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Gap Analysis Techniques for Easy Medical Device 60601 3rd Edition Electrical Safety Testing

August 1, 2013 4:45 pm | by Vincent Crabtree, Ph.D., Project Manager, StarFish Medical | Comments

In Part 1 of this blog, I’ll describe the background and approaches we at StarFish Medical took for more modern devices with a comprehensive technical file, with five top tips. In Part 2, I’ll describe how we recertified for older devices where the design documentation was less comprehensive, with seven top tips.

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Made in China…But at What Cost?

July 31, 2013 4:56 pm | by Sean Fenske, Editor-in-Chief, MDT | Comments

When it comes to business and manufacturing, I have to admit, I’m not always the “Rah! Rah! USA!” guy. As a consumer, I believe in getting the best product for my dollar, regardless of where it is made. My mother used to continue to buy U.S. cars because she believed in “buying American” even though each and every car she got would give her some sort of mechanical problem for a significant amount of the time that she owned it.

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A Drug Delivery Technology Revolution

July 31, 2013 4:18 pm | by Tristan Sedgwick, Marketing Communications Manager, Farm | Farm | Comments

These are exciting times in the drug delivery industry. A host of new delivery platforms is in development, some of which have recently reached the market. The primary goal of these developments is to create systems that optimize a drug’s therapeutic value, but it’s also believed that finding better ways to get a drug into a patient’s system in a safer and more consistent way will lead to better compliance and outcome.

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Surface Mount Technology vs. Workstation Design

July 30, 2013 4:55 pm | by Jim Norton, President, Custom Products & Services Inc. | Comments

In today’s modern electronic SMT assembly facilities, the design and flexibility of the workstation is critical to maintain quality, workflow, and ergonomics. Unlike the old, static, welded frame workstations of the past that were never moved or reconfigured, the modern workstations now incorporate a modular, flexible, adaptable design with a wide variety of options that allow tremendous flexibility.

Color Retention in Materials Can Ease Patients’ Minds

July 29, 2013 12:47 pm | by Gopal R. Saraiya, Global Segment Leader, Medical Devices, Eastman Chemical Company | Eastman Chemical Company | Comments

The highly aggressive sterilization methods used on medical devices to help combat healthcare-associated infections (HAIs) are harsh and can cause color shift. Medical devices that become discolored from sterilization can comprise patient safety and public peace of mind.

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Addressing UDI Compliance with Direct Printing

July 23, 2013 5:10 pm | by Rachel Hammer, Product Manager, Roland DGA Corp. | Roland DGA Corporation | Comments

As a manufacturer, the UDI rule allows us to take more than 30 years of experience in the development of marking and imaging technologies to satisfy a critical need in a new market. In terms of assisting our customers in their efforts to become compliant, we now offer the MPX-90M impact printer.

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The FDA’s UDI Rule Is Coming…Ready?

July 23, 2013 5:05 pm | by Scott Pugh, Vice President, Solution and Service Innovation, Verify Brand | Verify Brand, LLC | Comments

The FDA UDI rule will standardize the way the medical device industry identifies its products, which is a foundational step toward utilizing companies who offer higher value, more complex solutions. Engaging these solutions is critical to helping manufacturers secure supply chains, deter counterfeiting, and ensure patients have access to safe medical devices.

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Lasers Address UDI Needs

July 23, 2013 4:57 pm | by Thomas Burdel, National Sales Manager TruMark, TRUMPF | Trumpf Inc. | Comments

In reference to the UDI rule, the FDA estimates more than 1,200 companies are in need of equipment or have already implemented direct part marking into production. Of the 1,200 companies, roughly 700 are medical implant manufacturers, while the remaining 500 produce multi-use devices, such as surgical instruments.

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‘Standards’ for Home Healthcare

July 23, 2013 4:44 pm | by Todd Konieczny, Assistant Chief Engineer, Americas Region; Technical Manager, Medical Division, Intertek | Comments

The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”

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Encouraging Patient Compliance Through the Device

July 22, 2013 2:02 pm | by Yusuf Shirazi, Founder & CEO, Usability.Pro | Usability. Pro | Comments

Encouraging compliance is a critically important—and often overlooked—aspect of a product’s design. Compliance is relegated to a discussion between patient and caregiver, but I believe the device should play an active role. First, the user experience must be friendly.

Complete Understanding of Device is Key to Testing Success

July 18, 2013 3:00 pm | by Maciej Jakucki, Associate Director of Engineering Operations and Team Leader, Medical Device Testing, Accutek | Comments

From a test engineer’s perspective, understanding final requirements, application, and quantifiable goals for testing before a protocol or test plan is executed is crucial to the success and efficacy of a device used directly by the patient.  

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Questions to Ask Prior to Designing for Patients

July 18, 2013 2:30 pm | by Al Ng, Director, Engineering—Linear Bearings & Guides, Thomson Industries | Thomson Industries | Comments

One recurring challenge in designing products for use directly by the patient is the difficulty in predicting long term aspects and the impact of a given medical device on a diverse group of users due to their varied characteristics and sensitivities, as most new medical technologies have limited information related to their long term results and side effects.

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Sensing Success: Designing in the Right Sensor

July 16, 2013 3:21 pm | by A.J. Smith, Director of Product Marketing, Honeywell Sensing and Control | Honeywell Sensing And Control | Comments

The biggest challenge for many medical device designers is selecting sensors that can help them optimize designs for size, cost, and complexity. A modular sensor design provides a single device that can be optimized for a variety of markets or customers, enabling a designer to select the right sensor with the appropriate functionality.

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Achieving Design Success via Communication in the Value Chain

July 16, 2013 3:03 pm | by Jonathan Martha, Medical Segment Manager, Portescap | Portescap | Comments

In today’s global market, lack of effective communication through the value chain is the greatest obstacle to successful home device design. To gain an advantage in the market, OEMs are continuously outsourcing component design and procurement. By doing so, OEMs increase the number of different entities involved in the value chain.

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A Breakdown of the Top 10 Critical RoHS2 Requirements

July 15, 2013 3:42 pm | by Katina Kravik, CEO, Northwire-NWI Lab360 | Comments

While legal enforcement dates for RoHS2 compliance is July 22, 2014, Northwire, a leading OEM, is alerting their valued customers in medical equipment manufacturing of the critical details to make certain they comply with CE-mark. Originally published in July 2011, the Recast RoHS Directive dictates that all medical devices, electrical and electronic OEMs comply with new standards.

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