Let's Combinate - Drugs + Devices

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.

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.

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.

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

One of the hardest parts of auditing is not knowing what to look for.It is deciding where to start. Do you trace a deviation? Walk the process? Focus on one department? Audit CAPA across the organization? Or pull on a thread that does not quite make sense?

In this video, Subhi walks through six audit strategies from the ASQ Certified Quality Auditor Body of Knowledge and explains how they apply in real-world pharma, biotech, and combination product audits.

The six strategies covered are:
1. Tracing
2. Process Approach
3. Process-Based Management
4. Department Method
5. Element Method
6. Discovery Method

These approaches are useful whether you are auditing a supplier, a manufacturing site, a testing laboratory, or a quality system that spans drug, device, and combination product responsibilities.

Need support with combination product quality, auditing, supplier quality, or quality system strategy?

Schedule a Let’s Combinate intro call:
https://calendly.com/letscombinate/let-s-combinate-intro-session

Learn more about Let’s Combinate:
https://letscombinate.com

Preparing for the CQA exam?

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

Chapters:
00:00 Six Audit Strategies Overview
01:12 Tracing Method Explained
02:59 Process Approach Workflow
04:27 Process-Based Management
05:46 Department Method Deep Dive
06:27 Element Method Across the QMS
07:12 Discovery Method: Pull the Thread
08:55 Summary: Pros and Cons
11:31 Final Tips and Next Steps

Subhi 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.

#Pharma #Biotech #Quality #Auditing #QualityAudits #CQA #GMP #CombinationProducts #QualitySystems #ISO13485