Let's Combinate - Pharma + Medical Devices with Subhi Saadeh podcast

261 - Getting Pharma/Device Products Into Clinical Trials: INDs, IDEs & FDA Meetings

Show notes

Getting pharma, medical device, and drug-device combination products into clinical trials takes a clear strategy for INDs, IDEs, FDA meetings, and first-in-human studies.

Dr. Robert Bilkovski joins Subhi Saadeh to discuss clinical development, pre-IND meetings, Q-Submissions, clinical trial design, site selection, and sponsor oversight.

What should you have figured out before meeting with FDA? How does the clinical strategy change when you pair an existing drug with a new delivery device? And what happens between preparing a submission and enrolling the first patient?

IN THIS EPISODE

• The chief medical officer’s role in clinical development, safety, and medical affairs• Clinical strategy for drugs, medical devices, and combination products• Bridging an existing drug to a new delivery device• INDs, IDEs, and preparing for first-in-human studies• Bringing focused questions and a proposed strategy to FDA meetings• Using early studies to inform endpoints, sample sizes, and labeling• Selecting, qualifying, and activating clinical trial sites• Sponsor oversight and considerations for studies outside the United States

ABOUT DR. ROBERT BILKOVSKI

Contact Robert: http://www.RNBVenturesConsulting.com/podcast

Dr. Robert Bilkovski is an emergency physician whose industry experience includes Hospira, GE Healthcare, and Abbott Molecular. He advises companies on clinical development as a fractional chief medical officer and is the author of Make Your Story Believable: Diagnosing the Pitfalls of Healthcare Innovation.

ABOUT SUBHI SAADEH

Subhi Saadeh is the founder of Combinate and host of Let’s Combinate, helping pharmaceutical and medical device companies solve the quality challenges where drugs and devices meet. His career spans engineering and quality roles at Baxter, Pfizer, and Gilead, supporting drug delivery systems and combination products from development and clinical use through launch and commercial manufacturing.

His experience includes prefilled syringes, autoinjectors, infusion devices, and a frozen prefilled syringe platform supplying more than 100 million units annually. He has chaired industry working groups through the Combination Products Coalition and Rx-360, contributed to AAMI’s combination product work, and co-created the CQA Master Class. Subhi is an ASQ Certified Quality Auditor and Certified Quality Engineer, an ISO 13485 Lead Auditor, and a bioengineering graduate of the University of Illinois Chicago.

WORK WITH SUBHI

Consulting, audits, and training:https://letscombinate.com/services/

Discuss your project:https://calendly.com/letscombinate/quick-chat

LinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21/

Email: subhi@letscombinate.com

RESOURCES

Free guide: Drug vs. Device Qualityhttps://letscombinate.kit.com/216fbfc6c2

CQA Master Class:https://cqeacademy.teachable.com/p/the-cqa-master-class-course

FOLLOW LET’S COMBINATE

YouTube:https://www.youtube.com/@LetsCombinate

Spotify:https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

Apple Podcasts:https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792

#ClinicalTrials #CombinationProducts #FDA

Nov 2, 2026 38 min

267 - What Pharma Wants from CDMOs: Quality, Pricing & Trust | Kaan Kekec

Show notes

What pharma companies want from CDMOs, and how closely that matches what CDMOs think matters. Recorded at CDMO Live Americas with Kaan Kekec, Partner at Simon-Kucher, on the CDMO Growth Report 2026: why quality ranked first for sponsors while CDMOs emphasized speed, how to validate a value proposition, and pricing challenges for drug delivery devices.

Drawing on research conducted with PharmaSource, Kaan explains the gap between sponsor expectations and supplier perceptions. We discuss why quality needs to be demonstrated throughout a partnership, how companies can validate their value proposition, and what drug delivery device suppliers miss when they don't understand the markets their products ultimately serve.

IN THIS EPISODE

- Why quality ranked first for sponsors while CDMOs placed more weight on speed

- Why your value proposition needs to reflect what customers recognize and value

- How customer interviews and competitor comparisons reveal blind spots

- Why large pharma and small biotech need different conversations

- How access to technical experts can influence customer experience and win rates

- Pricing challenges for drug delivery devices across regions and end markets

- Integrated device manufacturing, fill-finish, and assembly

- Why certifications alone don't tell the whole quality story

- How clearer expectations can improve sponsor-CDMO partnerships

ABOUT KAAN KEKEC

Kaan-Fabian Kekec is a Partner at Simon-Kucher with 15 years of consulting experience helping pharma services and drug delivery companies improve their commercial strategy, pricing, and customer value proposition.

Kaan on LinkedIn:

https://www.linkedin.com/in/kaan-fabian-kekec-3b799632/

CDMO Growth Report 2026 (Simon-Kucher, with PharmaSource):

https://www.simon-kucher.com/en/insights/cdmo-growth-report-2026

Thank you to Luke and the CDMO Live team for the opportunity to record this conversation in person.

https://pharmasource.global/events/cdmo-live-americas/

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.

CONNECT WITH SUBHI

Consulting, audits, and training:

https://letscombinate.com/services/

Discuss a project:

https://calendly.com/letscombinate/quick-chat

LinkedIn:

https://www.linkedin.com/in/subhi-saadeh-1169aa21/

Email:

subhi@letscombinate.com

FOLLOW LET'S COMBINATE

YouTube:

https://www.youtube.com/@LetsCombinate

Spotify:

https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

#CombinationProducts #HumanFactors #RiskManagement

Oct 12, 2026 34 min

257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

Show notes

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

12:10 Wrap-up

About me

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.

🌐 https://letscombinate.com

📅 https://calendly.com/letscombinate/quick-chat

💼 https://www.linkedin.com/in/subhi-saadeh-1169aa21

✉️ subhi@letscombinate.com

#CombinationProducts #21CFRPart4 #QMSR

Oct 5, 2026 13 min

256 - The New FDA Inspection Playbook: Where to Start with QMSR

Show notes

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

05:47 Four major subsystems to six QMS areas

06:57 Inspection models and record selection

07:37 Risk, controls, and inspection evidence

08:08 What’s next in the series

THE SERIES

1. QSIT to QMSR: Understanding the new inspection program

2. Inspection models, coverage, and record selection

3. The six QMS areas and how they connect

4. Inspection readiness: Preparing people, processes, and records, with lessons from early QMSR warning letters

RESOURCES

FDA Compliance Program 7382.850 — Inspection of Medical Device Manufacturers

Part III begins on page 20. Attachment A details the QMS areas, elements, and requirements.

https://www.fda.gov/media/80195/download

FDA Investigations Operations Manual — Chapter 5

https://www.fda.gov/media/166533/download

FDA QMSR Frequently Asked Questions

https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions

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. 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.

CONNECT WITH SUBHI

Consulting, audits, and training:

https://letscombinate.com

LinkedIn:

https://www.linkedin.com/in/subhi-saadeh-1169aa21/

Schedule a quick chat:

https://calendly.com/letscombinate/quick-chat

Email:

subhi@letscombinate.com

FOLLOW LET’S COMBINATE

YouTube:

https://www.youtube.com/@LetsCombinate

Spotify:

https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

Apple Podcasts:

https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792

Sep 28, 2026 9 min

255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

Show notes

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

Sep 21, 2026 12 min

254 - Saying No Is the Easy Part of Quality

Show notes

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

05:02 No When Requirements Break

05:44 No to Schedule Pressure

07:48 Bad No From Preference

08:33 Bad No From Uncertainty

09:20 Overkill and Phase GMPs

10:08 Build Flexible Quality Culture

12:16 Wrap Up and Takeaways

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.

Connect with Subhi Saadeh

LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/

Website: http://letscombinate.com/

Book a quick chat: https://calendly.com/letscombinate/quick-chat

Email: subhi@letscombinate.com

Listen / Follow Let’s Combinate

YouTube: https://www.youtube.com/@LetsCombinate

Spotify: https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

Apple Podcasts: https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792

#Quality #CombinationProducts #Pharma #MedTech #RiskManagement #GMP #DesignControls #SupplierQuality #QualitySystems #LetsCombinate

Sep 13, 2026 12 min

253 - FDA Is Making Big Changes to Its Inspection Approach

Show notes

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.

Connect with Eric

LinkedIn: https://www.linkedin.com/in/ericspittmanmba-fda
Project Farma: https://projectfarma.com/

About Subhi Saadeh

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.

Connect with Subhi

LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/
YouTube: https://www.youtube.com/@LetsCombinate
Website: https://letscombinate.com/

Sep 7, 2026 46 min

252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

Show notes

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

01:45 Perfect World vs. Reality

02:49 What Is Acceptance Sampling?

03:53 Attributes vs. Variables

05:21 What Is AQL?

07:05 Risk & the OC Curve

09:57 Producer & Consumer Risk

12:05 Practical Takeaway

About Subhi Saadeh

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)

**Connect with Subhi:**

LinkedIn: [https://www.linkedin.com/in/subhi-saadeh-1169aa21](https://www.linkedin.com/in/subhi-saadeh-1169aa21)

Email: [subhi@letscombinate.com](mailto:subhi@letscombinate.com)

#AQL #AcceptanceSampling #QualityEngineering #Pharma #MedicalDevices #CombinationProducts #ISO2859 #ISO3951

Aug 31, 2026 13 min

251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy

Show notes

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?

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:

Website: Let’s Combinate

LinkedIn: Subhi Saadeh on LinkedIn

Email: subhi@letscombinate.com

Aug 24, 2026 49 min

I'm Changing The Podcast

Show notes

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.

See you Monday.

🌐 https://letscombinate.com

📅 https://calendly.com/letscombinate/let-s-combinate-intro-session

💼 https://www.linkedin.com/in/subhi-saadeh-1169aa21

About Subhi Saadeh

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.

Aug 18, 2026 3 min

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

Show notes

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today.

In this video, I walk through where PI 006-4 fits within the broader GMP framework, how it relates to EU Annex 15, and the sections I think are most worth paying attention to.

A few of the major themes include a much stronger emphasis on quality risk management and lifecycle thinking, more explicit expectations around statistics, sampling, variability, and process capability, a move away from treating three validation batches as a default answer, and clearer discussion of traditional validation, continuous process verification (CPV), hybrid approaches, and ongoing process verification (OPV).

The goal isn't to suggest that all of these concepts are brand new. Many have been developing across the industry for years. What is interesting is seeing how PIC/S has now pulled them together into an updated recommendation that reflects current qualification and validation thinking.

Chapters

00:00 Big Update Overview

01:02 Who PIC/S Serves

01:28 Annex 15 Relationship

02:12 Scope and Exclusions

02:39 Why Update Now

04:05 Four Key Changes

04:47 Risk and Lifecycle Shift

06:43 Statistics and Sampling

07:48 Rethinking the Three-Batch Rule

08:30 Ongoing Process Verification

09:11 Traditional, CPV and Hybrid Approaches

10:45 Key Takeaways

About Subhi

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Connect With Let’s Combinate

Website:
https://www.letscombinate.com

Schedule an intro call:
https://calendly.com/letscombinate/let-s-combinate-intro-session

LinkedIn:
https://www.linkedin.com/in/subhi-saadeh-1169aa21

Apple Podcasts:
https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792

Spotify:
https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

Documents Discussed

PIC/S PI 006-4 — Recommendations on Qualification and Validation (2026)
https://picscheme.org/docview/11277

PIC/S PI 006-3 — Validation Master Plan, IQ/OQ, Non-Sterile Process Validation & Cleaning Validation (2007)
https://picscheme.org/docview/3447

EMA / PIC/S Concept Paper — Revision of Annex 15: Qualification and Validation (2026)
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf

PIC/S Publications Page
https://picscheme.org/en/publications

Aug 12, 2026 11 min

249 - The Best Audit Advice Nobody Told Me

Show notes

Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve.

In this video, I share the lessons I learned as I moved from being audited and supporting audit rooms to conducting audits as a certified lead auditor:

1) Audit the system, not the person: The goal is to understand how the system operates, not to catch an individual making a mistake.

2) Look for patterns, not isolated errors: One typo is different from a recurring or systemic problem, unless the individual event is critical.

3) Scope the audit before you start: The objective, criteria, time, resources, and agenda need to align before the audit begins.

4) Technical expertise is not the same as audit skill: Auditing requires its own tools, tactics, strategies, interviewing skills, and qualification.

5) Lower the temperature to get better evidence: People communicate more clearly when the auditor reduces unnecessary anxiety, although assertiveness is sometimes necessary when information is being withheld.

Chapters

00:00 Audits Aren’t Gotchas

00:38 Audit the System, Not the Person

03:16 Look for Patterns, Not Isolated Mistakes

05:27 Set a Clear Audit Scope

08:21 Auditing Is Its Own Skill and Being Technical Helps

11:11 Lower the Temperature and Be a Human

About Subhi

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical-device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Learn more:

https://letscombinate.com/

subhi@letscombinate.com

Connect with Subhi on LinkedIn:

https://www.linkedin.com/in/subhi-saadeh-1169aa21

Aug 5, 2026 14 min

248 - What Is a Quality Unit? QA vs. QC Explained

Show notes

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?

In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, medical-device, and combination-product companies. We’ll look at the Quality Unit’s major responsibilities, why QA is generally system- and process-focused, why QC is generally testing- and product-focused, and why the organizational structure varies between companies.

CHAPTERS

00:00 What is a Quality Unit?

01:18 The Quality Unit as the umbrella function

01:55 Three major Quality Unit responsibilities

03:08 What functions may sit within Quality

04:08 Establishing, operating, and releasing

04:37 Quality Assurance vs. Quality Control

05:38 Common QA responsibilities

06:16 Common QC responsibilities

06:53 Why pharma and device companies look different

07:32 Drug vs. device terminology

08:06 How QC supports product release

08:26 Final QA vs. QC summary

KEY TAKEAWAYS

• The Quality Unit provides overall quality oversight.

• QA primarily focuses on systems and processes.

• QC primarily focuses on inspection, measurement, and testing.

• QC testing provides essential evidence supporting product disposition.

• Exact responsibilities and reporting structures vary by company and industry.

How are QA and QC organized at your company? Share your experience in the comments.

#QualityAssurance #QualityControl #QualityUnit #Pharma #MedicalDevices #qualitymanagement

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management.

Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Learn more about Let’s Combinate:

https://www.letscombinate.com

Schedule an introductory call:

https://calendly.com/letscombinate/let-s-combinate-intro-session

Connect with Subhi on LinkedIn:

https://www.linkedin.com/in/subhi-saadeh-1169aa21

Listen to Let’s Combinate on Apple Podcasts:

https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792

Listen on Spotify:

https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

Jul 29, 2026 9 min

247 - Why Everyone in Pharma and MedTech Should Work in Quality

Show notes

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of how regulated businesses actually operate.

In this video, Subhi Saadeh explains three reasons everyone in the industry should consider spending time in quality:

You learn how the business works. Quality follows the product across its lifecycle from development and suppliers through manufacturing, operations, regulatory changes, and post-market activities.

You develop judgment. Quality professionals regularly make structured, risk-based decisions in gray areas and document those decisions so they can withstand audits, inspections, and future review.

You learn to influence without owning everything. Quality is often accountable for outcomes without directly controlling every activity, which requires strong questions, clear communication, and the ability to help teams navigate competing priorities.

Even if you do not spend your entire career in quality, the experience can make you a stronger decision-maker, collaborator, and leader throughout the rest of your career.

00:00 Why Quality Matters

00:35 Why Work in Quality

01:41 Reason One: Learn How the Business Works

02:47 Reason Two: Make Defensible Decisions

05:23 Reason Three: Influence Without Authority

07:43 Key Takeaways

About Subhi

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 the intersection of drugs, devices, quality, and regulatory requirements.

Jul 22, 2026 8 min

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

Show notes

Most discussions about One QMS focus on harmonization.

But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organizations structure a QMS.

In this episode, I compare centralized, decentralized, and federated (hybrid) Quality Management System models, including the trade-offs of each in terms of ownership, standardization, flexibility, governance, and decision-making.

We also walk through how the document hierarchy typically differs across each model—from the Quality Policy and Quality Manual to standards, SOPs, work instructions, and records—and discuss why governance often has a greater impact on success than the operating model itself.

Timestamps

00:00 Why "One QMS" Is Trending

01:33 The Three Primary QMS Models

01:50 Centralized QMS

02:01 Decentralized QMS

02:28 Federated (Hybrid) QMS

03:50 Comparing the Document Hierarchy

04:14 Centralized Document Structure

05:04 Decentralized Document Structure

05:22 Federated Standards, SOPs, and Governance

06:50 The QMS Tree: Philosophy, Governance, and Execution

08:20 Why Governance Matters More Than the Model

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Jul 15, 2026 9 min

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

Show notes

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and what it takes to build a drug-device combination product from a patient need.

Julia was born with salt-wasting congenital adrenal hyperplasia, a life-threatening form of adrenal insufficiency. Because her body cannot make cortisol, she takes cortisol replacement daily and may need an emergency hydrocortisone injection during a crisis.

The problem?

The current emergency injection can take upto 14 steps to prepare, mix, and administer.

Julia explains why the liquid and powder need to stay separate for stability, why the current process is so difficult during an emergency, and how Solution Medical is developing a proprietary dual-chamber primary container to simplify reconstitution while maintaining shelf life without refrigeration.

We also discuss how the company evolved from a device idea into a drug-led 505(b)(2) NDA program, the development of a four-step prefilled syringe and two-step auto-injector, human factors testing with both patients and injection-naive users, manufacturing challenges in aseptic processing, supplier trust, regulatory strategy, and the broader platform potential for other mix-before-inject drugs.

Chapters

00:00 Meet Julia Anthony

01:04 Living Without Cortisol

02:03 The 14-Step Injection

05:01 Building a Combination Product

07:54 From Device Concept to Pharma Company

10:06 Needles, Steps, and Testing

13:25 Patient Insights and Human Factors

16:58 Real-World Access Challenges

21:50 Why Not a Liquid Formulation?

24:15 Regulatory Pathway: 505(b)(2)

25:13 Manufacturing and Partner Trust

27:32 Rare Disease and Supplier Power

31:53 Platform Vision Beyond Adrenal Insufficiency

38:05 Reconstitution Is the Hard Part

41:12 COVID Tailwinds and Timeline

43:38 Where to Find Solution Medical

44:42 Final Thoughts on Cortisol

About Subhi

Subhi Saadeh is a consultant, trainer, and auditor focused on quality, regulatory, manufacturing, and supplier challenges for drugs, devices, and combination products.

Through Let’s Combinate, Subhi helps companies navigate the messy intersection of pharmaceutical and medical device requirements through consulting, training, audits, and practical education.

He also hosts Let’s Combinate: Drugs + Devices, where he speaks with leaders building, regulating, manufacturing, and improving combination products.

Jul 8, 2026 45 min

244 - 5 Critical Quality Differences Between Drugs and Devices

Show notes

Download the free Drug vs. Device Quality comparison guide here:https://letscombinate.kit.com/216fbfc6c2

In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same and highlights five key areas where they differ for combination products.

Drug quality often focuses on consistently remaking the product that was proven clinically, using critical quality attributes, specifications, analytical methods, stability, process validation, and batch release.

Device quality emphasizes design robustness and intended use through design controls and product realization, from user needs and design inputs to validation and design transfer.

This episode covers five major differences:

Quality philosophy and evidence

Development approach

Risk management

Regulatory submission focus

Lifecycle management and change control

The goal is not to force one system onto the other. The goal is to understand the differences early enough to intentionally integrate drug and device quality across development, manufacturing, regulatory strategy, and lifecycle management.

Chapters

00:00 Drugs vs. Devices: Why Quality Differs

00:20 Intro and Practical Guide

00:50 Quality Philosophy and Evidence

02:27 Development Approach Differences

03:56 Risk Management Mindsets

05:48 Regulatory Submission Focus

06:23 Lifecycle and Change Control

08:03 Summary and Next Steps

Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

Jul 1, 2026 9 min

243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

Show notes

Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-session

Finished medical devices can create a lot of surprises when they are added to combination product kits.

A needle, vial adapter, filter, or transfer device may already be sterile, cleared, qualified, and sold at massive scale.

But already on the market does not automatically mean ready for your combination product.

In this episode, I talk through the challenges of selecting finished medical devices for combination product kits and the three lifecycle moments that usually determine whether qualification goes smoothly or turns into a late-stage problem.

We cover:

* Why “already approved” does not mean combination-product ready

* Why you inherit the supplier’s design, QMS, packaging, validation, change control, and outsourcing decisions

* What to think about before supplier selection

* How to set expectations during supplier selection

* Why structured qualification matters

* How PPAP concepts like process flow, PFMEA, control plans, inspections, sampling, and validation evidence can help

The main point: A commercially available device may be qualified for someone else’s intended use. Your job is to determine whether it is qualified for yours.

Chapters:

00:00 Device Selection Stakes

02:05 Common Supplier Myths

03:54 Inheriting the Device QMS

04:53 Three Crucial Moments

05:51 Before Selection: Intended Use

07:21 Packaging, Markets, and Risk Flags

08:55 During Selection: Set Expectations

10:33 Qualification: Use a Structured PPAP Approach

14:12 Wrap Up and Next Steps

Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics.

Let’s Combinate helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across drug and device domains.

#CombinationProducts #MedicalDevices #PharmaQuality #SupplierQuality #DrugDeviceCombinationProducts #PPAP #QualitySystems

Jun 24, 2026 15 min

Let's Combinate - Pharma + Medical Devices with Subhi Saadeh

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