Let's Combinate - Drugs + Devices (Subhi Saadeh)

In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development and combination products. Marta, with her unique background as a venture capitalist turned CRO founder, shares her insights on how TPPs serve as strategic documents that align clinical goals, regulatory requirements, and market strategies. The discussion delves into the key sections of a TPP, such as target indication, efficacy benchmarks, safety and toxicology, and regulatory strategy. Marta emphasizes the critical role of TPPs in preclinical stages and their impact on the overall success of drug development programs. The episode also explores the integration and collaboration required across various functions like R&D, quality, regulatory, and commercial teams to create and refine a robust TPP.

00:00 Introduction and Welcome

00:26 Meet Marta: CEO of Radius Research

00:58 Understanding Target Product Profiles (TPPs)

01:44 The Importance of TPPs in Drug Development

01:59 Defining a TPP

03:22 TPP as a Strategic Document

05:28 TPP in Preclinical and Clinical Stages

07:09 Challenges and Misconceptions in TPP Development

14:27 Regulatory Considerations for TPPs

14:53 Sections of a TPP

39:07 Understanding Toxicology Evaluations

39:34 FDA Requirements for Pre-IND Talks

39:51 TPP and Toxicity Thresholds

41:41 Go/No-Go Criteria in TPP

42:50 PKPD and Drug Distribution

45:40 Drug Formulation and Quality Attributes

46:36 Regulatory Strategy and 505(b)(2) Pathway

52:34 Differentiation and Risk Assessment

01:03:42 Transition from Discovery to Development

01:07:48 Combination Products and Delivery Systems

01:09:35 Conclusion and Contact Information

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. She can be reached at mnew@radyusresearch.com

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 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, 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 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

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.

In this episode, Subhi delves into 'Quality is Free' by Philip Crosby, a seminal book in quality management. Highlighting its personal significance, the host discusses the core concept that quality, when properly managed, incurs no extra cost, aligning with prevention rather than fixing issues.

The episode dissects five erroneous beliefs about quality, including the idea that quality equates to luxury, that it is intangible and immeasurable, and that quality issues stem from workers or are confined to the quality department. Emphasizing a holistic and preventative approach, the discussion reflects on different quality philosophies and the importance of leadership alignment. The episode concludes by encouraging listeners to read the book themselves for a deeper understanding of quality management principles. 00:00 Introduction to 'Quality is Free' 00:24 The Impact of 'Quality is Free' 01:30 Key Concepts: What We Think We Know is All Wrong 02:23 5 Erroneous Beliefs About Quality 06:26 Measuring Quality: Cost and Prevention 09:09 Quality "Responsibility" in Different Departments 15:02 Aligning Leadership and Quality Management 17:05 Conclusion Subhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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 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 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, 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 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.

In this episode of Let's Combinate, host Subhi Saadeh delves into the significance of ICH Q12 for the pharmaceutical industry, especially concerning established conditions and drug-device combination products. Subhi explains how Q12 enhances lifecycle management, streamlines post-approval changes, and improves regulatory alignment. He breaks down critical concepts such as established conditions, product lifecycle management (PLCM), and post-approval change management protocols (PACMPs). Subhi outlines the benefits and challenges of adopting ICH Q12 and encourages listeners to familiarize themselves with its guidelines. 00:00 Introduction and Welcome 00:31 Topic Overview: ICH Q12 and Established Conditions 01:01 Understanding ICH Q12: Life Cycle Management 02:26 Importance of Post Approval Changes 04:11 Key Concepts of ICH Q12 06:14 Practical Example of ICH Q12 Application 07:45 Benefits and Challenges of ICH Q12 10:32 Final Thoughts and Encouragement 11:26 Closing Remarks and Contact Information

In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, quality, and product development settings. Subhi, who has worked on vaccines, biologics, and small molecules in prefilled syringe systems He explores what makes a prefilled syringe a combination product and explains the varying regulatory requirements across different regions, including the US, EU, China, and Japan. The episode emphasizes the importance of understanding these differences to ensure success in product development and market approval. Saadeh also invites viewers to engage and provide feedback in the comments section.00:00 Introduction to Prefilled Syringes01:54 Understanding Combination Products02:32 Regulatory Frameworks for Prefilled Syringes04:59 Global Regulatory Perspectives06:10 Key Takeaways and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Pre-filled Syringes: Are They Really Combination Products?

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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 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 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 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.

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, 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 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 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 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 

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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.

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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

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️

Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/

Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.

In this episode of Let's Combinate, host Subhi Sadeh welcomes regulatory expert Doug Mead. Doug, who brings extensive experience in regulatory affairs for medical devices and combination products, discusses the significant role of the 'Drugs at FDA' database in navigating submission strategies. They explore how AI is being used to search through this database efficiently and reveal both the benefits and limitations of AI in regulatory processes. Doug also shares insights into the evolution of FDA’s review processes, the importance of validation, and the practical application of AI in regulatory work.00:00 Welcome and Introduction00:07 Meet Doug Mead: Regulatory Expert00:58 Understanding the Drugs at FDA Database01:25 Navigating Review Memos and Regulatory Strategies04:18 Challenges and Limitations of the FDA Database07:23 Advanced Search Techniques and AI Integration10:58 Developing a Specialized AI Search Tool14:57 Practical Applications and Client Benefits33:22 Conclusion and Contact InformationDouglass(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.comSubhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.Artificial intelligence in Pharma, AI Pharma, AI Medical Devices, Medical Device AI

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/.

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 

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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

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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.

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/

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️

Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/

Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.

In this episode of Let's Combinate, host Subhi Saadeh interviews Shelley Amster, a trailblazer in reproductive health with over 45 years of experience.

Shelley shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3Daughters. They discuss the early days of IVF, overcoming career-related insecurities, and the challenges and advancements in fertility treatments. Shelley also talks about her experience in managing technical conferences and offers advice for early-career professionals. The conversation covers innovative technologies in women's health, particularly in IUD development and surgical advancements.00:00 Welcome to Let's Combinate00:13 Pioneering in Reproductive Health00:42 Early Challenges and Opportunities02:10 Breaking Barriers in IVF04:52 Career Reflections and Lessons06:40 Conference Planning Insights13:37 Overcoming Shyness and Networking19:11 Retirement and Career Advice26:21 Innovations in Women's Health30:26 Future Technologies and Closing ThoughtsShelley Amster is a trailblazer in reproductive medicine with over 45 years of experience, including being one of the first IVF lab directors in the United States. Currently an advisor at Three Daughters, she has dedicated her career to advancing fertility treatments, IUD development, and surgical innovations in women’s health. Shelley is also a seasoned conference organizer and mentor, sharing invaluable insights with early-career professionals in the field.Subhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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.

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, 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.

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 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 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 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, 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 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, 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.

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 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, 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 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 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 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 combinatepodcast@gmail.com

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, 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 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 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 David@lifescienceprofessionals.com

**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 contact@lifescienceprofessionals.com. For information requests, email them at info@lifescienceprofessionals.com. Feel free to connect and message him on LinkedIn.

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.

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, 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 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 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 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.

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 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 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.

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 larry@mgmt-ctrl.com

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.

In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable drug products. He explains the importance of these standards in preventing health risks such as embolisms and allergic reactions. The episode outlines the methods used for testing, including light obscuration and microscopic particle count tests, as well as the required visual inspections for visible particles. Subhi also discusses the differences in scope between USP and ISO standards and emphasizes the critical role of operator training and clean handling practices in ensuring product safety. 00:00 Introduction to Today's Topic: Particles 00:48 Understanding USP and Its Role 02:52 Diving into USP 788: Sub-Visible Particles 05:40 Testing Methods for Sub-Visible Particles 07:00 Acceptance Criteria for Sub-Visible Particles 08:53 Exploring USP 790: Visible Particles 11:12 Inspection Techniques and Practical Considerations 12:50 Conclusion and Wrap-Up Subhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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.

Discover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potential impact of this innovative technology on drug administration and patient care.In this episode of 'Let's Combinate Drugs and Devices,' host Subhi Saadeh is joined by Eric Suglalski, Founder and CTO of Archimedic, to discuss the often-overlooked role of ampules in drug delivery. Eric highlights the stability and contamination resistance benefits of ampules, despite the industry's shift towards vials and pre-filled syringes. He elaborates on the time and cost factors that make transitioning to pre-filled syringes challenging for pharmaceutical companies. The discussion also covers Eric's work on the Ampule Filled Syringe (AFS) system, which aims to combine the usability of pre-filled syringes with the stability of ampules. They delve into the historical context of ampules, global usage patterns, and the hurdles faced in implementing ampule-based technologies. Eric invites interested pharma companies to explore potential collaborations with Ampulous.00:00 Introduction and Guest Welcome00:17 The Overlooked Potential of Ampoules02:11 Challenges with Vials and Prefilled Syringes05:01 The Cost and Time Barrier to Prefilled Syringes08:29 Introducing Ampulous: A New Solution10:36 Technical Details of Ampule Filled Syringes14:39 Historical Context and Global Use of Ampoules16:38 Addressing Concerns and Resistance18:01 Human Factors and Usability19:44 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application. Subhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action).

They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems.

The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.

00:00 Introduction and Guest Introduction

00:33 Understanding CAPA in Pharma and MedTech

01:08 Regulatory Differences and Their Implications

03:12 Event Handling and Investigation Processes

08:13 CAPA System Effectiveness

13:57 Quality System Approaches in Pharma and MedTech

26:22 Root Cause Analysis and Continuous Improvement

30:43 Conclusion and Contact Information

Aaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.

Subhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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.

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Who Was Walter Shewhart? Link

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 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 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 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.

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"

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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.

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ASQ - H. James Harrington: Link 

H. James Harrington: Link 

Books Written by H. James Harrington: Link

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.

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 larry@mgmt-ctrl.com #qualityassurance #quality #leanmanufacturing #medicaldevice #riskmanagement

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, 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 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 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 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
jfries@rx-360.org

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.

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️

Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/

Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.

In this episode of Let's Combinate, host Subhi Saadeh interviews Bill Facteau, President and CEO of Earlens Corporation, who has over three decades of experience in the medical device industry, focusing on hearing innovations. Bill discusses his journey in the ear, nose, and throat field, including his motivation to improve hearing aid technology due to personal experiences and unmet needs in the market. The conversation covers the limitations of traditional air conduction hearing aids, the unique advantages of Earlens' technology, and the broader industry challenges such as lack of education and reimbursement issues. Bill also highlights the critical importance of treating hearing loss to prevent cognitive decline and other health issues.

The episode concludes with leadership advice and a discussion on books that have influenced Bill's career.

00:00 Introduction and Guest Welcome

00:42 Bill Facto's Career Journey

03:01 Challenges in Hearing Aid Technology

08:15 Preventing Hearing Loss

12:05 Ear Lens Innovation

33:03 Hearing Loss and Cognitive Health

35:01 Leadership and Personal Insights

39:36 Conclusion and Contact Information

Bill Facteau is the President and CEO of Earlens Corp, which is focused on transforming the hearing aid industry with its novel and proprietary light-based technology. Prior to joining Earlens, Mr. Facteau served as President and CEO of Acclarent, the company that created Balloon Sinuplasty, which was ultimately acquired by JNJ for $800M. Mr. Facteau has served as a Board Director on a number of successfully acquired ventures including Acclarent, Neotract, CVI, Cabachon and ExploraMed.

Subhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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 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 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 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 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, 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 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 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.

In this episode of Let's Combinate Drugs and Devices, host Subhi Siddhey welcomes Eric Sugalski, founder and CTO of Archimedic. Eric shares insights into the complexities of working as a CDMO, emphasizing the importance of recognizing whether a sponsor company needs overflow capacity or specialized expertise. They discuss common pitfalls, such as companies getting in their own way by misaligning their needs with their outsourcing strategy and the detrimental effects of premature concept lock. Eric highlights the value of giving design firms creative space, the importance of early user research, and the impact of timing and market readiness on project success. He also elaborates on the benefits of open-source quality management systems and hands-on market research to bridge the gap between engineers and users. Together, they explore how to set up projects for success through balanced, well-researched approaches.00:00 Introduction and Guest Welcome00:13 Challenges in Outsourcing for Pharma and Med Device Companies01:04 Importance of Expertise in Outsourcing03:27 Effective Collaboration with CDMOs04:41 Concept Development and Design Requirements05:38 Balancing Innovation and Practicality07:48 Commercialization and Product Development09:57 Understanding User Needs in Design20:47 Advice for Aspiring Engineers25:15 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application.Subhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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

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 

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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. 

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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, 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, 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.

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 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 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, 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 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

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com

🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.

This episode dives into the world of GXPs, the essential guidelines for ensuring quality and safety in pharmaceutical and medical device industries. The host explains various GXPs, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GVP), and Good Automated Manufacturing Practices (GAMP).

Each GXP covers different stages from preclinical research to post-market safety, ensuring that products are produced safely, effectively, and consistently. The episode emphasizes the importance of understanding these regulations to guarantee the delivery of high-quality products to patients.

00:00 Introduction to GXPs

02:06 Understanding Good Manufacturing Practices (GMP)

03:27 Exploring Good Laboratory Practices (GLP)

04:35 The Importance of Good Clinical Practices (GCP)

05:44 Ensuring Safety with Good Distribution Practices (GDP)

06:55 Monitoring with Good Pharmacovigilance Practices (GVP)

07:48 Good Automated Manufacturing Practices (GAMP)

08:45 How GXPs Work Together

10:45 Conclusion and Final Thoughts

Subhi Saadeh is a Quality Professional and host of Let's Combinate. 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 questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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 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, 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 sneadle@combinationprod.com.