In this episode of Let’s Combinate, host Subhi Saadeh is joined by Mark Burchnall, Director of Engineering at PSN Labs, to break down the evolving role of mechanical modeling and simulation in medical device and combination product development.

Mark, an expert in mechanical modeling & finite element analysis (FEA) and a licensed professional engineershares how modeling can dramatically reduce prototyping cycles, support regulatory submissions, and lower test burden when applied appropriately.

Mark disucsses:

Why modeling is often misunderstood

When it can replace (or complement) traditional testing

What makes a model “credible” under ASME V&V 40

How to build internal processes for regulatory-grade models

And what every skeptic (or startup) needs to know before adopting modeling

⏱️ Timestamps:

00:00 Introduction and Guest Welcome

00:17 Mark's Expertise in Mechanical Modeling

01:28 Subhi’s Foundational Experience

04:09 The Importance of Modeling in Engineering

05:44 Challenges and Misconceptions in Modeling

10:52 Life Cycle and Inputs of a Model

16:21 Types of Models and Their Applications

17:49 Numerical Solvers and Sensitivity Analysis

21:28 CAD, Fluid Properties, and Starting a Model

22:00 Defining the “Question of Interest”

23:21 Modeling Cycle and Initial Steps

24:35 Verification and Validation in Modeling

25:40 Assessing Model Risk and Credibility

31:43 Regulatory Guidelines and Industry Practices

39:15 Implementing Modeling in Product Development

42:17 Conclusion and Contact Information

Mark is a product development consultant with over 15 years of experience in the Medical and Combination device sectors. As the Director of Engineering at PSN Labs, Mark leads the engineering department, offering invaluable support to clients in new product development, computational modeling and simulation, test method development, functional prototyping, contract manufacturing, and on-market remediation. His team specializes in designing devices that incorporate various design principles, including manufacturing, assembly, sustainability, biocompatibility, reprocessing, and reliability. Mark’s background encompasses the development of innovative healthcare solutions in areas such as drug delivery, surgical robotics, pharmaceutical packaging, and catheters. His expertise ensures patient safety and regulatory compliance throughout the design process. Mark holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Mechanical Engineering from the University of Cincinnati.

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh highlights five critical aspects of the FDA's new Quality Management System Regulation (QMSR) that you may have missed. Subhi explains the historical context of QSR and ISO 13485, their 1996 origins, and the drive for harmonization that began in 2018. Key insights include the alignment with ISO 13485, additional FDA-specific expectations, the continued importance of risk management, the removal of certain industry exemptions, and the urgent two-year compliance timeline ending in February 2026. Subhi emphasizes the necessity of updating internal quality management systems and training staff to meet these new regulatory requirements.Timelines:00:00 Introduction to FDA QMSR00:29 Historical Context and Timeline02:22 Key Takeaway 1: Harmonization with ISO 1348504:06 Key Takeaway 2: FDA's Additional Expectations05:18 Key Takeaway 3: Risk Management Expectations06:18 Key Takeaway 4: Removal of Exemptions07:44 Key Takeaway 5: Compliance Deadline09:13 Conclusion and Final ThoughtsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let’s Combinate, host Subhi Saadeh breaks down the critical role of quality agreements in the pharmaceutical and medical device industries.A quality agreement is a written document that defines GxP responsibilities between parties—such as sponsors, product owners, and contract partners. It doesn’t cover business terms like payments or IP: instead, it focuses on quality responsibilities and operational accountability.

Subhi explores regulatory expectations from the FDA, ICH Q10, and ISO 13485, emphasizing that even when work is outsourced, responsibility always stays with the product owner. He outlines five key sections every quality agreement should cover:

-Deviation & Non-Conformance Handling

-Change Control

-Audits & Regulatory Inspections

-Complaint Handling & Field Actions

-Documentation & Record Retention

This episode highlights common pitfalls, vague language to avoid, and why quality agreements must be clear, specific, and actionable especially when something goes wrong.

⏱️ Timestamps

00:00 – Intro: Why Quality Agreements Matter

01:23 – What Is a Quality Agreement?

03:24 – Regulatory Expectations (FDA, ICH Q10, ISO 13485)

04:51 – FDA’s Quality Agreement Guidance Explained

06:34 – Common Pitfalls & Misunderstandings

08:00 – The 5 Critical Sections Every Agreement Needs

12:34 – Final Thoughts: Make It Real. Make It Work

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

From Episode 195 with Archana Sah

In this clip of the larger interview with Archana Sah, she covers the critical phases and elements of clinical trials—from phase one focusing on safety to phase three assessing effectiveness in diverse populations. Key aspects include the importance of the trial design, the role of comparator arms, regulatory requirements, patient recruitment, and the cultural preferences that influence trial protocols. The episode provides an in-depth look at how data is collected and analyzed to ensure the safety and efficacy of new drugs.00:00 Introduction to Clinical Trials00:26 Phases of Clinical Trials02:09 Designing Oncology Trials04:00 Protocol Design and Regulatory Approval05:27 Patient-Centric Considerations06:25 Vendor Roles and Statistical Analysis

In this episode, I go over 8 lessons to maximize your first 90 days in Life Sciences. These include understanding the impact of their roles, adopting a professional mindset, passing the first 90-day test, avoiding the 'silent trap,' finding mentors, valuing feedback, mastering systems, and taking responsibility for their careers. Subhi emphasizes that these lessons can significantly accelerate growth and career advancement for newcomers to the industry.Link to course: subhisaadeh.gumroad.com/l/6figurebiomedical00:00 Introduction: Starting Your Career Journey00:54 Lesson 1: Your Role Can Have a Big Impact02:55 Lesson 2: Adopting a Professional Mindset04:06 Lesson 3: The First 90 Days Are Crucial05:09 Lesson 4: Avoiding the Silent Trap06:35 Lesson 5: Finding the Right Mentors07:14 Lesson 6: Embrace Feedback as Fuel07:51 Lesson 7: Mastering the Systems08:47 Lesson 8: Taking Responsibility for Your Career09:19 Conclusion and Additional ResourcesSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, Archana shares her insights on the critical factors involved in designing clinical trials, from phase one safety profiling to pivotal phase three trials. She also discusses the importance of patient diversity, the ethical considerations in clinical research, and the future of clinical trials, including decentralized trials and the use of advanced technologies. The conversation highlights the intricate balance between maintaining rigorous scientific standards and adapting to new methodologies to enhance patient recruitment and data integrity. Time Stamps: 00:00 Welcome and Introduction 00:28 Understanding Clinical Trial Design 00:58 Phases of Clinical Trials 02:27 Oncology Trials and Patient Pathways 05:00 Protocol Design and Regulatory Considerations 08:40 Patient Preferences and Vendor Selection 18:53 Types of Clinical Trials 23:01 Understanding BA and BE Studies 24:39 Clinical Coordination of BA/BE Studies 25:15 Infrastructure and Emergency Management in Clinical Trials 26:19 Addressing Mistrust in Clinical Trials 29:54 Ensuring Diversity in Clinical Trials 32:41 The Rise of Decentralized Clinical Trials 39:06 Challenges and Solutions in Decentralized Trials 42:49 Technology and Regulation in Clinical Trials 47:28 Final Thoughts and Contact InformationArchana Sah is a Clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals including Tecentriq® in multiple indications and combinations, Alecensa®, Polivy®, Hemlibra®, Gazyva®, Pixuvri®. She has held various global positions within Biotech, Big pharma, CRO including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, and two Oncology biotech start up companies. She has also worked in healthcare technology as the Senior Vice President of Digital and Decentralized Solutions at Medable Inc. She is now an independent strategy consultant and Board Advisor and provides strategic advisory services to pharma, biotechs, digital healthtech software companies, venture firms in clinical development and operations as well as on leveraging innovative patient centered digital health technologies in a fit for purpose approach to improve diversity, access and efficiencies within the healthcare ecosystem. She has been honored as Top20 women in immuno oncology drug development and featured in PharmaFEATURES on Oncology drug development and Digital Health technology.She has routinely led several industry collaboration consortiums. She is the co-founding chair and member of Society for Clinical Research Sites Oncology Board and chaired the Annual Oncology Summits. She is a current Mentor for the CancerX Moonshot program dedicated to revolutionizing advancements in cancer care, clinical trials, patient support, biotech & pharma and drive integration of digital tools in oncology. She serves on the Leadership Council for Decentralized Trials and Research Alliance(DTRA) and as their Evidence/Publications Librarian. She also serves as an Advisor to American Cancer Society Cancer Action Network (ACS CAN) and is a reviewer for the international Journal of the American Cancer Society "Cancer". Invited advisor and keynote/speaker at several industry conferences.Contact: [email protected] 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 Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.

In this episode I sit down with Mike Denzer, a mechanical engineer, inventor, and trusted leader in the combination product space. We talk about the power of networking not just as a tool for finding your next job, but as a foundation for building a meaningful and resilient career in pharma and medtech.Mike shares what it’s like to develop life-changing devices like Amgen’s Auto Click autoinjector, how he built credibility across R&D and regulatory teams, and why asking good questions and being generous with your time pays off more than any formal title. If you’ve ever struggled to balance technical depth with approachability or you’re trying to navigate CROs, design controls, or cross-functional chaos, I hope you enjoy this conversation! ⏱️ Timestamps00:00 Welcome and introduction00:56 Why networking matters01:57 Life-changing moments in engineering09:45 Challenges and innovations in autoinjectors14:47 CROs, sponsors, and collaboration18:22 Mike’s favorite projects and final thoughtsAbout Mike Denzer:Mike Denzer is a mechanical engineer, inventor, and combination product leader with over 20 years of experience in drug delivery system development. He’s held leadership roles at companies like Amgen, Teva, Bristol Myers Squibb, and Kymanox, and is credited as an inventor on five U.S. patents related to autoinjector platforms and delivery technology.He’s the founder of Combo Products LLC, where he now consults on combination product design, human factors strategy, and technical development. Mike is widely respected for his collaborative style and clear communication across engineering, clinical, regulatory, and quality functions.Contact Mike: [email protected] 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 Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.

In this episode of Let’s Combinate, host Subhi Saadeh is joined by Kirk Petyo, Managing Partner at Talent Factory Medical and founder of Talent Factory Recruiting.

If you're a bioengineering student, recent grad, or early-career professional trying to break into medical devices, biotech, or pharma—this one's for you.With extensive experience recruiting for regulated industries like aerospace, medical devices, and pharmaceuticals, Kirk offers grounded, actionable insights for early-career professionals and hiring managers alike.

This episode covers how to craft a strong resume, the importance of knowing your career “why,” how to stand out to recruiters, and why onshoring and shifting regulatory trends matter for the next generation of talent in life sciences.

Timestamps

00:00 – Welcome and Guest Introduction

00:35 – Kirk's Career Journey and Advice

02:18 – Navigating Early Career Challenges

03:12 – Building a Strong Resume and Networking

04:38 – The Importance of Specificity in Job Applications 08:56 – Recruitment Insights and Industry Trends

12:05 – Personal Experiences and Lessons Learned

18:49 – Advice for Upcoming Graduates

23:18 – The Importance of Passion in Job Interviews

24:00 – Evaluating Candidates Beyond Experience

24:58 – Personal Stories and Career Choices

30:55 – Bioengineering vs. Mechanical Engineering

41:34 – Industry Trends and Onshoring

44:18 – Entry-Level Opportunities and Recruitment

About Kirk Petyo

Kirk Petyo is the Managing Partner at Talent Factory Medical and founder of Talent Factory Recruiting. He has spent his career recruiting top talent in highly regulated industries like aerospace, medical devices, biotech, and pharma. Known for his ability to bridge business needs with real human connections, Kirk helps companies grow stronger teams—and helps candidates navigate complex career decisions with clarity and purpose.

About the Host

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 Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.

Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.

If you’ve ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical, high-level explanation of what a combination product is. It’s meant for anyone who works in or around pharma, medtech, or biotech and wants a clear, shareable reference—without getting into detailed regulatory definitions or region-specific nuances.I’m Subhi Saadeh, and I’ve spent my career in drug-device combination products. In this short reference video, I walk through:- What defines a combination product- Two key factors: primary mode of action and how components are combined- The difference between drug-led and device-led products- Examples of single-entity, co-packaged, and cross-labeled products

00:00 Introduction to Drug Device Combination Products

00:31 Defining Combination Products

00:54 Philosophical Factors of Combination Products

01:10 Drug-Led Combination Products

01:51 Device-Led Combination Products

02:32 Combination Configurations

03:50 Summary and Conclusion

Additional Resources: - 21 CFR Part 4 FDA regulation on Current Good Manufacturing Practice (CGMP) requirements for combination products https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4- FDA Guidance: Current Good Manufacturing Practice Requirements for Combination Productshttps://www.fda.gov/media/90652/download- FDA Combination Products Overview Page https://www.fda.gov/combination-products- 21 CFR Part 3 Regulations on combination product classification and primary mode of action (PMOA) https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-3- EU MDR Article 117 Requirements for drug-device combinations under the European Medical Device Regulation (Regulation (EU) 2017/745) https://health.ec.europa.eu/system/files/2021-10/md_mdr_2017-745_en_0.pdf

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

You’ve heard it before: If it’s not documented, it didn’t happen. But in life sciences, documentation isn’t just a formality—it’s the foundation of trust, compliance, and product quality. In this episode, Subhi Saadeh breaks down what documentation actually means by exploring the principles of ALCOA and ALCOA+.Learn where these principles come from, how they’re applied, and why they still matter—even in today's digital systems. From FDA guidances to $500M data scandals, this episode covers what goes wrong when data integrity isn’t taken seriously.⏱️ Timestamps:00:00 – Introduction: Why Documentation Still Matters01:24 – Defining Data Integrity in Regulated Industries03:06 – ALCOA Explained: Attributable, Legible, Contemporaneous, Original, Accurate07:18 – ALCOA Plus: Complete, Consistent, Enduring, Available08:54 – Real-World Examples: From Whiteout to Warning Letters11:00 – Why Old SOPs Can Ruin New Inspections12:21 – Final Thoughts: Documentation Is About Trust, Not Just Compliance🔍 What You’ll Learn:How ALCOA originated in the 1990s FDA frameworkWhy banning whiteout in labs is about more than inkThe difference between original vs. accurate vs. complete dataHow legacy documentation can break inspectionsThe role of tribal knowledge in document managementThe limits of electronic systems without strong governanceWhy AI and searchability are the next frontier for data integrityHow to think about documentation as a system of trust📚 Mentioned Resources:MHRA GxP Data Integrity Guidance (2018)FDA Guidance for Industry: Data Integrity and Compliance with CGMPBottle of Lies by Katherine EbanSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.