Ebook

Using Real-Time Data to Drive Continuous Improvement
Through the use of a real-world example, this article illustrates the process for using data to realize continuous improvement opportunities.
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Continuously Improving New Product Development in Medical Device Manufacturing
To stay competitive, medical device companies and their contract manufacturers must find ways to continuously improve their new product development—getting to mar- ket faster than competitors while also ensuring quality.
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5 Strategies for Managing Medical Product Supply Chain Uncertainty
Utilizing real-time data to deliver customers’ orders on time—while ensuring quality and maintaining margins.
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The Case For Just-In-Time Inventory Systems in Challenging Times
While too much inventory may be an invisible cost, a more obvious problem is the opposite condition—running out of inventory when it is needed.
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EO Optimization and Potential Effects on Sterile Barrier Packaging
Ethylene oxide (EO) is the most common medical device sterilization modality. About 50 percent of sterile medical devices on the market are sterilized with EO.
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Patient-Specific Implants Often Require More Testing
His name may not carry the notoriety of Robert Jones, Hugh Owen Thomas, or even Sir John Charnley, but Duncan Dowson is nevertheless an orthopedic icon in his own right.
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Extractable Chemical Characterization and Risk Assessment: What Is the Worst-Case?
While you may not want to think of the words “worst case” relating to your product, these words are critical in designing a chemical-characterization study and assessing those results in a toxicological-risk assessment.
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Understanding Biological Evaluation Plans
According to ISO 10993-1:2018, “the biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971.”
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What Cleaning Procedure Should You Have in Place for Your Reusable Device?
ISO 17664:2017 provides guidance on this issue and states that “At least one validated automated cleaning method (which may include a validated manual cleaning method as part of the automated cleaning validation) shall be specified unless the medical device cannot withstand any such process, in which case a statement shall be provided which alerts the user to this issue.”
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Four Important Things to Know About Particulate Testing and Medical Devices
Particulate testing is required for medical devices to ensure patient safety, but there isn’t a lot of guidance available. Here are four important things you need to know about particulate testing on medical devices.
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Cast in a Different Mold: A Medical Molding Roundtable
This mainstay in medical manufacturing is subject to material and technology advances as well as competition from newer fabrication methods.
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Little Big Parts: Micromolding Under the Microscope
Changing healthcare regulations and hospitals’ war on germs are driving innovation in medical device materials.
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Spectrum Plastics Group Announces Building Renovation & Cleanroom Expansion at Minneapolis Facility
Spectrum Plastics Group is excited to announce a significant renovation and cleanroom explansion project at its Minneapolis, MN Facility.
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Medical Device Implantable and Bioresorbable Components and Materials
As implantable medical devices and their components become smaller and complex, their designs become more innovative with enhanced functionality—often the result of carefully engineered advanced materials.
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