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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Safeguarding Your Supply Chain
Medical device firms need to leverage track-and-trace technologies to help ensure reliability. 
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Realizing Production Efficiency Through ERP Solutions
Medical product outsourcers share insights and best practices through a survey of manufacturers that’s centered around their outlook for 2020.
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5 Tech Investments for Accelerating Medical Device Manufacturing Growth
Companies growing at 10 percent or higher year over year share their insights via an industry survey.
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Agility Helps Core Technology Thrive in the COVID-19 Market
How one supplier was able to meet spikes in demand as many employees worked from home..
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Validating Your QMS the ‘EZ Way’
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Securing approval for an eQMS solution is only the beginning; ensuring it’s properly installed and set up is arguably more significant.

Pathways to Care: Tubing Technologies
Tubing is incorporated into a variety of medical technologies, which is why the demands on manufacturers of the components are increasing substantially. 
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Well Over a Decade Later…
The Saga of Non-DEHP PVC and Medical Devices.
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Illuminating Insights: An eBook Exclusive
Medical tubing experts from Spectrum Plastics share their thoughts on topics from materials to multilumens.
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The Effect of Crystallinity on PEEK Performance in Extrusions
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Challenging Channels: Tubing Innovations Enable Greater Device Capabilities
Technical innovations provided by tubing suppliers fulfill the various needs of medical device manufacturers.
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The Science of Multi-Layer Extruded Tubing and Medical Devices Incorporating Such Tubing
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Illuminating Tubing's Future
Supply chain considerations and Industry 4.0 could help shape the tubing marketplace for future medical devices.
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Practical Matters
Changing healthcare regulations and hospitals' war on germs are driving innovation in medical device materials.
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Extruding Solutions for Medtech
As medtech OEM demands of extruders increase, materials, technlogies, and processes help answer the call.
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Go Out There and Show Them What You're Made Of
Whether traditional, tunable, or completely new, manufacturers want their medical materials to do it all.
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To Tubing's Limits
Today's medical device companies want custom tubing that stretches manufacturing's capabilities.
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Providing the Tools to Ensure Success is a Highly Regulated Industry

Five Strategies to Reduce Liability
A quality management system can provide the tools to enable an OEM to maintain focus on its core business.
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Software’s Coming of Age
Successful software integration is the key to reaching higher quality and lower costs.
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ISO 13485:2016—Are Your Suppliers Ready?
The ISO standard has been released and manufacturers need to ensure their supplier quality-related procedures are compliant.
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Compliance Challenges: Avoiding the Potential Dangers of QuickBooks and Spreadsheets
Implementing an ERP solution early can allow it to scale with the company as the bussiness gros and needs increase.
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How a Lack of Streamlined, Electronic Data Puts Your Medical Business at Risk
A comprehensive ERP solution can help companies address FDA compliance and CFR regulations.
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How Excelling at Cost of Quality Accelerates Company Growth
Four takeaways from a McKinsey study offer insights on the correlation between high product quality and revenue.
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