Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

Let's Combinate - Drugs + Devices with Subhi Saadeh episodes

May 18, 2022 033 - "Specialization" with Erik Barkley
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
1 hr 11 min
May 11, 2022 032 - “Quality is Free”
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.
24 min
May 04, 2022 031 - "The Five Stages Of Regulatory Grief" with Michelle Lott
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.
1 hr 20 min
April 27, 2022030 - "Why Don't I Try?" with Marc Koska
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
1 hr 38 min
April 20, 2022029 - "Purpose" with Marla Phillips
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.
1 hr 35 min
April 13, 2022 028 - "How Much Does Poor Quality Cost?" with H. James Harrington
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
1 hr 11 min
April 06, 2022 027 - "Become a Historian of the Problem" with Duane Mancini
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.
1 hr
March 30, 2022 026 - "Quality" with H. James Harrington
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
51 min
March 23, 2022 025 - “The Frying Pan to the Fire” with Edwin Bills
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
1 hr 32 min
March 16, 2022024 - "Operating Under Constraints "with Naveen Agarwal
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.
1 hr 13 min