Ensuring compliance with IEC 60601-1 is simply a must for every medical device manufacturer. However, with revisions and updates, it’s difficult for a company to ensure they are constantly in compliance unless they have a dedicated expert on staff. Therefore, an excellent solution for this challenge is to partner with a company that is exactly that—an expert on the standard.
The demand for less invasive devices is persistently growing, putting the pressure on engineers to put forth quality, innovative products, all while staying ahead of the competition. ER and surgical robotics and minimally invasive devices are currently holding the spotlight, seeing some of the most promising growth and innovation.
In an environment that requires ever increasing cost cutting measures, supply chain stability, and manufacturing flexibility, the contract manufacturer can be a critical partner in the financial success of a legacy device that is still enjoying profitability or in the launch of a brand new innovation that has beat the competition to market.
Innovative control technology offers medical professionals and technicians the potential to do much more with diagnostic imaging equipment. This article looks at intuitive controls that can be used for radiological applications that offer an interface much closer to familiar consumer devices.
As processing speeds in electronics continue to rise and packaging continues to shrink, sensitive internal components are located closer and closer together. Higher clock speeds coupled with increased density of components leads to increasing amounts of electromagnetic interference and radio frequency interference noise.
Through the use of advanced CNC machine technology, one manufacturer of prosthetic and orthotic devices is making substantial improvements to its production. Otto Bock, a leading supplier of these devices based in Germany, worked in cooperation with the CNC carving machine builder, Bornemann, to produce a series of machines...
The field of Tissue Engineering, an interdisciplinary field focused on building or regenerating functional three-dimensional tissues, has deployed several fabrication strategies aimed at bringing cells and structure together to generate tissue.
Medical technology continues to grow smaller, yet remains robust, delivering an array of features that help enhance the level of care provided. One challenge is in powering these devices while keeping in mind the trend toward miniaturization. This article looks at lithium technology options and reviews the offerings of each type for medical devices.
The welding of plastics using laser technology enables the rapid, clean result medical device manufacturers want. However, when welding clear or translucent plastics, additives must be used in order for the bond to occur. That is, until now. New laser technology enables these types of plastics to be welded without any additives being used.
Rapid prototyping must accurately portray what a completed design will entail, and how a completed design will function. The product may even need to mirror injection molded parts. Enter cast urethanes. This article highlights the benefits of using this technology for prototype parts as well as short run productions.
While options may be limited overall, selecting the right package testing laboratory can still be critical for a medical device manufacturer to ensure a timely and on-budget product launch. Therefore, keeping the following five considerations in mind when going through the selection process can make a significant impact on a company’s success.
Micro molding can provide an excellent alternative for designing and manufacturing medical devices used in minimally invasive surgery. Micro manufacturing processes overcome the limitations of established technologies, facilitating smaller components, incorporating complex features, reducing the number of components, eliminating outdated processes, reducing manufacturing costs, and increasing production yields.
Medical device product development teams are often asked to develop new features for new devices or updated generations of existing devices. Often, due to cost or resource restrictions, a decision needs to be made between including one feature versus another.
Today’s medical staffs increasingly rely upon wireless networks and devices to conduct critical-care applications, access electronic medical records and test results, and to share information throughout facilities. At the same time, Wi-Fi networks in healthcare facilities are being pushed to the limits by the Bring Your Own Device (BYOD) trend among patients and guests.
The FDA and Department of Homeland Security recently issued an alert urging medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats. This came in response to an ICS-CERT publication of a list of more than 300 devices with hard coded passwords.