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Extending IEC 60601-1 Type Testing to Production

July 10, 2012 2:54 pm | by Jeff Lind | Compliance West USA | Comments

Manufacturing tests can help OEMs to meet cost, quality, and delivery objectives. Rather than limiting certain tests to the design or initial stages of the product development process, conducting them throughout production can help to ensure a smooth approval process. Additionally, performance benchmarks that are obtained from the testing procedures can aid in monitoring product reliability.

5 Factors to Identifying the Best Leak Tester for You

July 10, 2012 2:46 pm | by Joe Pustka | Uson, L.P. | Comments

The laws of physics that determine the best match leak test methods have not changed. What has changed is the technology available—both the leak testers and the automation for full or semi-automated test and assembly machinery—that make one or another leak tester the best match technology. This article reviews five factors that need to be considered to ensure the best choice is made.

60601 3rd Edition Transition Solution

July 10, 2012 2:26 pm | by UL Staff | Underwriters Laboratories Inc. | Comments

While many companies are concerned with the impact the 3rd edition of IEC 60601-1 will have on their medical device products, what they first need to determine is which products will actually be impacted. Preparing products for the new standard does not need to rely heavily on valuable resources. This article looks at the considerations prior to transitioning a product for the new standard.

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Roundtable Q&A: Materials

July 10, 2012 2:09 pm | Materion Corporation, Momentive Performance Materials Inc., Polyzen, Inc. | Comments

This month, insights on materials topics—desirable benefits, development focus, and influence on design—are shared. Question 1: Beyond the physical characteristics, what benefits are medical device manufacturers most interested in when selecting a material?

Roundtable Q&A: Testing & Inspection

July 10, 2012 2:01 pm | National Instruments Corporation, Intertech Development Company | Comments

Question 1: What are the common missteps OEMs make when planning a testing solution for their medical devices?

Roundtable Q&A: Medical Electronics

July 10, 2012 1:43 pm | Logic PD, Inc., Freescale Semiconductor, Inc., Microchip Technology Inc., Minnetronix, Inc. | Comments

Question 1: What is the most significant challenge in the miniaturization of medical electronic devices?

Machining Critical Features into Stamped Parts can be a Cost-Effective Option

July 10, 2012 1:27 pm | by Mike Vanadestine and Robert Allen | Connecticut Spring & Stamping | Comments

For one Connecticut manufacturer of close tolerance precision stamped and coiled metal parts, an 8-year journey to provide its customers with higher precision parts from progressive tools has reached a happy ending, with the incorporation of in-house CNC machining that allows them to stamp parts at a very low cost, and then machine crucial features into them.

A Guide to Forming Strategic Partnerships to Gain a Competitive Edge

July 3, 2012 1:42 pm | by James Field | Celestica, Inc. | Comments

Fierce competition, economic pressures and increasingly stringent regulatory requirements are motivating medical device manufacturers to uncover new ways to introduce products efficiently while remaining tightly focused on the innovations that drive success. At the same time, manufacturers want to cost-effectively extend the lifecycle of product lines to maximize return on investment.

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Low-mass solution to 'tombstone' dilemma is identified

July 3, 2012 1:29 pm | by Eric Reno | Suntron Corporation | Comments

Electronics manufacturers share a common goal: to produce the highest-quality product possible. What they don't always share are the processes required to achieve that goal. To ensure that quality is maintained from start to finish, the cost of marginal quality is constantly monitored and evaluated, especially with regard to internal process controls. Recently, component "tombstone," a recorded internal process control defect, has emerged as a matter of growing interest.

Manufacturing Source Provides Product Enhancements And Precision Machining Of 22 Different Components

July 2, 2012 4:36 pm | by Liam Quirke | Marshall Manufacturing | Comments

Marshall Manufacturing Company was chosen by Dr. Emil Verban to manufacture the patented Drillstops®, which increase the safety and precision of dental implant procedures. In use, a tiny set-screw locks the stop to the drill bit, the stop rotates with the drill bit while avoiding tissue damage as the drill penetrates the bone.

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Reduced Cabling Means No Signal Error for Ultrasonic Equipment Testing

July 2, 2012 4:05 pm | by Hack Summer | Comments

From prenatal exams to torn ACLs, ultrasound imaging for medical purposes is used to visualize muscles, tendons, fetuses and internal organs. The technology for imaging has been around more than fifty years and has become one of the most common, non-invasive diagnostic tools in the medical industry. Testing the ultrasound machinery is an intricate process with a high need for accuracy. For this reason, one of the largest international medical diagnostic equipment manufacturers for ultrasound imaging machinery trusts the Moog Animatics SmartMotor on their testing equipment. The SmartMotor was able to supply the precision motion control with the least amount of electrical noise (electrical noise interferes with ultrasound beam alignment).

Laser Seam Sealing of Electronic and Opto-electronic Packages: A welder’s tips for getting beyond 99 percent yield

July 2, 2012 9:39 am | by Dr. Geoff Shannon | Miyachi Unitek Corp. | Comments

Seam sealing is the process that permanently bonds the package and lid of a device, providing a barrier for the internal components for the device’s operational lifetime. This is typically the last critical step in the package manufacturing process, so it is among the most important.  The completed product performs a vital function and has a high dollar value, so creating a barrier to contamination ingress is essential. The stakes are high – optoelectronic packages for fiber optic cables transmitting signals sometimes in the middle of the ocean must last for a very long time since replacement is difficult and costly. Similarly, aerospace RF/microwave packages perform essential functions, making it imperative to prevent external environmental conditions from penetrating the package, even in extremely aggressive environments.

Applying Tech: Cardiovascular

June 27, 2012 5:38 pm | Comments

How are you influencing cardiovascular devices?

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RTP Company's Glow-in-the-Dark Masterbatch Helps Medics Save Lives

June 27, 2012 8:46 am | by Tim Duncan | Rtp Company | Comments

When the inventors of the Rip Shears Ripper received feedback from medics in the field that their life-saving product would be even more effective if it glowed in the dark, they and co-developer ICON Injection Molding, sought assistance from custom...

Buy it or Build it? The Great Start-up Dilemma

June 20, 2012 11:23 am | by Pat Pickerell | Peridot Corp. Precision Manufacturing | Comments

Whether venture capital or angel-funded, medical device start-up companies are often brought to life by doctors with big ideas who have found a quicker or more effective way to treat a particular pathology. Many of these doctors are entrepreneurs at heart and are most happy when immersed in the adrenaline rush of a new start-up. But no matter how novel the device, the passion and zeal behind that drives these new medical innovations must be channeled into a process that will make the idea a commercial success.

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