On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses:

00:00 Introduction

02:29 Understanding the FDA's New Guidance:

05:05 Challenges in Supplier Management and the

08:22 Navigating Change Management

11:43 Insights on Regulatory Compliance

25:26 The Importance of Dimensional Tolerances

32:56 Closing Thoughts

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

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

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

On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses: 00:00 Welcome to Episode 150! 03:00 Challenges and Innovations in Ocular Drug Delivery 09:30 Understanding Intravitreal Injections 13:26 Regulatory Considerations for Ocular Products 20:48 Innovations in Glaucoma Treatment 29:18 The Personal Impact of Vision Loss 35:40 Book Recommendations and Final Thoughts

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

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

On this episode, Larry and I discuss: 

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

- Predictive Quality Management across both medical device and pharma 

- Management Review and Compliance/Effectiveness/Efficiency 

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

- His Books and what’s to come 

Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at larry@mgmt-ctrl.com

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

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

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

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

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

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

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

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

- Human Factors vs. Usability Engineering vs. Design Validation

- Risk Management and User Risk

- Summative HF Evaluation and Sampling

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

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

- Materials for Biomedical Applications

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

- Commercialization Considerations

- 4 Major Factors for the appropriate selection of materials

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

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

- Free Speech and Promotional Compliance

- Misbranding

- Regulatory vs. Legal Compliance

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

- Sunshine Act

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

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

- The Inflation Reduction Act 

- Out of Pocket Costs 

- Part B and Part D Drugs 

- Price Negotiation vs. Price Control 

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

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

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

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

On this episode, 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/

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

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

Who Was Walter Shewhart? Link

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

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: - Behavioral Neuroscience and the soft skills of Quality - Quality, Compliance and Risk Management - Pharmacogenomics and Orwell - Combination Products Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.

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

-Pharmaceutical Innovation in the last several decades

-Patient-Centricity in Pharma

-Innovation vs. Implementing Existing Technologies

-Genius Being a Birthright & Mediocrity Being Self imposed

-Telemedicine & Digital Health

-Decentralized Clinical Trials

- Artificial Intelligence, Wonder and Fear

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

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

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

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

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

Links: 

Book: Comprehensive Guide to Clinical Research

Podcast: Link

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

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

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

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

Yousef's Articles: 

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

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

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

- Safety function (Drug vs. Device)

- 21 CFR Part 4 Subpart B 

- Specific Post-Market Safety Reporting Expectations

- Industry Challenges with implementing PMSR Requirements

- Working in Quality with a background in Safety

- Self Marketing, Toastmasters and Professional Development

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

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

- How he got into recruiting

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

- Interview Matrix - interview strategies for objective unbiased candidate selection

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

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

- When a recruiter should be engaged?

- His Podcast The MedTech Talent Lab 

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

Mitch Robbins is the founder and Managing Director of The Anthony Michael Group. Mitch has an extensive background in the recruitment and staffing industry.  Prior to founding The Anthony Michael Group, Mitch worked for two of the most prestigious, nationally recognized search firms Spherion and Management Recruiters International (MRI). Mitch achieved a ranking as high as #12 out of over 3,500 recruiters within MRI. He was the recipient of multiple achievement awards for excellence in recruiting. These included the Southwest Region Rookie of the Year, and MRI’s Pacesetter distinction. Mitch has been the choice of the experts to deliver training to both rookie and seasoned recruiters across multiple disciplines on numerous occasions. The Anthony Michael Group, or AMG, is a boutique executive search firm. Headquartered in a suburb of Denver, CO we assist Food, Beverage, Pharmaceutical, Biotech, Medical Device, and Diagnostics organizations across the United States to hire the top 15% of Regulatory & Quality leadership talent at the CXO, VP, Director, and Manager levels. When you work with The Anthony Michael Group, you can count on our team’s tenacity, authenticity, and accountability while we deliver results for you.

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

Links

AMG About - Link

AMG Blog - Link

MedTech Talent Lab - Recorded Shows Link 

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

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

- How Erik and I met a few years ago

- How he works with coffee farms around the globe

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

- The roasting process

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

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

- Coffee Roasters and Coffee Books he recommends

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

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

www.tugboatcoffee.com

This is a solo episode. On this episode, Subhi goes through:

01:51 Draft FDA Guidance - Platform Technology Designation Program for Drug Development Guidance for Industry

13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)

18:25 USP - <1157> USP-Listed Device Monographs and Recommendations for Product Quality and Performance Testing of the Drug Component of Combination Products

20:10 Race Recap: Sugar Badger 50K

26:51 Conclusion

Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. Subhi is an Ironman Triathlete and a Marathoner/Ultramarathoner.

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

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

Amazon Link to the Book: Link

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

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

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

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

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

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

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

- Being Outspoken and Honest 

- What she's observed between large and small organizations

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

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

- The 5 stages of regulatory grief 

- QMSR Harmonization

- Audit Preparation

(See Michelle's Blog @ LeanRAQA.com)

(See Michelle's Podcast @ Spotify Link)

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

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

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

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

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

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

Marc Koska: Link

Apiject: Link

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

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

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

Pathway for Patient Health: Link 

Pathway for Patient Health Quality Science Program : Link 

Pathway for Patient Health Hiring Portal: Link 

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

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

Future of Xavier Health: Link

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

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

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

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

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

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

Dr. H. James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and president of ASQ and has multiple quality awards named after him. He's currently the CEO of Harrington Management systems, an International consulting firm focused on performance improvement, strategic planning, and organizational alignment for both private and public organization. 

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

Link to Episode 1 with H. James Harrington: Link 

ASQ - H. James Harrington: Link 

H. James Harrington: Link 

Books Written by H. James Harrington: Link

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

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

His first experience in Quality at 6 years old 

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

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

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

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

Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and president of ASQ and has multiple quality awards named after him. He's currently the CEO of Harrington Management systems, an International consulting firm focused on performance improvement, strategic planning, and organizational alignment for both private and public organization.

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

ASQ - H. James Harrington: Link 

H. James Harrington: Link 

Books Written by H. James Harrington: Link

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

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

Naveen and I discuss: 

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

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

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

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

00:31 Larry's Perspective on Quality

03:21 Importance of KPIs in Management Review

04:13 Management Review and Control

09:09 Operational Framework and Business Structure

18:46 Effective Business Processes

24:42 Understanding Role Expectations and Aggregating Work

25:51 Management Review: Strategy and Tactical Levels

28:47 Operational and Systemic Levels of Management

30:15 Balancing Capability and Capacity

31:37 Improvement and Execution in Business Operations

37:25 The Role of CAPA in Quality Management

44:54 Building a Culture of Quality and Continual Improvement

46:36 Conclusion and Resources for Further Learning

Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at larry@mgmt-ctrl.com

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

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

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

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

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

Karandeep can be found at: Linkedin Profile 

The MedTech Podcast: Podcast Link

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

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

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

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

Links:

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

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

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

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

https://www.niazi.com/expertise

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

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

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

In this final segment of the episode with Larry, we discuss the Final P: People. In this episode we discuss skillsets, training and competency, communication for teamwork, establishing a culture of trust and accountability and all of this culminating into the creation of a strong Culture of Quality. Larry ends the episode by giving an example of how he's seen people and the soft science surrounding quality culture applied very well. Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at larry@mgmt-ctrl.com

In Part 2 of this episode, Larry and I discuss the Second P: Process. I start the episode by asking Larry to explain the difference between a Quality System and a Quality Management System(QMS) to set the foundation. Larry then moves on to explain have a control environment should be well established(policies, standards, procedures, governance, etc), Risk Management for processes and poking holes in your organization's ways of working, control activities, flow of information, monitoring, management review and continuous improvement. Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at larry@mgmt-ctrl.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.

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

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

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

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

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