career in Quality Engineering

Vincent (Vin) Cafiso, serves as the Founder and Managing Consultant of Practical Compliance Solutions. His professional journey commenced as an FDA investigator, after which he transitioned into the industry. Throughout his career, he has held diverse positions at well-established medical device companies such as BD, Smith & Nephew, BioArray Solutions, and Impulse Dynamics. He consults on medical device quality management and can be reached on linkedin here or via the web on https://practicalcomplianceresults.com/about

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 risk acceptability charts, risk & quality policy, explaining vs. justifying risk based decision making with regards to the traffic light charts that most companies use for risk acceptance.

Episode Chapters:

02:00 Interpreting the QMSR and Its Implications

05:56 Impact of QMSR on Risk Management

08:34 Risk Management in Practice

12:09 Insights from FDA Inspections and Warning Letters

23:30 The Importance of Process-Based Approach

24:57 Deep Dive into Risk Policy and Risk Acceptability

26:05 Understanding the Framework of 14971

26:42 The Role of Quality Policy in Risk Management

27:32 Risk Control

29:47 Risk Acceptability in Risk Policy

30:59 Understanding Risk Matrix

32:16 Risk Control and Quality Policy

41:00 Understanding Risk Acceptability Charts

Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.

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 Combination Product Space

19:17 The Role of Regulatory Teams

23:12 The Importance of Team Formation and Alignment

33:20 The Vision for Coalition

34:44 Conclusion

Prior to founding COALITION, a collaboration consultancy focussed on speeding progress in highly regulated industries, Mat spent 20 years leading companies within the MedTech and Combination Products spaces. Over this time, Mat developed a formula for success on how to turbo charge collaboration and progress where effective cooperation between multiple disciplines is essential. The key learnings from many successes and plenty of challenges have been distilled in to the approach at the core of COALITION's services and detailed in Mat's upcoming book - "Collaboration - where it's difficult, it's vital."

Email: [email protected]

Website: www.coalition.ltd

Linkedin: https://www.linkedin.com/in/mat-stratton-a6269317/

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 Comments Review and Final Thoughts

Links:

• QMSR Final Rule Amendments: https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
• QMSR Final Rule FAQ: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked
• 21 CFR 820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820?toc=1
• 21 CFR 4 (Changes Introduced): https://www.ecfr.gov/compare/2024-02-02/to/2024-02-01/title-21/chapter-I/subchapter-A/part-4/subpart-A
• Device cGMP's 21 CFR 820 (1978): https://archives.federalregister.gov/issue_slice/1978/7/21/31497-31571.pdf#page=12
• Reserved Definition: https://www.archives.gov/federal-register/cfr/about.html#:~:text=An%20agency%20uses%20%22%5BReserved%5D,a%20printing%20or%20computer%20error.
• ANSI View Only Copy of ISO13485 (No Cost): https://ibr.ansi.org/Standards/iso1.aspx

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.

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 outside the quality field. The discussion also highlighted the value of certification courses for professional development. Lastly, they recommend several books for personal and professional growth.

00:01 Introduction and Guest Introduction

04:56 #1: Mentors, Mentors, Mentors: The Importance of Mentorship in Quality Engineering

13:48 #2: The Value of Tough Assignments in Professional Growth

18:44 The Power of Lifelong Learning

19:08 #3: The Importance of Lifelong Learning

20:04 The Struggle of Choosing What to Learn

22:28 Balancing Professional and Personal Learning

23:24 #4: The Underrated Value of Soft Skills

27:43 #5: Leaving Quality

29:21 #6 (Bonus) The Benefits of Professional Certifications

Andy's Website: https://cqeacademy.com/

Youtube: https://www.youtube.com/@CQEAcademy

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 operational changes in the mid-2010s streamlined FDA's specialized areas. The speaker discusses his inspection methods and how a focus on critical thinking rather than procedural controls leads to more substantial findings, particularly in data integrity within quality control labs across industries. He emphasizes the need for quality-driven, honest investigations in addressing deviations and believes a switch from a compliance-focused mindset to a quality-oriented one should be the future standard.

00:00 Early Career and Diverse Experiences

00:43 Understanding FDA Regulations and Import Work

02:28 Moving Overseas and Program Realignment

07:44 Challenges with Data Integrity

10:33 Understanding the Root Cause of Data Integrity Issues

10:54 The Role of Data Governance and Regulatory Guidance

22:24 Challenges of Field Inspections

24:07 Manipulation of Product Quality

25:26 Jurisdiction and Quality Systems

27:53 Lab Controls and Data Integrity

36:04 Addressing Unknown Discrepancies

39:34 The Importance of Honest Reporting

Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since 2019. Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in big data management and compliance with 21 CFR Part 11.

PIC/S Guidance on Data Integrity: https://picscheme.org/docview/4234

Live Oak: https://www.liveoakqa.com/

Peter's Blog: https://www.liveoakqa.com/blog-1

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 questioning. Lastly, he invites audience feedback to continually improve the show. 00:04 Guest Introduction: Jim Fries 05:45 The Concept and Process for Joint Audits 10:03 Regulatory Compliance and Audit Scoping 15:07 Reevaluation and Frequency of Audits 16:33 Evaluating RX 360's Ability to Conduct Audits 19:13 Understanding the Role of RX 360 in Auditing 19:41 Licensable Audit Reports 20:34 Challenges in the Industry and the Benefits of Joint Auditing 23:31 Addressing the Challenges in Auditing 23:49 The Role of Education in Joint Auditing 25:39 The Impact of RX 360's Working Groups 27:37 The Origin and Evolution of RX 360 29:59 The Importance of Networking and Relationship Building 35:28 How to Connect with Rx360

Jim Fries has touched the healthcare industry for 25 years. For the last 5 plus years he has led Rx-360, a nonprofit industry pharmaceutical consortium, dedicated to supply chain integrity, material quality, and patient safety.
Jim’s background before Rx-360 was geared towards building and leading organizations in the medical device, and diagnostic arena. He has led advisory and guideline committees in the cardiovascular and diabetes arena, authored multiple CPT codes, has also been a delegate to the WHO, and has also led many FDA pathway groups. Jim joins us today as a lifelong advocate of patient safety.

www.rx-360.org
[email protected]

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 highlights some of the challenges and opportunities in the Pharma industry, including the impacts of silos, the complexities of commercialization, and the importance of having a deep understanding of the industry for successful product development and market launch.

00:00 Introduction and Guest Presentation

00:53 Guest's Journey in Medical Device and Pharma Industry

03:10 Transition from Bench Scientist to Business Side

08:31 Commercialization Challenges in Pharmaceutical Industry

13:37 Successes and Failures in the Industry

26:41 Career Advice for Aspiring Professionals: Large vs. Small Companies

32:44 Conclusion

Sayed Badrawi has several decades of business, marketing, and scientific experience in pharmaceutical and biotech companies. He was most recently the CEO of PDS Life Sciences, a global provider of software and services used in preclinical research at top-ten pharma companies. He currently serves on the Board of ISI Life Sciences, a startup focused on diagnostics and therapeutics for use in oncology. He is also providing strategy consulting for several early stage start-ups. Previously, he was the Director and Head of new product commercialization at Mitsubishi Tanabe Pharma America, one of the largest pharma companies headquartered in Japan.

Other experiences include senior pharma marketing positions at Abbott Laboratories and Eli Lilly. Sayed started his career at Amgen as a research associate and was part of the team to first clone and express erythropoietin, one of the first biotech blockbusters. Sayed has an AB degree in microbiology and immunology from the University of California, Berkeley, and an MBA from the University of Chicago’s Booth School of Business.

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 explains the need for compliance checks, supply chain management, traceability documentation, and regulatory responsibilities in the context of the EUMDR. He also discusses his company's role as an authorized representative, importer, and consultant, and the various services they offer to help medical device manufacturers navigate regulatory complexities.

00:03 Introduction and Guest Introduction

01:47 Understanding the Economic Operator Model

07:56 Legal Manufacturer

09:41 The Role of the Authorized Representative and PRRC

23:39 Understanding the Role and Responsibility of Authorized Representatives

26:14 The Role of Importers and Distributors

27:38 The Importance of Traceability in the Supply Chain

38:14 Terminating a Mandate with a Manufacturer

40:55 Conclusion and Easy Medical Device

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses.

Easymedicaldevice.com

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 and parameters set by the EU and ISO, and he suggests various resources, including Annex one and the ISO 14644 standard, for learning more about sterile processing and clean room requirements.

01:01 Experiences in Clean Room

04:23 Exploring Clean Rooms

15:43 Differences Between Isolators and RABs

19:15 Different Types of Isolators

25:53 Understanding the Standards and Guidelines

28:36 How to Learn More About Clean Rooms?

30:13 Conclusion

David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin here or at [email protected]

**About David Simoens:**

David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.

**Key Specializations:**

- Aseptic Fill/Finish including Lyophilization

- New Product Introductions

- Cytotoxic and High Potency Environments

- Integrated Commissioning, Qualification, Validation

- Radiopharmaceuticals

- Business growth and optimization

- Enterprise Quality Management Systems

- Career coaching

**Entrepreneurial Venture: Life Science Professionals**

As the founder of Life Science Professionals, David leverages his extensive executive leadership and hands-on industry expertise to deliver tailored solutions. The firm specializes in guiding clients through the complexities of project management, engineering, and quality.

**Active Involvement in ISPE:**

Beyond his consulting work, David is deeply committed to advancing the industry through active participation in the International Society for Pharmaceutical Engineering (ISPE). Currently, he serves in key leadership roles, including:

- Secretary for the Global Project Management COP

- Secretary for the Great Lakes Chapter

- Steering Committee Member for Digital Validation

- Steering Committee Member for the Special Interest Group on AI and Machine Learning

- Participant in Mentorship Program with Women In Pharma

**Contact Information:**

For all business inquiries, please reach out to David and his team at [email protected]. For information requests, email them at [email protected]. Feel free to connect and message him on LinkedIn.

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 provides case examples, discusses trends, future prospects of DMFs and MAFs, and offers advice for companies dealing with aspects of master file content.

Markers:

01:46 Understanding Drug Master Files and Device Master Files

05:11 Doug's Experience with Master Files

07:43 Challenges and Advantages of Using Master Files

11:33 The Role of Device Master Files

12:44 Overlap Between DMFs and MAFs

31:14 The Future of Master Files

Douglass(Doug) Mead is Founder of CP Pathways. He's a highly experienced combination products regulatory expert with more than 40 years of experience in large and small pharma and medical device companies. He has a diverse background in regulatory affairs for drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments.

www.cppathways.com

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. Additionally, they delve into managing product responsibilities, the varied international reporting requirements, and the use of technology for improved efficiency.

00:54 Post-Market Safety Reporting

05:23 Challenges in Post-Market Safety Reporting

07:57 Reporting Databases

10:05 21 CFR Part 4b Guidance

11:50 Managing Product Responsibilities

19:12 Challenges in Handling Platforms

23:10 Understanding Health Hazard Assessment

25:32 International Approach to Reporting

Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.

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 sterilization process works, safety considerations, validation, and the use of gas sterilization in combination products. Lastly, Jeanne discuss sterilization process development and the challenges that come with gas sterilization.

00:23 Deep Dive into Gas Sterilization

00:46 Applications and Limitations of Gas Sterilization

01:51 Understanding Material Permeability in Gas Sterilization

02:29 Gas Sterilization in Medical Devices

06:15 Different Types of Gases Used in Sterilization

07:41 Safety and Environmental Risks of Gas Sterilization

14:14 Understanding the Gas Sterilization Process

18:25 Safety Measures in Handling Gas Sterilization

25:39 Validation and Bioburden Considerations in Gas Sterilization

35:28 Gas Sterilization in Combination Products

Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.

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 professionals in the industry who strive to ensure patients receive quality. Eban also discusses her findings on fraudulent practices in manufacturing plants and the role of quality data in drug production. The episode sheds light on the importance of understanding the manufacturing process behind generic drugs and critical quality control issues needing urgent attention.

Time-Stamps:

02:12 The Start of the Investigation into Generic Drug Quality

08:59 The Impact of Quality Issues on Global Health

12:54 Understanding the FDA's Role in Drug Quality Control

16:55 The Struggle to Maintain Quality in the Pharmaceutical Industry

18:39 The Ranbaxy Story

27:45 Peter Baker

30:19 Quality Stories

33:27 Conclusion and Final Thoughts

Link to Katherine's Book: Bottle of Lies: The Inside Story of the Generic Drug Boom, is a New York Times bestseller and one of the New York Times’ 100 Notable Books of 2019.

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 factors like product density, cycle development, dosimeters, sterilization and the bioburden. The episode ends with a look at the regulatory approval process, addressing the timeline for validating an irradiation sterilization cycle.

00:22 Understanding Irradiation Sterilization

00:34 Differences between Autoclaving and Irradiation

04:22 The Impact of Product Density on Irradiation

05:09 The Role of Dose in Irradiation Sterilization

06:21 E-beam Sterilization

08:52 Impact of Gamma Sterilization on Different Materials

22:07 The Role of Bioburden in Irradiation Sterilization

30:19 Dosimetric Release

37:31 Gamma Irradiation for Combination Products

41:59 The Process of Validating an Irradiation Sterilization Cycle

Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.

On this episode, I was joined by Ira Mann, President at IQ Referrals. Ira and I discuss:

- Pharma/MedTech Market and Positioning for Success

- Why people leave good companies

- Finding Motivation in Pharma/Quality

- Remote Work, Insourcing, On-Shoring in US Manufacturing

Ira Mann is President, IQ Referrals. With more than 20 years in the recruiting industry, Ira is an expert at placing top professionals in the Quality, Validation, Regulatory Affairs, Cold Chain, Environmental Monitoring and Sterilization specialties, and is strategically aligned with experts conducting searches in Engineering, R&D and Manufacturing Management.

On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss: -Steam Sterilization - Moist and Dry Heat -Biological/Chemical Indicators, Placement and Resistance -Cycle Development and Validation -Overkill Cycles vs Product Specific Cycles -Parametric Release of Steam Sterilized Products

 Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA.

On this solo episode, I go through a list of 7 books I recommend for med tech, biotech and combination product professionals. 

The books are:

1. Quality is Free by Phillip Crosby
2. The Combination Products Handbook by Susan Needle
3. What Country has the Best Healthcare by Ezekiel Emanuel 
4. Switch by Dan and Chip Heath
5. Managing Oneself by Peter Drucker
6. Bottle of Lies by Katherine Evan
7. The Pyramid Principle by Barbara Minto

I find that I read a lot more in December so wanted to give you all some recommendations this Thanksgiving week. Happy Thanksgiving!

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 

• Dealing with CDMO's and CXO's
• Supply Chain and Logistics and Pharma and Medical Devices
• Reverse Knowledge Transfer
• Building Trust with CXO's and Leveraging Surveys
• The future of the CDMO Market

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.

On this episode, I was joined by Martin Van Trieste, Author of Protecting the Patient at All Costs: The Drug Watch Dogs and is the Former Chief Quality Officer at Amgen and Former CEO at Civica Rx.

Martin and I discuss:

- Protecting the Patient at All Costs

- Quality Leadership and being a Chief Quality Officer in Big Pharma

- Supply Chain Security

- Generic Drugs and Shortages

Martin Van Trieste is an accomplished entrepreneur, board governance expert, executive coach and biopharmaceutical executive. Martin Van Trieste is the Former President and CEO of Civica Rx.

Prior to joining Civica Rx, he worked with Amgen, a leading biotechnology company and also previously served as vice president of worldwide quality for Bayer Healthcare’s Biological Products Division and vice president of quality assurance for the Hospital Products Division for Abbott Laboratories.

Van Trieste has also taken on ventures of his own. He’s the founder of Rx-360, an international nonprofit organization that enhances patient safety by increasing security and quality in the biopharmaceutical supply chain.

He has also served as the chairman of the Parenteral Drug Association (PDA) Board of Directors and was honored with the 2020 Joseph B. Sprowls Lecturer award. 

On this episode I was joined by Margaret Jenkins, who's the Founder and Principal at Global Pharma Solutions. Margaret and I discuss:

• Clinical Data interpretation and authoring
• eCTD Module 2 Overview
• Learning drug assays with a device background

• Non-Clinical eCTD Module 4
• Clinical eCTD Module 5

Margaret Jenkins is the Founder and Principal at Global Pharma Solutions where she works closely with clients to provide strategic solutions, allowing them to follow the most efficient pathway to registration and launch in their chosen markets. Margaret has more than 30 years’ experience in the Pharmaceutical industry both in the UK and Australia, spanning drug discovery, drug development and Regulatory Affairs.
Margaret has hands-on experience in numerous successful global submissions in both the innovator and generic spaces for: US, EU, Asia Pacific and ANZ. Margaret has written all 5 modules of the CTD including writing clinical overviews and summaries, several module 3s (CMC), and summarizing pre-clinical reports.

On this episode I was joined by Michelle Wu, CEO and Founder of Nyquist. On this episode Michelle and I discuss: - Pre-Trained Models and Generative AI - Distilling Decades of MedTech Data/Historical Data Review - Adopting new technologies in Quality and Regulatory Affairs - Removing the tribal knowledge barrier Michelle Wu is the Founder and CEO of NyquistData Inc. Michelle has over seven years of experience in strategic planning, business development, and global strategy. Prior to NyquistData, Michelle was the Founder of Anora.ai, a company that provides artificial intelligence services. Michelle has also worked as a Co-Founder at Waveall Inc., where they helped connect people with common interests through mealtime. Michelle began their career as an Analyst at The Boston Consulting Group. Michelle holds a bachelor's degree in economics from Harvard University. Michelle Wu pursued a Master of Business Administration (M.B.A.) at Stanford University Graduate School of Business with a focus in healthcare and investment. Prior to that, they completed a Bachelor's degree in Foreign Languages and Literatures, General from Peking University.

On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them! 

If you'd like to hear more about Michelle checkout episode 031, 077, checkout Michelle's Blog @ LeanRAQA.com and Michelle's Podcast RAQA Today.

Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.

Links: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2024fy2024

https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-statement-fda-continues-take-steps-strengthen-premarket-notification-510k-program

On this episode, I was joined by Nathan Roman, an expert in temperature mapping and environmental validation. On this episode, Nathan and I discuss:

- Temperature Mapping and Monitoring

- Validation and Commissioning

- Changes in Data Logger Technology

- Cold Chain vs. Ambient

Nathan Roman is a highly accomplished expert in equipment commissioning, qualification, and validation, with over 23 years of hands-on experience in the Health & Life Science industry. In his current role, he successfully manages a team of experts, develops business strategies, and oversees the growth of his practice, all while delivering exceptional services to a diverse portfolio of clients.With expertise in cGMP compliant facilities, R&D labs, and temperature mapping, Nathan ensures regulatory compliance. He excels in placing temperature sensors in control chambers, streamlining processes for faster delivery. Nathan aids professionals in achieving compliance, providing training, collaborating with vendors, and offering temperature mapping guidance. An industry thought leader, he empowers clients with mapping knowledge, sensor placement strategies, and equipment qualification expertise.

On this episode, I reflect on 8 lessons I learned from recording 100 Episodes of the Combinate Podcast and Ironman Chatanooga.

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.

For feedback on the show or suggestions please contact [email protected]

On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss:

• New FDA Guidance:
• Critical Task Definition for Combination Products
• Pre-Clinical HF Studies in readiness for IND Submission
• URRA
• Human Factors Validation vs. Design Validation

Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly, Philips Healthcare, and Baxter Healthcare. She is an active member of AAMI where she has contributed to the development and revision of human factors technical information reports and international standards. Learn more about Design Science's impact on Healthcare Technology by following @designscience on all social media platforms.

On this episode, I was joined by Charles Gellman, CEO of HiDO. - How to know people are actually taking their medications - Eliminating Medication Errors in the Home - Medication Reconciliation, Drug Libraries and Dealing with Contraindications - Clinical Trial Monitoring in the Future - Chaining Technology and Re-Training Behavioral Change Charles Gellman is the CEO & Co-Founder of HiDO Health. NIH funded research in collaboration with Stanford and Rush Universities. He is one of the top voices on AI assisted robotics, digital health and the impact on care. Charles Gellman was recently featured in a full feature documentary, "AI Robotics... The HiDO Story." He publishes his analyses regularly in the newsletter, "The Future of Care." He is a former advisor for StartXMed and has worked in various executive roles at Startups as well as Fortune 500 companies. He received an MSHI degree from University of California at Davis, Medical School. HiDO Documentary Trailerhttps://www.youtube.com/watch?v=ljnFImTNpwg

On this episode, I was joined by ⁠Amy Wilson and Cliff Berry, authors of "Do Quality Differently: The Playbook for Creating More Success in Biopharma (or Any) Manufacturing".

Amy and Cliff walkthrough:

• Human Performance and Challenges
• Defining Accountability from a Quality World-View
• Good Written Human Guidance
• Automating Procedure and QMS Feedback
• Categorizing Deviations Appropriately
• Blue Line vs. Black Line: Work as Imagined vs. Work as Completed

Amy Wilson: Amy has more than 20 years of biopharma manufacturing experience, focusing on human & organizational performance, operational excellence, risk management and technical training. She has led a global integration of Human & Organizational Performance within biopharma manufacturing. Amy has a Ph.D. in Industrial Engineering from North Carolina State University.

Cliff Berry: Cliff has worked in the domain of Human & Organizational Performance for over 20 years. He has experience in commercial nuclear electric generation, electric transmission & distribution, gas distribution, nuclear plant systems controls hardware & software integration, and most recently in biopharma manufacturing since 2015 where his primary focus is on creating more quality success. Cliff has a M.S. in Occupational Ergonomics & Safety from the University of Massachusetts Lowell.

On this episode, I was joined by Megan Polidano, Head of Clinical and Regulatory affairs at Vaxxas.

Megan walks through:

• Micro-Array Patches and Needle Free Injections
• EPAR's and AusPAR's
• Combination Products in Australia
• Clinical Trials in Australia
• Australia Regulatory Pathways - Core A and Core B

Megan Polidano is the Head of Clinical and Regulatory affairs at Vaxxas. Megan has worked in regulatory affairs since 2007 and have worked for large pharmaceutical and medical device companies as well as small biotechnology companies in Australia and in the US.

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:

• Episode 100 and the first recording with Larry!
• Quality - Big Q/little q
• Building a QMS and Commercializing a product at a startup
• Predictive Quality Management, PDCA and TOC
• Lessons from Pharma, Combination Products, and CRO Companies
• Communicating quality

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]

On this episode, I was joined by Janine Jamieson, European Editor at International Pharmaceutical Quality. In this episode, Janine walks through: -Medical Device vs. Medicinal Product Reviews in the EU -Working at MHRA as a Pre-Market Reviewer on Devices with an Ancillary Medicinal Substance -Notified Bodies, EU MDR and Article 117 -European Commission, Member States and European Member States Structure -Writing about combination products in the EU Janine is European Editor at IPQ (International Pharmaceutical Quality) Publications, living in Sweden and writing about the regulatory dialogue at biopharma conferences. She writes about quality/CMC issues, innovation and reliance, and drug-device combination products. Between 1997 and 2016, Janine was a pharmaceutical assessor at the UK MHRA, where she focused on device-drug combination products, working with several EU notified bodies, and with MHRA colleagues on drug-device combination products and borderline classification issues. She helped with training, set up a cross-agency combination product working group, and was involved in horizon scanning and innovation office activities at MHRA and EMA. She has also been an enthusiastic contributor to TOPRA, The Organization for Professionals in Regulatory Affairs, from special interest networks to training and chairing conference sessions.

On this episode I was joined by Bijan Elahi, Award winning Medical Device Risk Management author, educator and consultant.

Bijan walks through:

• MedTech vs. Aerospace - Differences in Risk Management Approaches
• Risk Control/Reduction - AFAP vs. ALARP or ALARA and Global Requirements
• Quantifying Benefit and Benefit/Risk
• Risk Control Measures
• What a good risk management process looks

Bijan Elahi has worked in risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices. In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide. Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. At the invitation of the FDA, he is also teaching a graduate course on medical device risk management at Drexel University (Philadelphia, USA).

Contact: You can contact Bijan at his website: https://www.medtechsafety.com

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:

• Predictive Quality Management and PDCA
• Business Process Capabilities and process stewardship
• 3 Lines of Quality Defense
• COSO Risk Management

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]

On this episode I was joined by Heather Johnson who's the CEO of Ingenium.

In this episode, expect to learn:

• Why Waste Management in Pharma might be more complicated than you might think

• Different kinds of sharps, why sharps are challenging and what happens to sharps containers?

• Waste potential and repurposing orphan chemicals

• And what Zero Waste means for sustainability

Heather Johnson has over 25 years of expertise in the hazardous waste management industry as a C-level Executive, Sales/Marketing Director and Account Manager. As a seasoned entrepreneur who has launched several existing waste management firms, Heather is a founding partner of INGENIUM and currently serves as its Chief Executive Officer.

Heather’s innovative vision into sustainability for regulated waste management has positioned INGENIUM as an industry leader in innovative waste to energy programs and has provided INGENIUM’s clients with environmentally friendly alternatives to waste disposal, including zero waste initiatives. Heather is well known for her participation in the industry, including her past presidency of BioNet, a non-profit association devoted to biological safety. She has also served on the Board of Directors for several local non-profit organizations and has made community service a priority for INGENIUM and its employees.

On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal. In this episode, Naveen discussses: - How FMEA's fit into ISO14971 - pFMEA's from External Partners and linking to risk files - Simplifying Risk Management outputs for Audit Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert. Show Notes and Links: Let’s Talk Risk Newsletter: https://naveenagarwalphd.substack.com Naveen’s Video on “When FDA Disagrees with your risk calculation method”: https://youtu.be/Y14_RTHMGqw Warning Letter 1: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medtronic-inc-617539-12092021 Warning Letter 2: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/irhythm-technologies-inc-643474-05252023 M

On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD).

Rumi walks through:

• Connected Devices and Combination Products
• How Regulators approach regulating new technologies
• Traceability Technologies and what they mean for manufacturing and use
• Comparability Protocols and Pre-Determined Change Controls for Drugs and Devices

Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.

On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss:

• Supplier Management for Combination Products
• Drug & Device Analytical Testing
• Considerations for Biologics
• Connected/Digital Health
• Changing Regulatory Landscape for Combination Products

Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. 
Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development.  Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries. 
She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees.  Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. 

On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: • Distinguishing differences in framework between the Device QSR/QMS and Drug cGMP’s • Learnings from Training FDA CDER and CBER on device requirements • Lessons from being Head of QA at a manufacturing site and internal audit • Teaching through AAMI and his YouTube channel: Quality Systems Explained Aaron Snyder is a quality management systems expert and is currently VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products. Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP’s topics on his YouTube channel: Quality Systems Explained.

On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss:

• Part 1 of The Combination Products Handbook: A Practical Guide to Combination Products and Other Combined Use Systems: Foundation
• Subhi's questions on each chapter
• What she learned from authoring and coordinating of the book

Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience.  She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press.  

Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development.  Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries.   

She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees.  Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request.  She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums.   Susan can be reached at [email protected].

On This Episode, I was joined by Harsh Thakkar, CEO of Qualtivate. Harsh walks through:

- Automating Quality with No Code Tools

- Software Validation

- Infrastructure Software

- Out of the Box

- Configured Software

- Custom Software Systems

Harsh Thakkar is the CEO and founder of Qualtivate, a data-driven quality management consulting firm for life sciences.  He is an industry veteran who has spent more than a decade in quality assurance and regulatory compliance roles with companies like Takeda, Biogen, Merck, Johnson & Johnson, and Bristol Myers Squibb.  He is an American Society of Quality (ASQ) Certified Quality Auditor and Certified Manager of Quality/Organizational Excellence.

Show References:

McKinsey article: https://www.mckinsey.com/industries/life-sciences/our-insights/smart-quality-reimagining-the-way-quality-works

FDA CSA guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software

Naval Ravikant's book: https://www.navalmanack.com/

On this episode, I was joined by Peter Birch, CEO and Host of Talking HealthTech. Peter walks through:

- Talking HealthTech Podcast with 350+ Episodes - HealthTech Innovation in Australia

- Audience building - Peter/TH's Creative Process for Podcasting (2/3/4 episodes per week)

Peter Birch is Founder and CEO of Talking HealthTech - a podcast and membership community to learn and connect about technology in healthcare. In addition, Pete is a director of the Medical Software Industry Association (MSIA) who are the voice of healthcare software vendors in Australia, and also director of MetaOptima Technology who are helping clinicians diagnose skin cancer using artificial intelligence. He is also on the NSW State Committee for the Australasia Institute of Digital Health, and is a NSW State Facilitator for the Australian Clinical Entrepreneurs Program (AUSCEP). He holds a Master of Business Administration (MBA), is a Certified Health Informatician (CHIA), and also a Certified Practicing Accountant (CPA).

On this episode, I outline an introduction to one of my favorite APQP tools, Production Part Approval Process(PPAP):

- What is PPAP

- Inputs, Process, Triggers and Interactions

- PPAP Elements and Tools

- The difference between first article inspection(FAI) and Capability Studies

- Applications and Challenges in use

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.

For feedback on the show or suggestions please contact [email protected]

On this I was joined by Ferdous Al-Faruque, Senior Editor at RAPS. Danny discusses: • Landing in Medical Devices and Pharma Regulatory Affairs • Rules of engagement • On the record, Off the record, On Background • Danny's Process in writing, editing and publishing Ferdous Al-Faruque, known as Danny, is Senior Editor at RAPS and specializes in reporting on regulatory affairs, new medical device technologies such as mobile health, combination products, unique device identifiers, and issues surrounding interoperability and cyber security.

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions.

Fran and I discuss:

(0:00) Component Machinability

(3:47) Stopper/Plunger Coating vs Lamination

(13:22) Stopper/Plunger Manufacturing

(26:14) USP 381/382

Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals.She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products.

Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas.DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018.

On this episode I was joined by Jacob Laporte, Co-Founder of the Novartis Biome. Jacob discusses:

• (1:56)Harvard PhD to Consulting in Innovation Management
• (11:50)Core & Non-Core Innovation
• (21:09)Digital Technologies in Pharma
• (27:39)Democratizing Access and Clinical Trials
• (32:35)Proteomics

Dr. Jacob LaPorte is an ex-Harvard chemist and ex-McKinsey consultant who is passionate about leading digital transformations to improve healthcare for patients. Jacob founded and led The BIOME by Novartis (aka Novartis Biome), the company’s first-ever, externally-branded innovation lab. Prior to joining Novartis, Jake founded Snapdragon Chemistry, a company focused on transforming chemical manufacturing using digital technologies and artificial intelligence.

On this episode, I was joined by Marta New, the CEO of Radyus Research. Dr. New discusses:

• (0:00) Intro
• (1:37) Pre-Clinical Planning
• (7:15) What's the purpose of an IND?
• (14:10) Administration Route Selection
• (19:00) Candidate Selection and Animal Models
• (30:10) Pre-IND Meeting
• (44:00) IND Submissions and Approval

Marta New PhD MBA is the CEO of Radyus Research. She is an experienced drug developer with a background in early-stage venture capital, considerable pharma R&D, and university technology transfer. 

On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments.

Derek walks through:

- (2:30) Holistic Approach to CCI

- (5:50) Risk Management and CCI

- (7:30) Lyophilized vs. Liquid CCI

- (12:20) Capping/Crimping Parameters and Residual Seal Force(RSF)

- (14:30) EU Annex I and USP 1207 Requirements

Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.

On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda.  Niedre discusses: * Common Technical Document * Combination Products Structure for eCTD Submissions * EU vs. US Submission Expectations * Design Controls and Human Factors data placement * Regulatory Roles and Responsibilities in Pharma Niedre Heckman, PhD, MPH, FRAPS is the Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. She's a fellow of Regulatory Affairs Professionals Society (RAPS) (FRAPS), and holds an MPH and PhD in Public Health. Niedre has worked at Takeda, Baxter International Inc., Shire, Baxalta, 3M, and GSK. Niedre has a wide career in Regulatory Affairs, Quality, and Research with focuses in many modalities of medical devices, pharmaceuticals and combination products. Niedre couples her background in RA & QA with her expertise in public health to bring a uniquely patient centric point of view.

On this episode I was joined by Bob Nesbitt, Chair of ISO TC 84 and Director of Combination Products R&D at Abbvie. Bob discusses: - ISO TC 84: Needle Based Injectors, Insulin Syringes, Auto Disable Syringes, On Body Injectors, Sharps Prevention, Cartridge Based Pen Injectors, Inhalers, Single use Drug Delivery devices, Catheters, etc - Crazy Bob's Medical Device - Relationship between AAMI, ANSI, and ISO - Committee work for industry and advancing the State of the Art Bob's Book Recommendation: The Immortal Life of Henrietta Lacks (Link) Bob Nesbitt, is Senior Director, E2E Combination Product, Platform, and Process Development at Abbvie. After “retiring” from Eli Lilly In January 2015, Bob joined Abbvie's Combination Product Development group, where he led the Human Factors group. At Lilly, Bob lead a team that created over a dozen drug delivery devices; taking them from concept to reality. Bob has been involved in the US and International Standards (ISO) Community sInce 1999, working with passionate, knowledgeable Medical Device and Standards personnel from all over the world to create standards which "raise the bar" in Patient Safety in this regulated industry. Currently, he serves as the ISO International Chair for TC84. Prior to becoming chair of TC 84, Bob was an Expert or Convener for various committees, and was the Industry Co-Chair for US TC84 TAG from 2004-2020.

On this episode, I was joined by Derek Duncan, Director and VP of Product Management at Lighthouse Instruments. Derek walks through: - CCIT vs. Sterility Testing - Difference between Deterministic and Probabilistic Methods - 9 CCI Test Methods in 9 Minutes - CCI vs. Permeation Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection.

On this episode, I was joined by Rumi Young, Director of Regulatory Policy at Beckton Dickinson(BD). Rumi walks through: - How FDA Reviews Combination Products - Industry's role in shaping policy - Essential Performance Requirements - IMDRF and International Harmonization Opportunities Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.

On this episode, I was joined by Ramin Rafiei PhD, CEO of Unleash Health.

Ramin discusses:

• Experiences in Integrating Combination Products and Digital Health
• Prevention + Intervention in Health Care
• Incentives and Outcomes
• Unleashing consumer brands to improve health

Dr Ramin Rafiei is a senior executive and entrepreneur in healthcare and life sciences, specializing in profitable top-line growth and digital transformation. Ramin has led the creation of new businesses and business units globally across diverse sectors including medical devices, healthcare services, biopharmaceuticals, photonics and high-tech manufacturing. Ramin also serves as a Chairman and Board member for US-based VC & Private Equity backed healthcare and technology companies.

Dr Rafiei is a trusted advisor to Big Tech and Life Sciences companies and serves as a Faculty member at UC San Diego, California. Ramin is the co-founder of Reformulate Health, a global advisory practice focused on strategic commercial, innovation and investment services for leading companies in the biopharmaceutical, biotechnology, digital healthcare, and healthcare investment industries. Ramin holds a Ph.D. in Experimental Nuclear Physics from The Australian National University, with acute understanding of data science, measurement science and machine learning (deep learning) methods.

Links:

1. https://www.linkedin.com/in/drrafiei/
   
2. https://twitter.com/DrRafiei
   
3. https://unleash.health/
   
4. https://reformulatehealth.com/
   
5. https://medium.com/@drrafiei/prevention-as-a-service-a-business-model-that-will-fix-healthcare-166dad254ce5

On this episode, Michelle Lott of LeanRAQA walks the listeners through 8 FDA Databases and how to use them! 

If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today.

Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.

On this episode, I was joined by Joanna Gallant of JGTA. Joanna walks through:

• Training programs at companies that had consent decrees
• The difference between good training and bad GMP training
• Competence in knowledge work
• Human Error 

Joanna Gallant is an experienced, solutions-driven Quality and training professional who has spent more than 30 years in pharmaceutical, biotechnology, tissue culture and medical device development and manufacturing environments. Over her career, she has provided regulatory, technical, skill, and management development training support to all operations functions, as well as IT, R&D, Customer Service and senior management. Now, as a training system consultant, she works with clients to design and deliver custom training and build/remediate training systems, including in support of regulatory audit observations and commitments. Joanna has been a GMP TEA member since 2001, and now serves on the Board of Directors as an Advisor. She is one of the founders of the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011. Joanna writes a popular article series for Pharmaceutical Online on the people side of pharma & GMP, provides monthly interactive web courses through LifeScience Training Institute, and through her JGTA, LLC business, authored GMP Training Can Be Fun! along with an ever-expanding line of GMP training games and activities.

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 

- FDA Drug Shortages Report 

- Drug Shortages and Drug Pricing 

- How he approaches Mastering new skill sets and building deep understanding in new areas

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.

On this episode, I was joined by Christiana Hoffman, Executive Consultant & Business Development Manager at anteris medical GmbH. Christiana walks through:

- Article 117 requirements for Combination Products in EU

- Notified Body Opinions, Timelines, and Interactions\

-Reporting for Combination and when does Eudamed Apply

Christiana is a medical device and combination product professional within the Medtech and Pharma industry. She worked for both mid size and global manufacturers but one of the largest Notified Body TÜV SÜD, where she was responsible for Combination Products in her last role. Over the years she gained profound expertise in auditing QMS / MDD / MDR, assessing technical documentation incl. biocompatibility of a wide range of class IIa products. She is a certified auditor for ISO 13485 (TÜV SÜD) and QMB (TÜV SÜD). Christiana’s main focus and experience as SME is Article 117 MDR.  Within TÜV she was overall responsible for implementing and improving the NBOp assessment process within TÜV SÜD for the DACH & Nordics region. She is a recognized conference speaker for drug device combination products, biocompatibility and EU medical device regulation.

On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses: The Anatomy of a Hazard Hazard Source(HS), Initiating Mechanisms (IM) and Target-Threat Outcome (TTO) Clifton Ericcson How concepts/tools like these fit into the ISO14971 and ISO TR 24971 framworks Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.

On this episode, I was joined by Dan Formosa, legendary designer and founder of ThinkActHuman. On this episode, Dan walks through: - Eliminating the need for instruction through good design - Drug/Device Combination Product Usability - Collaborating with OXO on a Pre-Filled Syringe - Creating the worlds first toothbrush designed for children - Usability and his book on simplifying baseball Dan Formosa is the Founder of ThinkActHuman and is an award-winning researcher in the fields of usability, biomechanics and design. From 1981 to 1990 he helped create Smart Design, a multi-awarding winning company that works across the physical and digital to design meaningful experiences. He has worked with clients such as Ford, HP, Johnson & Johnson, LG Electronics, Microsoft, OXO, and UCB. Dan’s original work on OXO Good Grips kitchen tools helped them become a symbol of inclusive design. He hosts the "Well Equipped" series on Epicurious and has had millions of views on his usability and design lessons/recommendations for household products.  Links Well Equipped Series on Epicurious: 5 TikTok Gadgets Tested By Design Expert | Well Equipped | Epicurious - YouTube About me - DAN FORMOSA

On this episode, I was joined by Etienne Nichols, who is a Medical Device Guru and Host of the Global Medical Device Podcast. Etienne Discusses: 

-Translating lessons from the Steel Industry into MedTech

-His experience on combination products 

- What is the most important quality system element? 

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.

On this episode, I was joined by Paul Jansen, who's a drug/device consultant, advisor, and board member in the combination products space. Paul discusses: 

- His experience leading combination product focused organizations at Eli Lilly & Sanofi 

- The first autoinjectors and the history surrounding ISO 11608 

- Managing a product line, owning P&L and the product development mindset shift that came with that 

Paul Jansen is currently working as a Drug Device Development Consultant. He is also on the Board of Directors at Subcuject and sits on the Advisory Boards of Evoleen, Windgap & Kymanox. He was formerly Associate Vice President, Medical Device Development, Sanofi until his retirement in January 2017. Paul has extensive experience in the design, development, manufacturing and lifecycle management of medical devices. Paul has multiple patents to his name and has deep experience in the creation and management of intellectual property portfolios. He has successfully led teams that have developed and launched several award winning devices, including Lantus SoloStar the world’s most popular insulin pen injection device. In addition, he has expertise in the design and development of injection molding systems and electronic components. Paul has been a long time member of the International Standards Organization serving as Working Group Convenor and Expert on many work groups responsible for standards related to injection devices. Until January 2022 he was the Chair of Technical Committee 84, Devices for the Administration of Medicinal Products and Catheters.

On this episode, Michelle Lott discusses the EU MDR Extension that was formalized by the European Commission and what it means for industry.  If you'd like to hear more about Michelle checkout episode 031 "The 5 stages of Regulatory Grief" and checkout Michelle's Blog @ LeanRAQA.com) and Michelle's Podcast RAQA Today. Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.

On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses:

· His book Mythical Medical

· Benefit (As part of Benefit/Risk)

· PRRC Role and EU MDR

David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk management, regulatory, and quality. He brings 25 years’ global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies, e.g., BSI, DEKRA, Medcert, and TÜV SÜD. He previously accepted a 4-year appointment from the United States Department of Health & Human Services to serve as the Industry Representative on the FDA’s General Hospital and Personal Use Devices Advisory Committee in FDA’s Center for Devices and Radiological Health (CDRH). He is certified as a Lead Auditor for Quality Management Systems ISO13485 and holds certificates for Design Control, Risk Management, Six Sigma and CAPA. He qualified as an EU Person Responsible for Regulatory Compliance (PRRC)

On this episode I was joined by Jane M. True, VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead at Pfizer.

• Following career tracks, "experience", and non-linear career progression

• Practical tips for presenting and nerves

• Storyboarding and the Minto Principle

• How Flu Vaccines are developed globally

• mRNA and what it may mean for product development and org structures

Jane is an expert in mRNA and vaccine product commercialization and has held executive and leadership roles at Pfizer, Sequiris, PWC, and Capegemini. 

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions.

Fran and I discuss:

• Her career at West Pharmaceuticals starting in the lab and retiring as Chief Scientific Officer
• Becoming experienced in Marketing, QA and RA
• What the C-Suit expects from individual contributors
• How to recognize opportunities and when to say yes

Fran DeGrazio. President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals. 

She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products. Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas.

DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018

This solo episode walks through 8 of the quality lessons I learned by losing 100lbs over the last 10 years. They are:

• Change takes time
• Change starts from a small decision 
• More pain does not equal more pain/Quality is free.
• Prevention is part of performance
• Environment is as critical as habit
• Managing constraint changes as the quality journey evolves
• Quality is conformance to requirements
• Data is important. MY data is the most important.
• Outperforming a bad process is complacency waiting to happen

I hope you enjoyed this solo episode! Wishing you all the best and a happy holiday season!

On this episode, I was joined again by Skip Creveling. During the last episode, Skip walked through Design for Six Sigma(DFSS), and finding/measuring what's important(critical parameters and tolerancing).  In this episode, he discusses: Design and Development processes in Pharma and MedTech How DFSS can be integrated into lifecycle management Design Review strategies Clyde "Skip" Creveling is the President & Founder of PDSS Inc. Skip has led the DFSS initiatives at Merck, Motorola, Carrier Corporation, StorageTek, Cummins Engine, Becton-Dickinson, Mine Safety Appliances, Callaway Golf, 3M, Samsung SDI, Sequa Corp. and Universal Instruments. Prior to founding PDSS, Skip worked at Eastman Kodak for 17 years as a product development engineer within the Office Imaging Division and  spent more than 10 years as a systems engineer for Heidelberg Digital as a member of the System Engineering Group. Skip also served an Assistant Professor at Rochester Institute of Technology, developing and teaching undergraduate and graduate courses in mechanical engineering design, product and production system development, concept design, robust design, and tolerance design. Skip is also a certified expert in Taguchi Methods.

On this episode, I was joined by Niedre Heckman, MPH, PhD, FRAPS, Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. Niedre discusses: - Challenges with global regulatory strategies for combination products - Impact of regulatory strategies on patients and product adoption - Becoming an FRAPS, and building wide expertise in QA & RA - Being a great teammate/colleague Niedre Heckman, PhD, MPH, FRAPS is the Director of Regulatory Affairs Strategy, CMC, Medical Devices, Combination Products at Takeda. She's a fellow of Regulatory Affairs Professionals Society (RAPS) (FRAPS), and holds an MPH and PhD in Public Health. Niedre has worked at Takeda, Baxter International Inc., Shire, Baxalta, 3M, and GSK. Niedre has a wide career in Regulatory Affairs, Quality, and Research with focuses in many modalities of medical devices, pharmaceuticals and combination products. Niedre couples her background in RA & QA with her expertise in public health to bring a uniquely patient centric point of view.

I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy.  Stefan discusses: Discounts, Rebates, and how Co-Payment is different in Europe How data is presented to payers in Europe and European Reimbursement Germany/AMNOG Process Negotiation Dr. Stefan Walzer is a healthcare economist, podcaster, and CEO of MArS Market Access & Pricing Strategy GmbH based in Germany. He previously worked as a payer consultant for various global pharmaceutical and medical device / diagnostic companies, successfully launching their products across the world. Dr. Walzer was also the Global Payer Strategy Leader for various products and compounds of F. Hoffmann – La Roche AG, where he successfully developed early payer strategies as well as launching and maintaining the reimbursement process for top brands and early compounds. Dr. Walzer is experienced in the development of early payer strategies and the related evidence generation. Furthermore he is also capable in translating the clinical and economic evidence into successful reimbursement submissions and pricing negotiations especially in Austria, Germany and Switzerland. Additionally he also teaches at the Master course of Consumer Health Care at the Charité in Berlin (Germany) and is a tutor in market access and health technology assessment at the State University of Baden-Wuerttemberg (Germany). From 2018-2019 Dr. Walzer was the head of the committee “Inpatient care” of the German Health Economic Association (DGGÖ). Furthermore he is a leading member of the Special Interest group for Medicial Nutritions at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Dr. Walzer is also a member of the Austrian Health Economic Association (ATHEA) and the newly founded Swiss Health Economic Association. Additionally, he is also a member of the Access Advisory Committee of the Global Pneumonia Prevention Coalition. Dr. Walzer received a Master of Science in Economics from the University of Tuebingen (Germany), a PhD in Health Economics from the University of Zurich (Switzerland) and a Diploma in Clinical Trials from the London School of Hygiene and Tropical Medicine (UK). He is co-author of more than 40 peer-reviewed scientific articles and more than 100 scientific abstracts. Furthermore Dr. Walzer is the Editor in Chief of the German Journal of ClinicoEconomics (www.germanjournal-clinicoeconomics.de) and the lead author of the book chapter “Vergütungshöhe und Preissetzung” [Reimbursement value and pricing] in Business Planning in Health Care (http://www.springer.com/de/book/9783658081850). MAP Podcast: Link MAP Youtube Channel: Link

On this episode, I was joined by Skip Creveling, President and Founder of PDSS Inc. Skip walks through: Learning from Genichi Taguchi and Stuart Pugh The 7 Steps to Robust Design Design for Six Sigma(DFSS) Six Sigma in Marketing Tolerancing and Critical Parameters Clyde "Skip" Creveling is the President & Founder of PDSS Inc. Skip has led the DFSS initiatives at Merck, Motorola, Carrier Corporation, StorageTek, Cummins Engine, Becton-Dickinson, Mine Safety Appliances, Callaway Golf, 3M, Samsung SDI, Sequa Corp. and Universal Instruments. Prior to founding PDSS, Skip worked at Eastman Kodak for 17 years as a product development engineer within the Office Imaging Division and  spent more than 10 years as a systems engineer for Heidelberg Digital as a member of the System Engineering Group. Skip also served an Assistant Professor at Rochester Institute of Technology, developing and teaching undergraduate and graduate courses in mechanical engineering design, product and production system development, concept design, robust design, and tolerance design. Skip is also a certified expert in Taguchi Methods.

Elena Kyria, CEO of Elemed joins the podcast and discusses: - Why People stay in roles and why they leave -Starting Elemed -The trusted advisory role that recruiters play -Community work on EU MDR and RAPS Elena Kyria is an award-winning talent acquisition specialist in the Medtech industry. She is the CEO of Elemed and in charge of executive placements across Europe. Elena runs one of the largest linkedin groups focused on EU MDR and is the Head of Communications/Marketing for the Switzerland chapter of RAPS.

On this episode, I was joined by Ethan Drower, of Citemed. Ethan is a prolem-driven, software engineer and fellow Chicagoan who's focused on making literature review for EU MDR Clinical Evaluation Reports(CER) more efficient, traceable and robust. Ethan and I discuss: - A problem-driven career - Challenges with EU MDR Clinical Evaluation Reports(CER's) - Literature Search and Literature Review Ethan Drower is the Co-Founder and Operating Partner of CiteMed, which is revolutionizing the European Union Medical Device Regulation (EU MDR) process. Literature Search and Review is the cornerstone of medical device companies’ Clinical Evaluation Report, and CiteMed has made this process more streamlined and optimized than ever. CiteMed’s top goal is to help companies get their medical products to market as quickly as possible, all while maintaining state-of-the-art compliance with the European Commission regulations. 

On this episode, I was joined again by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss: - PMSR and Risk Management  - Patient Safety, Pharmacovigilance, Medical Affairs, Clinical Affairs in Medical Device and Pharma companies. - PMSR Regulatory Landscape Globally (Outside of the US) Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.

On this episode, I was joined by Rizwan Chaudhrey, of RSK Life Sciences Media. Rizwan and I discuss: Launching Chats with Chaudhrey during the Pandemic Conferences and Expos How to use LinkedIn to build your personal brand Getting Started Rizwan is a blogger on Life Science/ Pharma Bio-Pharma from Drug Discovery to Drug Delivery and all things in between. He aims to connect and Inform those working across the whole value chain, through news, video interviews, podcasts and content. Rizwan's  Podcast Series: #ChatsWithChaudhrey The Podcast can be found on his YouTube Channel: RSK Life Science Media https://youtube.com/channel/UC9vdET2xLlGweqveW6JmQdQ

On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University.

Darshan and I discuss:

- Non-Promotional Speech and Scientific Discussion

- Medical Affairs vs. Sales and interaction with HCP's

- Free Speech in Tech and what it might mean for Pharma

Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and speaker, who takes a holistic approach to the healthcare and life sciences industries. Through the lens of patient centricity, including the underlying concepts of privacy, transparency, innovation, and access, Darshan looks at the broader implementation of programs by life sciences companies and healthcare professionals. With a background in creating companies, developing products, and helping guide finished products through the approval process where he has sold products as a pharmacist, Darshan has a unique perspective on how the pharmaceutical, regulatory, and life sciences industries intersect and function.

On this episode, I was joined by Alexandra Benbadis, Usability Leader at Sanofi. Alexandra and I discuss: - Critical Tasks: What the guidance says , how to select them and what it means for HF study design - Knowledge Tasks: Meeting regulatory expectations and evaluation the IFU - Usability, HF Studies and Residual Risk Prior to joining Sanofi as Usability Leader, Alexandra Benbadis was a Senior Human Factors Consultant at Emergo by UL. She's a two-time Tufts alumna and has taught two courses through the Tufts Experimental College focused on the design of public spaces and inclusive design.

On this episode, I was joined by Richard Houlihan, CEO of Eirmed. Richard and I discuss:

- History of Eudamed (Starting with EU Legislation in 2010)

- The 6 modules of Eudamed (PMS, Vigilance & Post-Market Surveillance, Clinical Investigations, Certificates, Market Surveillance, Actor Registration)

- Responsibilities for Economic Operators (Manufacturers, Importers, Authorised Representatives, System and Procedure Packs)

Richard Houlihan is the CEO of Eirmed, a company focused on helping companies achieve compliance with the EU Commission EUDAMED requirements including training, software, data preparation and processing, and support. He has been in the IT space for more than 25 years with almost 10 of them with the EU Commission. He can be reached at eudamed.com.

On this episode I was joined by Chris Tsai from Boothroyd Dewhurst, Inc. Chris and I discuss:

• Value Engineering at Eastman Kodak in the 1990's
• Inventing and Deploying Concurrent Engineering
• Defining Design Robustness 
• QFD and Design Control in Non-Regulated Industries
• Verb/Noun Pairs and Product Development
• Design for Manufacturability and Assembly

Chris Tsai is the Director of Implementation at Boothroyd Dewhurst Inc. Chris is a Lean Six Sigma and Value Analysis/Value Engineering professional with a thirst for harvesting productivity and quality improvements and a passion for professional growth. He's worked in a diverse set of new product development (NPD) and manufacturing operations management experience. He's been recognized for his decisive, consistent leadership style, strong team building skills, focus on personnel & organization development, and the persistent and effective application of productivity and quality improvement tools. 

On this special episode of the podcast, I was joined by Larry Mager. As the 52nd episode, I wanted to thank Larry for being my first interview a little more than a year ago! 

On this episode, Larry and I discuss: 

- His experiences with Pharma and CRO clients vs. Medical Device 

- Predictive Quality Management across both medical device and pharma 

- Management Review and Compliance/Effectiveness/Efficiency 

- Prioritization, finding the right metrics and not measuring every process 

- His Books and what’s to come 

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]

On this episode, I was joined by Bassil Akra, the CEO of AKRA Team. Bassil and I discuss:

• EU MDR and Implementation Timeframe
• Notified Bodies, Competent Authorities, MOH's and the EU Commission
• Article 117 & Drug/Device Combination Products
• Differences between MDD and MDR for Economic Operators
• His Favorite Book: EU MDR

Dr. Bassil Akra spent the last year supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.

On this episode, I was joined by Dr. James Somauroo of SomX and The HealthTech Podcast. James and I discuss:

• HealthTech Communication 
• Growing a Passion
• The HealthTech Podcast
• Healthtech Pigeon
• Delegating vs. Creating Systems

James is the founder of SomX: The Healthtech Agency and supports the best healthtech companies in the world. He covers healthtech for Forbes as a contributor, hosts The Health-Tech Podcast, which has listeners in >120 countries and is the Editor-In-Chief of the Healthtech Pigeon newsletter. He is an anaesthetics and ICU doctor by training, has held roles in leadership, management and innovation at NHS England, Health Education England and the British Medical Journal and previously directed two healthtech accelerators; DigitalHealth.London, which provided startups with market access to the NHS, saving £48M for the UK health service and HS., which built, scaled and invested in deep technology companies. He has degrees in medicine, biomedical sciences and education and is a guest lecturer on healthtech innovation and entrepreneurship at academic institutions around the world.

On this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss:

- FDA Human Factors Review for Combination Products (CDRH, CDER/DMEPA, OCP)

- Human Factors vs. Usability Engineering vs. Design Validation

- Risk Management and User Risk

- Summative HF Evaluation and Sampling

Shannon is the President of Agilis Consulting Group, an assistant professor in the Quality Science Education program at Pathway for Patient Health and is active on several standards and conference committees for medical devices and combination products. Formerly, Shannon worked as Team Lead for Human Factors in FDA’s Center for Devices and Radiological Health (CDRH) and as human factors reviewer within the Center for Drug Evaluation and Research (CDER), Division of Medication Error Prevention and Analysis (DMEPA).

On this episode of the podcast, I was joined by Hsinjin Yang of Pioneer Scientific Solutions. Hsinjin and I discuss:

- Materials for Biomedical Applications

- Mechanical Properties, Physical Properties, Biocompatibility, E&L and Sterilization

- Commercialization Considerations

- 4 Major Factors for the appropriate selection of materials

Dr. Hsinjin Yang PhD is a Materials Engineer with more than 30 years of experience in the areas of Polymers/Materials Science and Engineering for infrastructure in renewable energy systems, biomedical devices/packaging, medication delivery system, optical ophthalmic lens, imaging materials and polymer blends. He has 25 patents (21 issued & 4 filed), and more than 50 publications in Journals or Book Chapter or Conference Proceedings.

On this episode I was joined by Darshan Kulkarni, Host of DarshanTalks, Attorney at the Kulkarni Law Firm and Adjunct Law Professor at Drexel University.

- Free Speech and Promotional Compliance

- Misbranding

- Regulatory vs. Legal Compliance

- From Congress to the FDA - the flow from legislation to regulations

- Sunshine Act

Darshan Kulkarni is an FDA regulatory lawyer, author, professor, and speaker, who takes a holistic approach to the healthcare and life sciences industries. Through the lens of patient centricity, including the underlying concepts of privacy, transparency, innovation, and access, Darshan looks at the broader implementation of programs by life sciences companies and healthcare professionals. With a background in creating companies, developing products, and helping guide finished products through the approval process where he has sold products as a pharmacist, Darshan has a unique perspective on how the pharmaceutical, regulatory, and life sciences industries intersect and function.

On this episode of the podcast, I was joined by Sarfaraz Niazi. Dr. Niazi and I disucss: 

- The Inflation Reduction Act 

- Out of Pocket Costs 

- Part B and Part D Drugs 

- Price Negotiation vs. Price Control 

Prof. Sarfaraz K. Niazi, Ph.D., SI, FRSB, FPAMS, FACB, founder of Pharmaceutical Scientist Inc. and Adello Biologics (acquired by Kashiv Biosciences), is an adjunct professor at the University of Illinois. A prolific inventor with scores of patents in a variety of fields to his name, Sarfaraz has developed the MayaBio® bioprocessing platform that allows faster development and manufacturing of biological products at the lowest cost. Sarfaraz has published extensively including consumer articles and books, refereed scientific research, technical handbooks, poetry translations, philosophic rhetoric, and technical textbooks that are required reading worldwide. He has written most books in the field of bioprocess engineering and biosimilars. His honors include the prestigious University of Illinois Alumnus of the Year Award, Inductee into Chicago Entrepreneurs Hall of Fame, the Star of Distinction—the high civil award from Pakistan; Forbes magazine has called him, “The Most Interesting Man Revolutionizing the Health World.” https://www.niazi.com/expertise

On this episode, we were joined again by Susan Neadle! This episode was focused on the current state of Combination Products globally. Susan and I discuss: - CPC Summit and Updates from FDA - Essential Performance Requirements(EPR's) - ASTM Harmonization for an International  Combination Products Terminology Standard -Different Approaches to Combination Products Globally : US, EU, UK, Canada, Japan, China, Australia, and Saudi Arabia -Upcoming Combination Products Conferences in Q4 Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience.  She is Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership and technical skills and experience to provide hands-on design-to-value, program management, quality & compliance, and regulatory consulting services, for pharmaceutical, biotech and medical device industries. Among her many significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee. Most recently, Susan served as Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development. Susan retired from Johnson & Johnson. Her distinguished career there of more than 25 years included integral leadership roles in R&D, Quality Engineering, Design-to-Value, Risk Management and Quality Systems, spanning pharmaceuticals, medical devices, and consumer health. She led the team that defined and successfully implemented the globally integrated business model to meet Combination Products regulations for Janssen.

On this episode, I was joined by Dr. Kasem Akhras, Senior Director, Translational Access, Geneconomics & Outcomes Research - New Products  at Novartis. Dr. Akhras and I discuss: -His Book "Frontiers in Market Access" -History of Market Access from the 1980's to now -Where the Market Access function fits in within Product Development -Market Access and Clinical Trials -Over-Utilization -Value Based Pricing -US Pharmaceutical Prices Dr. Akhras is a global Pharmaceutical Expert with 25 years of experience leading and building teams in the most critical functions in the Pharmaceutical Industry; Pricing, Reimbursement, Market Access, and Health Policy. Visionary, Passionate, and results driven leader. Well published in peer-reviewed journal and author of the book Frontiers in Market Access - A Practical Approach of Mastering Market Access. Dr. Akhras has held roles in Market Access and Health Economics at Novartis, Astrazeneca, Pfizer, Takeda, J&J and Sanofi. He is an Adjunct Professor at the University of Illinois at Chicago - Department of Pharmacy Systems, Outcomes and Policy.

On this episode of the podcast, I was joined by Shadeed Salem, the Founder and President of Synergy Bioscience. Shadeed and I discuss: -War Stories in method validation and NCR/OOS's -What is it that you're going to test and what are you testing for? -Differences between drug and device methods including Analytical, Physical, Mechanical and Visual methods -Method Development vs. Method Validation -How to treat compendia methods (USP, ISO, etc) -Specificity, Bias, Linearity, Gage R&R Shadeed Salem MSc MBA CQE CQMOE CQA CSSBB CPGP is an industry matter expert with proven expertise in the establishment and remediation of quality systems based on regulatory requirements such as the FDA 21CFR 210, 211, QSR 820, ISO 9001, ISO 13485, ISO 14971, ISO 14644, and IEC 60601 and guidelines such as ICH, WHO, and PIC/S for pharmaceutical and medical device industries. Thorough knowledge and high level of expertise in writing protocols and implementing numerous validation studies such as Analytical Method Development/Validation, equipment qualification (IQ/OQ/PQ), Cleaning Validation, Cleanroom Qualification, Water System Qualification, as well as manufacturing process validations. Exceptionally skilled in performing Corrective Action / Preventive Action (CAPA) and Root Cause Analysis, Out of Specifications (OOS) Investigations, quality system auditing and compliance gap assessment, as well as providing training based on cGMP requirements.

On this episode of the podcast, I walk through some of the takeaways I got from reading "Statistical Method from the Viewpoint of Quality Control" by Walter A. Shewhart.

---------------------------------------------------------- 

Who Was Walter Shewhart? Link

On this episode of the podcast, I was joined by Jane Sarasohn Kahn of Health Populi and THINK-Health. Jane and I discuss: - US Healthcare System - Healthcare economics before Healthcare economics - Her Book: Health Consuming - Health Consuming vs. Health Citizenship - US vs. European Healthcare systems Jane is a health economist, advisor and trend-weaver to organizations at the intersection of health, technology and people. Jane founded THINK-Health after working with health care consultancies in the US and Europe. Jane’s clients span the health/care ecosystem: technology, pharma and life sciences, providers, plans, financial services and consumer goods. She founded the Health Populi blog in 2007. Jane advises on strategy via environmental analysis, scenario and strategic planning. She is on the advisory boards of CanSurround, CAQH’s U.S. Health Efficiency Index, the Health 2.0 Conference, healthBank, HIMSS Connected Health Committee, the Society for Participatory Medicine, Stupid Cancer, and WEGO Health. In her community of Phoenixville, PA, Jane sits on the Board of The Clinic, a free clinic for residents. Jane is a frequent speaker, listed with AHA’s Speakers Express and Executive Speakers Bureau.

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - Behavioral Neuroscience and the soft skills of Quality - Quality, Compliance and Risk Management - Pharmacogenomics and Orwell - Combination Products 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.

On this episode of the podcast, I was joined by John Nosta of NostaLab. John and I discuss:

-Pharmaceutical Innovation in the last several decades

-Patient-Centricity in Pharma

-Innovation vs. Implementing Existing Technologies

-Genius Being a Birthright & Mediocrity Being Self imposed

-Telemedicine & Digital Health

-Decentralized Clinical Trials

- Artificial Intelligence, Wonder and Fear

John Nosta is the founder of NOSTALAB—a digital health think tank recognized globally for an inspired vision of transformation. His focus is on guiding companies, NGOs, and governments through the dynamics of exponential change and the diffusion of innovation into complex systems. He is also a member of the Google Health Advisory Board. Further, John is also a frequent and popular contributor to Fortune, Forbes, Psychology Today and Bloomberg. He has also been published in prestigious peer-reviewed journals including The American Journal of Physiology, Circulation, and The American Journal of Hematology. In 2019, he was named to the World Health Organization’s Digital Health Roster of Experts.

On this episode, I was joined by Dan Sfera, aka "The Clinical Trials Guru". Dan and I discuss:

• Clinical Trials from the View of the Patient and the link to Primary Care
• Institutional Review Boards
• Informed Consent
• Patient Accrual, Inclusion/Exclusion and Screen Failure
• Role of the Sponsor
• Sponsor/CRO/Study Site Dynamics
• Roadblocks in Clinical Research
• Decentralized Clinical Trials

Dan Sfera is the Founder and Site Director of Yuma Clinical Trials, Founder of the CRA and CRC Academies, Co-Founder of DSCS Sweat Equity and Investments, and one of the Author's of the Comprehensive Guide to Clinical Research. He is also the Host of The Random Musings from The Clinical Trials Guru Podcast.

------------------------------------------------------------------------------------------------------------------------------

Links: 

Book: Comprehensive Guide to Clinical Research

Podcast: Link

On this episode I go through the lessons I've learned through the podcasting process, and reflect on the first 25 episodes of the Combinate Podcast.

Constructive Feedback or Guest Suggestions can be made at letscombinate.com

On this episode of the podcast, I was joined by Yousef Arman, Founder of The Vial Store. Yousef and I discuss:

• His background growing up around Pharmacists and Pharmacies
• What starting a Pharmacy Requires and Day to Day Operations
• Pharmacy Pricing/Costs and how they make money
• Demand Planning, Formularies and how pharmacies always seem to have medications
• The role of Specialty Pharmacies in developing areas
• The Vial Store and where the idea came from

Yousef's Articles: 

• The Evolution of Pharmacy – A Short History Part 1 – The Ancients:  Link
• The Evolution of Pharmacy – A Short History Part 2 – The Middle Ages to 1900: Link
• The Evolution of Pharmacy – A Short History Part 3 – The Last 150 Years: Link

Yousef Arman, is the Founder of The Vial Store. Established in August 2015, The Vial Store provides reliable, cost effective and quality products that exceed its customers’ expectations.  It demonstrates relentless commitment to quality, integrity and continuous improvements.
Headquartered in Chicago, Illinois, the company sells vials, ointment bottles, pharmacy jars, prescription bags and other pharmacy supplies across the United States and Canada.

On this episode, I was joined by Dr. Khaudeja Bano, Vice President of Combination Product Quality at Amgen. On this episode Khaudeja and I discuss:

- Safety function (Drug vs. Device)

- 21 CFR Part 4 Subpart B 

- Specific Post-Market Safety Reporting Expectations

- Industry Challenges with implementing PMSR Requirements

- Working in Quality with a background in Safety

- Self Marketing, Toastmasters and Professional Development

Dr. Khaudeja Bano is the VP of Combination Products Quality at Amgen. Executive director of combination product safety. She's held multiple roles at other companies  as well like Abbvie, Abbott, and Guidant and is the chair of the Post Market Safety committee for the combination products coalition.

On this episode, I was joined by Mitch Robbins, founder of the Anthony Michael Group based in Denver, Co. Mitch and I discuss:

- How he got into recruiting

- The business model for recruiting (contract, retained, engaged)

- Interview Matrix - interview strategies for objective unbiased candidate selection

- The overall recruiting/hiring process and some of the tools AMG uses to find the best candidates (Market Mapping, Intake Calls, and More)

- How to select the best candidate by using a case study or test drive

- When a recruiter should be engaged?

- His Podcast The MedTech Talent Lab 

----------------------------------------------------------------------------------------------------

Mitch Robbins is the founder and Managing Director of The Anthony Michael Group. Mitch has an extensive background in the recruitment and staffing industry.  Prior to founding The Anthony Michael Group, Mitch worked for two of the most prestigious, nationally recognized search firms Spherion and Management Recruiters International (MRI). Mitch achieved a ranking as high as #12 out of over 3,500 recruiters within MRI.

He was the recipient of multiple achievement awards for excellence in recruiting. These included the Southwest Region Rookie of the Year, and MRI’s Pacesetter distinction. Mitch has been the choice of the experts to deliver training to both rookie and seasoned recruiters across multiple disciplines on numerous occasions.

The Anthony Michael Group, or AMG, is a boutique executive search firm. Headquartered in a suburb of Denver, CO we assist Food, Beverage, Pharmaceutical, Biotech, Medical Device, and Diagnostics organizations across the United States to hire the top 15% of Regulatory & Quality leadership talent at the CXO, VP, Director, and Manager levels. When you work with The Anthony Michael Group, you can count on our team’s tenacity, authenticity, and accountability while we deliver results for you.

-------------------------------------------------------------------------

Links

AMG About - Link

AMG Blog - Link

MedTech Talent Lab - Recorded Shows Link 

MedTech Talent Lab - Live Weekly on Linkedin at 2PM EST Wednesdays at Link

On this episode of the podcast, we go off our normal topics within BioTech and MedTech and discuss a topic that is near and dear to me; Coffee! I was joined by my friend Erik Barkley, Founder and Owner of Tugboat Coffee Roasters. Erik and I discuss:

- How Erik and I met a few years ago

- How he works with coffee farms around the globe

- The life of a coffee bean: growing, processing, roasting and brewing

- The roasting process

- What some of the grading, certifications mean around coffee, and how to buy coffee as a consumer

- Tips and Tricks for making the best drip, pour over, and espresso at home

- Coffee Roasters and Coffee Books he recommends

--------------------------------------------------

Erik Barkley is the Founder and Owner of Tugboat Coffee, a wholesale, specialty coffee roaster dedicated to creating profitable coffee service for our customers through low overhead and focused services.

www.tugboatcoffee.com

In this episode I walk through some of the concepts of the book "Quality is Free" by Phillip Crosby.

------------------------------------------------------------

Amazon Link to the Book: Link

-----------------------------------------------------------

Who Was Phillip Crosby(From ASQ): Philip B. Crosby was a legend in the discipline of quality. A noted quality professional, consultant, and author, he is widely recognized for promoting the concept of "zero defects" and for defining quality as conformance to requirements.

Crosby's career as a quality professional began in 1952 after serving in World War II and Korea. In 1979, he founded Philip Crosby Associates, Inc. (PCA), teaching management how to establish a preventive culture to get things done right the first time.

Crosby was recognized by corporations around the globe as a "guru" of quality management, and a business philosopher and innovator who changed the way organizations seek to achieve greater efficiency, reliability, and profitability.

Crosby's first book, Quality is Free, has been credited with playing a large part in beginning the quality revolution in the United States and Europe. He published a total of 13 books, including The Absolutes of Leadership in 1996 and Quality and Me, an autobiography filled with lessons from life published in 1999.

On this episode of the podcast, I was joined by Michelle Lott of Lean RAQA. Michelle and I discuss:

- Her background starting at a manufacturing site and moving into QA and RA

- Being Outspoken and Honest 

- What she's observed between large and small organizations

- Her Experience being an industry rep on the FDA Device GMP Advisory Committee

- Regulations vs. Guidance's and how they come about

- The 5 stages of regulatory grief 

- QMSR Harmonization

- Audit Preparation

(See Michelle's Blog @ LeanRAQA.com)

(See Michelle's Podcast @ Spotify Link)

------------------------------------------------------

Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!). She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. She has a weakness for tequila and anything barbecued.

On this episode of the Combinate Podcast, I was joined by Marc Koska, Founder of Apiject. Marc and I discuss:

• The Importance of Understanding a Problem
• Developing Models for Courtrooms in the US Virgin Islands
• How he discovered the problem with Syringe Re-Use and HIV
• The development of the K1 Syringe
• How he drove the outlawing of reusable syringes in India
• Some Problems of Pre-Filled Delivery Systems Currently
• The Apiject BFS Design
• Future of Apiject and Solving Drug Delivery Challenges
• The importance of Self Motivation
• Biomimicry

Marc Koska is best known for his breakthrough invention the K1 syringe which is a non-reusable syringe that prevents the transmission of blood borne diseases. He is the founder and Head of R&D at Apiject and is the originator of the ApiJect BFS single-dose injector.

Since beginning his work in the late 1980’s, Marc is credited with saving 10 million lives, having invented solutions, changed WHO policy and best practice on the ground through advocacy and campaigning.

Marc Koska: Link

Apiject: Link

On This Episode, I was joined by Marla Phillips of Pathway for Patient Health. Marla and I discuss: 

• Pathway for Patient Health Training the Next Generations - What students can do? 
• Quality for the 21st Century 
• Chief Quality Officer Forum 
• FDA/Industry Collaborations 
• How Xavier Health Came to be and the Future of Xavier Health 
• Supply by Design 
• The importance of doing things with purpose 

------------------------------------------------------------- 

Pathway for Patient Health: Link 

Pathway for Patient Health Quality Science Program : Link 

Pathway for Patient Health Hiring Portal: Link 

Good Supply Practices/Supply by Design: Link 1 & Link 2 

USP <1083> GOOD DISTRIBUTION PRACTICES—SUPPLY CHAIN INTEGRITY: Link 

Future of Xavier Health: Link

 ----------------------------------------------------------------- 

Marla Phillips PhD founded Pathway for Patient Health in 2018, and leads cultural, quality and supply chain initiatives with regulators and industry professionals for the betterment of patient health around the world. Phillips is a frequently invited speaker for major industry association conferences across the country each year, including the PDA/FDA Joint Regulatory Conference, AdvaMed Medtech Conference, Cold Chain Global Forum, USP, IPEC, and the FDA’s own Association of Food and Drug Officials. In 2008, Phillips founded, Xavier Health at Xavier University. In this role, Phillips was asked to co-lead with FDA the CDRH Case for Quality metrics initiative from 2014-2016, which culminated in work that continues to support the Case for Quality program. 

She led the Good Supply Practices (GSP) initiative with the FDA Office of the Commissioner, CDER, pharmaceutical and medical device professionals, and suppliers, which has been published for global industry adoption. Additionally, Phillips founded the FDA/Xavier PharmaLink Conference, FDA/Xavier MedCon Conference, AI Summit and Combination Products Summit for global regulators and industry professionals. 

Phillips began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She has expertise in leading FDA inspections and readiness, quality, analytical testing and validation, supply chain, stability program management, process validation, manufacturing, and packaging operations. Phillips holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.

This is Part 2 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss: His Book - Poor Quality Costs(PQC) Why Cost of Quality has a bad connotation to it Direct vs. Indirect Poor Quality Costs White Collar Poor Quality Costs and Process Ownership/Optimization Burying the problem vs. Putting it to bed Problems and impact on customer retention Starting a PQC System and how to prioritize in implementation Executive Management Errors & PQC 

--------------------------------------------------------------------------------------------------------------- 

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. 

--------------------------------------------------------------------------------------------------------------- 

Link to Episode 1 with H. James Harrington: Link 

ASQ - H. James Harrington: Link 

H. James Harrington: Link 

Books Written by H. James Harrington: Link

On this episode, I was joined by Duane Mancini, CEO and Managing Partner of Project Medtech and host of the Project Medtech Podcast. Duane and I discuss: Why he enjoys working with Startups Reimbursement considerations for Startups Importance of Regulatory Strategy for Startups Project Medtech and Medtech Money Podcasts Startup Symposiums Combination Products Startups Startup Symposium in Columbus, OH on 15-Jun-2022 - Register here Book Recommendation: Your Life Depends on It: What You can do to make better choices about your health Link ------------------------------------------------------------------------------------------------------------------------------------------------------ Duane Mancini is a chemist by training and holds a Master of Science degree in Medicinal Chemistry from the University of Toledo.  He started his medical device career at NAMSA as a technical advisor who specialized in overall biological safety planning including the use of chemical characterization to reduce the amount of biocompatibility testing needed for approval. He then moved into a senior technical advisor role at NAMSA and worked with clients on regulatory, reimbursement, and clinical strategies.  This unique and end-to-end background enabled him to be chosen to help lead NAMSA’s MRO team.  In this role, he applied the NAMSA MRO approach (end to end CRO services) to medical device companies in order to accelerate time to market.  This role required working with mostly medical device start-up companies in developing and executing a get-to-market strategy. Duane then worked for Labcorp on the Medical Device and Diagnostic team as a Business Development Director bringing regulatory, reimbursement, pre-clinical and clinical support to his Medtech clients. He is currently the CEO and Managing Partner of Project Medtech.  Project Medtech is a media and advisory firm that is committed to supporting the delivery and development of innovative medical technology.

This is Part 1 of the episode with H. James Harrington PhD of Harrington Management Systems. On this part of the episode Dr. Harrington and I discuss: 

His first experience in Quality at 6 years old 

The evolution of Quality over the last century Quality in a service vs. a product 

What the "Gurus" of Quality were like: Juran, Ishikawa, Feigenbaum, and Crosby 

ISO:56002 and the Innovation Process Considered one of the Quality "gurus"

-------------------------------------------------------------------------------------------------

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.

--------------------------------------------------------------------------------------------------------------- 

ASQ - H. James Harrington: Link 

H. James Harrington: Link 

Books Written by H. James Harrington: Link

On this episode of the podcast we had Edwin Bills, a Risk Management Expert that was on the committees for ISO14971:2019, ISO TR24971:2020 and AAMI TIR 105:2020. Ed and I discuss Combination Products Risk Management including: His background as an educator Entering Quality after being taught by some of the quality gurus in the 1980's The history of Risk Management in medical devices and what it was like before ISO 14971 Advice for how someone new should look at the risk management documents and standards ISO 14971:2019 Medical devices — Application of risk management to medical devices ISO TR 24971:2020 Guidance On The Application Of ISO 14971 AAMI TIR 105:2020 Risk management guidance for combination products Differences and Similarities between ISO14971 and ICH Q9 Philosophically Constituent vs. Finished Combination Product Risk Management Requirements vs. Guidance in the standards and technical reports Probabilities & Estimation in Risk Management (P1/P2 method) Risk Acceptability and Benefit to Risk  Risk Management for Clinical Trials Why he loves Risk Management During his career in medical devices, Ed has held a number of quality and regulatory affairs positions. He is an ASQ Fellow and is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. Ed is also Regulatory Affairs Certified through the Regulatory Affairs Professionals Society and obtained BS and Masters degrees from the University of Cincinnati. Ed served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical device participated in the development of ISO 14971 risk management standard for medical devices. Ed is a current member of the ISO Technical Committee on medical device risk management, which has now completed the 3rd edition of ISO 14971 and the second edition of ISO TR 24971. Ed was also part of the AAMI committee that authored TIR105. In 2016, he co-edited, with Stan Mastrangelo, "Lifecycle Risk Management for Healthcare Products from Research Through Disposal" published by Davis Publishing and available at www.pda.org. Had has also written extensively on medical device and combination product risk management Ed has presented training courses for the American Association of Medical Instrumentation (AAMI) in the area of design controls, risk management, and quality systems, and presented courses at the University of Southern California and the University of Washington in their regulatory affairs graduate programs, and has served as an adjunct professor in the Health Products Risk Management graduate program at Virginia Tech. Currently, he is consulting in the area of medical device quality, regulatory, product liability and risk management. Links: --------------------------------------------------------------- Edwin Bills Linkedin: Link Article Discussed in the Episode -  "What Does EN ISO 14971:2019's New Amendment Mean For Harmonisation? " - Link

On this episode of the podcast, Naveen Agarwal PhD from Creative Analytics Solutions.

Naveen and I discuss: 

• Running almost 1500 miles and the importance of constraints 
• Risk Management Vigilance vs. Surveillance 
• Customer Experience focused Quality Improvement and Post-Market Surveillance 
• Common Issues with P1/P2 Implementation  
• Data Based Decision Making Frameworks
• Methods NIST Malcolm Baldridge Award Appraisal 
• Toastmasters 

Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.

On this episode of the podcast we had Dr. David Albert of AliveCor, a medical doctor, scientist and entrepreneur who has founded several successful companies and ventures in MedTech like AliveCor and others that have been acquired by companies like GE Healthcare. Dr. Albert and I discuss: Pursuing a Career and Family Simultaneously Becoming an Inventor Physician by Chance The unexpected reception that started AliveCor His inventions and Patents The importance of being optimistic and opportunistic The lessons he learned having created 4 businesses  His amazing fire alarm inventions under Lifetone Technologies Artificial Intelligence in remote patient monitoring devices David Albert, MD, an Oklahoma native, is a physician, inventor and serial entrepreneur who has developed life-saving technologies and products over the last 30 years, turning an number of those innovations into tech startups. Today, he is a founder of three technology companies, InnovAlaram, Lifetone Technology, and AliveCor. His previous startups include Carazonix Corop(sold to Arrhythmia Research Technology) and Data Critical(sold to GE). Dr. Albert left GE in 2004 as Chief Scientist of GE Cardiology to disrupt several new markets. His latest invention, AliveCor's KardiaMobile personal ECG technology, became a global sensation via a Youtube Video in Jan 2011 around the CES show and was featured on ABC, CBS, CNN and Fox News and others. Dr. Albert has 75 issued patents and has lectured at the entrepreneurship programs at MIT and other universities. Dr. Albert graduated with honors from Harvard College and Duke University Medical Schools.

On this episode, we were joined by Susan Neadle. If you work on Combination Products, Susan is someone you need to know. Her and I discuss: Her career starting in consumer health and pivoting into Medical Devices then Pharmaceuticals Design to Value, Design Excellence and Process Excellence The History of Combination Products regulation and what it was like implementing 21 CFR Part 4 as it was revealed. Creating future plans using tools like the Merlin Exercise, and Future/Back Vocabulary in Combination Products AAMI TIR 48 and TIR 105 Her involvement in ASTM, AAMI, ISPE, FPIA, DIA, AFDA, TOPRA and RAPS Prioritization, Passion and her upcoming book ------------------------------------- Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. Networked, published, highly active in numerous industry groups and with links to a number of teaching institutions, Susan brings deep knowledge, and genuine passion for sharing that knowledge, with others. Susan’s leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence. She is Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership and technical skills and experience to provide hands-on design-to-value, program management, quality & compliance, and regulatory consulting services, for pharmaceutical, biotech and medical device industries. Among her many significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee, and teaches a Master’s Curriculum on Combination Products at University of Maryland Baltimore Campus. Most recently, Susan served as Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development and portfolio/project management from initial clinical investigation through registration and commercial lifecycle. She served as an advisor for internal regulatory policy priorities, health authority engagement and submissions approaches through strategic engagement and mentoring of colleagues for individual projects and portfolio. She led interactions with multiple global health authorities, and served as a catalyst for external consortium deliverables and strategic direction. Susan retired from Johnson & Johnson. Her distinguished career there of more than 25 years included integral leadership roles in R&D, Quality Engineering, Design-to-Value, Risk Management and Quality Systems, spanning pharmaceuticals, medical devices, and consumer health sectors, including strategic Enterprise leadership as Chair of J&J’s Design Council, advancing world-class practices in customer-centric product/process design and development. She led the team that defined and successfully implemented the globally integrated business model to meet Combination Products regulations for Janssen.

On this episode of the podcast we had Karandeep Singh Badwal. Karandeep and I discuss:

• Why QA/RA is the place to be (if you're so inclined)
• Intended Use, Indications and Use cases
• Where software startups struggle
• Eudamed
• Cybersecurity
• Artificial Intelligence in Medical Devices
• SaMD and Digital Health Considerations related to the MDR
• Impact of Brexit on existing and future products within the EU and UK
• Robert Green and his books
• His Podcast: The Med Tech Podcast

------------------------------------------------------------

Karandeep is a QA/RA consultant and host of The MedTech Podcast with a mission to help you understand the Quality, Regulatory Affairs and Compliance of Medical Devices, Digital Health and Biotech. 

Karandeep can be found at: Linkedin Profile 

The MedTech Podcast: Podcast Link

On this episode we had Kathy Walsh, Director and Principal at Quality Systems. Kathy and I discuss:

• Her Book: "Eliminating the Gobbledygook:  secrets to writing plain language procedures"
• Her background starting as a PhD Microbiologist and moving into Quality Systems/Technical Writing
• Where most companies have issues with their procedures 
• Plain Language Skills: Active voice vs. passive voice, Process Mapping, Inference Building, Sentence Parsing, document structure and more
• The origins and history of "plain language"
• The history of Fonts
• How to make for more efficient document reviews and advice she has for writing technical documents and procedures

Dr. Kathy Walsh is a scientist, a  PhD biochemist with post-doctoral work turned QS expert. She helps companies in regulated industries design & implement quality compliance solutions that increase productivity and master the quality challenges in their marketplace. She most recently wrote her book "Eliminating the Gobbledygook:  secrets to writing plain language procedures" and is joined us from  Melbourne, Australia.

------------------------------------------------------

Links:

• Kathy can be reached on LinkedIn HERE
• QSN: https://www.qualitysystemsnow.com.au/
• Eliminating the Gobbledygook:  secrets to writing plain language procedures: Book Link

On this episode of the podcast we had Omar M Khateeb, the host of the State of MedTech, and Founder of Khateeb&Co where he Helps MedTech Companies Grow Sales & Drive Product Adoption Using Social Media. Omar and I talk about him leaving medical school to pursue his purpose, intuition vs. ego, the death of the existing medtech sales process and where it's going post-pandemic, MedTech and the Metaverse, and the power of reading & taking action. Omar M. Khateeb is a marketing leader who has developed marketing strategies at two publicly traded surgical robotic companies through their IPOs as well as co-founded and successfully launched a consumer product for men’s fashion. Having successfully crowdfunded and launched a consumer product, Omar brings his knowledge of B2C marketing through digital channels to a B2B world. His areas of focus are category design, driving adoption of new technologies, and developing strategies to channel attention towards generating demand. Currently he is principal at Khateeb & Co, a strategic advisory firm whose mission is to help medtech companies grow revenue through social media. In his spare time, he enjoys teaching, mentoring young professionals, and donating his marketing expertise to non-profits. He also spends time speaking at various industry conferences on topics around digital marketing, business development, and market engineering. Omar can be reached on Linkedin at https://www.linkedin.com/in/okhateeb/. You can follow with him on Facebook, Instagram, Twitter (@OmarMKhateeb) or Youtube (Mind Loom with Omar M Khateeb). I implore you to listen to his podcast here: https://open.spotify.com/show/5NVrQLfLk0EXDeKDdX7BB6?si=ZrdzqZImQR6Y66RuVi1kjg

On this episode of the podcast, we had Professor Sarfaraz Niazi, a "Renaissance Man" if I ever met one. We discuss what biosimilars are and how they differ from generics, how he predicted biologics and biosimilars would be the future of medicine, his inventions starting from coffee mugs and hats to bioreactors that don't have an exhaust, how he passed the federal bar exam without attending law school, how he writes 4 to 5 books a year(with more than 50 books published), passions vs. hobbies, how he schedules his day and more.

Prof. Sarfaraz K. Niazi, Ph.D., SI, FRSB, FPAMS, FACB, founder of Pharmaceutical Scientist Inc. and Adello Biologics (acquired by Kashiv Biosciences), is an adjunct professor at the University of Illinois. A prolific inventor with scores of patents in a variety of fields to his name, Sarfaraz has developed the MayaBio® bioprocessing platform that allows faster development and manufacturing of biological products at the lowest cost. Sarfaraz has published extensively including consumer articles and books, refereed scientific research, technical handbooks, poetry translations, philosophic rhetoric, and technical textbooks that are required reading worldwide. He has written most books in the field of bioprocess engineering and biosimilars. His honors include the prestigious University of Illinois Alumnus of the Year Award, Inductee into Chicago Entrepreneurs Hall of Fame, the Star of Distinction—the high civil award from Pakistan; Forbes magazine has called him, “The Most Interesting Man Revolutionizing the Health World.”

https://www.niazi.com/expertise

On the podcast this week, we had Ahmed Zobi, CEO of Syntr Technologies. Ahmed and I talk about jumping into Syntr Technologies feet first, what bootstrapping in medtech looks like, the grant submission process for funding, being a young CEO and figuring out where to trust your gut and where you need help, how Covid impacted his startup, leading with emotional intelligence, and where Syntr is going.  Ahmed Zobi is the Founder and CEO of Syntr Health with experience in microfluidics and biomechanics, and has headed research and development, management, and grant submissions. He has successfully attained all funding and has guided the company towards 510(K) clearance and commercialization of the SyntrFuge System. Ahmed received his BS in Biomedical Engineering, specializing in micro and nanotechnology, from the University of California, Irvine, and recently received his EMBA from Quantic School of Business and Technology. Syntr Health Technologies, Inc is a start-up company that was founded by biomedical engineers and experienced surgeons. Together, we have developed and tested a processing device, the SyntrFuge™ System, for the microsizing of adipose tissue for body contouring. How microfat is processed is incredibly important to its viability. The SyntrFuge System utilizes the precision of automation to deliver dependable results every time. We are on a mission to empower practices to offer innovative and natural solutions for their patients.

This episode of the Combinate Podcast is with Joe Hage. Joe and I talk all things medical device marketing. We discuss how storytelling is even more important for medical devices than other industries, how he helps clients clarify their vision and messaging, the importance of being specific and concise, the medical device marketing process, hist start in the food industry and transitioning into MedTech, a single book recommendation and the 10x Medical Device Conference. Joe Hage leads the Medical Devices Group(MDG) with more than 350,000 subscribers, the most useful website serving the medical device industry. Joe also runs his company, Medical Markom, where he provides medical device marketing services, and helps companies engage qualified prospects. He is the host of the 10x Medical Device Conferences where he unites Medical Devices Group members in fun and educational forums each year. Medical Devices Group: https://www.medicaldevicesgroup.net/ Medical Marcom HELL List mentioned in the podcast: https://medicalmarcom.com/medical-device-marketing/selling-medical-devices-2019/ The 10X Medical Device Conference will be in San Diego, CA this year on May 10-12: https://medicaldeviceevents.com/

On this episode of the podcast we had Monir El Azzouzi of Easy Medical Device. Monir and I focus on EU MDR and discuss the difference between EU MDR and US regulations, the history of the MDD being updated to MDR in 2017, Notified Bodies(their role and how they are formed), CE Marking and medical device clearance, considerations for CMO’s and private label, the role of Authorized Representatives, books be recommends and the importance of thought and integrity in QA.  Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses. If you'd like to support the show, please share, subscribe and rate on Apple Podcasts and Spotify. If you have any feedback or requests please contact [email protected].

This Episode is with Larry Mager of Mgmt-Ctrl. In this episode Larry and I continue where we left off in 002 - "Seeing David in the Stone". In that episode he walked the audience through the importance of having Predictive Quality Management or PQM. That it's not an afterthought, but rather a beforethought. It should be intentional. In this episode, Larry and I chop it up about the well where PQM starts: Product. As Product is the output of the existing Process and People, before an organization moves to attempt to remediate systematic issues like QMS or Competency/Training/Development, it should ensure that it's product is Safe and Effective. We go over a quick overview of PQM, Sources of information to feed into risk assessment, Safety Signal Identification and Confirmation, Risk Control, and ensuring the State of the Art(SOTA) benefit of Patient Safety. 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]

In Part 2 of this episode, Larry and I discuss the Second P: Process. I start the episode by asking Larry to explain the difference between a Quality System and a Quality Management System(QMS) to set the foundation. Larry then moves on to explain have a control environment should be well established(policies, standards, procedures, governance, etc), Risk Management for processes and poking holes in your organization's ways of working, control activities, flow of information, monitoring, management review and continuous improvement. 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]

In this final segment of the episode with Larry, we discuss the Final P: People. In this episode we discuss skillsets, training and competency, communication for teamwork, establishing a culture of trust and accountability and all of this culminating into the creation of a strong Culture of Quality. Larry ends the episode by giving an example of how he's seen people and the soft science surrounding quality culture applied very well. 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]

This episode of the podcast was with Jumha Abu-Razeq of Stoopid Fit. I wanted to bring Jumha on in preparation for 2022. Jumha was the first coach I hired and I did so after losing 100 lbs and finding that despite my success in weight loss, my relationship with food still needed a lot of work. I still didn't feel in control. I believe for us to be the best professionals we can be, it’s important to be healthy physically and mentally and in that way health is not defined as the absence of sickness but something that’s more positive than that. I found great success in working with him and I hope you find value in this interview.

Jumha and I talk about his thoughts on New Years resolutions, goal setting, fat loss, sleep, stress, health and his recommendations for who should get coaching. I hope you enjoy the episode with Jumha! 

Jumha Aburezeq is Owner and Operator of lifestyle nutrition coaching brand Stoopidfit. His mission is to help as many people as possible break free from complexity and restriction, by embrace simplicity and freedom to live happier and healthier lives.

Happy Holidays everyone! On this episode of the Combinate Podcast, we had Sara Waxberg McNew, Chief Scientific Officer at Design Science. Sara and I talk about her interest in Human Factors and her career, we discuss who is a user and how to get close to them, how to read the ANSI/AAMI HE75:2009 (R2018) and IEC 62366-1:2015 standards, the design validation process and how human factors formative and summative evaluations fit in, human factors considerations for combination products, and figuring out what users need vs. want. Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly and Company, Philips Healthcare, and Baxter Healthcare. Throughout these experiences, she has led cross functional teams, selected and managed human factors consultants (and now is one), interacted with the FDA and international regulatory agencies, and executed on created corporate level strategic plans for human factors. At each of these organizations, she was accountable to ensure intended end-users are effectively represented and their needs are considered throughout the product lifecycle in order to reduce the potential for use error, satisfy target customers, and comply with regulatory requirements. Sara has a B.S. in Human Factors Engineering and Biomedical Engineering Design from Tufts University, where she has also completed her M.S. course work. She is an active member of the Association for Advancement of Medical Instrumentation (AAMI) where she has contributed to the development and revision of human factors technical information reports and international standards.  Design Science is retained by the world’s leading companies to assure that their products fit user needs. Design Science conducts rigorous research and design user interfaces to optimize usability, safety, and customer appeal of products. Founded in 1991, Design Science was one of the first consultancies to focus on the person/product interface. They have deep roots in those product categories where usability is mission critical—particularly medical devices, but also other products that are tools: commercial, industrial, or consumer.

Have you ever wondered what goes into a good story? Enter Margot Leitman. Margot and I talk about why people fear story telling, what people can do if they feel they have no good stories, the anatomy of a good story, and the importance of good story telling in business. Margot Leitman is an award-winning storyteller, best-selling author, speaker and teacher originally from Matawan, New Jersey. A leading expert in the growing field of storytelling, Leitman has written two books on the subject: the best-selling, Long Story Short- the Only Storytelling Guide You'll Ever Need and her latest What’s Your Story? A Workbook For the Storyteller in All of Us both from Sasquatch Books. Her comedic memoir, Gawky…Tales of an Extra Long Awkward Phase is available from Seal Press/ Perseus Books. She has written for NBC, DreamWorks TV, the Hallmark Channel and the PixL Network and a variety of print and online sources including Cosmo and Backstage Magazine. In 2016 she worked as the west coast story scout for This American Life. Margot is a five-time winner of The Moth StorySLAM, and was the Moth GrandSLAM winner in New York City achieving the series' first ever score of a perfect 10. Her stories have been featured on NPR's “The Moth Podcast,” “Good Food," “Unfictional,” "Strangers," and is a frequent contributor to the popular podcast “RISK!" Leitman is the founder of the storytelling program at the UCB Theatre, where she has performed in dozens of shows over the years and is a frequent monologist at their flagship show "Asssscat."  Margot travels all over the world as a public speaker, storyteller and teacher. Internationally she has performed and taught at the SPOKEN FEST in Mumbai, India as well as a six-week teaching residency at the Blue Room Theatre in Australia. In her spare time Leitman is an amateur baker, avid yogi and a devoted bibliophile. A proud graduate of the Ithaca College Theatre Department, Leitman now resides in Los Angeles. Margot can be reached at https://www.margotleitman.com/contact.

On this episode of the Combinate Podcast, we had David Simoens, COO at cGMP Consulting Group. David and I discuss his career, and dive deep into commissioning, qualification, and validation. David outlines the activities in including discussing URS, DQ, FAT/SAT, IQ, OQ and PQ. David outlines the a risk based approach for streamlining commissioning and qualification activities, highlights some important things to watch out for and also gives some great book recommendations! 

David Simoens is a certified Project Management Professional with over 7 years of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radio-pharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. Currently, David is supporting NPI launches for a large pharmaceutical company and operating a 100 person consulting company across multiple clients.

Founded in 2001, cGMP Consulting Inc. has strived to help our clients adopt new technologies and ensure that changes to your processes are compliant with current Good Manufacturing Practices (cGMP). Our experienced engineering and quality assurance consultants have helped many industry leading companies identify and remediate gaps, support international pharmaceutical manufacturing, and implement cGMP requirements.

On this episode, we had Charles “Chuck” Ventura. Chuck is a the CEO of Hemotek Medical and President of Ventura Solutions. He has extensive product development, commercialization, and business management experience in the Medical Device industry. Chuck is a seasoned Medical Device leader with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support. He also has start up experience in business development and investment management. Chuck received his Bachelor’s degree in Bioengineering with a minor in Electrical Engineering from the University of Illinois at Chicago. He went on to earn his Master’s degree in Mechanical and Aerospace Engineering from the Illinois Institute of Technology. Chuck and I talk about: * His career entry and expectations vs. reality * Starting at the bottom and trusting the process * How working as a systems and risk engineer influences his style in leading his companies * Building business acumen * The clinical study process for medical devices * Staffing advice for college juniors and seniors to land their first job

On this episode, I had Marta New PhD MBA. Marta and I talk about how business school changed her perspective, depth vs. the value of information when it comes to decision making, mentors in her career and their influence on her development, her experience starting a new company, her time in venture capital and the due diligence process, lessons during the pandemic and some of the influences that inspire her. Happy Thanksgiving! Marta is the CEO of Radyus Research. Before starting Radyus, Marta was the co-founding Partner at Agent Capital, a life sciences-focused venture capital firm based in Cambridge, MA. While at Agent, Marta participated in multiple deals in oncology, immunology and rare disease areas including Orchard Therapeutics (NASDAQ:ORTX), Precision Biosciences (NASDAQ:DITL), Pliant Therapeutics and Verge Genomics, among others. Prior to Agent Capital, Marta was a Principal investor at Baxalta Ventures, the corporate venture capital arm of Baxalta in Cambridge MA, where she was  on the investment dilligence team and served as a board observer for Gadeta BV (acquired by Kite/Gilead, 2018), Syntimmune (acq. by Alexion, 2018), and Vitesse Biologics (early stage accelerator funded by Baxalta, Mayo Clinic and Velocity Pharmaceutical Development). Marta started her investment career at Baxter Ventures, the corporate venture capital arm of Baxter in Chicago, IL, transitioning from the Global Renal Marketing franchise, where she was the commercial lead for multiple new products for the Chinese and European markets. She joined Baxter from Northwestern University’s Innovation and New Ventures Office where she was responsible for licensing negotiations, commercial assessment of patents, and industry alliance management. She received her Ph.D. from the University of Illinois at Chicago in microbiology and immunology and completed her post-doctoral training at Northwestern University. She also received an MBA from Northwestern University Kellogg School of Management in Chicago, IL.

On this episode we had one of my most impactful engineering professors, Miiri Kotche PhD. 

In this episode we discuss:

• Starting as a Validation Engineer and making the decision to go back into academia 
• Teaching engineering students during the pandemic
• Answering the age old question: "Do you use your degree?"
• Moving to Finland and her experience as a Fullbright Scholar at VTT
• STEM Programs and giving back

Dr. Kotche is the Associate Dean for Undergraduate Affairs and a Clinical Professor of Biomedical Engineering at the UIC College of Engineering. Her focus is on providing real-world experiences in education for bioengineering and medical students, by bringing industry experience in product development into the classroom. Miiri leads two programs—the Clinical Immersion Program for engineering and medical students, and the Bioengineering Experience for (High School) Science Teachers (BEST). Miiri is the Director of the Medical Accelerator for Devices Laboratory (MAD Lab) at the UIC Innovation Center, where an interdisciplinary student team of graduate-level engineers, designers, business and medical students provides early concept and business development of medical devices for clinicians across the campus.

Miiri has been recognized as a U.S. Fulbright Scholar, UIC Master Teaching Scholar, UIC College of Medicine Rising Star, UIC Teaching Award recipient and College of Engineering Faculty Teaching Award recipient.

Dr. Kotche can be reached at [email protected]

-------------------------------

PS - apologies for my mic coming in and out a few times. I've found the issue and addressed.

On this episode of the Combinate Podcast we have the runner that needs no introduction, John Bingham. John is the best selling author of the books, “The Courage to Start”, “No Need for Speed” and “Marathoning for Mortals”. He is also the man behind the famous Runner’s World Magazine column “The Penguins Chronicles”. On this episode John and I discuss starting running in his 40’s, his favorite of his 45 marathons, his books, owning his own race, the lessons he learned finishing races last or not finishing at all, his career and many more. John can be found at Johnbingham.com For any feedback or recommendations of future guests feel free to reach me at [email protected]

On this episode we had Cameron Jones PhD, Co-Founder and CEO at Avasys. Cameron holds a PhD from University of Kentucky and did Post-Doctoral work at John’s Hopkins University. He has a passion for innovation and trying to find and address unmet clinical needs by working with the clinicians to craft fit for purpose solutions. In this episode we discuss the relationship between academia and innovation, how he pursued industry in graduate school, his upbringing, compassion and his zest for life. Cameron can be reached at http://www.avasysmedical.com/services/.

I’m truly happy I discovered Andy Robertson before I took my own CQE exam. His tools, lessons and strategies were crucial in passing the exam on my first try. His passion and love for quality engineering jumped out and after becoming more familiar with his content and style, I thought “I have to meet this guy”. On this episode we discuss study habits, mastery, learning styles, applying CQE principles, and caring as a pillar of leadership. Andy Robertson is a CQE’s CQE. Andy is a career engineer and learner who worked in the medical device industry in various roles in R&D, Operations and QA. He has spent the last decade teaching and mentoring his students to pass the CQE exam and recently moved to drive CQE Academy full time. Andy can be reached at cqeacademy.com and has a YouTube channel as well. Hope you enjoy and as always, if you’d like to help the show, feel free to share. #quality #qa #medicaldevice #leadership

In this episode I sit down with Mark Swanson. We discuss Mark’s background and early career, his entrance into QA, his participation on standard work groups for ISO13485 and ISO9001, the standards process and more. Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and a Principal Consultant of Quality and Regulatory Expert Partners (QRx Partners); a partnership consulting firm focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all quality roles. He is a senior member of ASQ, corporate AAMI member (serving on several AAMI committees) and a RAPS member. Mark has spent several years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) that published the revision of ISO 13485 in 2016 and was the project co-lead for the guidebook on ISO 13485. Mark is the chair of AAMI mirror committee for WG6 on post-market surveillance, member of the US mirror committee for JWG1 for ISO 14971/TR 24971 and has also participated with ISO TC176, on ISO 9000:2015 & ISO 9001:2015 as well as IWA31 on the application of risk management. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single management system.

Excited to drop episode 002- “Seeing David in the Stone: Predictive Quality Management” with Larry Mager from Mgmt-Ctrl. I hope you enjoy this episode! Apple Podcasts: https://tinyurl.com/7y9k5kj8 Spotify: https://tinyurl.com/3w5chwhf Larry and I discuss a lot in this episode, most notably what Predictive Quality Management is and how “Quality is Free”. Larry Mager is the author of the books “The Quality Journey” and “Management Control Quality plan”. 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] #qualityassurance #quality #leanmanufacturing #medicaldevice #riskmanagement

I wanted the first episode to be very special so I invited someone who was instrumental in my development as an engineer and a person. I’d like to introduce you to Episode 001 - “Learning Never Exhausts the Mind” with Rick Doe! https://www.linkedin.com/in/rick-doe-aa312330