While the advent of electronic health data offers impressive potential when it comes to treatment and diagnosis, it brings with it a host of security issues. The issue is cumbersome and often slow-moving regulatory bodies are scrambling to keep up with the quickly changing landscape of the medical world and they’re leaving a path of semi-regulation in their wake.
Nowhere is the concept of developing a system with ‘point-products’ more hazardous than in...
On average, implantable devices account for 30 percent of total hospital supply spend, and make...
Training is extremely important to the future of manufacturing in the United States, yet in many states, it has fallen by the wayside. Training for skilled manufacturing positions has been hit by a perfect storm of budget cuts and the mistaken idea that all young workers should go to college. What training exists has a near-exclusive focus on non-manufacturing skills.
For companies involved in designing and developing medical devices and diagnostic instruments, adhering to design control principles at every stage is critical. This begins with the identification of user requirements (voice of the customer) and continues through verification and validation testing.
Design engineers are charged with creating reliable, high quality, safe medical devices that easily (and quickly) pass U.S. FDA and other geographies’ regulatory requirements. Because of the unique challenges that a medical device OEM must overcome to stay competitive, more and more OEMs are choosing to outsource manufacturing.
Wireless healthcare is upon us. Each day, it seems more devices and technology are becoming untethered or new capabilities are being added to wireless devices. No longer are the applications of wireless devices limited to patient monitoring, but rather an array of therapies are now available for treating patients at home or even on the go.
Critics of the new 2.3% medical device excise tax are hitting new heights with their claims of dire consequences. Conservative blogger and attorney Johnathan Emord blogged that the tax will "wipe out an entire industry," and further asserts that the tax is "one of the most draconian tax burdens in history." What are the facts? Is the industry overreacting?
Unique energy-based surgical devices afford broad clinical use in the cutting, coagulation, and ablation of tissues using a high velocity jet of thermal plasma, and the PlasmaJet surgical system is one example of this medical device evolution. Plasma is formed when sufficient energy is added to remove outer electrons from a gas to form ions.
In an era of intense media pressure, growing patient power, and escalating litigation, it is extraordinary that so many medical device recalls are due to labeling errors. After years of robust, highly compliant medical research and product design, ensuring the correct information is included with each device should be a given.
Miniaturization of medical devices is dependent upon the reliability of their assembled components, which is crucial for proper functioning devices. Miniaturization creates material challenges—especially in electronic medical device applications such as implantable cardiac devices.
It is a well-known fact that innovation is the true lifeblood of a medical device company. In an industry where approximately 80 percent of revenue for a medical device company comes from products introduced in the last five years, strategic growth requires continuous and efficient innovation.
Many manufacturing facilities have opted to follow the path toward a “5S” workplace organizational and housekeeping methodology as part of continuous improvement or lean manufacturing processes. 5S is a system to reduce waste and optimize productivity through maintaining an orderly workplace and using visual cues to achieve more consistent operational results.
Will the OR of the future see robots completely replace human surgeons? While there are some ways in which robots can replace human involvement during surgery, it’s unlikely that robots will completely replace human surgeons. This is because human intuition, reasoning, and experience will continue to be invaluable.
Will the OR of the future see robots completely replace human surgeons? Robotic technologies combined with improved sensors and sophisticated intelligence will make inroads into many aspects of medical care, including surgical centers and operating rooms.
Engineers and buyers in the medical device manufacturing industry should note the following date: July 22, 2014. That is the day medical electronics must comply with the EU’s Restriction on Hazardous Substances (RoHS) regulation. Medical devices have so far been exempt from RoHS, which requires the elimination of lead, cadmium, mercury, and other substances from electronics.
2012 was a year marked by a great deal of uncertainty for medical device manufacturers in the U.S. with several key issues up in the air, including proposed changes to the FDA’s device review and approval process, healthcare reforms, and the medical device excise tax. That said, analysts are still predicting growth in the medical device market, moving forward.
When you are a patient in a hospital, you tend to expect that the electronics are either top of the line or at least functioning correctly. You expect that the devices doctors implant in your body are reliable and safe. These seem like safe assumptions. Unfortunately, you could be mistaken.