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Let's Combinate

Subhi Saadeh with industry guests on drug-device combination products: development, regulatory strategy, human factors and quality for products such as injectors, inhalers and on-body devices.

266 episodes · 158 hours · since 2021

Visit Let's Combinate

Let's Combinate is filed under medical devices, product development and interviews. Its most recent episode published on , so it is still actively publishing. Listeners have left 4 ratings on Apple Podcasts, averaging 5 out of 5.

Latest episodes

The 10 newest episodes of Let's Combinate, each with a summary and chapters.

  • · 34m

    258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

    Ben Locwin, Vice President at Reliant Life Sciences, and Subhi Saadeh, Founder of Let's Combinate, discuss the divergent quality philosophies of pharmaceutical and medical device industries, focusing on combination products. They explain how human factors studies must account for different user types (HCP vs. lay) even with platform devices, and how CDMO scorecards often fail to reflect operational reality due to subjective weighting. The conversation details the differences between ISO 14971 and ICH Q9 risk management, emphasizing the need for FMEA as a living document updated with real-world data.

    Quality & yieldSourcing & supply chain
    6 chapters

  • · 12m

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

    Subhi Saadeh, a consultant and auditor specializing in combination products, explains the CGMP requirements under 21 CFR Part 4 for products containing both drug and device elements. She details the scope of single-entity and co-packaged products, the baseline expectation of meeting all applicable regulations, and the two compliance paths: full integration or a streamlined approach. Saadeh outlines specific ISO 13485 sections required for drug-based systems and 21 CFR Part 211 sections for device-based systems, highlighting complexities like management review differences and reserve sample storage.

    Certification & compliance
    1 chapters

  • · 9m

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

    Subhi Saadeh, founder of Let’s Combinate, introduces a four-part series on FDA inspection readiness under the new Quality Management System Regulation (QMSR), explaining how the retired QSIT framework has been replaced by Compliance Program 7382.850. He highlights advice from former FDA investigator Eric Pittman, who advises industry to focus exclusively on Section III of compliance programs as the primary roadmap for inspections. The episode details the shift from QSIT’s four major subsystems to six QMS areas, emphasizing a risk-based approach where investigators evaluate product risks and control effectiveness.

    Certification & compliance
    3 chapters

  • · 11m

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

    Subhi Saadeh, founder of Let's Combinate, explains audit interviewing techniques developed with partner Andy Robertson, emphasizing that interviews are the bridge to verifying quality systems beyond desktop reviews. He details how to build rapport, use open-ended questions, and avoid checklist-driven approaches to get accurate evidence from auditees. The episode covers handling special situations like group interviews and translators, and managing challenges such as uncooperative escorts or time constraints during audits.

    Quality & yield
    1 chapters

  • · 12m

    254 - Saying No Is the Easy Part of Quality

    Subhi Saadeh, founder of Let’s Combinate, outlines four scenarios where quality professionals must firmly say no, including real patient risk, insufficient evidence, requirement violations, and schedule pressure. He contrasts these with three weak reasons for saying no, such as personal preference, technical uncertainty, and applying excessive GMP rigor to early-stage development. Saadeh advocates for a flexible quality culture that distinguishes between rigid compliance and risk-based decision-making, using a drug delivery platform case study to illustrate evidence-based stops.

    Quality & yieldMedical & health devices
    1 chapters

  • · 45m

    253 - FDA Is Making Big Changes to Its Inspection Approach

    Eric Pittman, former Bioresearch Monitoring West Division Director at the FDA and now VP at Project Farma, explains the FDA's transition from a specialized program-aligned inspection model back to a broader, medical-product-specific generalist model under the new Office of Investigations and Inspections (OII). He details the operational differences between routine inspections under Section 704 and undercover investigations under Section 702, emphasizing that investigators prioritize human subject safety over minor regulatory technicalities. Pittman advises industry to focus on the FDA’s Investigations Operations Manual (IOM) and specific compliance programs rather than cosmetic facility improvements, noting that the end of QSIT has shifted focus to broader process evaluation.

    Certification & complianceQuality & yield
    11 chapters

  • · 13m

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

    Subhi Saadeh, founder of Let's Combinate, explains the fundamentals of acceptance sampling, clarifying that it is a probability-based tool rather than a guarantee of quality. He distinguishes between attribute sampling (counting defects) and variable sampling (measuring characteristics), referencing standards like ISO 2859-1 and ISO 3951. Saadeh details how Acceptance Quality Limit (AQL) indexes sampling plans and introduces Operating Characteristic (OC) curves to visualize producer and consumer risk. The episode concludes that selecting a sampling plan is a judgment call to balance the risk of rejecting good batches against accepting bad ones.

    Quality & yieldCertification & compliance
    1 chapters

  • · 49m

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

    Steven Kaufman, Founder of Combination Product Solutions and fractional CCO at Portal Instruments, discusses the evolving drug delivery landscape, highlighting the shift toward larger-volume subcutaneous injections (5-10 mL) and the critical role of sustainability in device selection. He explains that while oral GLP-1s are popular, injectables offer superior efficacy and adherence for many patients, driving demand for both disposable and reusable auto-injectors. Kaufman emphasizes that commercial success in 2026 requires solving specific challenges like high viscosity and injection time, rather than just competing on price or form factor. He predicts that sustainability will be the dominant force shaping the next generation of devices through 2035, with companies like Eco-Injet and Portal leading the way.

    Mechanical engineeringMarketing & brand
    8 chapters

  • · 2m

    I'm Changing The Podcast

    Subhi Saadeh, host of the combination product podcast Let's Combinate, announces a schedule change from Wednesday to Monday after 250 consecutive weekly episodes. He reflects on maintaining consistency through major life events and cites advice from Dr. James Sumaru of Samex and the Health Tech podcast about the importance of creating value even when no one is listening. Saadeh expresses gratitude to his audience for their weekly engagement and confirms the content focus remains unchanged.

    Creator business
    1 chapters

  • · 11m

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

    Subhi Saadeh, founder of Let's Combinate, analyzes the 2026 update to PIC/S PI 006-4, the first major revision to qualification and validation recommendations in nearly 20 years. He details how the document shifts from the 2007 PI 006-3 standard toward a lifecycle approach with stronger Quality Risk Management (QRM) and explicit statistical requirements for sampling and process capability. Saadeh highlights the removal of the rigid 'three-batch rule' and the clear distinction between Continuous Process Verification (CPV) for initial validation and Ongoing Process Verification (OPV) for routine manufacturing.

    Certification & compliance
    1 chapters

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