Hardware Podcasts

223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations

Let's Combinate · 21 Jan 2026 · 9m

What this episode covers

Subhi Saadeh, host of Let's Combinate and founder of Let's Combinate BioWorks, breaks down the 2025 draft update to the ICH Q1 stability guideline, explaining that the new 100+ page document consolidates legacy guidelines rather than introducing new science. She outlines core stability concepts such as time-dependency, the supportive role of accelerated aging, and the critical link between container-closure systems and product quality. Saadeh specifically addresses how ICH Q1 applies to drug-device combination products, noting that while shelf life is driven by the drug, device materials and in-use conditions significantly impact stability.

Most relevant to

established companies

Topics

Mentioned

Companies
Let's Combinate BioWorks
Also
ICH Q1, ICH Q5C

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 38m

    #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    Subhi Saadeh, host of the Combinate Podcast and expert in combination products, discusses the regulatory complexities of integrating drugs, devices, and biologics, including the differences between US FDA and EU regulatory pathways. He explains the definitions of single entity, co-packaged, and cross-labeled products, and addresses common misconceptions about the differences between drug and device quality systems. Saadeh also shares his journey of starting the podcast to maintain consistent learning and production, highlighting the importance of lifelong learning and leveraging coaching to balance technical and business aspects of the MedTech industry.

    Medical & health devicesCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 45m

    #446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss

    Dr. Kristy Katzenmeyer-Pleuss, President of KP Medical Device Consulting, explains how manufacturers often overlook critical phases of the medical device life cycle, such as transportation, shelf life, and decommissioning, focusing too narrowly on patient use. She highlights the impact of the upcoming ISO 10993-1:2025 standard on biological evaluations and warns that devices approved in the EU may face unexpected FDA deficiencies regarding 'worst-case' testing for reusable or in situ curing devices. Dr. Katzenmeyer-Pleuss advises narrowing material suppliers and reprocessing options in the Instructions for Use (IFU) early to reduce testing burdens and emphasizes integrating quality systems to capture learnings across a company's portfolio.

    Validation & product-market fitQuality & yield
    7 chapters

  • Global Medical Device Podcast · 37m

    #445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech

    Thor Rollins, a leader at Nelson Labs and convener of the ISO committee revising ISO 10933-1, explains the 2025 standard's shift from checkbox testing to a risk-based approach aligned with ISO 14971. He details new requirements for lifecycle evaluation, particularly for reprocessed devices, and the concept of biological equivalence to reduce redundant testing. Rollins also discusses the US's rejection of the draft due to lack of guidance, the upcoming technical specifications, and practical advice for companies at different stages of development.

    Certification & complianceMaterials & manufacturing processes
    8 chapters

  • Global Medical Device Podcast · 35m

    #467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment

    Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), explains the regulatory complexities of combination products, focusing on how the Primary Mode of Action (PMOA) dictates FDA oversight. He details the challenges pharmaceutical companies face when integrating device Quality Management Systems (QMSR/ISO 13485) into their existing CGMP frameworks under 21 CFR Part 4. The discussion covers specific friction points like risk management alignment (AAMI TIR105 vs. ICH Q9), labeling classifications, and the critical need for transparent change control protocols between device manufacturers and pharma partners.

    Certification & complianceDesign for manufacturing & NPI
    8 chapters

  • Global Medical Device Podcast · 29m

    #418: Biocompatibility Brief - What Medical Device Companies Need to Know

    Marina Daineko, a MedTech expert and chemist specializing in biological evaluations, explains the critical importance of integrating biocompatibility into a company's Quality Management System (QMS) rather than treating it as an isolated task. She details the necessity of analyzing raw data, such as the silver ion cytotoxicity anomaly, and distinguishing between extractables and leachables to assess cumulative risks for long-term implanted devices like the Ishur contraceptive. Daineko emphasizes that the revised ISO 10993-1 standard drives a shift from reactive testing to proactive risk assessment, requiring cross-functional communication to ensure patient safety throughout the device lifecycle.

    Medical & health devicesQuality & yield
    8 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.