Acist (Advanced Contrast Imaging System Technology) is a medical-device company that specializes in developing contrast injection systems in the fields of cardiology and radiology. Acist’s devices infuse dye into the vascular system, letting physicians visualize anatomies.
Additive manufacturing is exploding on the manufacturing scene as leading companies are transitioning from “analog” to “digital” manufacturing in order to recognize cost saving and design benefits not possible through traditional manufacturing , said Dave Burns, President and COO of ExOne.
Substantial legal requirements result in more complex functional specifications for the implant manufacturers: From the design, including the materials, through production, the complete process chain must be documented and validated. CNC-controlled high-tech machines support the prosthetics manufacturers and permit high-quality products to be manufactured, despite being subjected to the continuing high cost pressures.
The Biomedical Research Institute BIOMED located at Hasselt University in Belgium, in conjunction with Orbis Centre in Sittard-Geleen, Xilloc Medical BV located at Maastricht University and Cam bioceramics BV in Leiden have managed to successfully remove the lower jaw of an elderly woman and replace it with one created with 3D printing. While artificial parts built via 3D printing are nothing new in the world of surgery and reconstructive surgery in particular, nothing as sophisticated as a lower jaw had ever been successfully implanted into an elderly patient through such a process.
Why isn’t identifying the right ball spline for an application straightforward and easy? Demystify the semantic differences in the literature and it will, at least, be easier. We’ll do this by thinking of ball splines in terms of how their various configurations affect their functions and then compare their functionality to application requirements.
As the frontier of medicine continues to push new limits, device manufacturers strive to not only keep pace, but to lead the pack with new healthcare solutions. Companies know that perpetual innovation is key to staying ahead of the competition and continually leverage their time and resources to optimize product development to ensure their success and sustainability in this dynamic market.
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.
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.
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.
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?
Question 1: What are the common missteps OEMs make when planning a testing solution for their medical devices?
Question 1: What is the most significant challenge in the miniaturization of medical electronic devices?
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.
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.
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.