FEATURED EDITORIAL
Lilly's Unified Mindset For A Global Parenteral and Device Manufacturing Network
Eli Lilly and Company's one-team mindset aims to templatize facility design while remaining nimble enough to react to new manufacturing breakthroughs.
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Supplier quality failures are a leading cause of medical device recalls. This article distills a practical framework for managing supplier quality, from standard off-the-shelf items to custom contract-manufactured components.
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A case study highlighting the importance of drug and device team alignment on control strategy, defining what to control and which controls can and should be implemented.
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Defining combination product CQAs across drug and device enables an end-to-end control strategy that improves product quality from the start of development.
INDUSTRY INSIGHTS
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Package With A Purpose
Packaging shapes how devices are understood, handled, and used. A human-centered approach surfaces critical info sooner, reduces errors, and strengthens safety and usability.
For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.
Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.
Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.
Build regulatory strategy into your company from day one — not as support, but as a core driver of value, risk management, and successful commercialization.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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