Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

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

February 22, 2023 073 - Anatomy of a Hazard, Clifton Ericcson, ISO 14971/24971 Risk Management with Naveen Agarwal
On this episode, I was joined again by one of my favorite people in risk management, Naveen Agarwal of Creative Analytics Solutions and ExceedQM. Naveen discusses:
The Anatomy of a Hazard
Hazard Source(HS), Initiating Mechanisms (IM) and Target-Threat Outcome (TTO)
Clifton Ericcson
How concepts/tools like these fit into the ISO14971 and ISO TR 24971 framworks
Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.
20 min
February 15, 2023 072 - OXO PFS, Drug/Device Usability, Toothbrushes for Children, Epicurious Series and Baseball with Dan Formosa
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
54 min
February 08, 2023 071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols
On this episode, I was joined by Etienne Nichols, who is a Medical Device Guru and Host of the Global Medical Device Podcast. Etienne Discusses:
-Translating lessons from the Steel Industry into MedTech
-His experience on combination products
- What is the most important quality system element?
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market.
1 hr
February 01, 2023 070 - The First Auto-Injectors, ISO-11608 History, and Managing Product with Paul Jansen
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.
51 min
January 25, 2023 069 - EU MDR Extension with Michelle Lott
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.
18 min
January 18, 2023 068 - Benefit/Risk Ratios, PRRC, and Mythical Medical with David Rutledge
On this episode I was joined by David Rutledge, author of Mythical Medical and CEO of Global Strategic Solutions. David Discusses:
· His book Mythical Medical
· Benefit (As part of Benefit/Risk)
· PRRC Role and EU MDR
David R Rutledge, Pharm.D., FCCP, FAHA is a results-oriented consultant for clinical evaluation and investigation, clinical risk management, regulatory, and quality. He brings 25 years’ global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies, e.g., BSI, DEKRA, Medcert, and TÜV SÜD. He previously accepted a 4-year appointment from the United States Department of Health & Human Services to serve as the Industry Representative on the FDA’s General Hospital and Personal Use Devices Advisory Committee in FDA’s Center for Devices and Radiological Health (CDRH). He is certified as a Lead Auditor for Quality Management Systems ISO13485 and holds certificates for Design Control, Risk Management, Six Sigma and CAPA. He qualified as an EU Person Responsible for Regulatory Compliance (PRRC)
48 min
January 11, 2023 067 - mRNA, Flu Vaccines, Good Presentations, and Non-Linear Career Paths with Jane M. True
On this episode I was joined by Jane M. True, VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead at Pfizer.
• Following career tracks, "experience", and non-linear career progression
• Practical tips for presenting and nerves
• Storyboarding and the Minto Principle
• How Flu Vaccines are developed globally
• mRNA and what it may mean for product development and org structures
Jane is an expert in mRNA and vaccine product commercialization and has held executive and leadership roles at Pfizer, Sequiris, PWC, and Capegemini.

48 min
January 04, 2023066 -Scientist to CSO, Learning QA/RA & Marketing, and Saying Yes to Oppurtunities with Fran DeGrazio
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions.
Fran and I discuss:
Her career at West Pharmaceuticals starting in the lab and retiring as Chief Scientific Officer

Becoming experienced in Marketing, QA and RA

What the C-Suit expects from individual contributors

How to recognize opportunities and when to say yes
Fran DeGrazio. President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals.
She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products. Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas.
DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018
56 min
December 28, 2022065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh
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!
30 min
December 21, 2022 064 - Pharma and Medical Device Development Processes, DFSS and Design Reviews with Skip Creveling
On this episode, I was joined again by Skip Creveling. During the last episode, Skip walked through Design for Six Sigma(DFSS), and finding/measuring what's important(critical parameters and tolerancing).
In this episode, he discusses:
Design and Development processes in Pharma and MedTech
How DFSS can be integrated into lifecycle management
Design Review strategies
Clyde "Skip" Creveling is the President & Founder of PDSS Inc. Skip has led the DFSS initiatives at Merck, Motorola, Carrier Corporation, StorageTek, Cummins Engine, Becton-Dickinson, Mine Safety Appliances, Callaway Golf, 3M, Samsung SDI, Sequa Corp. and Universal Instruments. Prior to founding PDSS, Skip worked at Eastman Kodak for 17 years as a product development engineer within the Office Imaging Division and spent more than 10 years as a systems engineer for Heidelberg Digital as a member of the System Engineering Group. Skip also served an Assistant Professor at Rochester Institute of Technology, developing and teaching undergraduate and graduate courses in mechanical engineering design, product and production system development, concept design, robust design, and tolerance design. Skip is also a certified expert in Taguchi Methods.
55 min