Should the FDA review process be more relaxed in favor of faster review times at the expense of potentially greater impact to the well-being of patients when a device does fail?
Ensuring the medical device packaging is sufficient to meet the needs of all challenges during a device’s journey is as important as the integrity of the device itself. This article outlines four key considerations OEMs need to address in order to ensure they are establishing a solid foundation upon which to build their package testing program.
The quality of 2D imaging has improved significantly over the years. However, it still cannot compare to the wealth of information that can be ascertained from viewing a 3D image. New technology offers 3D imaging results from traditional 2D equipment.
The “futuristic” technology of lasers is not so far fetched anymore. In fact, most don’t give them a second thought. They are used in a variety of industries, including both the manufacture of medical devices and in the finished devices themselves. This article reviews the critical role of lasers in the development of orthopedic implants and the key role they serve.
Medical Device Manufacturers’ business needs have changed significantly over the past several years, evolving the roles that technology plays within their manufacturing process. Two key technologies, Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM), have developed into critical success factors for these manufacturers.
The ATW Companies (A. T. Wall Company, located in Warwick, RI, Judson A. Smith Company, located in Boyertown, PA, and Parmatech Corporation, based in Petaluma, CA.) have found a niche as a valuable resource and strategic partner with its customers, rather than simply a supplier. By focusing on the factors driving its customers’ business and communicating with them to solve their problems, the firm has earned a reputation for making its customers successful.
The recent federal announcement of its $547 million grant release to facilitate Health Information Exchanges (HIEs) at the state level seems like new life is being given to the data exchange landscape.
When design engineers who need special cable constructions hear the word custom, they often cringe, conjuring up dollar signs and delays. That doesn’t have to be the case anymore. Due to customer feedback and overseas competition, progressive manufacturers have adapted to make custom cable solutions accessible.
Electronic medical devices, especially those that come into contact with the human body, are at risk for electrostatic discharge (ESD.) Inadequate protection may damage the IC or interfere with communications critical to patient care. This article shows how to choose an ESD device that will give the best chance of a successful first pass design.
What is scaled manufacturing? Scaled manufacturing takes a medical device idea or concept from prototype to production in quantities required to meet customer demand with absolute consistency and reliability. Because of the competitive advantage scaled manufacturing offers, product designers can expand or retract supply with minimal effort, cost, or infrastructure—creating an efficient response to unpredictable industry and customer demands.
Mapping/ablation catheters are used to treat atrial fibrillation. Current mechanical catheters can be difficult and time consuming to operate and hinder reproducible and consistent ablation. This article describes new electroactive polymer (EAP) technology that provides the basis for the development of electronically controlled steerable actuators. The EAP technology will enable standard catheter platforms to incorporate advanced micro-steerability, reduced procedure times and advanced automation capabilities. The innovative electrically steered catheters will benefit millions of Americans who are suffering from atrial fibrillation.
Diagnostic laboratories have an important role to play in ensuring patient safety. The chance for human errors and omissions is high in specimen collection, testing, and blood transfusions because these processes have so many manual steps. Automating specimen collection and transfusion management can create closed loop systems that virtually eliminate errors in labeling of specimens, incorrect patient draws, and incorrect transfusions.
Computed tomography (CT) has come a long way since its public inception in 1972. The rapid improvement of computer technology and the increasing capabilities of CT scans have gone hand in hand. CT scans that used to take hours are now being completed in seconds. This increase in capabilities has led to CT scans being used more often and in more ways than ever before. The use of CT in the medical nondestructive testing (NDT) field is one example that has grown tremendously in the past few years, and it is also the focus of the following article.
As the medical industry evolves and technology in medical devices becomes more advanced, it is necessary to protect those ideas. Medical device engineers and manufacturers often look to the physician to improve such devices and make related...
In the last few months, the medical device community has found itself amidst a political fallout that threatens any forthcoming economic improvements. To fund the healthcare reforms set forth by Congress, medical device manufacturers will soon be charged a 2.3 percent excise tax on the sale of most medical devices.