ARTICLES BY ERIC LARSON
Medtech Material Selection For Performance And Feel
When designing a medical device, material selection can be difficult, especially with thousands of plastic material options available. While material properties, environmental effects, regulatory requirements, and cost almost always are considered, "feel" is often overlooked – despite its importance to user and patient satisfaction, as well as market success.
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Medical Plastics: Material Selection Based On Feel
From prioritizing material properties to establishing desired values for each property, selecting plastic materials based on feel is a complicated undertaking. To elicit the most desirable user response from the device, it can be helpful to consider the what, rather than the how.
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09.01.26 -- Optimize Your eQMS And Strengthen Quality Systems
09/01/26 Med Device Online Newsletter
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The New Reality Of Particulate Risk: What Drug Manufacturers Need To Know
Particulate-related recalls account for 37% of US FDA injectable drug actions, and evolving FDA and EU GMP requirements are raising the compliance bar for manufacturers.
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Planning For Scale Up: Building For Long Term Flexibility
Decisions made during clinical manufacturing have lasting consequences at commercial scale. This article examines how fill/finish equipment choices shape long-term flexibility, throughput, and operational continuity.
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Minimizing Particulate Risk: Designing For Control
Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.
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Protecting Your Drug Product: Integrating Engineering And Quality
Engineering decisions in fill/finish directly shape product quality and sterility assurance. This article examines how inert gas purging, plunger placement, dosing verification, and barrier systems interact across line design.
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Establishing A Container Closure System — Engineering For Integrity
CCS design in aseptic manufacturing involves more than component selection. This article examines how elastomeric closures, barrier configurations, component formats, and plunger placement affect integrity and line performance.
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Start Packaging Development Early: De-Risk Before You Build
When packaging development follows fill/finish line selection rather than informing it, teams face avoidable retrofits and delays. This article examines why earlier alignment changes outcomes.
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Navigating The New Era Of Design Controls For SaMDs: A Strategic Guide
This article explores the current state of design controls for software as a medical devices (SaMDs), focusing on the FDA’s recent regulatory shifts, the integration of Agile methodologies, and the evolving landscape of AI/ML.
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