Let's Combinate - Drugs + Devices

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

In this final episode of the ICH Quality series, we walk through the most important concepts in ICH Q14 and how they fit into the broader ICH quality framework.

Rather than reviewing the guideline section by section, this episode focuses on the ideas that are most useful in practice:
Why does ICH Q14 start with the Analytical Target Profile (ATP)?
How is it different from ICH Q2?
How do you develop analytical procedures using a science- and risk-based approach?
And what does all of this have to do with ICH Q12 and lifecycle management?

One quick note: at the time of recording, ICH Q14 remains under public comment, so some details may evolve before the final version is adopted.

Chapters
00:00 – Intro and ICH Q14 vs. Q2
01:08 – The Analytical Target Profile (ATP)
04:16 – The Analytical Procedure Lifecycle
05:32 – Risk-Based Development and Enhanced Approaches
06:20 – Where ICH Q2 Fits: Validation
08:04 – Connecting Q14 to ICH Q12 and Lifecycle Management
09:22 – Closing the ICH Quality Series

In this episode, we cover:
• Why ICH Q14 exists
• The difference between ICH Q14 and ICH Q2
• What an Analytical Target Profile (ATP) is
• ATP examples and performance criteria
• Technology selection and fit-for-purpose methods
• The analytical procedure lifecycle
• Risk assessments and enhanced development approaches
• Multivariate experiments and DOE concepts
• Analytical procedure control strategies
• Validation and the role of ICH Q2
• Lifecycle management of analytical procedures
• The connection between ICH Q14 and ICH Q12
• Why understanding matters more than simply checking a box

If you've followed along through the ICH Quality series, one of the themes that keeps showing up is that quality isn't something you test into products at the end. Whether we're talking about Q8, Q9, Q10, Q12, or now Q14, the emphasis continues to shift toward building knowledge, understanding risk, and using that understanding throughout the lifecycle.

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, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, speaker, and host of the Let's Combinate podcast, with experience across companies including Pfizer, Gilead, and Baxter supporting vaccines, biologics, generics, and combination products.

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

🎙️ Let's Combinate Podcast:
https://www.letscombinate.com

#ICHQ14 #ICHQ2 #ICHQ12 #AnalyticalValidation #PharmaQuality #QualityByDesign #LifecycleManagement #DrugDevelopment #CombinationProducts