Medical device manufacturers have traditionally used paper-based methods to guide and track the execution of manufacturing processes, including paper device history records (DHR). But industry leaders have made strides in adopting automated processes. However, now they are facing challenges in scaling these systems, especially across globally distributed production facilities and when contracting with manufacturing partners. Gathering, standardizing, and contextualizing real-time manufacturing data across all participants in the supply chain can enable automated validation of product equipment and processes.
One of many crucial steps a single-use medical device takes on its journey from concept to commercial product is sterilization. Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living microbes from medical devices; however, manufacturers must take care to control and minimize ethylene oxide residuals remaining in devices after sterilization has taken place.
A Platform Approach to Securing Your Medical Devices
As a result of the increasing sophistication of the medical device development process and the increasing demand for an ever-narrowing margin of error, medical device companies small and large are turning to medical device development organizations to outsource their product development. 
LSR is great for medical applications, but is the tooling worth the trouble?
Clinical chemistry analyzers often utilize machine vision technology to increase automation, maximize throughput, improve user safety from biohazards, and diminish the risk of cross-contamination. This paper identifies key issues to consider during the pre-sorting process within clinical analyzer applications and current trends using machine vision technology within these applications.
As the landscape for medical device development continues to transform, medical device developers are recognizing a serious need to rethink their approach to product development. This means moving from a traditionally siloed and nearsighted approach to one with considerable foresight and vision.
Great products are composed of great individual components that are increasingly assessed from every possible physical perspective. As failure is not an option for medical devices, business success calls for the optimization of every part. Eventually, the components are assembled, powered, and controlled as an integrated system: they must therefore be designed as a system to meet peak performance requirements and regulatory safety standards. Building and testing integrated product systems and subsystems can be costly and may not identify optimal configurations and/or potential shortcomings.
Clippard’s new Isolation Valves 101 white paper explores the characteristics of three main types of valves commonly used to isolate media—rocker isolation valves, diaphragm isolation valves, and pinch valves. Read about the advantages and disadvantages of each and which valve types are best for particular types of applications.
The global market for auto injectors—such as EpiPens—is predicted to skyrocket over the next decade. Significant savings in manufacturing can be accrued by designing a single auto-injector to accommodate interchangeable springs for medications of different viscosities.