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The Prototyping Challenges with Micro Molding: A Comparative Study of Prototyping Methods for Micro Molding Applications
4/27/2011
The goal of this paper is to discuss the various methods, challenges and variables for prototyping micro-sized and/or micro-featured plastic parts. It is also important to recognize that every part design is different...
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What is Micro-Molding?
4/27/2011
There seems to be a lot of talk these days about micro-molding. This reflects the increased interest from designers and manufacturers in producing and procuring high precision, micro-featured plastic parts. The result...
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Process Validation 101
4/19/2011
Attribute sampling is based on the confidence level and quality level. For example, to be 95% confident of a minimum 95% yield, the minimum sample size would be 58.4 units, which is rounded up to 59 units....
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Case Study: Vertical Integration Accelerates Speed to Market
4/19/2011
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Case Study: Bringing an Entire Product Line to Market
4/19/2011
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Case Study: Improving a Device and Accelerating Speed to Market
4/19/2011
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Fiber Laser Welding of High Integrity Implantable Medical Devices
LaserStar Technologies Corporation
4/6/2011
Medical implantable devices like pacemakers, ICDs and leads are progressively becoming more compact and lighter. Some of the components used for hermetic and structural welding are still large and thick enough for...
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Enabling 21 CFR Part 11 Compliance
4/5/2011
The Food and Drug Administration’s Code of Federal Regulations Title 21 Part 11 (FDA 21 CFR Part 11) helps streamline compliance with a wide range of FDA regulations by supporting FDA regulated industries in their...
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Are You Ready to Build Fighter Jet Rigor into Your Medical Devices... and Save Money Doing It?
4/5/2011
Orthopedic manufacturers are always looking for ways to expedite product design and revision. They would also like to refine their processes according to contemporary form-centric design principles. The story of...
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Overview of a Parametric Release Validation for EO Sterilization
3/30/2011
This TechTip provides an overview of the validation process for parametric release of an ethylene oxide sterilization cycle, including: differences between traditional biological monitoring and parametric release, steps...
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Medical Device Quality Systems Demystified: Why Companies Need Best-of-Breed ERP, PLM and EQMS
3/17/2011
Intense global pressures, such as more stringent regulatory scrutiny, tax increases and reimbursement challenges are causing stalled top-line growth for medical device organizations and prompting them to find ways to...
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Selecting a Wireless Technology for "Medical-Grade" Foot Controls
3/15/2011
Historically medical device manufacturers, requiring a foot control as a human interface, have used a cabled unit that would plug-into the console of the device being operated. Until recently, a “cabled...
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A Holistic Approach to Product Introduction and Change Processes
2/25/2011
The world's leading medical device companies are focused on delivering new products that improve patient outcomes and enable the medical community to deliver the best possible patient care. In today's...
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Custom Cable Is Here to Stay
2/23/2011
When design engineers who need special cable constructions hear the word custom, they often cringe, conjuring up dollar signs and delays. That doesn’t have to be the case anymore. Due to customer feedback and...
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Developing Diagnostic Products Using Polymer Laminate Technology
2/18/2011
In the development of newer molecular and immunodiagnostic products, panels of tests are launched on a single platform. To accomplish this, complex fluid circuits that perform sample preparation and sample distribution...
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Single-Use Systems - Show Me the Green! Economic and Environmental Benefits of Single-Use Systems
Value Plastics, A Nordson Company
2/16/2011
About a decade ago, the debate about Single-Use Systems (SUS) vs. traditional stainless-steel was just a whisper: reusable steel was favored because it was the system that process designers and users had relied on for...
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Next-Generation Packaging for CRM Applications
1/31/2011
The medical profession is conservative and changes slowly; and rightly so. With the lives of patients on the line, conservatism goes hand in hand with proven safety and efficacy. But with the current healthcare...
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Spotlight on Medical Device Manufacturing: 6 Ways to Justify Prices and Rein in Costs with Enterprise Software
1/24/2011
Medical device manufacturers have long marketed their products with limited concern for costs. But today, an aging population and skyrocketing medical costs are prompting private insurers and government payers worldwide...
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Size, Reliability and Security: The Essential Ingredients for Medical Devices
1/21/2011
Improved electronics technology will bring a new generation of devices that provide portability, connectivity, lower cost and data security. This whitepaper, which also includes several application briefs, describes how...
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The Critical Questions When Micromolding for an MIS Device
1/13/2011
Asking the right questions when selecting a high performance plastic for micromolding an MIS device could reap some great competitive advantages. This article will review the micromolding process and cover the important...
