Combinate Podcast - Combining Drugs and Devices

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 & 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/

• 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 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: mat.stratton@coalition.ltd

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 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 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 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 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, 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 subhi@letscombinate.com

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 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 larry@mgmt-ctrl.com

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 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 larry@mgmt-ctrl.com

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 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 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 subhi@letscombinate.com

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.