Browse Topic: Medical device labeling

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Capturing Unique Device Identifier Data on Non-Sterile Orthopedic ImplantsTBMG-3497008/01/2019
Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier (UDI) Rule, healthcare providers have an opportunity to capture and leverage the data contained in these unique device identifiers (UDIs) to improve the quality of care.
Quality Assurance: Risk Mitigation for Lithium-Ion Battery PacksTBMG-2642502/01/2017
Safety and reliability are the key concerns when determining the right power source for a medical device. Lithium-ion (Li-ion) batteries are often considered for their higher energy density, lighter weight, longer cycle life, superior capacity retention, and ability to withstand a broad range of ambient temperatures. However, with an increasing number of potentially dangerous incidents — including fires and explosions — from Li-ion batteries, quality assurance is more important than ever for error and risk prevention, particularly for medical devices that use these power sources. Having a holistic quality approach across the battery product lifecycle is essential for achieving safe, high-quality, and environmentally friendly products.
The Next Industrial Revolution and What It Could Mean for Medical Device ManufacturingTBMG-2607212/01/2016
The next industrial revolution is on its way. It is bringing innovative technologies that are available and proven and placing them in the modern manufacturing plants. The cloud, the Internet of Things, mobile computing technology, embedded computing, advanced analytical software, and 3D printing all have a part to play in the future of manufacturing. Known as Industry 4.0, this revolution will change the way we manufacture devices by enabling much greater levels of distributed intelligence for greater production autonomy, flexibility, and economy.
Smooth Compliance: Considerations for UDI Labeling InitiativesTBMG-2278809/01/2015
In September 2013, the FDA announced new regulations for medical device manufacturers known as UDI (Unique Device Identifier) that would require all medical devices to bear a label containing specific information by the year 2020. The regulations were designed to phase in over a seven-year period, affecting different classes of medical devices at different compliance deadlines.
Medical Design Engineers Can ‘Make Their Mark’ with Transfer Pad ImprintingTBMG-1929904/01/2014
Eventually, many design engineers who create new medical devices are faced with choosing a method with which to mark or brand their products. At the end of the complex task of creating and vetting a new product, marking is often an afterthought, because, after all, “How hard can it be?” However, as many discover over time, marking is one of those details that bears some deliberation. Whether it’s a logo impression, color identification on an instrument, or graduation marks on catheters or guidewires, imprint precision, image crispness, and permanent adhesion are extremely important. There are several effective ways to mark a product, but there are limitations.
The FDA’s UDI Rule is Final: What’s Next?TBMG-1875812/01/2013
The U.S. Food and Drug Administration (FDA) published the final rule for the unique device identification system (UDI) during the UDI Conference in Baltimore, MD, and released it on September 24, 2013. This much anticipated rule will provide a consistent way to identify medical devices and ensure that proper safety regulations are being followed. The rule was established to improve the quality of information in medical device adverse events reports and assist the FDA in determining issues with medical devices as they arise. Now that the rule has been set, medical device manufacturers need to ensure they understand the rule so they can properly comply with the regulation.
Speeding the Path to CommoditizationTBMG-1656506/01/2013
Over the past decade, the power of physician preference has steadily diminished in the face of hospital and physician consolidation, continuing pricing pressures, and structural changes in payment systems brought about by US healthcare reform. While physicians continue to exert strong influence over health system purchasing decisions, they’re no longer the only game in town — and they’re facing increasingly stiff headwinds.
Eye on the Medical Device Industry: Technology Is Key to ComplianceTBMG-1618004/01/2013
The medical device industry is a highly competitive arena, and earning market recognition depends on the ability to keep innovating. To remain competitive, medical device companies are pushing products out the door to be the first to market while working on the next best thing.
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