Hello Combi-Nation!
Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on.
My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers.
Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!
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259 - The Career Lesson I Learned the Hard Way in Pharma
Monday, October 19, 2026 • Duration 05:54
Career growth in pharma and medical devices takes technical knowledge, leadership, and the ability to earn your team’s trust. In this episode, Subhi Saadeh shares a lesson from leading a drug-device combination product program that changed how he approached his career in quality.
Early in my career, I was excited about getting on big projects, gaining exposure, and proving what I could do. But leading a team with deeper technical expertise than I had taught me something I had to learn the hard way: it’s not about you.
I share how asking questions, following through, and helping people address their problems helped me earn their respect and become a more effective lead.
In this episode:
- Understanding what your team and stakeholders need from you
- Leading technical experts while building your own experience
- Being coachable and following through on what you learn
- Applying customer focus beyond the quality system
- Building credibility by helping others move their work forward
- What a mentor meant by “their cookie, your crumb”
Chapters:
00:00 The career lesson: It’s not about you
00:25 Career exposure and proving yourself
00:53 Why people value having you around
01:17 Customer focus in quality and leadership
02:03 Leading a complex combination product program
03:25 Feeling out of your depth
03:42 Understanding what your team needs
04:02 Being coachable and earning credibility
05:07 Rethinking career growth and success
06:10 “Their cookie, your crumb”
About Subhi:
Subhi Saadeh is a Quality Professional, Founder & Principal of Combinate, and host of Let’s Combinate: Drugs + Devices. With a background in Quality, Manufacturing Operations, and R&D, he has works with medical device and pharmaceutical organizations supporting the development and launch of combination products for vaccines, generics, and biologics.
Subhi served as the International Committee Chair for the Combination Products Coalition (CPC) and was a member of ASTM Committee E55. He previously served on AAMI’s Combination Products Committee. He is an ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), and ISO 13485 Lead Auditor.
Subscribe for weekly conversations where drugs and devices meet.
For questions, inquiries, or suggestions, please reach out at letscombinate.com or email subhi@letscombinate.com.
258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin
Monday, October 12, 2026 • Duration 34:15
Combination product quality with Ben Locwin: why drug and device quality systems differ, how human factors studies are designed, what to do when a CDMO's clean audit doesn't match its performance, and how ISO 14971 risk management compares with ICH Q9.
This conversation was recorded for Ben Locwin's Life Science Shifts podcast from Reliant Life Sciences, with Subhi Saadeh as the guest. It covers where pharma and medical device thinking diverge, and what that means when one product has to satisfy both.
IN THIS EPISODE
- Why drugs and devices prove safety and effectiveness in different ways
- Drug development (clinical, nonclinical, CMC) vs. device design controls
- Why the same syringe can need new human factors work for a different user
- How human factors studies are built: patient and caregiver arms, trained and untrained users
- CGMPs for combination products: QMSR, ISO 13485, ICH, and PIC/S
- Global harmonization: IMDRF for devices, ICH for drugs, and the gap for combination products
- CDMO oversight when the supplier scorecard and the audit result don't match what you see
- ISO 14971 and ISO/TR 24971 vs. ICH Q9: initial and updated probability
- FMEA as a living document
TIMESTAMPS
0:00 Pharma vs. medical device quality: two philosophies
2:10 Drug development vs. device design controls
4:29 Why device trials rarely use placebo controls
9:52 Platform technology and delivery devices
12:10 Same device, different user: bracketing and generic platforms
14:14 Human factors studies: recruitment, study arms, formative studies
257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products
Monday, October 5, 2026 • Duration 12:57
21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 Subpart A section by section: the scope, the key definitions, which CGMPs apply, and the two ways to comply, including the streamlined approach under 4.4(b).
Updated for February 2026, when the device side moved to the QMSR and ISO 13485, plus the new medical gas provisions.
Working on your first combination product program? Watch this next: https://youtu.be/uG_Ea__-Pjc
Want a second set of eyes on your combination product quality system? Book a quick call: https://calendly.com/letscombinate/quick-chat
Sources
21 CFR Part 4 (eCFR): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4
FDA Guidance, CGMP Requirements for Combination Products: https://www.fda.gov/media/90425/download
Chapters
0:00 Intro
0:50 21 CFR Part 4 Subpart A vs. Subpart B
2:00 Full compliance vs. the streamlined approach
2:39 21 CFR 4.1: Scope (single-entity and co-packaged)
3:52 21 CFR 4.2 and 4.3: Definitions and which CGMPs apply
4:37 21 CFR 4.4: How to comply with CGMPs for combination products
5:38 Drug-based system: ISO 13485 and QMSR provisions to add
7:58 Device-based system: 21 CFR 211 provisions to add
11:24 Medical gas and 4.4(c)–(e): separate facilities
256 - The New FDA Inspection Playbook: Where to Start with QMSR
Monday, September 28, 2026 • Duration 09:29
QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382.850.
What does that mean for industry and how should we use the new program to prepare?
In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh introduces a four-part series on QMSR inspection readiness. We compare QSIT’s four major inspection subsystems with the new program’s six QMS areas, explore how risk informs inspection coverage, and identify where industry should start reading.
The episode also features an excerpt from Subhi’s conversation with Eric Pittman, a former FDA investigator who spent a decade as editor-in-chief of FDA’s Investigations Operations Manual.
IN THIS EPISODE
• What replaced QSIT and where to find it
• Why Part III is a useful starting point for industry
• How FDA reorganized inspection coverage into six QMS areas
• How product risks and risk management documentation help guide record selection
• What’s coming in the QMSR inspection readiness series
TIMESTAMPS
00:00 QSIT is gone: What changed with QMSR
00:50 The new FDA inspection program
01:39 The four-part inspection readiness series
02:47 Eric Pittman: Where industry should start
04:14 Will FDA publish a new QSIT guide?
05:06 Comparing the old and new inspection approaches
255 - Audit Interview Techniques: How Good Auditors Get Better Evidence
Monday, September 21, 2026 • Duration 11:30
A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In this episode, I pulled one of the lessons from the auditing course Andy Robertson and I developed and walk through some of the fundamentals of audit interviewing: building rapport, asking open-ended questions, avoiding overly checklist-driven interviews, corroborating information, managing group interviews and translators, and handling some of the situations that make interviews difficult.If documents and records alone were enough to understand the quality of an organization, every audit could be a desktop audit. People are a huge part of what makes an audit work.Full CQA Master Class:https://cqeacademy.teachable.com/p/the-cqa-master-class-courseChapters0:00 Intro1:39 Interviewing Fundamentals3:04 Conversational vs. Checklist3:49 Building Rapport4:29 Focus on the Process5:30 Open-Ended Questions5:58 Corroborating Information6:44 Group Interviews7:29 Using Translators8:20 Interview Challenges10:29 Time Management11:16 ClosingAbout SubhiSubhi Saadeh is the Founder and Principal of Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across pharma, biotech, medical devices, and combination products.Learn more about Let’s Combinate:https://letscombinate.com/Connect with Subhi on LinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21Need help?https://calendly.com/letscombinate/let-s-combinate-intro-session#Quality #Auditing #QualityAssurance #CQA #Pharma #MedicalDevices #CombinationProducts
254 - Saying No Is the Easy Part of Quality
Sunday, September 13, 2026 • Duration 12:25
Quality has a reputation for saying no.
Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer.
In this episode, Subhi breaks down four situations where Quality should absolutely stop the train, and a few where it’s worth stepping back and asking what’s really driving the no in the first place.
Subhi covers:
when there is real patient or product risk
when the evidence doesn’t support the decision
when moving forward would clearly violate requirements or SOPs
when schedule or business pressure is pushing a team to close something that isn’t actually closed
He also talks through some weaker reasons Quality says no, including:
personal preference or “this is how we’ve always done it”
uncertainty from lack of technical familiarity
applying more GMP rigor than the stage of development actually requires
If you work in quality, combination products, development, manufacturing, or technical leadership, this is a practical look at how to think about “no” in a more risk-based way.
Timestamps
00:00 Why Quality Says No
00:45 Channel Intro and Setup
02:02 No When Risk Is Real
03:06 No When Evidence Fails
253 - FDA Is Making Big Changes to Its Inspection Approach
Monday, September 7, 2026 • Duration 45:53
FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model.
Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ inspections, led the Bioresearch Monitoring Division West, and served for a decade as editor-in-chief of FDA’s Investigations Operations Manual.
In this episode, Eric explains how FDA investigators are trained to think, the difference between technical expertise and inspection skill, why investigators sometimes “phone home,” and what the transition from ORA to OII means for the agency’s inspection model.
We also discuss BIMO inspections, the difference between inspections and investigations, the end of QSIT, and how companies can use FDA’s Investigations Operations Manual and compliance programs to prepare more effectively.
Timestamps
00:00 Introduction 00:48 FDA’s generalist and specialist inspection models 03:52 What is Bioresearch Monitoring (BIMO)? 05:03 What makes someone an effective FDA investigator? 08:39 Technical expertise versus auditing and inspection skills 11:25 What FDA investigators are actually looking for 14:07 Eric’s experience conducting 800–1,000 inspections 15:11 How investigators prepare, inspect, and write reports 19:44 Why FDA investigators sometimes “phone home” 23:35 The transition from ORA to OII 28:00 What responsibilities remain within OII? 30:31 FDA inspections versus investigations 33:05 The IOM, QSIT, and investigator discretion 38:25 How industry should use FDA compliance programs 44:13 What companies waste time preparing for 45:55 Where to find Eric
About Eric Pittman
Eric Pittman is Vice President of Quality Assurance and Regulatory Affairs at Project Farma. Before moving into industry, he spent more than 20 years at FDA across drugs, devices, foods, biologics, and bioresearch monitoring.
He served as Division Director for Bioresearch Monitoring West, was the U.S. delegate to the OECD Working Party on Good Laboratory Practice, and spent a decade as editor-in-chief of FDA’s Investigations Operations Manual. Eric is also an adjunct professor in Temple University’s QA/RA graduate program.
252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)
Monday, August 31, 2026 • Duration 13:06
Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality.
In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually means, the difference between sampling by attributes and variables, and the risk involved when we use a sample to make an accept/reject decision about an entire lot.
We’ll also introduce Operating Characteristic (OC) curves, producer risk, and consumer risk — because acceptance sampling is probability-based and every sampling plan comes with tradeoffs.
This is the first video in a series on acceptance sampling. Future videos will go deeper into attribute sampling, variable sampling, and how to select and apply sampling plans in practice.
Topics Covered:
* What acceptance sampling is
* Why acceptance sampling is probability-based
* AQL — Acceptance Quality Limit
* Why AQL does not simply mean “allowable percent defective”
* Attribute vs. variable acceptance sampling
* ISO 2859-1 / ANSI-ASQ Z1.4
* ISO 3951 / ANSI-ASQ Z1.9
* Operating Characteristic (OC) curves
* Producer risk vs. consumer risk
* How overly tight or overly loose sampling plans can create problems
Chapters
00:00 Introduction
01:30 Why Acceptance Sampling Matters
251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy
Monday, August 24, 2026 • Duration 49:29
In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug delivery device market is headed and what it takes for new technologies to actually make it to patients.
Steven brings more than 21 years of experience across drug delivery and combination products, spanning strategy, business development, commercialization, consulting, and executive leadership.
The conversation explores what makes a drug delivery device commercially successful in 2026, why pharma companies can be hesitant to adopt unproven technologies, and how device companies can differentiate in an increasingly crowded market. Steven also discusses the growth of larger-volume subcutaneous delivery, the tradeoffs between reusable and disposable devices, sustainability, primary container strategy, and the changing role of sales and business development in drug delivery.
Subhi and Steven also dig into oral GLP-1s and whether oral drugs could ultimately displace injectables. Steven explains why route of administration alone does not determine the better solution — efficacy, patient adherence, cost, usability, and the overall treatment experience all matter.
The episode closes with Steven looking ahead to 2035 and explaining why he believes sustainability will be one of the major forces shaping the next generation of drug delivery devices.
Timestamps
00:00 Introduction and Steven’s Drug Delivery “Bookshelf”
02:24 From Marketing to Drug Delivery Strategy
06:10 What Makes a Device Commercially Successful in 2026?
11:11 Is the Large-Volume Injection Market Getting Crowded?
I'm Changing The Podcast
Tuesday, August 18, 2026 • Duration 02:47
After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change.
Starting now, new episodes will go live Mondays at 5:00 AM CT.
To everyone who watches, listens, shares, or has been part of the journey: thank you. This podcast has been one of the most enriching things I’ve ever done.
Subhi Saadeh is a combination product quality and compliance professional, consultant, auditor, trainer, and host of Let’s Combinate: Drugs + Devices, where he explores the intersection of pharmaceutical and medical device quality.
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15:40 CGMPs for combination products: QMSR, ISO 13485, ICH, PIC/S
16:58 Harmonization: IMDRF and ICH
19:12 Conway's Law and organizational inertia
22:06 Staying objective as a consultant
25:10 CDMO oversight: when the scorecard doesn't match reality
30:18 Scoring bias in subjective weighting
31:14 ISO 14971 vs. ICH Q9 risk management
32:32 FMEA as a living document
RELATED VIDEOS
Pharma vs. Medical Device Quality Systems: 5 Differences
https://youtu.be/xG0htEu0ph4
Working with a Device CDMO: Common Sponsor Mistakes
https://youtu.be/d2SDwndXuCk
ICH Q9 Explained
https://youtu.be/Is67hbh71RY
Design Controls Explained for Pharma and Combination Product Teams
https://youtu.be/f7esiLpUhfM
Need help with CDMO oversight, supplier audits, or risk management on a combination product?
https://letscombinate.com/services/
ABOUT BEN LOCWIN
Ben Locwin is Vice President at Reliant Life Sciences and host of the Life Science Shifts podcast. His work spans drug therapies, vaccines, and medical devices, and he is a frequent industry speaker and commentator on pharma and medical device quality.
Reliant Life Sciences:
https://www.reliantlifesciences.com/
ABOUT SUBHI SAADEH
Subhi Saadeh is the Founder and Principal of Let's Combinate, a consultant, auditor, and trainer specializing in drug-device combination products, medical devices, and pharmaceutical quality systems. He has held quality and engineering roles at Pfizer, Gilead, and Baxter, with experience spanning quality, R&D, and commercialization and a focus on design controls, supplier quality, inspection readiness, and translating regulatory expectations into practical execution.
Subhi is an ISO 13485 Lead Auditor and an ASQ Certified Quality Auditor and Certified Quality Engineer. He has chaired the Combination Product Working Group for Rx-360, served as International Committee Chair for the Combination Products Coalition (CPC) and as a member of ASTM Committee E55, and served on AAMI's Combination Products Committee.
I'm Subhi Saadeh. I help companies make drug and device quality systems work together. I'm a consultant, auditor, and trainer focused on combination products, an ISO 13485 Lead Auditor, and an ASQ CQA and CQE. I've worked on prefilled syringes, autoinjectors, IV bags, cartridges, and vial-based systems, from clinical through commercial.
Subhi Saadeh is the Founder and Principal of Let’s Combinate, a consultant, auditor, and trainer specializing in drug-device combination products, medical devices, and pharmaceutical quality systems. His experience spans quality, R&D, and commercialization, with a focus on design controls, supplier quality, inspection readiness, and translating regulatory expectations into practical execution.
Subhi is an ISO 13485 Lead Auditor and an ASQ Certified Quality Auditor and Certified Quality Engineer.
Subhi Saadeh is a consultant, trainer, auditor, and the Founder and Principal of Let’s Combinate. He has spent his career across medical devices and pharmaceuticals, with experience spanning research and development, industrialization, quality systems, and combination products. Through Let’s Combinate, he helps professionals and organizations better understand and navigate the intersection of drugs, devices, quality, and regulatory requirements.
Subhi Saadeh is a combination-product quality professional, consultant, and host of Let’s Combinate: Drugs + Devices. His work focuses on the intersection of pharmaceutical and medical-device requirements, including combination-product quality systems, design controls, supplier quality, manufacturing, inspection readiness, and regulatory strategy.
Through Let’s Combinate, Subhi brings together regulators, industry leaders, and technical experts to make complex drug-device topics easier to understand and apply.
Subhi Saadeh is the Founder and Principal of Let’s Combinate, an independent media, education, and consulting company focused on drug device combination products, quality systems, and quality engineering.
Subhi is a consultant, trainer, and auditor with a background spanning R&D, industrialization, commercialization, and quality across the pharmaceutical and medical device industries.
He is also the host of Let’s Combinate: Drugs + Devices where he talks with industry leaders and breaks down complex quality, regulatory, device, pharma and combination-product topics.
**Need help with consulting, training, or auditing?**
Learn more at: [https://www.letscombinate.com](https://www.letscombinate.com)
14:28 The Chicken-and-Egg Problem With New Device Technologies
19:25 CDAs, Proprietary Information and Working With New Suppliers
22:31 How Do You Sell a Drug Delivery Device in 2026?
29:17 Why Drug Delivery Is Still “Sexy”
31:20 Oral Drugs, Adherence and the Mucinex Horse Pill
33:18 Reusable Devices and Human Factors
35:22 Sustainability as a Drug Delivery Market Force
39:32 Cartridge vs. Prefilled Syringe
43:57 If You Had to Bet on One Drug Delivery Trend Through 2035
46:55 IV Drugs and the Shift Toward Subcutaneous Delivery
49:15 Steven’s Book Recommendation: Make Your Bed
51:22 Where to Find Steven
Steven Kaufman Bio
Steven Kaufman is the Founder of Combination Product Solutions, Inc. and a drug delivery and combination product executive with more than 21 years of industry experience.
His career has spanned device strategy, commercialization, business development, consulting, executive leadership, and entrepreneurship. Steven has held senior roles across the drug delivery industry and today works with device companies, biotech and pharmaceutical organizations, and investors on commercialization, technology strategy, platform evaluation, and bringing new drug delivery technologies to market.
Steven also serves as fractional Chief Commercial Officer at Portal Instruments.
Connect with Steven
Website: Combination Product Solutions
Email: info@combinationproductsolutions.com
LinkedIn: Steven Kaufman on LinkedIn
Subhi Saadeh Bio
Subhi Saadeh is a Quality Professional and host of Let’s Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large medical device and pharmaceutical organizations supporting the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.
For questions, inquiries, consulting, or episode suggestions:
